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Monday, September 19, 2016

Procrit

Generic Name: epoetin alfa (Injection route)

e-POE-e-tin AL-fa

Injection route(Solution)

Erythropoiesis-stimulating agents (ESAs) increase the risks for death, myocardial infarction, stroke, and other serious cardiovascular events. In patients with chronic kidney disease (CKD), patients are at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of 11 g/dL and above in clinical studies. No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks. Therefore, in patients with CKD, use at the lowest sufficient dose is recommended. In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies. In patients with cancer, use the lowest ESA dose needed to avoid RBC transfusions and serious cardiovascular and thromboembolic reactions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program (www.esa-apprise.com or 1-866-284-8089) to prescribe and/or dispense epoetin alfa to patients with cancer. Patients receiving myelosuppressive chemotherapy should not be treated with ESAs when the anticipated outcome is cure. Deep venous thrombosis prophylaxis should be considered when epoetin alfa is used preoperatively .

Commonly used brand name(s)

In the U.S.

Epogen

Procrit

Available Dosage Forms:

Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Erythropoietin

Uses For Procrit

Epoetin injection is a man-made version of human erythropoietin (EPO). EPO is produced naturally in the body, mostly by the kidneys. It stimulates the bone marrow to produce red blood cells. If the body does not produce enough EPO, severe anemia can occur. This often occurs in patients whose kidneys are not working properly. Epoetin is used to treat severe anemia in patients with kidney disease.

Epoetin may also be used to prevent or treat anemia that is caused by surgery or medicines that are used for other conditions, such as AIDS or cancer.

This medicine is available only with your doctor's prescription.

Before Using Procrit

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of epoetin injection in children over the age of one month.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of epoetin injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of epoetin alfa

This section provides information on the proper use of a number of products that contain epoetin alfa. It may not be specific to Procrit. Please read with care.

Epoetin injection is usually given by a doctor after a kidney dialysis treatment or in a hospital or clinic. It may be given as a shot under your skin or into a vein. However, medicines given by injection are sometimes used at home. If you will be using epoetin at home, your doctor will teach you how the injections are to be given. You will also have a chance to practice giving them. Be sure that you understand exactly how the medicine is prepared and injected.

Cancer patients who use epoetin injection must read about and become familiar with the ESA APPRISE Oncology Program. Your doctor will explain the program to you and your child. Make sure you understand how the program works and talk to your doctor if you have any questions.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using this medicine at home:

Store the vials (glass containers) in the refrigerator and protect them from bright light. Do not allow the vials to freeze.

Do not shake the vial before you use it.

When you are ready for a dose, carefully look at the medicine in the vial. If the medicine has changed color, or if you see specks (particles) floating in it, do not use it.

Use a new needle and syringe each time you inject your medicine.

You will be shown the body areas where this shot can be given.

If you use the vials that have one dose, you might not use all of the medicine in each vial. Use each vial only one time and throw any extra medicine away. Do not save an opened vial.

If you use the vial that has enough medicine for more than one dose, put it back in the refrigerator after your dose. Write the date on the vial that you first used it and throw away any unused medicine after 21 days.

Throw away used needles in a hard closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- For anemia from chronic kidney failure:
  - Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 to 100 units per kilogram (kg) injected into a vein or under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
  - Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 units per kg injected into a vein or under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
  - Infants younger than 1 month of age—Use and dose must be determined by your doctor.
- For anemia from cancer chemotherapy:
  - Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 150 units per kilogram (kg) injected under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
  - Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 600 units per kg injected into a vein once a week. Your doctor may need to adjust the dose to determine the best dose for you.
  - Infants younger than 1 month of age—Use and dose must be determined by your doctor.
- For anemia from HIV therapy:
  - Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 100 units per kilogram (kg) injected into a vein or under the skin three times a week for 8 weeks. Your doctor may need to adjust the dose to determine the best dose for you.
  - Children and teenagers 8 months to 17 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 units per kg injected into a vein or under the skin two or three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
  - Infants younger than 8 months of age—Use and dose must be determined by your doctor.
- For anemia from surgery:
  - Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 300 units per kilogram (kg) injected under the skin for 10 days before the surgery, on the day of the surgery, and for 4 days after surgery.
  - Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor.
  - Infants younger than 1 month of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from bright light. Keep your medicine in the original package until you are ready to use it.

Precautions While Using Procrit

It is very important that your doctor check the blood of you or your child on a regular basis while you are using this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away. .

Do not use this medicine if you or your child have had an allergic reaction to albumin or products derived from human or animal cells.

This medicine contains benzyl alcohol which may cause serious reactions to newborn or premature infants. Discuss this with your doctor if you are concerned.

Epoetin sometimes causes convulsions (seizures), especially during the first 90 days of treatment. During this time, it is best to avoid driving, operating heavy machinery, or other activities that could cause serious injury if a seizure occurs while you are performing them.

People with severe anemia usually feel very tired and sick. When epoetin begins to work, usually in about 6 weeks, most people start to feel better. Some people are able to be more active. However, epoetin only corrects anemia. It has no effect on kidney disease or any other medical problem that needs regular medical attention. Therefore, even if you or your child are feeling much better, it is very important that you do not miss any appointments with your doctor or any dialysis treatments. .

This medicine may increase your risk of having serious heart and blood vessel problems, such as congestive heart failure, heart attacks, or stroke. Check with your doctor right away if you or your child start having chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking. .

This medicine may increase your risk of having blood clots, especially in patients who use epoetin alfa before a major surgery. Check with your doctor right away if you or your child have chest pain; trouble with breathing; a sudden problem with vision; or pain, redness, or swelling in your arms or legs while using this medicine.

This medicine may cause blood clots to form in the access port (A-V shunt) for patients with chronic kidney disease who receive dialysis treatments. This would cause the access port to stop working. Tell your doctor right away if you or your child see blood clots forming in the access port.

When used in patients with certain types of cancer (e.g., breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the cancer for some patients. If you or your child are concerned about this, talk with your doctor.

Epoetin is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Many people with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by epoetin treatment) may need to be on a special diet and/or to take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you or your child follow your special diet and take your medicines regularly, even if you are feeling better.

This medicine may cause serious allergic reactions. Stop using this medicine and call your doctor right away if you or your child have a rash; itching; dizziness, lightheadedness, or fainting; shortness of breath; trouble breathing; or any swelling of your hands, face, or mouth after you receive the medicine.

In addition to epoetin, your body needs iron to make red blood cells. Your doctor may direct you or your child to take iron supplements and vitamins (e.g., folic acid or vitamin B12) that help the iron work better. You may need to eat more foods that contain iron, folic acid, or vitamin B12, such as eggs, certain cereals, meats, and vegetables. Do not change your diet or take extra supplements before talking to your doctor. Be sure to follow your doctor's orders carefully, because epoetin will not work properly if there is not enough iron in your body.

