Tuesday, 13 March 2012

Clotrimazole Troches



Pronunciation: kloe-TRIM-uh-zole
Generic Name: Clotrimazole
Brand Name: Mycelex


Clotrimazole Troches are used for:

Treating or preventing fungal infections of the mouth and throat.


Clotrimazole Troches are an antifungal agent. It kills sensitive fungi by binding to the fungal cell membrane and weakening it. This allows the cell contents to leak out and results in the death of the fungus.


Do NOT use Clotrimazole Troches if:


  • you are allergic to any ingredient in Clotrimazole Troches

  • you are taking pimozide or an ergot alkaloid (eg, ergotamine)

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



Before using Clotrimazole Troches:


Some medical conditions may interact with Clotrimazole Troches. 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 liver disease

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


  • Ergot alkaloids (eg, ergotamine), imatinib, macrolide immunosuppressants (eg, tacrolimus), or pimozide because the actions and the risk of their side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clotrimazole Troches 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 Clotrimazole Troches:


Use Clotrimazole Troches as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Allow Clotrimazole Troches to dissolve slowly in your mouth. Do not chew or swallow whole.

  • To clear up your infection completely, use Clotrimazole Troches for the full course of treatment. Keep using it even if you feel better in a few days.

  • If you miss a dose of Clotrimazole Troches, 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 Clotrimazole Troches.



Important safety information:


  • Be sure to use Clotrimazole Troches for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • Lab tests, including liver function tests, may be performed while you use Clotrimazole Troches. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Clotrimazole Troches should not be used in CHILDREN younger than 3 years old; 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 Clotrimazole Troches while you are pregnant. It is not known if Clotrimazole Troches are found in breast milk. If you are or will be breast-feeding while you use Clotrimazole Troches, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Clotrimazole Troches:


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:



Itching; nausea; unpleasant mouth sensations; vomiting.



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).



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.



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.


Proper storage of Clotrimazole Troches:

Store Clotrimazole Troches at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clotrimazole Troches out of the reach of children and away from pets.


General information:


  • If you have any questions about Clotrimazole Troches, please talk with your doctor, pharmacist, or other health care provider.

  • Clotrimazole Troches are 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 Clotrimazole Troches. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Clotrimazole resources


  • Clotrimazole Use in Pregnancy & Breastfeeding
  • Clotrimazole Support Group
  • 2 Reviews for Clotrimazole - Add your own review/rating


Compare Clotrimazole with other medications


  • Cutaneous Candidiasis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
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  • Vaginal Yeast Infection

Julphamox




Julphamox may be available in the countries listed below.


Ingredient matches for Julphamox



Amoxicillin

Amoxicillin is reported as an ingredient of Julphamox in the following countries:


  • Romania

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Julphamox in the following countries:


  • Bahrain

  • Ecuador

  • Oman

International Drug Name Search

Wednesday, 7 March 2012

Prolastin


Generic Name: alpha-1 proteinase inhibitor human (Intravenous route)


AL-fa 1 PRO-teen-aze in-HIB-i-ter HUE-man


Commonly used brand name(s)

In the U.S.


  • Aralast

  • Aralast NP

  • Glassia

  • Prolastin

  • Prolastin-C

  • Zemaira

Available Dosage Forms:


  • Powder for Solution

  • Solution

Therapeutic Class: Blood Modifier Agent


Uses For Prolastin


Alpha-1 proteinase inhibitor injection, also called alpha 1-PI, is used to treat a certain type of emphysema (a lung condition). The emphysema is caused by the lack of a protein called alpha 1-antitrypsin (AAT) in the body. This medicine replaces the protein when the body does not produce enough.


This medicine is administered only by or under the immediate supervision of your doctor.


Before Using Prolastin


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 have not been performed on the relationship of age to the effects of alpha-1 proteinase inhibitor in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies have not been performed on the relationship of age to the effects of alpha-1 proteinase inhibitor in the geriatric population. Safety and efficacy have not been established.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • IgA deficiency with antibodies against IgA—Should not be used in patients with this condition.

Proper Use of alpha-1 proteinase inhibitor human

This section provides information on the proper use of a number of products that contain alpha-1 proteinase inhibitor human. It may not be specific to Prolastin. Please read with care.


A nurse or other trained health professional will give you this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.


This medicine is usually given once a week on a regular schedule. If you have any questions about this, check with your doctor.


Precautions While Using Prolastin


It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.


This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.


Alpha 1-PI 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 alpha 1-PI is very low and has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns. Your doctor may give you a hepatitis B vaccine before receiving this medicine.


Prolastin 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 or nurse immediately if any of the following side effects occur:


More common
  • Bladder pain

  • bloody or cloudy urine

  • body aches or pain

  • chills

  • cough

  • difficult, burning, or painful urination

  • difficulty with breathing

  • ear congestion

  • fever

  • frequent urge to urinate

  • headache

  • loss of voice

  • lower back or side pain

  • nasal congestion

  • runny nose

  • sneezing

  • sore throat

  • unusual tiredness or weakness

Rare
  • Bloating or swelling of the face, arms, hands, lower legs, or feet

  • blurred vision

  • chest pain

  • cough producing mucus

  • diarrhea

  • difficult or labored breathing

  • dizziness

  • feeling faint, dizzy, or lightheadedness

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

  • general feeling of discomfort or illness

  • joint pain

  • loss of appetite

  • muscle aches and pains

  • nausea

  • nervousness

  • noisy breathing

  • pounding in the ears

  • rapid weight gain

  • shivering

  • shortness of breath

  • slow or fast heartbeat

  • stuffy nose

  • sweating

  • tightness in the chest

  • tingling of the hands or feet

  • trouble sleeping

  • unusual weight gain or loss

  • vomiting

  • wheezing

Incidence not known
  • Confusion

  • difficulty with swallowing

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • fast, pounding, or irregular heartbeat or pulse

