ANDROXY Tablet (2017)
Βιβλιογραφική αναφορά
Συγγραφείς
Upsher-Smith Laboratories, LLC
Λέξεις κλειδιά
0832-0086
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Description
ANDROXY (Fluoxymesterone Tablets, USP) contains fluoxymesterone, a synthetic androgen. The androgens are steroids that develop and maintain primary and secondary male sex characteristics. Androgens are ...
2. Clinical Pharmacology
Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of prostate, ...
3. Indications and Usage
Males ANDROXY Tablets are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) Testicular failure ...
4. Contraindications
Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate and in women who are or may become pregnant. When administered to pregnant women, ...
5. Warnings
This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such ...
6.1. General
Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly, and menstrual irregularities). Discontinuation of drug therapy at the time of evidence of mild ...
6.2. Information for Patients
Male adolescent patients receiving androgens for delayed puberty should have bone development checked every six months. The physician should instruct patients to report any of the following side effects ...
6.3. Laboratory Tests
Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgen therapy <em>(see WARNINGS)</em>. Because of the hepatotoxicity ...
6.4. Drug Interactions
When administered concurrently, the following drugs may interact with androgens: <u>Anticoagulants, oral:</u> C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported ...
6.5. Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T<sub>4</sub> serum levels and increased resin uptake of T<sub>3</sub> and T<sub>4</sub>. Free thyroid hormone ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence ...
6.7. Pregnancy
Category X <em>(see CONTRAINDICATIONS)</em>
6.9. Nursing Mothers
It is not known whether androgens are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from androgens, ...
6.10. Pediatric Use
Androgen therapy should be used very cautiously in children and only by specialists who are aware of the adverse effects on bone maturation. Skeletal maturation must be monitored every six months by an ...
7. Adverse Reactions
<u>Endocrine and Urogenital:</u> Female: The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including ...
8. Drug Abuse and Dependence
ANDROXY Tablets are classified as a Schedule III controlled substance under the Anabolic Steroids Control Act of 1990.
9. Overdosage
There have been no reports of acute overdosage with androgens.
10. Dosage and Administration
ANDROXY (Fluoxymesterone Tablets, USP), for oral administration, may be given as a single daily dose or in divided doses. Dosage and duration of therapy will depend on age, sex, diagnosis, patients response ...
11. How Supplied
ANDROXY (Fluoxymesterone Tablets, USP) 10 mg are round, green, scored compressed tablets debossed with 832 and 86 and are available in bottles of 100. Dispense in a tight, light-resistant container as ...
12. Storage and Handling
Store at controlled room temperature 15–30°C (59–86°F). Keep out of reach of children.