Procrit Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest pain

fever

headache

increased blood pressure

shortness of breath

swelling of the face, fingers, ankles, feet, or lower legs

weight gain

Less common

Anxiety

blurred vision

change in skin color

change in vision

convulsions (seizures)

cough

dizziness or lightheadedness

double vision

fainting

fast heartbeat

migraine headache

nausea

pain or discomfort in the arms, jaw, back, or neck

pain, tenderness, or swelling of the foot or leg

pains in the chest, groin, or legs, especially calves of the legs

pale skin

partial or complete loss of vision in the eye

severe headaches of sudden onset

skin rash or hives

slurred speech

sore throat

sudden and severe inability to speak

sudden loss of coordination

sudden vision changes

sweating

temporary blindness

tenderness, pain, swelling, warmth, or skin discoloration at the injection site

unusual bleeding or bruising

unusual tiredness or weakness

vision problems

vomiting

weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain and swelling

bone or joint pain, muscle aches, chills, shivering, or sweating

constipation

diarrhea

dizziness

general feeling of tiredness or weakness

heartburn or belching, acid or sour stomach

inability to sleep

itching or stinging at the injection site

loss of strength or energy

muscle pain or weakness

skin pain

stomach discomfort, upset, or pain

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Procrit side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Procrit resources

Procrit Side Effects (in more detail)
Procrit Use in Pregnancy & Breastfeeding
Procrit Drug Interactions
Procrit Support Group
1 Review for Procrit - Add your own review/rating

Procrit Prescribing Information (FDA)

Procrit MedFacts Consumer Leaflet (Wolters Kluwer)

Procrit Consumer Overview

Epoetin Alfa Monograph (AHFS DI)

Epogen Consumer Overview

Epogen Prescribing Information (FDA)

Compare Procrit with other medications

Anemia
Anemia Associated with Chronic Renal Failure
Anemia Prior to Surgery
Anemia, Chemotherapy Induced
Anemia, Drug Induced

Profilnine SD

Generic Name: factor ix complex (Intravenous route, Injection route)

FAK-tor NINE

Commonly used brand name(s)

In the U.S.

Alphanine SD

Bebulin

Bebulin VH

Benefix

Mononine

Profilnine SD

Proplex T

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antihemophilic Agent

Uses For Profilnine SD

Factor IX is a protein produced naturally in the body. It helps the blood form clots to stop bleeding. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. This is a condition in which the body does not make enough factor IX. If you do not have enough factor IX and you become injured, your blood will not form clots as it should, and you may bleed into and damage your muscles and joints.

Injections of one form of factor IX, called factor IX complex, also are used to treat certain people with hemophilia A. In hemophilia A, sometimes called classical hemophilia, the body does not make enough factor VIII, and, just as in hemophilia B, the blood cannot form clots as it should. Injections of factor IX complex may be used in patients in whom the medicine used to treat hemophilia A is no longer effective. Injections of factor IX complex also may be used for other conditions as determined by your doctor.

The factor IX product that your doctor will give you is obtained naturally from human blood or artificially by a man-made process. Factor IX obtained from human blood has been treated and is not likely to contain harmful viruses such as hepatitis B virus, hepatitis C (non-A, non-B) virus, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made factor IX product does not contain these viruses.

Factor IX is available only with your doctor's prescription.

Before Using Profilnine SD

Allergies

Pediatric

Blood clots may be especially likely to occur in premature and newborn babies, who are usually more sensitive than adults to the effects of injections of factor IX.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of factor ix complex

This section provides information on the proper use of a number of products that contain factor ix complex. It may not be specific to Profilnine SD. Please read with care.

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.

To prepare this medicine:

Take the dry medicine and the liquid (diluent) out of the refrigerator and bring them to room temperature, as directed by your doctor.

When injecting the liquid (diluent) into the dry medicine, aim the stream of liquid (diluent) against the wall of the container of dry medicine to prevent foaming.

Swirl the container gently to dissolve the medicine. Do not shake the container.

Use this medicine right away. It should not be kept longer than 3 hours after it has been prepared.

A plastic disposable syringe and filter needle must be used with this medicine. The medicine may stick to the inside of a glass syringe, and you may not receive a full dose.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.

Dosing

The condition for which you are using this medicine.

Your body weight.

The amount of factor IX your body is able to make.

How much, how often, and where in your body you are bleeding.

Whether or not your body has built up a defense (antibody) against this medicine.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Some factor IX products must be stored in the refrigerator, and some may be kept at room temperature for short periods of time. Store this medicine as directed by your doctor or the manufacturer.

Precautions While Using Profilnine SD

If you were recently diagnosed with hemophilia B, you should receive hepatitis A and hepatitis B vaccines to reduce even further your risk of getting hepatitis A or hepatitis B from factor IX products.

After a while, your body may build up a defense (antibody) against this medicine. Tell your doctor if this medicine seems to be less effective than usual.

It is recommended that you carry identification stating that you have hemophilia A or hemophilia B. If you have any questions about what kind of identification to carry, check with your health care professional.

Profilnine SD Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

Changes in facial skin color

fast or irregular breathing

puffiness or swelling of the eyelids or around the eyes

shortness of breath, troubled breathing, tightness in chest, and/or wheezing

skin rash, hives, and/or itching

Check with your doctor immediately if any of the following side effects occur:

More common

Bluish coloring (especially of the hands and feet)

convulsions

dizziness or lightheadedness when getting up from a lying or sitting position

increased heart rate

large blue or purplish patches in the skin (at places of injection)

nausea or vomiting

pains in chest, groin, or legs (especially calves)

persistent bleeding from puncture sites, gums, or inner linings of the nose and/or mouth, or blood in the stool or urine

severe pain or pressure in the chest and/or the neck, back, or left arm

severe, sudden headache

shortness of breath or fast breathing

sudden loss of coordination

sudden and unexplained slurred speech, vision changes, and/or weakness or numbness in arm or leg

Check with your doctor immediately if any of the following side effects occur:

Less common

Burning or stinging at place of injection

changes in blood pressure or pulse rate

chills

drowsiness

fever

headache

nausea or vomiting

redness of face

shortness of breath

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Profilnine SD side effects (in more detail)

More Profilnine SD resources

Profilnine SD Side Effects (in more detail)
Profilnine SD Use in Pregnancy & Breastfeeding
Profilnine SD Drug Interactions
Profilnine SD Support Group
0 Reviews for Profilnine SD - Add your own review/rating

Profilnine SD Prescribing Information (FDA)

Profilnine SD Concise Consumer Information (Cerner Multum)

Profilnine SD MedFacts Consumer Leaflet (Wolters Kluwer)

Bebulin VH Prescribing Information (FDA)

Compare Profilnine SD with other medications

Factor IX Deficiency
Factor VII Deficiency
Hemophilia A with Inhibitors
Hemophilia B

Phenylephrine/Chlorpheniramine/Dextromethorphan

Pronunciation: FEN-il-EF-rin/KLOR-fen-IR-a-meen/DEX-troe-meth-OR-fan
Generic Name: Phenylephrine/Chlorpheniramine/Dextromethorphan
Brand Name: Maxichlor PEH DM

Phenylephrine/Chlorpheniramine/Dextromethorphan is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Phenylephrine/Chlorpheniramine/Dextromethorphan is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Phenylephrine/Chlorpheniramine/Dextromethorphan if:

you are allergic to any ingredient in Phenylephrine/Chlorpheniramine/Dextromethorphan

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, stomach ulcer, or narrow-angle glaucoma

you are unable to urinate or are having an asthma attack

you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Phenylephrine/Chlorpheniramine/Dextromethorphan:

Some medical conditions may interact with Phenylephrine/Chlorpheniramine/Dextromethorphan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; sleep apnea; mental or mood problems (eg, depression); or an overactive thyroid

if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

if you have a history of alcohol abuse, are in poor health, are very overweight, or are confined to a bed

Some MEDICINES MAY INTERACT with Phenylephrine/Chlorpheniramine/Dextromethorphan. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Phenylephrine/Chlorpheniramine/Dextromethorphan's side effects

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Phenylephrine/Chlorpheniramine/Dextromethorphan

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Phenylephrine/Chlorpheniramine/Dextromethorphan

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine/Chlorpheniramine/Dextromethorphan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Phenylephrine/Chlorpheniramine/Dextromethorphan:

Use Phenylephrine/Chlorpheniramine/Dextromethorphan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Phenylephrine/Chlorpheniramine/Dextromethorphan by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Take Phenylephrine/Chlorpheniramine/Dextromethorphan with a full glass of water (8 oz/240 mL).

