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Oxandrin
Overview
What is Oxandrin?
What does Oxandrin look like?
What are the available doses of Oxandrin?
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What should I talk to my health care provider before I take Oxandrin?
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How should I use Oxandrin?
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What interacts with Oxandrin?
- Known or suspected carcinoma of the prostate or the male breast.
- Carcinoma of the breast in females with hypercalcemia (androgenic anabolic steroids may stimulate osteolytic bone resorption).
- Pregnancy, because of possible masculinization of the fetus. Oxandrin has been shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when given in doses 9 times the human dose.
- Nephrosis, the nephrotic phase of nephritis.
- Hypercalcemia.
What are the warnings of Oxandrin?
Trasylol should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. Before initiating treatment with Trasylol, the recommendations below should be followed to manage a potential hypersensitivity or anaphylactic reaction: 1) Have standard emergency treatments for hypersensitivity or anaphylactic reactions readily available in the operating room (e.g., epinephrine, corticosteroids). 2) Administration of the initial (test) dose and loading dose should be done only when the patient is intubated and when conditions for rapid cannulation and initiation of cardiopulmonary bypass are present. 3) Delay the addition of Trasylol into the pump prime solution until after the loading dose has been safely administered.
Cholestatic hepatitis and jaundice may occur with 17-alpha-alkylated androgens at a relatively low dose. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, oxandrolone should be discontinued and the etiology should be determined. Drug-induced jaundice is reversible when the medication is discontinued.
In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis. Oxandrolone therapy should be discontinued if hypercalcemia occurs.
Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. Concomitant administration of adrenal cortical steroid or ACTH may increase the edema.
In children, androgen therapy may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect results in compromised adult height. The younger the child, the greater the risk of compromising final mature height. The effect on bone maturation should be monitored by assessing bone age of the left wrist and hand every 6 months (See ).
Geriatric patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
ANABOLIC STEROIDS HAVE NOT BEEN SHOWN TO ENHANCE ATHLETIC ABILITY.
What are the precautions of Oxandrin?
Concurrent dosing of oxandrolone with warfarin may result in unexpectedly large increases in the INR or prothrombin time (PT). When oxandrolone is prescribed to patients being treated with warfarin, doses of warfarin may need to be decreased
significantly to maintain the desirable INR level and diminish the risk of potentially serious bleeding
PRECAUTIONS: Drug Interactions
General
Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly). Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens. Menstrual irregularities may also occur.
Anabolic steroids may cause suppression of clotting factors II, V, VII, and X, and an increase in prothrombin time.
Information for Patients
The physician should instruct patients to report immediately any use of warfarin and any bleeding.
The physician should instruct patients to report any of the following side effects of androgens:
Males:
Females:
All patients:
Geriatric use
Oxandrin, at daily doses of 5 mg bid, and 10 mg bid, was evaluated in four clinical trials involving a total of 339 patients with different underlying medical conditions. The maximum duration of treatment was 4 months with the average duration of treatment from 68.5 days to 94.7 days across the studies. A total of 172 elderly patients ( ≥ 65 years of age) received Oxandrin treatment. Mean weight gain was similar in those ≥ 65 and those < 65 years of age. No significant differences in efficacy were detected between the 5 mg bid and 10 mg bid daily doses. The adverse event profiles were similar between the two age groups although the elderly, particularly in women, had a greater sensitivity to fluid retention and increases in hepatic transaminases. A single dose pharmacokinetic study in elderly volunteers revealed an increased half-life when compared to younger volunteers. (see ) Based on greater sensitivity to drug-induced fluid retention and transaminase elevations, a lower dose is recommended in the elderly (see ).
Laboratory Tests
Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of therapy. (See ).
Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically.
Periodic (every 6 months) x-ray examinations of bone age should be made during treatment of children to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers.
Androgenic anabolic steroids have been reported to increase low-density lipoproteins and decrease high-density lipoproteins. Therefore, caution is required when administering these agents to patients with a history of cardiovascular disease or who are at risk for cardiovascular disease. Serum determination of lipid levels should be performed periodically and therapy adjusted accordingly.
Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolic steroids.
Drug Interactions
Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain desired prothrombin time. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.
Oxandrolone may inhibit the metabolism of oral hypoglycemic agents.
In patients with edema, concomitant administration with adrenal cortical steroids or ACTH may increase the edema.
Drug/Laboratory test interactions
Anabolic steroids may decrease levels of thyroxine-binding globulin, resulting in decreased total T serum levels and increased resin uptake of T and T. Free thyroid hormone levels remain unchanged. In addition, a decrease in PBI and radioactive iodine uptake may occur.
Carcinogenesis, mutagenesis, impairment of fertility
Oxandrolone has not been tested in laboratory animals for carcinogenic or mutagenic effects. In 2-year chronic oral rat studies, a dose-related reduction of spermatogenesis and decreased organ weights (testes, prostate, seminal vesicles, ovaries, uterus, adrenals, and pituitary) were shown.
Liver cell tumors have been reported in patients receiving long-term therapy with androgenic anabolic steroids in high doses (See ). Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.
Pregnancy
Teratogenic effects-Pregnancy Category X (See ).
Nursing mothers
It is not known whether anabolic steroids are excreted in human milk. Because of the potential of serious adverse reactions in nursing infants from oxandrolone, 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.
Pediatric use
Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children and the effect may continue for 6 months after the drug has been stopped. Therefore, therapy should be monitored by x-ray studies at 6-month intervals in order to avoid the risk of compromising adult height. Androgenic anabolic steroid therapy should be used very cautiously in children and only by specialists who are aware of the effects on bone maturation (See ).
What are the side effects of Oxandrin?
Patients with moderate to severe COPD or COPD patients who are unresponsive to bronchodilators should be monitored closely for COPD exacerbation and fluid retention.
The following adverse reactions have been associated with use of anabolic steroids: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis with long-term therapy (See ). Reversible changes in liver function tests also occur including increased bromsulfophthalein (BSP) retention, changes in alkaline phosphatase and increases in serum bilirubin, aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT)
In males:
Prepubertal:
Postpubertal:
In females:
Clitoral enlargement, menstrual irregularities.
CNS:
Hematologic:
Breast:
Larynx:
Hair:
Skin:
Skeletal:
Fluid and electrolytes:
Metabolic/Endocrine:
What should I look out for while using Oxandrin?
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What might happen if I take too much Oxandrin?
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How should I store and handle Oxandrin?
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Clinical Information
Chemical Structure
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Non-Clinical Toxicology
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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