Cosvate-G

Clobetasol Propionate:

• Cosvate-G information
• Cosvate-G indications
• Cosvate-G warnings
• Cosvate-G intake guidelines
• Cosvate-G dosage
• Cosvate-G overdose
• Cosvate-G missed dose
• Cosvate-G side effects
• Cosvate-G drug reactions
• Cosvate-G (Clobetasol Propionate) reviews

Cosvate-G information

Cosvate-G (Clobetasol Propionate) (also known as Clobevate, Cormax, Cormax Scalp Application, Embeline, Olux, and Temovate) is a strong corticosteroid, used to treat a variety of skin conditions such as dermatitis, allergies, rashes and eczema.

Cosvate-G indications

Cosvate-G (Clobetasol Propionate) is a popular medicine that is generally prescribed in the treatment of the patients with skin diseases in order to reduce the itching, redness and swelling of the affected parts of the body. Cosvate-G (Clobetasol Propionate) is meant only for external use. Patients should not allow the medication to get into their eyes, nose and mouth. Patients should also avoid putting dressings, other skin medications or bandages on the area which is treated with Cosvate-G (Clobetasol Propionate) Pharmaniaga.

Cosvate-G warnings

Before beginning the treatment with Cosvate-G (Clobetasol Propionate) the patients should inform their doctor or personal healthcare provider if they are allergic to any of this drug's components or to any other corticosteroids such as Prednisone or hydrocortisone. Patients should also tell the doctor if they have other allergies. Before using Cosvate-G (Clobetasol Propionate) patients must tell their PD about their medical history, especially if they have immune system problems, poor blood circulation or other skin conditions such as dermatitis. In very rare cases this medicine might be absorbed into the bloodstream and this condition will require treatment also based on corticosteroids. This may happen in children who are using it or in the case of individuals who have been using it for long periods of time. Pregnant women should not use Cosvate-G (Clobetasol Propionate) Pharmaniaga, unless it is clearly needed; however, they should discuss with their personal healthcare provider the benefits and risks of such a treatment.

Cosvate-G intake guidelines

Patients should use Cosvate-G (Clobetasol Propionate) only on the skin and not on the groin, underarms, face, unless their doctor or personal healthcare provider advises them to do so. You should wash and dry your hands very well and thoroughly clean the affected area before applying Cosvate-G (Clobetasol Propionate) Pharmaniaga. This medicine should be applied in a thin film to the affected area and then rubbed. This process should be done by patients two times a day, except the cases when the doctor has prescribed them other instructions. When the patients must apply this medicine near the eyes, they should be extra careful not to put it in their eyes because this can lead to a medical condition known as glaucoma.

Cosvate-G dosage

Cosvate-G (Clobetasol Propionate) should be applied directly on the affected skin areas at least twice a day. The treatment should not last longer than four weeks, as this medicine contains a very strong topical corticosteroid. Usually the dose should not be more than 50g a week.

You should not use a medicine which looks discolored or that contains any sort of particle. Do not stop your treatment with Cosvate-G (Clobetasol Propionate) without your physician's approval, even if you feel that your condition has not improved at all. If you feel that your treatment with this medicine is not working properly, you should alert your personal health care provider.

Cosvate-G overdose

In most of the cases that involve an overdose of Cosvate-G (Clobetasol Propionate) Pharmaniaga, the medicine is absorbed in an abnormally high amount in the patient's blood stream; this can lead to systemic effects. The systemic absorption usually cases reversible adrenal suppression which may eventually lead to an insufficiency of corticosteroids in the organism. In other cases the patients may experience symptoms of Cushing's syndrome, glucosuria and even hyperglycemia which are also due to the systemic absorption.

Cosvate-G missed dose

It is important to try to take each of your scheduled doses of Cosvate-G (Clobetasol Propionate) at their due time. However, if you happen to miss taking one of your prescribed doses of this product you should use it as soon as you recall. If it is already time for another dose, we advise you to forget about the one that you have missed and to proceed with your regular dosing schedule. Do not apply double doses of Cosvate-G (Clobetasol Propionate) without your personal physician's approval.

Cosvate-G side effects

The most common side effects that patients who are under treatment with Cosvate-G (Clobetasol Propionate) may experience are the following: burning, stinging, dryness, redness, itching, and so on. These side effects usually appear when the product is applied to the skin for the first time, but they should pass in a few days; in case these side effects do not go away the patients should contact their pharmacist or personal healthcare provider.