If you miss a dose of Phenylephrine/Chlorpheniramine/Dextromethorphan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenylephrine/Chlorpheniramine/Dextromethorphan.

Important safety information:

Phenylephrine/Chlorpheniramine/Dextromethorphan may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Phenylephrine/Chlorpheniramine/Dextromethorphan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Phenylephrine/Chlorpheniramine/Dextromethorphan; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Do not take diet or appetite control medicines while you take Phenylephrine/Chlorpheniramine/Dextromethorphan without checking with your doctor.

Phenylephrine/Chlorpheniramine/Dextromethorphan has pseudoephedrine, chlorpheniramine, and dextromethorphan in it. Before you start any new medicine, check the label to see if it has pseudoephedrine, chlorpheniramine, or dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not use Phenylephrine/Chlorpheniramine/Dextromethorphan for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

Contact your doctor if you have a sore throat that is severe, lasts more than 2 days, or occurs with fever, rash, headache, nausea, or vomiting.

Tell your doctor if you have a fever that lasts more than 3 days or becomes worse.

Contact your doctor if you have a cough that lasts more than 7 days or occurs with fever, rash, or persistent headache.

Phenylephrine/Chlorpheniramine/Dextromethorphan may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Phenylephrine/Chlorpheniramine/Dextromethorphan. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Phenylephrine/Chlorpheniramine/Dextromethorphan may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Phenylephrine/Chlorpheniramine/Dextromethorphan for a few days before the tests.

Phenylephrine/Chlorpheniramine/Dextromethorphan may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Phenylephrine/Chlorpheniramine/Dextromethorphan.

Tell your doctor or dentist that you take Phenylephrine/Chlorpheniramine/Dextromethorphan before you receive any medical or dental care, emergency care, or surgery.

Use Phenylephrine/Chlorpheniramine/Dextromethorphan with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.

Caution is advised when using Phenylephrine/Chlorpheniramine/Dextromethorphan in CHILDREN; they may be more sensitive to its effects, especially excitability.

Phenylephrine/Chlorpheniramine/Dextromethorphan should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phenylephrine/Chlorpheniramine/Dextromethorphan while you are pregnant. It is not known if Phenylephrine/Chlorpheniramine/Dextromethorphan is found in breast milk. Do not breast-feed while taking Phenylephrine/Chlorpheniramine/Dextromethorphan.

When used for long periods of time or at high doses, Phenylephrine/Chlorpheniramine/Dextromethorphan may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Phenylephrine/Chlorpheniramine/Dextromethorphan stops working well. Do not take more than prescribed.

Some people who use Phenylephrine/Chlorpheniramine/Dextromethorphan for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Phenylephrine/Chlorpheniramine/Dextromethorphan suddenly, you may have WITHDRAWAL symptoms. These may include mental or mood changes (eg, depression).

Possible side effects of Phenylephrine/Chlorpheniramine/Dextromethorphan:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; increased sweating; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest tightness; clumsiness or unsteadiness; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or sore throat; flushing or redness of the face; hallucinations; mental or mood changes; numbness or tingling; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; vision problems (eg, double vision, severe or persistent blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Phenylephrine/Chlorpheniramine/Dextromethorphan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusual eye movements; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Phenylephrine/Chlorpheniramine/Dextromethorphan:

Store Phenylephrine/Chlorpheniramine/Dextromethorphan at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine/Chlorpheniramine/Dextromethorphan out of the reach of children and away from pets.

General information:

If you have any questions about Phenylephrine/Chlorpheniramine/Dextromethorphan, please talk with your doctor, pharmacist, or other health care provider.

Phenylephrine/Chlorpheniramine/Dextromethorphan is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Phenylephrine/Chlorpheniramine/Dextromethorphan. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Phenylephrine/Chlorpheniramine/Dextromethorphan resources

Phenylephrine/Chlorpheniramine/Dextromethorphan Side Effects (in more detail)
Phenylephrine/Chlorpheniramine/Dextromethorphan Use in Pregnancy & Breastfeeding
Phenylephrine/Chlorpheniramine/Dextromethorphan Drug Interactions
Phenylephrine/Chlorpheniramine/Dextromethorphan Support Group
6 Reviews for Phenylephrine/Chlorpheniramine/Dextromethorphan - Add your own review/rating

Compare Phenylephrine/Chlorpheniramine/Dextromethorphan with other medications

Cough and Nasal Congestion

Prevacid SoluTab

Generic Name: lansoprazole (Oral route)

lan-SOE-pra-zole

Commonly used brand name(s)

In the U.S.

Prevacid

Prevacid SoluTab

Available Dosage Forms:

Tablet Disintegrating, Delayed Release

Capsule, Delayed Release

Packet

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

Uses For Prevacid SoluTab

Lansoprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. Sometimes lansoprazole is used in combination with antibiotics (e.g., amoxicillin, clarithromycin) to treat ulcers associated with an infection caused by H. pylori bacteria.

Lansoprazole is also used to treat Zollinger-Ellison syndrome (ZES), which is a condition where the stomach produces too much acid.

Lansoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Prevacid SoluTab

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lansoprazole to treat GERD and erosive esophagitis in children 1 to 17 years of age. Safety and efficacy have not been established for children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lansoprazole in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atazanavir

Citalopram

Dasatinib

Delavirdine

Erlotinib

Mycophenolate Mofetil

Nelfinavir

Nilotinib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Calcium Carbonate

Cranberry

Dicumarol

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Phenprocoumon

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of lansoprazole

This section provides information on the proper use of a number of products that contain lansoprazole. It may not be specific to Prevacid SoluTab. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you are using this medicine without a prescription, follow the instructions on the medicine label.

Take this medicine before a meal and for the full time of treatment, even if you begin to feel better after a few days.

If you are taking this medicine to treat an ulcer that is associated with an H. pylori infection, take it together with the antibiotics (e.g., amoxicillin, clarithromycin) at the same time of day.

To use the capsule:

Swallow the capsule whole. Do not break, crush, or chew it.

If the capsule cannot be swallowed, open it and sprinkle the contents on one tablespoonful of applesauce, Ensure® pudding, cottage cheese, yogurt, or strained pears. Swallow the mixture right away. Do not chew or crush the granules.

The contents of the capsule can also be mixed with 2 ounces (1/4 cup or 60 mL) of apple juice, orange juice, or tomato juice. After mixing, drink and swallow the mixture right away. Do not chew or crush the granules. Refill the cup 2 more times with juice and drink the liquid to make sure all of the medicine is taken.