  • hives

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

  • skin rash

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
  • Feeling of warmth

  • itching skin

  • muscle or bone pain

  • pain or tenderness around the eyes and cheekbones

  • redness of the face, neck, arms, and occasionally, upper chest

  • sudden sweating

Rare
  • Back pain

  • bloating

  • change in taste

  • changes in vision

  • fever

  • hives or welts

  • loss of taste

  • pain

  • redness of the skin

  • sleepiness or unusual drowsiness

  • swelling of the joints

  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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: Prolastin 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.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Prolastin resources


  • Prolastin Side Effects (in more detail)
  • Prolastin Use in Pregnancy & Breastfeeding
  • Prolastin Support Group
  • 0 Reviews for Prolastin - Add your own review/rating


  • Aralast NP Prescribing Information (FDA)

  • Aralast NP MedFacts Consumer Leaflet (Wolters Kluwer)

  • Glassia Prescribing Information (FDA)

  • Glassia Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Glassia Consumer Overview

  • Prolastin-C Prescribing Information (FDA)

  • Zemaira Prescribing Information (FDA)

  • Zemaira Consumer Overview



Compare Prolastin with other medications


  • Alpha-1 Proteinase Inhibitor Deficiency

Tuesday, 6 March 2012

Hypurin Porcine Neutral Cartridges





1. Name Of The Medicinal Product



Hypurin® Porcine Neutral


2. Qualitative And Quantitative Composition



Crystalline Insulin Ph Eur (Porcine) 100IU/ml.



Neutral Insulin Injection Ph Eur (Porcine)



For excipients, see 6.1



3. Pharmaceutical Form



Solution for injection



A clear, colourless solution



4. Clinical Particulars



4.1 Therapeutic Indications



The treatment of insulin dependent diabetes mellitus.



May be used for diabetics who require an insulin of prompt onset and short duration. It is a suitable preparation for admixture with longer acting insulins. It is particularly useful where intermittent, short term or emergency therapy is required, during initial stabilisation and in the treatment of labile diabetes.



4.2 Posology And Method Of Administration



To be determined by the physician according to the needs of the patient.



Usually administered subcutaneously but where necessary it may be given intramuscularly or intravenously. After subcutaneous injection onset of action occurs within 30-60 minutes with an overall duration of 6-8 hours. Maximum effect is exerted over the mid-range.



4.3 Contraindications



Hypoglycaemia.



Hypersensitivity to insulin or to any of the excipients.



4.4 Special Warnings And Precautions For Use



Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9).



Blood or urinary glucose concentrations should be monitored and the urine tested for ketones by patients on insulin therapy.



Newly diagnosed diabetic patients may experience fluctuating insulin requirements during the first weeks, months or even years of treatment (the so-called 'honeymoon period').



Patients transferred to Hypurin® Porcine insulins from other commercially available preparations may require dosage adjustments.



The warning symptoms of hypoglycaemia may be changed, be less pronounced or absent in certain risk groups who should be advised accordingly. These include patients:



- in whom glycaemic control is greatly improved, e.g. by intensified insulin therapy



- with a long history of diabetes



- who are elderly



- receiving concomitant treatment with certain medicinal products e.g. beta blockers or clonidine.



Elderly diabetic patients are more susceptible to episodes of severe, rapid onset hypoglycaemia.



Combination of Hypurin® insulins with pioglitazone: Cases of cardiac failure have been reported when thiazolidinediones are used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Hypurin® is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.



Insulin requirements may increase during illness (this includes infection and accidental and surgical trauma), puberty or emotional upset.



Insulin resistance is frequently associated with lipid disorders, hypertension and ischaemic heart disease. Patients with insulin resistance usually require more than 200 units of insulin daily. Insulin resistance of the type manifested by greatly increased insulin requirements may be due to factors including antibody formation although some diseases, such as infections, endocrine hyperfunctional states (e.g. acromegaly, Cushing's syndrome, thyrotoxicosis) or stress can contribute to insulin resistance.



Insulin requirements may decrease with liver disease, disease of the adrenal, pituitary or thyroid glands and coeliac disease. In patients with severe renal impairment, insulin requirements may fall and dosage reduction may be necessary. The compensatory response to hypoglycaemia may also be impaired.



Insulin requirements may be increased in the premenstrual period but may be reduced during or after a menstrual cycle.



Insulin requirements are usually reduced but occasionally increased during periods of increased activity.



Increase in subcutaneous blood flow, brought about by factors such as a hot bath, may increase the rate of absorption of insulin.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Drugs that may increase the requirement for insulin



Antipyschotics: chloropromazine



Corticosteroids



Diazoxide



Diuretics: thiazide diuretics or loop diuretics



Sympathomimetic agents



Thyroid hormone replacement therapy



Smoking may also antagonise the hypoglycaemic effect of insulin



Drugs that may decrease the requirement for insulin



ACE inhibitors



Alcohol: moderate or large amounts of alcohol (more than 2 units per day for women and more than 3 units per day for men) can decrease the requirements for insulin and may lead to hypoglycaemic attacks. Episodic heavy drinking ('binge' drinking) carries a particularly high risk of hypoglycaemic episodes.



Anabolic steroids



Analgesics: NSAIDS, or salicylates, particularly large doses of aspirin



Androgens: testosterone may enhance the hypoglycaemic effect of insulin



Anti-arrhythmics: disopyramide.



