DRUG ACKNOWLEDGEMENT OF RENAXIS™-50
Issued for Doctor’s convenience
To be used by Hospital, Laboratory & Registered Medical Practitioner
Each 1ml(ample) contains :-
In oily base
PHARMACOKINETICS FACTS & ETHICS >>>
Nandrolone Decanoate :
A sterile oleaginous solution containing per mL: Nandrolone Decanoate 200 mg with Benzyl Alcohol 5% as solubilizer/preservative, in Sesame Oil q.s. Nandrolone decanoate (C28H44O3) occurs as a fine, white to creamy white, crystalline powder. It is odorless, or may have a slight odor. Nandrolone decanoate is soluble in chloroform, in alcohol, in acetone, and in vegetable oils. It is practically insoluble in water.
Indications and Usage for Nandrolone
Nandrolone decanoate is indicated for the management of the anemia of renal insufficiency and has been shown to increase hemoglobin and red cell mass. Surgically induced anephric patients have been reported to be less responsive.
Nandrolone (19-nortestosterone) is an anabolic steroid. Nandrolone decanoate is used in the treatment of osteoporosis in postmenopausal women (though now not recommended) at a dose of 50 mg every three weeks. It is also used for some aplastic anemias.
The positive effects of the drug include muscle growth, appetite stimulation and increased red blood cell production and bone density. Clinical studies have shown it to be effective in treating anaemia, osteoporosis and some forms of neoplasia includingbreast cancer, and also acts as a progestin-based contraceptive. For these reasons, in the United States nandrolone received FDA approval in 1983.
Because nandrolone is not broken down into DHT, the deleterious effects common to most anabolic steroids on the scalp, skin, and prostate are lessened to a degree; but is rather broken down to the much weaker androgen dihydronandrolone. The lack of alkylation on the 17α-carbon drastically reduces the drug’s liver toxicity. Estrogenic effects resulting from reaction with aromataseare also reduced due to lessened enzyme interaction, but effects such as gynaecomastia and reduced libido still occur in larger doses because of other mechanisms. Other side-effects of abuse can include erectile dysfunction and cardiovascular damage, as well as several ailments resulting from the drug’s effect of lowering levels of luteinizing hormone through negative feedback. Erectile dysfunction is attributed to the weaker action of dihydronandrolone in the penis since dihydrotestosterone is a known sexual modulator.
Nandrolone Dosage and Administration
RENAXIS™-50 injection is intended for deep intramuscular injection only, into the gluteal muscle preferably. Dosage should be based on therapeutic response and consideration of the benefit to risk ratio. Duration of therapy will depend on the response of the condition and the appearance of adverse reactions. If possible, therapy should be intermittent. RENAXIS™-50 should be regarded as adjunctive therapy and adequate quantities of nutrients should be consumed in order to obtain maximal therapeutic effects. For example, when it is used in the treatment of refractory anemia, adequate iron intake is required for a maximal response.
Anemia of Renal Disease
A dose of RENAXIS™-50 per week is recommended for women and 100 to 200 mg per week for men. Drug therapy should be discontinued if no hematologic improvement is seen within the first six months. For children from 2 to 13 years of age, the average dose is 25 to 50 mg every 3 to 4 weeks. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
DRUG & OR LABORATORY TEST INTERACTIONS
Anabolic steroid therapy may decrease thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. Anabolic steroids may cause an increase in prothrombin time.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Nandrolone decanoate has not been tested in laboratory animals for carcinogenic or mutagenic effects. Liver cell tumors have been reported in patients receiving androgenic anabolic steroid therapy. Geriatric patients treated with anabolics may be at an increased risk for prostatic hypertrophy and prostatic carcinoma.
It is not known whether anabolic steroids are excreted in human milk. Many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from anabolic steroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The safety and efficacy of Nandrolone decanoate in children with metastatic breast cancer (rarely found) has not been established. Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children, and the effect may continue for six months after the drug has been stopped. Therefore, therapy should be monitored by X-ray studies at six month intervals in order to avoid the risk of compromising the adult height.
DIRECTIONS >>> As directed by Physician
Source : Wikipedia (About Nandrolone)
Drugs.com (ND FDA prescription/side-effects/uses)
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