To use the capsule with a nasogastric (NG) tube:

Open the capsule and mix the contents with 40 mL of apple juice. Do not use any other liquids.

Inject or pour the mixture into the nasogastric tube.

Flush the tube with more apple juice to rinse all of the medicine from the tube into the stomach.

To use the orally disintegrating tablet:

Make sure your hands are dry before you handle the tablet.

Do not crush, chew, break, or cut the tablet.

Place the tablet on the tongue, with or without water, and allow it to dissolve into particles. Swallow the particles right away.

To use the orally disintegrating tablet with an oral syringe:

Make sure your hands are dry before you handle the tablet.

Do not crush, break, or cut the tablet.

For the 15 mg tablet: Place it in the oral syringe and add 4 mL of water.

For the 30 mg tablet: Place it in the oral syringe and add 10 mL of water.

Shake the syringe gently until the tablet dissolves and is mixed well.

Give the mixture within 15 minutes.

Refill the syringe with 2 mL (15 mg tablet) or 5 mL (30 mg tablet) of water and shake it gently. Give the mixture to make sure all of the medicine is taken.

To use the orally disintegrating tablet with a nasogastric (NG) tube:

Make sure your hands are dry before you handle the tablet.

Do not crush, break, or cut the tablet.

For the 15 mg tablet: Place it in the syringe and add 4 mL of water.

For the 30 mg tablet: Place it in the syringe and add 10 mL of water.

Shake the syringe gently until the tablet dissolves and is mixed well.

Inject or pour the mixture into the nasogastric tube within 15 minutes.

Refill the syringe with 5 mL of water and shake it gently. Flush the tube with the water to rinse all of the medicine from the tube into the stomach.

Dosing

For oral dosage forms (capsules or orally disintegrating tablets):
- To treat duodenal ulcers:
  - Adults—15 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- To treat duodenal ulcers with H. pylori infection:
  - Adults—30 milligrams (mg) before meals 2 or 3 times a day. The dose is usually taken together with amoxicillin or clarithromycin plus amoxicillin. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- To treat erosive esophagitis:
  - Adults—15 to 30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Teenagers and children 12 years of age—30 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children 1 to 11 years of age and weighing over 30 kg—30 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children 1 to 11 years of age and weighing 30 kg or less—15 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children younger than 1 year of age—Use and dose must be determined by your doctor.
- To treat gastric ulcers:
  - Adults—15 to 30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- To treat gastroesophageal reflux disease (GERD):
  - Adults, teenagers, and children 12 years of age—15 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Children 1 to 11 years of age and weighing over 30 kg—30 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children 1 to 11 years of age and weighing 30 kg or less—15 mg once a day before a meal. Your doctor may adjust your dose if needed.
  - Children younger than 1 year of age—Use and dose must be determined by your doctor.
- To treat Zollinger-Ellison syndrome (ZES):
  - Adults—60 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Prevacid SoluTab

It is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, discuss this with your doctor.

Lansoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you have osteoporosis, if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Prevacid SoluTab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea

skin rash or itching

Less common

Abdominal or stomach pain

increased or decreased appetite

joint pain

nausea

vomiting

Rare

Anxiety

cold or flu-like symptoms

constipation

increased cough

mental depression

muscle pain

rectal bleeding

unusual bleeding or bruising

Incidence not known

Abdominal or stomach tenderness

back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bloating

bloody, black, or tarry stools

change in mental status

chest pain

chills

clay colored stools

constipation

cough or hoarseness

dark or bloody urine

difficulty with swallowing

drowsiness

fast heartbeat

fever

general body swelling

high fever

hives

indigestion

loss of appetite

lower back or side pain

mood or mental changes

muscle spasms (tetany) or twitching seizures

nosebleeds

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

red skin lesions, often with a purple center

seizures

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the feet or lower legs

swollen or painful glands

tightness in the chest

trembling

unusual tiredness or weakness

wheezing

yellowing of the eyes or skin

More common

Dizziness

headache

Less common

Bleeding, blistering, burning, coldness, or discoloration of the skin

mild nausea

Rare

Acid or sour stomach

bad, unusual or unpleasant (after) taste

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

feeling faint, dizzy, or lightheaded

feeling of heat or warmth

flushing or redness of the skin, especially on the face and neck

heartburn

indigestion

mild diarrhea

mild headache

mild vomiting

stomach discomfort, upset, or pain

sweating

Incidence not known

Decrease in passing urine (dribbling)

decrease in the frequency of urination

decrease in urine volume

difficulty with speaking

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Prevacid SoluTab side effects (in more detail)

More Prevacid SoluTab resources

Prevacid SoluTab Side Effects (in more detail)
Prevacid SoluTab Use in Pregnancy & Breastfeeding
Drug Images
Prevacid SoluTab Drug Interactions
Prevacid SoluTab Support Group
0 Reviews for Prevacid SoluTab - Add your own review/rating

Prevacid SoluTab Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Lansoprazole Professional Patient Advice (Wolters Kluwer)

Lansoprazole Prescribing Information (FDA)

Lansoprazole MedFacts Consumer Leaflet (Wolters Kluwer)

Lansoprazole Monograph (AHFS DI)

Prevacid Prescribing Information (FDA)

Prevacid Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Prevacid Consumer Overview

Compare Prevacid SoluTab with other medications

Aspiration Pneumonia
Barrett's Esophagus
Duodenal Ulcer
Duodenal Ulcer Prophylaxis
Erosive Esophagitis
GERD
Helicobacter Pylori Infection
Multiple Endocrine Adenomas
NSAID-Induced Gastric Ulcer
NSAID-Induced Ulcer Prophylaxis
Stomach Ulcer
Systemic Mastocytosis
Zollinger-Ellison Syndrome

Pedia-Lax Liquid rectal

Generic Name: glycerin (rectal) (GLISS er in)

Brand Names: Colace Glycerin Suppositories, Fleet Babylax, Fleet Glycerin Suppositories Adult, Fleet Glycerin Suppositories Pediatric, Glycerin Suppositories Maximum Strength, Pedia-Lax Liquid, Sani-Supp

What is Pedia-Lax Liquid (glycerin (rectal))?

Glycerin rectal is used as a laxative. It works by causing the intestines to hold more water, which softens the stool.

Glycerin rectal is used to treat constipation or to cleanse the bowel before a rectal exam or other intestinal procedure.

Glycerin rectal may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Pedia-Lax Liquid (glycerin (rectal))?

Before using glycerin rectal, tell your doctor if you have nausea, vomiting, stomach pain, rectal bleeding, a change in bowel habits that has lasted for 2 weeks or longer, toxic megacolon, or if you have used another laxative for longer than 1 week.

Do not take glycerin rectal by mouth. It is for use only in your rectum. Call your doctor if this medication does not cause you to have a bowel movement within 1 hour after use. Do not use glycerin rectal more than once in a 24-hour period. Do not use other laxatives in combination with glycerin rectal unless your doctor has told you to. Stop using glycerin rectal and call your doctor at once if you have severe stomach pain or cramping, bloody diarrhea, or severe rectal pain, bleeding, or irritation.

What should I discuss with my health care provider before using Pedia-Lax Liquid (glycerin (rectal))?

You should not use this medication if you are allergic to glycerin.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using glycerin rectal, tell your doctor if you have:

nausea, vomiting, and stomach pain;

rectal bleeding;

a change in bowel habits that has lasted for 2 weeks or longer;

intestinal blockage;

ulcerative colitis, toxic megacolon; or

if you have used another laxative for longer than 1 week.