Concomitant use of insulin with quinidine may increase the risk of hypoglycaemia occurring.



Anti-depressants: monoamine oxidase inhibitors or fluoxetine.



Concomitant use of amitriptyline with insulin may lead to hypoglycaemia.



Antihypertensives: guanethidine



Antimalarials: concomitant use of insulin with antimalarials such as chloroquine or quinine may increase the risk of hypoglycaemia occurring.



Fenfluramine



Hormone antagonists: octreotide



Lipid-regulating drugs: fibrates



Mebendazole



Pentoxifylline: the hypoglycaemic activity of insulin may be potentiated by concomitant administration of high-dose pentoxifylline injection.



Tetracyclines: tetracyclines such as oxytetracycline



Drugs that may increase or decrease the requirements for insulin



Antihypertensives: clonidine. Signs and symptoms of hypoglycaemia may be masked by clonidine.



Beta blockers: beta blockers. Some of the warning signs of insulin-induced hypoglycaemia may be masked.



Calcium channel blockers: nifedipine may occasionally impair glucose tolerance.



Cyclophosphamide



Isoniazid



Lipid-regulating drugs: gemfibrozil



Oral contraceptives



4.6 Pregnancy And Lactation



Pregnancy



A decreased requirement for insulin may be observed in the early stages of pregnancy. However, in the second and third trimesters, insulin requirements may increase. Insulin requirements should therefore be assessed frequently by an experienced diabetic physician.



Maternal insulin requirements may decrease after delivery. As this decrease can be at an unpredictable rate, the maternal blood glucose should be closely monitored.



Congenital abnormality is more common in offspring of diabetic than non-diabetic women.



Lactation



Caution should be exercised when prescribing to lactating women. Lactating women may require adjustments in insulin dose and diet.



4.7 Effects On Ability To Drive And Use Machines



The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).



Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.



4.8 Undesirable Effects



Metabolic disorders:



• Hypoglycaemia is the most common adverse effect associated with insulin therapy. For symptoms of hypoglycaemia, refer to section 4.9, Overdosage.



• Hypokalaemia may occur with insulin therapy.



• Insulin therapy may lead to weight gain.



General disorders and administration site conditions:



Lipodystrophy (atrophy or hypertrophy of the fat tissue) may occur at the injection site. Stinging or sensations of warmth or burning at the site of injection may also occur.



Immune system disorders:



Insulin hypersensitivity can occur with animal insulins, but appears less likely with purified insulins and there is minimal evidence that such effects occur with Hypurin insulins. Allergic reactions to phenol and m-cresol contained as preservative and to zinc and protamine may occur.



• Local hypersensitivity: Local allergic reactions to insulin such as pruritus, erythema and oedema may occur at the injection site.



• Generalised hypersensitivity: Generalised hypersensitivity may produce urticaria, nausea, dyspnoea or wheezing and, in rare cases, anaphylactic reactions. Severe, angioedema is a rare adverse effect of insulin treatment occurring most often at the initiation of therapy.



4.9 Overdose



a) Symptoms



Overdosage causes hypoglycaemia. Symptoms include yawning, hunger, pallor, restlessness, weakness, sweating, trembling, confusion, anxiety, nervousness, excitement, irritability, aggression, altered behaviour, deep respiration, cramps, headache, paraesthesia and/or numbness of the nose, mouth, fingers or toes, reduced consciousness, visual disturbance, including blurred vision and double vision, slurred speech, difficulty in finding words, difficulty in concentration, drowsiness, fatigue, convulsions, hemiplegia, paralysis, tachycardia and/or palpitations, myocardial ischaemia and cerebral oedema which, if untreated, will lead to collapse, coma and/or irreversible brain damage.



Hypokalaemia may also occur with insulin overdose.



b) Treatment



Mild hypoglycaemia will respond to oral administration of glucose or sugar and rest.



Moderately severe hypoglycaemia can be treated by intramuscular or subcutaneous injection of glucagon followed by oral carbohydrate when the patient is sufficiently recovered.



For patients who are comatose or who have failed to respond to glucagon injection an intravenous injection of strong Dextrose Injection BP should be given.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC Code – A10A A



Insulin output from the pancreas of a healthy person is about 50 units per day, which is sufficient to maintain the fasting blood sugar concentration in the range 0.8 ± 0.2mg/ml. In diabetes mellitus, the blood sugar rises in an uncontrolled manner. Parenterally administered insulin causes a fall in blood sugar concentration and increased storage of glycogen in the liver. In the diabetic it raises the respiratory quotient after a carbohydrate meal and prevents the formation of ketone bodies. The rise in blood sugar concentration caused by adrenaline and corticosteroids, glucagon and posterior pituitary extract is reversed by insulin.



5.2 Pharmacokinetic Properties



Insulin is rapidly absorbed from subcutaneous tissue or muscle following injection.



Insulin is metabolised mainly in the liver and a small amount is excreted in the urine.



The plasma half-life is four to five minutes. The half-life after subcutaneous injection is about four hours and after intramuscular injection about two hours.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber that are additional to that already included in other sections.



6. Pharmaceutical Particulars



6.1 List Of Excipients



m-Cresol



Phenol



Sodium phosphate



Glycerol



Water for injections



6.2 Incompatibilities



Neutral Insulin must not be mixed with solutions containing aminophylline.



6.3 Shelf Life



36 months.



Following injection of the first dose the product should be used within 28 days. Discard any unused material after this time.



6.4 Special Precautions For Storage



Store at 2oC - 8oC.



Do not freeze.



Cartridges in use must not be stored in a refrigerator.



Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.



From a microbiological point of view the opening carries a risk of microbial contamination and aseptic handling is a necessity.