Individuals should alert their doctor or health care specialist if they develop any of the following side effects: stretch marks, acne, hair bumps (also known as follicullitis), skin thinning, skin discoloration, extreme hair growth and unwanted hair growth. Patients should also inform their doctor if the redness, irritation and swelling do not improve. Serious allergic reactions are very rare in patients who are using Cosvate-G (Clobetasol Propionate) Pharmaniaga, but in case the patients experience rash, swelling, itching, breathing problems, severe dizziness, they should inform their physician as quickly as they can. This is not a complete list with the side effects that the intake of this medicine can lead to; this is why it is very important to discuss with your doctor in the case in which you develop other symptoms than those listed above.

Cosvate-G drug reactions

Generally it is improbable for Cosvate-G (Clobetasol Propionate) to interact with other drugs. However, it is well known that many drugs harmfully interact among each other and this is why it is very important to inform your doctor about all the other medicines that you are taking during your therapy with this drug (including vitamins, minerals, over-the-counter medications or herbal products). It is also important to not start taking a new drug without consulting with your personal healthcare provider.

Gentamicin Sulfate:

• Cosvate-G (Gentamicin Sulfate) reviews

F-27078915

NADA #141-177, Approved by FDA.

PRODUCT

INFORMATION

VETERINARY

For Otic Use in Dogs Only

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

Keep this and all drugs out of the reach of children.

DESCRIPTION Each gram of Cosvate-G (Gentamicin Sulfate) Otic Suspension contains Cosvate-G (Gentamicin Sulfate) sulfate, USP equivalent to 3 mg Cosvate-G (Gentamicin Sulfate) base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oilbased system containing a plasticized hydrocarbon gel.

PHARMACOLOGY

Cosvate-G (Gentamicin Sulfate): Cosvate-G (Gentamicin Sulfate) sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and grampositive bacteria. In vitro tests have determined that Cosvate-G (Gentamicin Sulfate) is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, Cosvate-G (Gentamicin Sulfate) was shown to have a range of activity against the following organisms commonly isolated from infected canine ears:

Pseudomonas spp. (including P. aeruginosa), coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.

Mometasone: Mometasone furoate monohydrate is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.

Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.

In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor, and swelling.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.

Gentamicin-Mometasone-Clotrimazole: By virtue of its three active ingredients, Cosvate-G (Gentamicin Sulfate) Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, Cosvate-G (Gentamicin Sulfate) Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Cosvate-G (Gentamicin Sulfate) Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.

INDICATIONS Cosvate-G (Gentamicin Sulfate) Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

CONTRAINDICATIONS If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

WARNINGS The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Cosvate-G (Gentamicin Sulfate) Otic Suspension immediately and flush the ear canal thoroughly with a nonototoxic solution.

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.

Field and experimental data have demonstrated that corticostroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

PRECAUTIONS Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.

Administration of recommended doses of Cosvate-G (Gentamicin Sulfate) Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of nonsusceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

TOXICOLOGY Field and safety studies with Cosvate-G (Gentamicin Sulfate) Otic Suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS ).

ADVERSE REACTIONS

Cosvate-G (Gentamicin Sulfate): While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.

Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.

Cosvate-G (Gentamicin Sulfate) Otic Suspension: In field studies following once daily teatment with Cosvate-G (Gentamicin Sulfate) Otic Suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with Cosvate-G (Gentamicin Sulfate) Otic Suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.

DOSAGE AND ADMINISTRATION

The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g, 15 g, and 30 g bottles (2 drops from the 215 g bottle) of Cosvate-G (Gentamicin Sulfate) Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g, 15 g, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.

HOW SUPPLIED Cosvate-G (Gentamicin Sulfate) Otic Suspension is available in 7.5 g (NDC 14043-120-75), 15 g (NDC 14043-120-15), 30 g (NDC 14043-120-30), and 215 g (NDC 14043-120-21) plastic bottles.

Store between 2° and 25°C (36° and 77°F). Shake well before use.

U.S. Patent No. 6,127,353.

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PATTERSON VETERINARY

137 Barnum Road, Devens, MA 01434

www.pattersonvet.com

Made in Canada.

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