It is not known whether glycerin rectal is harmful to an unborn baby when used during pregnancy. Before using this medication, tell your doctor if you are pregnant. Do not use this medication in a child younger than 2 years old. Seek your doctor's advice when using glycerin rectal in a child who is 2 to 5 years old.

How should I use Pedia-Lax Liquid (glycerin (rectal))?

Do not take glycerin rectal by mouth. It is for use only in your rectum.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Do not use glycerin rectal more than once in a 24-hour period.

This medication comes with patient instructions for using either the rectal suppository or the rectal enema. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Try to empty your bowel and bladder just before using the glycerin suppository or enema.

Remove the outer wrapper from the rectal suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

You may wet the suppository first with a small amount of water to make it easier to insert. Gently insert the suppository into the rectum, pointed tip first. The suppository will begin to melt once inserted and you should feel little or no discomfort while holding it in.

You should have a bowel movement within 15 to 60 minutes after using the suppository.

To use the rectal enema or liquid suppository, remove the protective cap and gently insert the tip of the applicator or bulb syringe into the rectum. Do not force the applicator into the rectum or injury could result. Slowly squeeze the bottle to place the medicine into the rectum. You do not need to empty the bottle completely and there may be a small amount of liquid left in the bottle after use.

For best results after using glycerin rectal, stay lying down until you feel the urge to have a bowel movement.

Call your doctor if this medication does not cause you to have a bowel movement within 1 hour after use. Store the rectal enema at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate them unless directed on the medicine label.

What happens if I miss a dose?

Since this medication is usually given only once as needed, you will not be on a dosing schedule. Do not use glycerin rectal more than once in a 24-hour period.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

If you use glycerin rectal as directed on the medicine label, an overdose is not likely to occur.

What should I avoid while using Pedia-Lax Liquid (glycerin (rectal))?

Avoid using other laxatives in combination with glycerin rectal unless your doctor has told you to.

Pedia-Lax Liquid (glycerin (rectal)) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using glycerin rectal and call your doctor at once if you have a serious side effect such as:

severe stomach pain or cramping

bloody diarrhea; or

severe rectal pain, bleeding, or irritation.

Less serious side effects may include:

diarrhea;

nausea or stomach discomfort; or

mild rectal pain or burning.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pedia-Lax Liquid (glycerin (rectal))?

There may be other drugs that can interact with glycerin rectal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Pedia-Lax Liquid resources

Pedia-Lax Liquid Side Effects (in more detail)
Pedia-Lax Liquid Use in Pregnancy & Breastfeeding
Pedia-Lax Liquid Drug Interactions
0 Reviews for Pedia-Lax - Add your own review/rating

Compare Pedia-Lax Liquid with other medications

Constipation

Where can I get more information?

Your pharmacist can provide more information about glycerin rectal.

See also: Pedia-Lax side effects (in more detail)

Previcox Chewable Tablets

Dosage Form: FOR ANIMAL USE ONLY
PREVICOX® (firocoxib) Chewable Tablets

For oral use in dogs only.

Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

PREVICOX (firocoxib) belongs to the coxib class of non-narcotic, non-steroidal anti-inflammatory drugs. Firocoxib is a white crystalline compound described chemically as 3-(cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)- 5,5-dimethylfuranone. The empirical formula is C17H20O5S, and the molecular weight is 336.4. The structural formula is shown below:

Pharmacokinetics

The absolute bioavailability of PREVICOX (firocoxib) is approximately 38% when administered as a 5 mg/kg oral dose to fasted adult dogs. Firocoxib is rapidly cleared from the blood via hepatic metabolism and fecal excretion (CLsystemic = ~0.4 L/hr/kg). Despite a high level of plasma protein binding (96%), firocoxib exhibits a large volume of distribution (Vdλ of total drug = ~4.6 L/kg) and a terminal elimination half life of 7.8 hours (%CV = 30%). The oral drug absorption process is highly variable among subjects. Co-administration of PREVICOX with food delays drug absorption (Tmax from 1 to 5 hours) and decreases peak concentrations (Cmax from 1.3 to 0.9 mcg/mL). However, food does not affect the overall oral bioavailability at the recommended dose.

Indications

PREVICOX (firocoxib) Chewable Tablets are indicated for the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.

Dosage and Administration

Always provide the Client Information Sheet with prescription. Carefully consider the potential benefits and risks of PREVICOX and other treatment options before deciding to use PREVICOX. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage of PREVICOX (firocoxib) for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. The dogs can be treated with PREVICOX approximately two hours prior to surgery. The tablets are scored and dosage should be calculated in half tablet increments. Previcox Chewable Tablets can be administered with or without food.

Contraindications

Dogs with known hypersensitivity to firocoxib should not receive PREVICOX.

Warnings

Not for use in humans. Keep this and all medications out of the reach of children. Consult a physician in case of accidental ingestion by humans.

For oral use in dogs only. Use of this product at doses above the recommended 2.27 mg/lb (5.0 mg/kg) in puppies less than seven months of age has been associated with serious adverse reactions, including death (see Animal Safety). Due to tablet sizes and scoring, dogs weighing less than 12.5 lb (5.7 kg) cannot be accurately dosed.

All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory testing to establish hematological and serum baseline data is recommended prior to and periodically during administration of any NSAID. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions and Animal Safety) and be given a Client Information Sheet about Previcox Chewable Tablets.

For technical assistance or to report suspected adverse events, call 1-877-217-3543.

Precautions

This product cannot be accurately dosed in dogs less than 12.5 pounds in body weight.

Consider appropriate washout times when switching from one NSAID to another or when switching from corticosteroid use to NSAID use.

As a class, cyclooxygenase inhibitory NSAIDs may be associated with renal, gastrointestinal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Dogs that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached and monitored. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since NSAIDS possess the potential to produce gastrointestinal ulceration and/or gastrointestinal perforation, concomitant use of Previcox Chewable Tablets with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. The concomitant use of protein bound drugs with Previcox Chewable Tablets has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant, and behavioral medications. The influence of concomitant drugs that may inhibit the metabolism of Previcox Chewable Tablets has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

If additional pain medication is needed after the daily dose of PREVICOX, a non-NSAID class of analgesic may be necessary.

Appropriate monitoring procedures should be employed during all surgical procedures. Anesthetic drugs may affect renal perfusion, approach concomitant use of anesthetics and NSAIDs cautiously. The use of parenteral fluids during surgery should be considered to decrease potential renal complications when using NSAIDs perioperatively.

The safe use of Previcox Chewable Tablets in pregnant, lactating or breeding dogs has not been evaluated.

Adverse Reactions

Osteoarthritis

In controlled field studies, 128 dogs (ages 11 months to 15 years) were evaluated for safety when given Previcox Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally once daily for 30 days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed adverse reactions during the study.

Adverse Reactions Seen in U.S. Field Studies
Adverse Reactions	Previcox n=128	Active Control n=121
Vomiting	5	8
Diarrhea	1	10
Decreased Appetite or Anorexia	3	3
Lethargy	1	3
Pain	2	1
Somnolence	1	1
Hyperactivity	1	0

PREVICOX (firocoxib) Chewable Tablets were safely used during field studies concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics.