In use storage times and conditions are the responsibility of the user.



6.5 Nature And Contents Of Container



1.5ml neutral glass cartridge sealed with a bromobutyl rubber bung and metal closure in packs of five.



3ml neutral glass cartridge sealed with a bromobutyl rubber bung and metal closure in packs of five.



6.6 Special Precautions For Disposal And Other Handling



The cartridge must not be used if the contents have been frozen or it contains lumps that do not disperse on mixing.



7. Marketing Authorisation Holder



Wockhardt UK Ltd



Ash Road North



Wrexham



LL13 9UF



U.K.



8. Marketing Authorisation Number(S)



PL 29831/0124



9. Date Of First Authorisation/Renewal Of The Authorisation



8th April 2008



10. Date Of Revision Of The Text



23 June 2011




Vetprofen





Dosage Form: FOR ANIMAL USE ONLY
Vetprofen™

(carprofen)

Caplets

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.



Vetprofen Description


Vetprofen (carprofen) is a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class that includes ibuprofen, naproxen, and ketoprofen. Carprofen is the nonproprietary designation for a substituted carbazole, 6-chloro-α-methyl-9H-carbazole-2-acetic acid. The empirical formula is C15H12ClNO2 and the molecular weight 273.72. The chemical structure of carprofen is:



Carprofen is a white, crystalline compound. It is freely soluble in ethanol, but practically insoluble in water at 25°C.



Vetprofen - Clinical Pharmacology


Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic activity approximately equipotent to indomethacin in animal models.1


The mechanism of action of carprofen, like that of other NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity. Two unique cyclooxygenases have been described in mammals.2 The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and renal function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in inflammation. Inhibition of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. The specificity of a particular NSAID for COX-2 versus COX-1 may vary from species to species.3 In an in vitro study using canine cell cultures, carprofen demonstrated selective inhibition of COX-2 versus COX-1.4 Clinical relevance of these data has not been shown. Carprofen has also been shown to inhibit the release of several prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system) inflammatory reactions.1


Several studies have demonstrated that carprofen has modulatory effects on both humoral and cellular immune responses.5-9 Data also indicate that carprofen inhibits the production of osteoclast-activating factor (OAF), PGE1, and PGE2 by its inhibitory effects on prostaglandin biosynthesis.1


Based upon comparison with data obtained from intravenous administration, carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered orally.10 Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and 25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8 hours) after single oral doses varying from 1-35 mg/kg of body weight. After a 100 mg single intravenous bolus dose, the mean elimination half-life was approximately 11.7 hours in the dog. Carprofen is more than 99% bound to plasma protein and exhibits a very small volume of distribution.


Carprofen is eliminated in the dog primarily by biotransformation in the liver followed by rapid excretion of the resulting metabolites (the ester glucuronide of carprofen and the ether glucuronides of 2 phenolic metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen) in the feces (70-80%) and urine (10-20%). Some enterohepatic circulation of the drug is observed.



INDICATIONS


Vetprofen is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.



Contraindications


Vetprofen should not be used in dogs exhibiting previous hypersensitivity to carprofen.



Warnings


Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs only. Do not use in cats.


All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse Reactions, Animal Safety and Post-Approval Experience).



Precautions


As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Effects may result from decreased prostaglandin production and inhibition of the enzyme cyclooxygenase which is responsible for the formation of prostaglandins from arachidonic acid.11-14 When NSAIDs inhibit prostaglandins that cause inflammation they may also inhibit those prostaglandins which maintain normal homeostatic function. These anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease more often than in healthy patients.12,14 NSAID therapy could unmask occult disease which has previously been undiagnosed due to the absence of apparent clinical signs. Patients with underlying renal disease for example, may experience exacerbation or decompensation of their renal disease while on NSAID therapy.11-14 The use of parenteral fluids during surgery should be considered to reduce the potential risk of renal complications when using NSAIDs perioperatively.


Carprofen is an NSAID, and as with others in that class, adverse reactions may occur with its use. The most frequently reported effects have been gastrointestinal signs. Events involving suspected renal, hematologic, neurologic, dermatologic, and hepatic effects have also been reported. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be approached cautiously, with appropriate monitoring. Since many NSAIDs possess the potential to induce gastrointestinal ulceration, concomitant use of carprofen with other anti-inflammatory drugs, such as corticosteroids and NSAIDs, should be avoided or very closely monitored. Sensitivity to drug-associated adverse reactions varies with the individual patient. For example, carprofen treatment was not associated with renal toxicity or gastrointestinal ulceration in well-controlled safety studies of up to ten times the dose in dogs.


Carprofen is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand's disease), as safety has not been established in dogs with these disorders. The safe use of carprofen in animals less than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not been established. Studies to determine the activity of carprofen when administered concomitantly with other protein-bound or similarly metabolized drugs have not been conducted. Drug compatibility should be monitored closely in patients requiring additional therapy. Such drugs commonly used include cardiac, anticonvulsant and behavioral medications. It has been suggested that treatment with carprofen may reduce the level of inhalant anesthetics needed.15


If additional pain medication is warranted after administration of the total daily dose of carprofen, alternative analgesia should be considered. The use of another NSAID is not recommended. Consider appropriate washout times when switching from one NSAID to another or when switching from corticosteroid use to NSAID use.



INFORMATION FOR DOG OWNERS


Vetprofen, 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 decreased appetite, vomiting, diarrhea, 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 Vetprofen 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.



Adverse Reactions


During investigational studies of osteoarthritis with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control.


