Bula dos Anabolizantes

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WINSTROL®-V

NDC 0009-3565-01, NDC 0009-3565-02

brand of stanozolol sterile suspension

Anabolic Therapy for Use in Dogs and Cats and Horses

DESCRIPTION

WINSTROL-V Sterile Suspension contains stanozolol which is 17-methyl-2´H-5a-androst-2-eno[3,2-c] pyrazol-17b-ol. It is a member of a unique series of heterocyclic steroids synthesized at the Sterling-Winthrop Research Institute. The unique endocrinologic activity of this compound was produced by the fusion of a pyrazole ring to a steroid nucleus. When administered to animals, WINSTROL-V was found to have an unusual pattern of biologic activity in that its anabolic (tissue-building) effect far outweighed its weak androgenic (masculinizing) influence.

CLINICAL PHARMACOLOGY

WINSTROL-V Sterile Suspension is classified as “anabolic steroid” because of the pronounced stimulatory effects on constructive metabolism. Stanozolol increases the retention of nitrogen and minerals, reverses tissue-depleting processes, and promotes better utilization of dietary protein. Its anabolic effects lead to improvement in appetite, increased vigor, and notable gains in weight. In this respect, it differs greatly from other steroids, such as the androgens, estrogens, and corticosteroids. Methyltestosterone also possesses anabolic action, but its predominant androgenic activity makes it unsuitable for long-term anabolic therapy. Although the frequently undesirable virilizing effects of the male sex hormones may be overcome by androgen-estrogen combinations, this does not improve their anabolic function. The corticosteroids (cortisone, prednisone, prednisolone, dexamethasone) comprise an entirely different group of steroids, which are well known for their antiinflammatory and antirheumatic activities. As a rule, prolonged use of the corticosteroids results in a catabolic (tissue-wasting) effect which may be relieved by anabolic therapy.

In a wide variety of tests in animals, WINSTROL-V was shown to possess high anabolic potency, whereas its androgenic effect was very low. Extensive clinical investigations by veterinary practitioners have confirmed its anabolic action and therapeutic usefulness in dogs, cats, and horses.

INDICATIONS

Anabolic therapy with WINSTROL-V Sterile Suspension is indicated whenever excessive tissue breakdown or extensive repair processes are proceeding. Such processes usually diminish protein reserves in the tissues, thus leading to negative nitrogen balance.

WINSTROL-V is indicated to reverse tissue-depleting processes and restore constructive metabolism. Anabolic therapy is intended primarily as an adjunct to other specific and supportive therapy, including nutrition therapy. Optimal results can be expected only when dietary intake is adequate and well balanced.

Dogs and Cats

WINSTROL-V Sterile Suspension is indicated when the therapeutic objective is to improve appetite, promote weight gain, and increase strength and vitality. For these reasons WINSTROL-V is recommended for anorexia, unthriftiness, weight loss, debility, cachexia, inanition and poor hair coat when these accompany disease, trauma, or old age. Since certain skin conditions occurring in older dogs (alopecia and some types of eczema, for example) are caused by metabolic disorders based on negative nitrogen balance, WINSTROL-V may help to control such conditions.

Horses

WINSTROL-V Sterile Suspension is recommended as an aid for treating debilitated horses when the therapeutic objective is to improve appetite, promote weight gain, improve general physical conditions, and accelerate recovery. Clinical conditions most amenable to treatment are debilitated states resulting from illness, surgery, traumatic injuries, or plain overwork. In clinical investigations, administration of WINSTROL-V frequently had a  marked effect on horses exhibiting diminished vitality and vigor due to over exertion.

CONTRAINDICATIONS

Because the data regarding use during pregnancy are insufficient, WINSTROL-V Sterile Suspension should not be administered to pregnant dogs and cats. In the absence of data on the effects of WINSTROL-V Sterile Suspension on stallions and pregnant mares or the teratogenicity on offspring, WINSTROL-V should not be used in these animals.

WARNINGS

Not for use in horses intended for food. Not for human use. Keep out of reach of children.

PRECAUTIONS

When receiving anabolic therapy, animals with impaired cardiac and renal function should be watched closely for the possibility of sodium and water retention. Special caution should be exercised in aged dogs suffering from chronic interstitial nephritis. In such cases, the progress of the disorder should be checked by means of laboratory tests and treatment discontinued if the drug appears to aggravate the disease.

ADVERSE REACTIONS

Mild androgenic effects may be noted after prolonged therapy with excessively high doses.

DOSAGE AND ADMINISTRATION

Whenever indicated, anabolic therapy should be prescribed in conjunction with or as a follow-up to other therapeutic measures.

Dogs and Cats

Because WINSTROL-V Sterile Suspension is absorbed slowly, injections may be given at weekly intervals. The suspension is best administered by deep intramuscular injection into the thigh. The recommended dose for cats and small breeds of dogs is 0.5 mL (25 mg) and for larger dogs, 1 mL (50 mg). If desired, WINSTROL-V Tablets and WINSTROL-V Sterile Suspension can be combined in a regimen of therapy. Many investigating clinicians gave an initial dose of the injectable form and then dispensed tablets for daily administration at home.

Horses

Only WINSTROL-V Sterile Suspension is recommended for administration to horses. The recommended dose is 25 mg per 100 pounds of body weight intramuscularly, equivalent to 5 mL (250 mg) for a 1,000 pound animal. Deep intramuscular injection in the gluteal region is recommended. Medication may be repeated at weekly intervals up to and including four weeks. In clinical trials, many animals required no more than one or two doses to achieve desirable therapeutic results.

HOW SUPPLIED

WINSTROL-V Sterile Suspension contains 50 mg stanozolol per mL and is available in the following package sizes:

10 mL multiple-dose vials . . . . . . . . . . . . . . NDC 0009-3565-01

30 mL multiple-dose vials . . . . . . . . . . . . . . NDC 0009-3565-02

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

Store at controlled room temperature 20° to 25° C (68° to 77° F)

[see USP].

NADA #30-844, Approved by FDA

Manufactured for

Pharmacia & Upjohn Company

Kalamazoo, Michigan 49001, USA

By

Abbott Laboratories

North Chicago, IL 60064, USA

Revised September 1997