Soft-tissue Surgery

In controlled field studies evaluating soft-tissue postoperative pain and inflammation, 258 dogs (ages 10.5 weeks to 16 years) were evaluated for safety when given Previcox Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally approximately 2 hours prior to surgery and once daily thereafter for up to two days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed reactions during the study.

Adverse Reactions Seen in the Soft-tissure Surgery Postoperative Pain Field Studies
Adverse Reactions	Firocoxib Group n=127	Control Group* n=131
* Sham-dosed (pilled)
Vomiting	5	6
Diarrhea	1	1
Bruising at Surgery Site	1	1
Respiratory Arrest	1	0
SQ Crepitus in Rear Leg and Flank	1	0
Swollen Paw	1	0

Orthopedic Surgery

In a controlled field study evaluating orthopedic postoperative pain and inflammation, 226 dogs of various breeds, ranging in age from 1 to 11.9 years in the PREVICOX-treated groups and 0.7 to 17 years in the control group were evaluated for safety. Of the 226 dogs, 118 were given Previcox Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally approximately 2 hours prior to surgery and once daily thereafter for a total of three days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed reactions during the study.

Adverse Reactions Seen in the Orthopedic Surgery Postoperative Pain Field Study
Adverse Reactions	Firocoxib Group n=118	Control Group* n=108
A case may be represented in more than one category.
* Sham-dosed (pilled). † One dog had hemorrhagic gastroenteritis.
Vomiting	1	0
Diarrhea	2†	1
Bruising at Surgery Site	2	3
Inappetence/Decreased Appetite	1	2
Pyrexia	0	1
Incision Swelling, Redness	9	5
Oozing Incision	2	0

Post-Approval Experience (Rev. 2009)

The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system:

Gastrointestinal: vomiting, anorexia, diarrhea, melena, gastrointestinal perforation, hematemesis, hematachezia, weight loss, gastrointestinal ulceration, peritonitis, abdominal pain, hypersalivation, nausea

Urinary: elevated BUN, elevated creatinine, polydypsia, polyuria, hematuria, urinary incontinence, proteinuria, kidney failure, azotemia, urinary tract infection

Neurological/Behavioral/Special Sense: depression/lethargy, ataxia, seizures, nervousness, confusion, weakness, hyperactivity, tremor, paresis, head tilt, nystagmus, mydriasis, aggression, uveitis

Hepatic: elevated ALP, elevated ALT, elevated bilirubin, decreased albumin, elevated AST, icterus, decreased or increased total protein and globulin, pancreatitis, ascites, liver failure, decreased BUN

Hematological: anemia, neutrophilia, thrombocytopenia, neutropenia

Cardiovascular/Respiratory: tachypnea, dyspnea, tachycardia

Dermatologic/Immunologic: pruritis, fever, alopecia, moist dermatitis, autoimmune hemolytic anemia, facial/muzzle edema, urticaria

In some cases, death has been reported as an outcome of the adverse events listed above.

For a complete listing of adverse reactions for firocoxib reported to the CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm

Information For Dog Owners

PREVICOX, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. Serious adverse reactions associated with this drug class can occur without warning and in rare situations result in death (see Adverse Reactions). Owners should be advised to discontinue PREVICOX therapy and contact their veterinarian immediately if signs of intolerance are observed. The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID.

Clinical Pharmacology

Mode of action

PREVICOX (firocoxib) is a cyclooxygenase-inhibiting (coxib) class, non-narcotic, non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic properties. There are two main cyclooxygenase enzymes, COX-1 and COX-2, and a newly discovered third enzyme, COX-3, which has yet to be fully characterized.1 Cyclooxygenase-1 (COX-1) is the enzyme responsible for facilitating constitutive physiologic processes, e.g., platelet aggregation, gastric mucosal protection, and renal perfusion.2 It also is constitutively expressed in the brain, spinal cord, and reproductive tract.3 Cyclooxygenase-2 (COX-2) is responsible for the synthesis of inflammatory mediators, but it is also constitutively expressed in the brain, spinal cord and kidneys.4,5,6 Cyclooxygenase-3 (COX-3) is also constitutively expressed in the canine and human brain and also the human heart.7 Results from in vitro studies showed firocoxib to be highly selective for the COX-2 enzyme when canine blood was exposed to drug concentrations comparable to those observed following a once daily 5 mg/kg oral dose in dogs.8 However, the clinical significance of these findings has not been established.

Effectiveness

Two hundred and forty-nine dogs of various breeds, ranging in age from 11 months to 20 years, and weighing 13 to 175 lbs, were randomly administered PREVICOX or an active control drug in two field studies. Dogs were assessed for lameness, pain on manipulation, range of motion, joint swelling, and overall improvement in a non-inferiority evaluation of PREVICOX compared with the active control. At the study's end, 87% of the owners rated PREVICOX-treated dogs as improved. Eighty-eight percent of dogs treated with PREVICOX were also judged improved by the veterinarians. Dogs treated with PREVICOX showed a level of improvement in veterinarian-assessed lameness, pain on palpation, range of motion, and owner-assessed improvement that was comparable to the active control. The level of improvement in PREVICOX-treated dogs in limb weight bearing on the force plate gait analysis assessment was comparable to the active control.

In a separate field study, two hundred fifty-eight client-owned dogs of various breeds, ranging in age from 10.5 weeks to 16 years and weighing from 7 to 168 lbs, were randomly administered PREVICOX or a control (sham-dosed-pilled) for the control of postoperative pain and inflammation associated with soft-tissue surgical procedures such as abdominal surgery (e.g. ovariohysterectomy, abdominal cryptorchidectomy, splenectomy, cystotomy) or major external surgeries (e.g. mastectomy, skin tumor removal ≥8 cm). The study demonstrated that PREVICOX treated dogs had significantly lower need for rescue medication than the control (sham-dosed-pilled) in controlling postoperative pain and inflammation associated with soft-surgery.

A multi-center field study with 226 client-owned dogs of various breeds, and ranging in age from 1 to 11.9 years in the PREVICOX-treated groups and 0.7 to 17 years in the control group was conducted. Dogs were randomly assigned to either the PREVICOX or the control (sham-dosed-pilled) group for the control of postoperative pain and inflammation associated with orthopedic surgery. Surgery to repair a ruptured cruciate ligament included the following stabilization procedures: fabellar suture and/or imbrication, fibular head transposition, tibial plateau leveling osteotomy (TPLO), and 'over the top' technique. The study (n = 220 for effectiveness) demonstrated that PREVICOX-treated dogs had significantly lower need for rescue medication than the control (sham-dosed-pilled) in controlling postoperative pain and inflammation associated with orthopedic surgery.

Palatability

Previcox Chewable Tablets were rated both convenient to administer (97.2%) and palatable to the dog (68.5%) by owners in multi-center field studies involving client-owned dogs of various breeds and sizes.