There were no serious adverse events reported during clinical field studies of osteoarthritis with once daily administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control.











































Percentage of Dogs with Abnormal Health Observations Reported in Osteoarthritis Field Study (2 mg/lb once daily)
ObservationCarprofen (n=129)Placebo (n=132)
Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical relevance.
Inappetance1.61.5
Vomiting3.13.8
Diarrhea/Soft stool3.14.5
Behavior change0.80.8
Dermatitis0.80.8
PU/PD0.8----
SAP increase7.88.3
ALT increase5.44.5
AST increase2.30.8
BUN increase3.11.5
Bilirubinuria16.312.1
Ketonuria14.79.1

During investigational studies of surgical pain for the caplet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control.








































Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily)
Observation*Carprofen (n=148)Placebo (n=149)

*

A single dog may have experienced more than one occurrence of an event

Vomiting10.113.4
Diarrhea/Soft stool6.16.0
Ocular disease2.70
Inappetance1.40
Dermatitis/skin lesion2.01.3
Dysrhythmia0.70
Apnea1.40
Oral/periodontal disease1.40
Pyrexia0.71.3
Urinary tract disease1.41.3
Wound drainage1.40

Post-Approval Experience


Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting. The categories of adverse reactions are listed in decreasing order of frequency by body system.


Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis.


Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers.


Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation.


Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria.


Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness.


Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis.


Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis.


Immunologic or hypersensitivity: Facial swelling, hives, erythema.


In rare situations, death has been associated with some of the adverse reactions listed above.


To report a suspected adverse reaction call 1-800-835-9496.



Vetprofen Dosage and Administration


Always provide Client Information Sheet with prescription. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Caplets are scored and dosage should be calculated in half-caplet increments.



EFFECTIVENESS


Confirmation of the effectiveness of carprofen for the relief of pain and inflammation associated with osteoarthritis, and for the control of postoperative pain associated with soft tissue and orthopedic surgeries was demonstrated in 5 placebo-controlled, masked studies examining the antiinflammatory and analgesic effectiveness of carprofen caplets in various breeds of dogs.


Separate placebo-controlled, masked, multicenter field studies confirmed the anti-inflammatory and analgesic effectiveness of carprofen caplets when dosed at 2 mg/lb once daily or when divided and administered at 1 mg/lb twice daily. In these two field studies, dogs diagnosed with osteoarthritis showed statistically significant overall improvement based on lameness evaluations by the veterinarian and owner observations when administered carprofen at labeled doses.


Separate placebo-controlled, masked, multicenter field studies confirmed the effectiveness of carprofen caplets for the control of postoperative pain when dosed at 2 mg/lb once daily in various breeds of dogs. In these studies, dogs presented for ovariohysterectomy, cruciate repair and aural surgeries were administered carprofen preoperatively and for a maximum of 3 days (soft tissue) or 4 days (orthopedic) postoperatively. In general, dogs administered carprofen showed statistically significant improvement in pain scores compared to controls.



ANIMAL SAFETY


Laboratory studies in unanesthetized dogs and clinical field studies have demonstrated that carprofen is well tolerated in dogs after oral administration.


In target animal safety studies, carprofen was administered orally to healthy Beagle dogs at 1, 3, and 5 mg/lb twice daily (1, 3 and 5 times the recommended total daily dose) for 42 consecutive days with no significant adverse reactions. Serum albumin for a single female dog receiving 5 mg/lb twice daily decreased to 2.1 g/dL after 2 weeks of treatment, returned to the pre-treatment value (2.6 g/dL) after 4 weeks of treatment, and was 2.3 g/dL at the final 6-week evaluation. Over the 6-week treatment period, black or bloody stools were observed in 1 dog (1 incident) treated with 1 mg/lb twice daily and in 1 dog (2 incidents) treated with 3 mg/lb twice daily. Redness of the colonic mucosa was observed in 1 male that received 3 mg/lb twice daily.


Two of 8 dogs receiving 10 mg/lb orally twice daily (10 times the recommended total daily dose) for 14 days exhibited hypoalbuminemia. The mean albumin level in the dogs receiving this dose was lower (2.38 g/dL) than each of 2 placebo control groups (2.88 and 2.93 g/dL, respectively). Three incidents of black or bloody stool were observed in 1 dog. Five of 8 dogs exhibited reddened areas of duodenal mucosa on gross pathologic examination. Histologic examination of these areas revealed no evidence of ulceration, but did show minimal congestion of the lamina propria in 2 of the 5 dogs.


In separate safety studies lasting 13 and 52 weeks, respectively, dogs were administered orally up to 11.4 mg/lb/day (5.7 times the recommended total daily dose of 2 mg/lb) of carprofen. In both studies, the drug was well tolerated clinically by all of the animals. No gross or histologic changes were seen in any of the treated animals. In both studies, dogs receiving the highest doses had average increases in serum L-alanine aminotransferase (ALT) of approximately 20 IU.


In the 52 week study, minor dermatologic changes occurred in dogs in each of the treatment groups but not in the control dogs. The changes were described as slight redness or rash and were diagnosed as nonspecific dermatitis. The possibility exists that these mild lesions were treatment related, but no dose relationship was observed.


Clinical field studies were conducted with 549 dogs of different breeds at the recommended oral doses for 14 days (297 dogs were included in a study evaluating 1 mg/lb twice daily and 252 dogs were included in a separate study evaluating 2 mg/lb once daily). In both studies the drug was clinically well tolerated and the incidence of clinical adverse reactions for carprofen- treated animals was no higher than placebo-treated animals (placebo contained inactive ingredients found in carprofen). For animals receiving 1 mg/lb twice daily, the mean post-treatment serum ALT values were 11 IU greater and 9 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. Differences were not statistically significant. For animals receiving 2 mg/lb once daily, the mean post-treatment serum ALT values were 4.5 IU greater and 0.9 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. In the latter study, 3 carprofen- treated dogs developed a 3-fold or greater increase in (ALT) and/or (AST) during the course of therapy. One placebo-treated dog had a greater than 2-fold increase in ALT. None of these animals showed clinical signs associated with laboratory value changes. Changes in the clinical laboratory values (hematology and clinical chemistry) were not considered clinically significant. The 1 mg/lb twice daily course of therapy was repeated as needed at 2-week intervals in 244 dogs, some for as long as 5 years.