Animal Safety

In a target animal safety study, firocoxib was administered orally to healthy adult Beagle dogs (eight dogs per group) at 5, 15, and 25 mg/kg (1, 3, and 5 times the recommended total daily dose) for 180 days. At the indicated dose of 5 mg/kg, there were no treatment related adverse events. Decreased appetite, vomiting, and diarrhea were seen in dogs in all dose groups, including unmedicated controls, although vomiting and diarrhea were seen more often in dogs in the 5X dose group. One dog in the 3X dose group was diagnosed with juvenile polyarteritis of unknown etiology after exhibiting recurrent episodes of vomiting and diarrhea, lethargy, pain, anorexia, ataxia, proprioceptive deficits, decreased albumin levels, decreased and then elevated platelet counts, increased bleeding times, and elevated liver enzymes. On histopathologic examination, a mild ileal ulcer was found in one 5X dog. This dog also had a decreased serum albumin which returned to normal by study completion. One control and three 5X dogs had focal areas of inflammation in the pylorus or small intestine. Vacuolization without inflammatory cell infiltrates was noted in the thalamic region of the brain in three control, one 3X, and three 5X dogs. Mean ALP was within the normal range for all groups but was greater in the 3X and 5X dose groups than in the control group. Transient decreases in serum albumin were seen in multiple animals in the 3X and 5X dose groups, and in one control animal.

In a separate safety study, firocoxib was administered orally to healthy juvenile (10-13 weeks of age) Beagle dogs at 5, 15, and 25 mg/kg (1, 3, and 5 times the recommended total daily dose) for 180 days. At the indicated (1X) dose of 5 mg/kg, on histopathologic examination, three out of six dogs had minimal periportal hepatic fatty change. On histopathologic examination, one control, one 1X, and two 5X dogs had diffuse slight hepatic fatty change. These animals showed no clinical signs and had no liver enzyme elevations. In the 3X dose group, one dog was euthanized because of poor clinical condition (Day 63). This dog also had a mildly decreased serum albumin. At study completion, out of five surviving and clinically normal 3X dogs, three had minimal periportal hepatic fatty change. Of twelve dogs in the 5X dose group, one died (Day 82) and three moribund dogs were euthanized (Days 38, 78, and 79) because of anorexia, poor weight gain, depression, and in one dog, vomiting. One of the euthanized dogs had ingested a rope toy. Two of these 5X dogs had mildly elevated liver enzymes. At necropsy all five of the dogs that died or were euthanized had moderate periportal or severe panzonal hepatic fatty change; two had duodenal ulceration; and two had pancreatic edema. Of two other clinically normal 5X dogs (out of four euthanized as comparators to the clinically affected dogs), one had slight and one had moderate periportal hepatic fatty change. Drug treatment was discontinued for four dogs in the 5X group. These dogs survived the remaining 14 weeks of the study. On average, the dogs in the 3X and 5X dose groups did not gain as much weight as control dogs. Rate of weight gain was measured (instead of weight loss) because these were young growing dogs. Thalamic vacuolation was seen in three of six dogs in the 3X dose group, five of twelve dogs in the 5X dose group, and to a lesser degree in two unmedicated controls. Diarrhea was seen in all dose groups, including unmedicated controls.

In a separate dose tolerance safety study involving a total of six dogs (two control dogs and four treated dogs), firocoxib was administered to four healthy adult Beagle dogs at 50 mg/kg (ten times the recommended daily dose) for twenty-two days. All dogs survived to the end of the study. Three of the four treated dogs developed small intestinal erosion or ulceration. Treated dogs that developed small intestinal erosion or ulceration had a higher incidence of vomiting, diarrhea, and decreased food consumption than control dogs. One of these dogs had severe duodenal ulceration, with hepatic fatty change and associated vomiting, diarrhea, anorexia, weight loss, ketonuria, and mild elevations in AST and ALT. All four treated dogs exhibited progressively decreasing serum albumin that, with the exception of one dog that developed hypoalbuminemia, remained within normal range. Mild weight loss also occurred in the treated group. One of the two control dogs and three of the four treated dogs exhibited transient increases in ALP that remained within normal range.

Storage

Store at room temperature, between 59°–86° F (15°–30° C). Brief periods up to 104° F (40° C) are permitted.

To Request a Material Safety Data Sheet (MSDS), call 1-877-217-3543.

How Supplied

PREVICOX is available as round, beige to tan, half-scored tablets in two strengths, containing 57 mg or 227 mg firocoxib. Each tablet strength is supplied in 3 count, 10 count and 30 count blister packages and 60 count bottles.

1: Willoughby DA, Moore AR and Colville-Nash PR. COX-1, COX-2, and COX-3 and the future treatment of chronic inflammatory disease. Lancet 2000;355:646-648.
2: Smith, et al., Pharmacological Analysis of Cyclo-oxygenase-1 in Inflammation. Proc. Natl. Acad. Sci. USA, Pharmacology 1998;95:13313-13318.
3: Jones CJ and Budsberg SC. Physiologic characteristics and clinical importance of the cyclooxygenase isoforms in dogs and cats. JAVMA 2000;217(5):721-729.
4: Zhang, et al., Inhibition of Cyco-oxygenase-2 Rapidly Reverses Inflammatory Hyperalgesia and Prostaglandin E2 Production. JPET 1997;283:1069-1075.
5: Jones and Budsberg, pp. 721-729.
6: Zhang, et al., pp. 1069-1075.
7: Chandrasekharan NV, Dai H, et al. COX-3, a cyclooxygenase-1 variant inhibited by acetaminophen and other analgesic/antipyretic drugs: Cloning, structure and expression. Proc. Natl. Acad. Sci. USA, 2002;99(21):13926-13931.
8: Data on file.

Made in Canada

Marketed by: Merial LLC, Duluth, GA 30096-4640, USA.

1-877-217-3543

U.S. Patent Nos. 5,981,576; 6,541,646; and 6,677,373

NADA 141-230, Approved by FDA

©2010 Merial. All Rights Reserved.

®PREVICOX is a registered trademark of Merial.

1050-1727-09

Rev. 01-2010

Information for Dog Owners about PREVICOX® (firocoxib) Chewable Tablets

Previcox Chewable Tablets are used for the control of pain and inflammation due to osteoarthritis or associated with soft-tissue and orthopedic surgery in your dog.

This summary contains important information about PREVICOX. You should read this information before you start giving your dog PREVICOX tablets and review it each time your prescription is refilled. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or you want to know more about PREVICOX.

What is PREVICOX?

PREVICOX is a veterinary prescription non-steroidal anti-inflammatory drug (NSAID) used to control pain and inflammation due to osteoarthritis, or associated with soft-tissue and orthopedic surgery in dogs.

Osteoarthritis is a painful condition caused by "wear and tear" of cartilage and other parts of the joints that may result in the following changes or signs in your dog:

Limping or lameness.

Decreased activity or exercise (reluctance to stand, climb stairs, jump or run, or difficulty in performing these activities).

Stiffness or decreased movement of joints.

PREVICOX is indicated for the control of postoperative pain and inflammation following soft-tissue and orthopedic surgeries (e.g. spays, cruciate ligament repair). Your veterinarian may administer PREVICOX before the procedure and recommend that the dog be treated for a few days after going home.

What kind of results can I expect when my dog is on PREVICOX for osteoarthritis?

While PREVICOX is not a cure for osteoarthritis, it can control the pain and inflammation and improve your dog's mobility.

Response varies from dog to dog, but improvement can be quite dramatic.

In most dogs, improvement can be seen within days.

If PREVICOX is discontinued or not given as directed, your dog's pain and inflammation may return.

What kind of results can I expect when my dog is on PREVICOX for the control of pain and inflammation following soft-tissue and orthopedic surgery?

Previcox Chewable Tablets allow your dog to recover more comfortably by controlling pain and inflammation following soft-tissue and orthopedic surgery.

Control of pain and inflammation may vary from dog to dog.

If Previcox Chewable Tablets are not given according to your veterinarian's directions, your dog's pain may return.

Consult your veterinarian if your dog appears to be uncomfortable.

Which dogs should not take PREVICOX?

Your dog should not be given PREVICOX if he/she:

Has an allergic reaction to firocoxib, the active ingredient in PREVICOX.

Has had an allergic reaction (such as hives, facial swelling, or red or itchy skin) to aspirin or other NSAIDs.

Is presently taking aspirin, other NSAIDs, or corticosteroids.

Is under 12.5 pounds in body weight.

Has pre-existing kidney or liver disease.

Has decreased appetite, vomiting or diarrhea.

PREVICOX should only be given to dogs.

People should not take PREVICOX. Keep PREVICOX and all medications out of the reach of children. Call your physician immediately if you accidentally take PREVICOX.

What to tell/ask your veterinarian before giving PREVICOX.

Talk to your veterinarian about:

The signs of osteoarthritis you have observed in your dog, such as limping or stiffness.

The importance of weight control in the management of osteoarthritis.

What tests might be done before PREVICOX is prescribed.

How often your dog may need to be examined by your veterinarian.

The risks and benefits of using PREVICOX. Serious adverse reactions, including death, have been associated with PREVICOX administration at doses above the recommended dose in puppies less than seven months of age.

Tell your veterinarian if your dog is currently experiencing or has ever had the following medical problems:

Any side effects from taking PREVICOX or other NSAIDs, such as aspirin.

Any digestive upset (vomiting and/or diarrhea).

Any kidney disease.

Any liver disease.

Tell your veterinarian about:

Any other medical problems or allergies that your dog has now, or has had in the past.

All medicines that you are giving or plan to give to your dog, including those you can get without a prescription and any dietary supplements.

Tell your veterinarian if your dog:

Is under 7 months of age.

Is pregnant, nursing or if you plan to breed your dog.

How to give PREVICOX to your dog.

PREVICOX should be given according to your veterinarian's instructions. Do not change the way you give PREVICOX to your dog without first speaking with your veterinarian. Your veterinarian will tell you what amount of PREVICOX is right for your dog and for how long it should be given. Most dogs will take Previcox Chewable Tablets from your hand, or you can place the tablet in your dog's mouth. PREVICOX may be given with or without food.

What are the possible side effects that may occur in my dog during PREVICOX therapy?

PREVICOX, like other NSAIDS, may cause some side effects. Serious side effects associated with NSAID therapy in dogs can occur with or without warning, and, in rare situations, result in death. The most common side effects associated with PREVICOX therapy involve the digestive tract (vomiting and decreased food consumption). Liver and kidney problems have also been reported with NSAIDs. Look for the following side effects that may indicate your dog is having a problem with PREVICOX:

Decrease or increase in appetite.

Vomiting.

Change in bowel movements (such as diarrhea, or black, tarry or bloody stools).

Change in behavior (such as decreased or increased activity level, incoordination, seizure, or aggression).

Yellowing of gums, skin, or whites of the eyes (jaundice).

Change in drinking habits (frequency or amount consumed).

Change in urination habits (frequency, color, or smell).

Change in skin (redness, scabs, or scratching).

Unexpected weight loss.

It is important to stop the medication and contact your veterinarian immediately if you think your dog has a medical problem or side effect while taking PREVICOX tablets. If you have additional questions about possible side effects, talk with your veterinarian or call 1-877-217-3543.

Can PREVICOX be given with other medications?

PREVICOX should not be given with other NSAIDs (for example, aspirin, carprofen, etodolac, deracoxib, meloxicam, or tepoxalin) or corticosteroids (for example, prednisone, cortisone, dexamethasone, or triamcinolone).

Tell your veterinarian about all medications that you have given your dog in the past, and any medications you are planning to give with PREVICOX tablets. This should include other medicines that you can get without a prescription or any dietary supplements. Your veterinarian may want to check that all of your dog's medicines can be given together.

What do I do in case my dog eats more than the prescribed amount of PREVICOX?

Consult your veterinarian immediately if your dog eats more than the prescribed amount of PREVICOX.

What else should I know about PREVICOX?

This sheet provides a summary of information about PREVICOX tablets. If you have any questions or concerns about PREVICOX, osteoarthritis pain, or postoperative pain following soft-tissue and orthopedic surgery, talk with your veterinarian.

As with all prescribed medicines, PREVICOX tablets should only be given to the dog for which they were prescribed. They should be given to your dog only for the condition for which they were prescribed, at the prescribed dose.

It is important to periodically discuss your dog's response to PREVICOX tablets. Your veterinarian will determine if your dog is responding as expected and if your dog should continue receiving PREVICOX tablets.

For technical assistance or to report suspected adverse reactions, call 1-877-217-3543.

1050-1727-09

Rev. 01-2010

PRINCIPAL DISPLAY PANEL - 57 mg Tablet Carton

Product 279150

Previcox®

(firocoxib)

Coxib-class non-steroidal

anti-inflammatory drug

For Oral Use in Dogs Only

Caution: Federal law restricts

this drug to use by or on the

order of a licensed veterinarian.

NADA 141-230, Approved by FDA

57 mg

60 Chewable Tablets

MERIAL

PRINCIPAL DISPLAY PANEL - 227 mg Tablet Carton

Product 279140

Previcox®

(firocoxib)

Coxib-class non-steroidal anti-inflammatory drug

For Oral Use in Dogs Only

Caution: Federal law restricts

this drug to use by or on the

order of a licensed veterinarian.

NADA 141-230,

Approved by FDA

227 mg

60 Chewable Tablets

MERIAL

PREVICOX
firocoxib tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	50604-9150
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FIROCOXIB (FIROCOXIB)	FIROCOXIB	57 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (Tan/Beige)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	M;57
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50604-9150-1	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		10 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50604-9150-1)
2	50604-9150-2	3 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
2		10 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50604-9150-2)
3	50604-9150-3	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
3		60 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50604-9150-3)
4	50604-9150-4	3 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
4		1 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50604-9150-4)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141230	07/21/2004

PREVICOX
firocoxib tablet, chewable

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	50604-9140
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FIROCOXIB (FIROCOXIB)	FIROCOXIB	227 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (Tan/Beige)	Score	2 pieces
Shape	ROUND	Size	15mm
Flavor		Imprint Code	M;227
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50604-9140-1	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		10 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50604-9140-1)
2	50604-9140-2	3 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
2		10 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50604-9140-2)
3	50604-9140-3	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
3		60 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (50604-9140-3)
4	50604-9140-4	3 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
4		1 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50604-9140-4)
5	50604-9140-5	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
5		10 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50604-9140-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141230	07/21/2004

Labeler - Merial Limited (034393582)

Revised: 09/2010Merial Limited

Monday, September 19, 2016

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What is Pedia-Lax Liquid (glycerin (rectal))?

What is the most important information I should know about Pedia-Lax Liquid (glycerin (rectal))?

What should I discuss with my health care provider before using Pedia-Lax Liquid (glycerin (rectal))?

How should I use Pedia-Lax Liquid (glycerin (rectal))?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using Pedia-Lax Liquid (glycerin (rectal))?