Clinical field studies were conducted in 297 dogs of different breeds undergoing orthopedic or soft tissue surgery. Dogs were administered 2 mg/lb of carprofen two hours prior to surgery then once daily, as needed for 2 days (soft tissue surgery) or 3 days (orthopedic surgery). Carprofen was well tolerated when used in conjunction with a variety of anesthetic-related drugs. The type and severity of abnormal health observations in carprofen-and placebo-treated animals were approximately equal and few in number (see Adverse Reactions). The most frequent abnormal health observation was vomiting and was observed at approximately the same frequency in carprofen- and placebo- treated animals. Changes in clinicopathologic indices of hematopoetic, renal, hepatic, and clotting function were not clinically significant. The mean post-treatment serum ALT values were 7.3 IU and 2.5 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. The mean post-treatment AST values were 3.1 IU less for dogs receiving carprofen and 0.2 IU greater for dogs receiving placebo.



STORAGE


Store at controlled room temperature 15°C - 30°C (59°F - 86°F).



How is Vetprofen Supplied


Vetprofen caplets are scored, and contain 25 mg, 75 mg, or 100 mg of carprofen per caplet. Each caplet size is packaged in bottles containing 30, 60, or 240 caplets.



REFERENCES


  1. Baruth H, et al: In Anti-Inflammatory and Anti-Rheumatic Drugs, Vol. II, Newer Anti-Inflammatory Drugs, Rainsford KD, ed. CRC Press, Boca Raton, pp. 33-47, 1986.

  2. Vane JR, Botting RM: Mechanism of action of anti-inflammatory drugs. Scand J Rheumatol 25:102, pp. 9-21.

  3. Grossman CJ, Wiseman J, Lucas FS, et al: Inhibition of constitutive and inducible cyclooxygenase activity in human platelets and mononuclear cells by NSAIDs and COX-2 inhibitors. Inflammation Research 44:253-257, 1995.

  4. Ricketts AP, Lundy KM, Seibel SB: Evaluation of selective inhibition of canine cyclooxygenase 1 and 2 by carprofen and other nonsteroidal anti-inflammatory drugs. Am J Vet Res 59:11, pp. 1441-1446, November 1998.

  5. Ceuppens JL, et al: Non-steroidal anti-inflammatory agents inhibit the synthesis of IgM rheumatoid factor in vitro. Lancet 1:528, 1982.

  6. Ceuppens JL, et al: Endogenous prostaglandin E2 enhances polyclonal immunoglobulin production by ionically inhibiting T suppressor cell activity. Cell Immunol 70:41, 1982.

  7. Schleimer RP, et al: The effects of prostaglandin synthesis inhibition on the immune response. Immunopharmacology 3:205, 1981.

  8. Leung KH, et al: Modulation of the development of cell mediated immunity: possible roles of the products of cyclooxygenase and lipoxygenase pathways of arachidonic acid metabolism.Int J Immunopharmacology 4:195, 1982.

  9. Veit BC: Immunoregulatory activity of cultured-induced suppressor macrophages. Cell Immunol 72:14, 1982.

  10. Schmitt M, et al: Biopharmaceutical evaluation of carprofen following single intravenous, oral, and rectal doses in dogs. Biopharm Drug Dispos 11(7): 585-94, 1990.

  11. Kore AM: Toxicology of nonsteriodal anti-inflammatory drugs. Veterinary Clinics of North America, Small Animal Practice 20, March 1990.

  12. Binns SH: Pathogenesis and pathophysiology of ischemic injury in cases of acute renal failure. Compend for Cont Ed 16:1, January 1994.

  13. Boothe DM: Prostaglandins: Physiology and clinical implications. Compend for Cont Ed 6:11, November 1984.

  14. Rubin SI: Nonsteroidal anti-inflammatory drugs, prostaglandins, and the kidney. JAVMA 188:9, May 1986.

  15. Ko CH, Lange DN, Mandsager RE, et al: Effects of butorphanol and carprofen on the minimal alveolar concentration of isoflurane in dogs. JAVMA 217:1025-1028, 2000.


For a copy of the Material Safety Data Sheet (MSDS) or to report adverse reactions call: 1-800-835-9496.


ANADA # 200-397, Approved by FDA.


Manufactured by:

Belcher Pharmaceuticals, Inc.

12393 Belcher Road, Suite 420

Largo, Florida 33773


Distributed by:

Vétoquinol U.S.A., Inc.

Buena, NJ 08310


July 2007


L071-VET


R-0707


Printed in USA



PATIENT PACKAGE INSERT


Dog Owner Information about

Vetprofen™ Caplets (carprofen)


Vetprofen™ (pronounced "Vet-pro-fen")

for Osteoarthritis and Post-Surgical Pain

Generic name: carprofen ("car-pro-fen")


This summary contains important information about Vetprofen. You should read this information before you start giving your dog Vetprofen and review it each time the 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 if you want to know more about Vetprofen.


What is Vetprofen?


Vetprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to reduce pain and inflammation (soreness) due to osteoarthritis and pain following surgery in dogs. Vetprofen is a prescription drug for dogs. It is available as a caplet and is given to dogs by mouth.


Osteoarthritis (OA) 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

To control surgical pain (e.g. for surgeries such as spays, ear procedures or orthopedic repairs) your veterinarian may administer Vetprofen before the procedure and recommend that your dog be treated for several days after going home.


What kind of results can I expect when my dog is on Vetprofen?


While Vetprofen is not a cure for osteoarthritis, it can relieve the pain and inflammation of OA and improve your dog's mobility.


  • Response varies from dog to dog but can be quite dramatic.

  • In most dogs, improvement can be seen in a matter of days.

  • If Vetprofen is discontinued or not given as directed, your dog's pain and inflammation may come back.

Who should not take Vetprofen?


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


  • Has had an allergic reaction to carprofen, the active ingredient of Vetprofen.

  • Has had an allergic reaction to aspirin or other NSAIDs (for example deracoxib, etodolac, firocoxib, meloxicam, phenylbutazone or tepoxalin) such as hives, facial swelling, or red or itchy skin.

Vetprofen should be given to dogs only.


Cats should not be given Vetprofen. Call your veterinarian immediately if your cat receives Vetprofen. People should not take Vetprofen. Keep Vetprofen and all medicines out of reach of children. Call your physician immediately if you accidentally take Vetprofen.


How to give Vetprofen to your dog.


Vetprofen should be given according to your veterinarian's instructions. Your veterinarian will tell you what amount of Vetprofen is right for your dog and for how long it should be given. Vetprofen should be given by mouth and may be given with or without food.


What to tell/ask your veterinarian before giving Vetprofen.


Talk to your veterinarian about:


  • The signs of OA you have observed (for example limping, stiffness).

  • The importance of weight control and exercise in the management of OA.

  • What tests might be done before Vetprofen is prescribed.

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

  • The risks and benefits of using Vetprofen.

Tell your veterinarian if your dog has ever had the following medical problems:


  • Experienced side effects from Vetprofen or other NSAIDs, such as aspirin

  • Digestive upset (vomiting and/or diarrhea)

  • Liver disease

  • Kidney disease

  • A bleeding disorder (for example, Von Willebrand's disease)

Tell your veterinarian about:


  • Any other medical problems or allergies that your dog has now or has had.

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

Tell your veterinarian if your dog is:


  • Pregnant, nursing or if you plan to breed your dog.

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


Vetprofen, like other drugs, may cause some side effects. Serious but rare side effects have been reported in dogs taking NSAIDs, including carprofen. Serious side effects can occur with or without warning and in rare situations result in death.


The most common NSAID-related side effects generally involve the stomach (such as bleeding ulcers), and liver or kidney problems. Look for the following side effects that can indicate your dog may be having a problem with Vetprofen or may have another medical problem:


  • 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, amount consumed)

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

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

It is important to stop therapy and contact your veterinarian immediately if you think your dog has a medical problem or side effect from Vetprofen therapy. If you have additional questions about possible side effects, talk to your veterinarian.


Can Vetprofen be given with other medicines?


Vetprofen should not be given with other NSAIDs (for example, aspirin, deracoxib, etodolac, firocoxib, meloxicam, tepoxalin) or steroids (for example, cortisone, dexamethasone, prednisone, triamcinolone).


Tell your veterinarian about all medicines you have given your dog in the past, and any medicines that you are planning to give with Vetprofen. This should include other medicines that you can get without a prescription. 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 Vetprofen?


Contact your veterinarian immediately if your dog eats more than the prescribed amount of Vetprofen.


What else should I know about Vetprofen?


This sheet provides a summary of information about Vetprofen. If you have any questions or concerns about Vetprofen, or osteoarthritis, or postoperative pain, talk to your veterinarian.


As with all prescribed medicines, Vetprofen should only be given to the dog for which it was prescribed. It should be given to your dog only for the condition for which it was prescribed.


It is important to periodically discuss your dog's response to Vetprofen at regular check ups. Your veterinarian will best determine if your dog is responding as expected and if your dog should continue receiving Vetprofen.


To report a suspected adverse reaction call 1-800-835-9496


Issued July 2007


Manufactured by:

Belcher Pharmaceuticals, Inc.

12393 Belcher Road, Suite 420

Largo, Florida 33773


Distributed by:

Vétoquinol U.S.A., Inc.

Buena, NJ 08310



PRINCIPAL DISPLAY PANEL - 25 mg Container


NDC 17030-309-13


Vetprofen ®

(carprofen) 25 mg


Non-Steroidal

Anti-Inflammatory Drug


For Oral Use

in Dogs Only


60 caplets


CAUTION: Federal law restricts this drug to use by or on the

order of a licensed veterinarian.


Vétoquinol


ANADA # 200-397

Approved by FDA




PRINCIPAL DISPLAY PANEL - 75 mg Container


NDC 17030-310-13


Vetprofen ®

(carprofen) 75 mg


Non-Steroidal

Anti-Inflammatory Drug


For Oral Use

in Dogs Only


60 caplets


CAUTION: Federal law restricts this drug to use by or on the

order of a licensed veterinarian.


Vétoquinol


ANADA # 200-397

Approved by FDA




PRINCIPAL DISPLAY PANEL - 100 mg Container


NDC 17030-311-13


Vetprofen ®

(carprofen) 100 mg


Non-Steroidal

Anti-Inflammatory Drug


For Oral Use

in Dogs Only


60 caplets


CAUTION: Federal law restricts this drug to use by or on the

order of a licensed veterinarian.


Vétoquinol


ANADA # 200-397

Approved by FDA










Vetprofen 
carprofen  tablet










Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)17030-309
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carprofen (Carprofen)Carprofen25 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize12mm
FlavorImprint Code25MG;BP;CAR
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
117030-309-14240 TABLET In 1 BOTTLE, DISPENSINGNone
217030-309-1360 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20039701/20/2008







Vetprofen 
carprofen  tablet










Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)17030-310
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carprofen (Carprofen)Carprofen75 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize15mm
FlavorImprint Code75MG;BP;CAR
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
117030-310-14240 TABLET In 1 BOTTLE, DISPENSINGNone
217030-310-1360 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20039701/20/2008







Vetprofen 
carprofen  tablet










Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)17030-311
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carprofen (Carprofen)Carprofen100 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize19mm
FlavorImprint Code100MG;BP;CAR
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
117030-311-14240 TABLET In 1 BOTTLE, DISPENSINGNone
217030-311-1360 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20039701/20/2008


Labeler - Vetoquinol USA Inc (106824209)









Establishment
NameAddressID/FEIOperations
Belcher Pharmaceuticals175968069MANUFACTURE
Revised: 06/2010Vetoquinol USA Inc

Monday, 5 March 2012

Famvir


Generic Name: famciclovir (Oral route)

fam-SYE-kloe-vir

Commonly used brand name(s)

In the U.S.


  • Famvir

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antiviral


Chemical Class: Guanosine Nucleoside Analog


Uses For Famvir


Famciclovir is used to treat the symptoms of herpes zoster (also known as shingles), a herpes virus infection of the skin. It is used to treat and suppress herpes labialis (cold sores) and recurrent episodes of genital herpes infection. This medicine is also used to treat recurrent herpes virus infections of the mucous membranes (lips and mouth) and genitals in HIV-infected patients. Although famciclovir will not cure genital herpes or herpes zoster, it does help relieve the pain and discomfort and helps the sores heal faster.


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


Before Using Famvir


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


No information is available on the relationship of age to the effects of famciclovir in children under 18 years of age. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of famciclovir in the elderly. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment of dose in patients receiving this medicine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal 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


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.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Galactose intolerance or

  • Glucose-galactose malabsorption or

  • Severe lactase deficiency—Should not use in patients with these conditions.

  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Famvir


Famciclovir is best used within 48 hours after the symptoms of shingles (for example, pain, burning, blisters) begin to appear, or within 6 hours after the symptoms of recurrent genital herpes (for example, pain, blisters) begin to appear.


Famciclovir may be taken with or without food.


To help clear up your herpes infection, keep taking famciclovir for the full time of treatment, even if your symptoms begin to clear up after a few days. Do not miss any doses and do not use this medicine more often or for a longer time than your doctor ordered.


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 oral dosage form (tablets):
    • For treatment of shingles:
      • Adults—500 milligrams (mg) every eight hours for seven days.

      • Children—Use and dose must be determined by your doctor.


    • For suppression of recurrent genital herpes:
      • Adults—250 milligrams (mg) two times a day for up to one year.

      • Children—Use and dose must be determined by your doctor.


    • For treatment of recurrent genital herpes:
      • Adults—1000 milligrams (mg) two times a day for one day.

      • Children—Use and dose must be determined by your doctor.


    • For treatment of recurrent herpes labialis (cold sores):
      • Adults—1500 milligrams (mg) as a single dose.

      • Children—Use and dose must be determined by your doctor.


    • For treatment of recurrent herpes infections in HIV-infected patients:
      • Adults—500 milligrams (mg) two times a day for seven days.

      • Children—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


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 Famvir


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


The areas affected by herpes should be kept as clean and dry as possible. Also, wear loose-fitting clothing to avoid irritating the sores (blisters).


This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are taking famciclovir.


This medicine does not prevent the sexual transmission of genital herpes. You should avoid having sex when lesions are present to avoid infecting your partner.


Famvir 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:


Incidence not known
  • Black, tarry stools

  • bleeding gums

  • blistering, peeling, or loosening of the skin

  • blood in urine or stools

  • chills

  • clay-colored stools

  • cough

  • dark urine

  • dizziness

  • fever

  • joint or muscle pain

  • loss of appetite

  • pinpoint red spots on the skin

  • red, irritated eyes

  • sore throat

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

  • unpleasant breath odor

  • unusual bleeding or bruising

  • vomiting of blood

  • yellow eyes or skin

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
  • Cramps

  • diarrhea

  • headache

  • heavy bleeding

  • nausea

  • stomach pain

Less common
  • Bloated, full feeling

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

  • confusion as to time, place, or person

  • excess air or gas in the stomach or intestines

  • hives or welts

  • holding false beliefs that cannot be changed by fact

  • itching skin

  • mood or mental changes

  • passing gas

  • rash

  • redness of skin

  • seeing, hearing, or feeling things that are not there

  • unusual excitement, nervousness, or restlessness

  • unusual tiredness or weakness

  • vomiting

Incidence not known
  • Sleepiness or unusual drowsiness

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: Famvir side effects (in more detail)



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More Famvir resources


  • Famvir Side Effects (in more detail)
  • Famvir Dosage
  • Famvir Use in Pregnancy & Breastfeeding
  • Drug Images
  • Famvir Drug Interactions
  • Famvir Support Group
  • 10 Reviews for Famvir - Add your own review/rating


  • Famvir Prescribing Information (FDA)

  • Famvir Consumer Overview

  • Famvir Monograph (AHFS DI)

  • Famvir MedFacts Consumer Leaflet (Wolters Kluwer)

  • Famciclovir Prescribing Information (FDA)

  • Famciclovir Professional Patient Advice (Wolters Kluwer)



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