Oxandrolone

When are you taking this medicine? Empty stomach Before food After food With a meal

Oxandrolone uses

• Indications and usage
• Drug abuse and dependence
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Oxandrolone reviews

INDICATIONS AND USAGE

Oxandrolone Tablets, USP are indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis (see DOSAGE AND ADMINISTRATION ).

DRUG ABUSE AND DEPENDENCE

Oxandrolone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III (non-narcotic).

CONTRAINDICATIONS

• 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. Oxandrolone 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.

WARNINGS

PELIOSIS HEPATIS, A CONDITION IN WHICH LIVER AND SOMETIMES SPLENIC TISSUE IS REPLACED WITH BLOOD-FILLED CYSTS, HAS BEEN REPORTED IN PATIENTS RECEIVING ANDROGENIC ANABOLIC STEROID THERAPY. THESE CYSTS ARE SOMETIMES PRESENT WITH MINIMAL HEPATIC DYSFUNCTION, BUT AT OTHER TIMES THEY HAVE BEEN ASSOCIATED WITH LIVER FAILURE. THEY ARE OFTEN NOT RECOGNIZED UNTIL LIFE-THREATENING LIVER FAILURE OR INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. WITHDRAWAL OF DRUG USUALLY RESULTS IN COMPLETE DISAPPEARANCE OF LESIONS.

LIVER CELL TUMORS ARE ALSO REPORTED. MOST OFTEN THESE TUMORS ARE BENIGN AND ANDROGEN-DEPENDENT, BUT FATAL MALIGNANT TUMORS HAVE BEEN REPORTED. WITHDRAWAL OF DRUG OFTEN RESULTS IN REGRESSION OR CESSATION OF PROGRESSION OF THE TUMOR. HOWEVER, HEPATIC TUMORS ASSOCIATED WITH ANDROGENS OR ANABOLIC STEROIDS ARE MUCH MORE VASCULAR THAN OTHER HEPATIC TUMORS AND MAY BE SILENT UNTIL LIFE-THREATENING INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. BLOOD LIPID CHANGES THAT ARE KNOWN TO BE ASSOCIATED WITH INCREASED RISK OF ATHEROSCLEROSIS ARE SEEN IN PATIENTS TREATED WITH ANDROGENS OR ANABOLIC STEROIDS. THESE CHANGES INCLUDE DECREASED HIGH-DENSITY LIPOPROTEINS AND SOMETIMES INCREASED LOW-DENSITY LIPOPROTEINS. THE CHANGES MAY BE VERY MARKED AND COULD HAVE A SERIOUS IMPACT ON THE RISK OF ATHEROSCLEROSIS AND CORONARY ARTERY DISEASE.

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 PRECAUTIONS, Laboratory Tests ).

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.

PRECAUTIONS

Concurrent dosing of Oxandrolone and warfarin may result in unexpectedly large increases in the International Normalized Ratio 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 (see 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:	Too frequent or persistent erections of the penis, appearance or aggravation of acne.
Females:	Hoarseness, acne, changes in menstrual periods, or more facial hair.
All patients:	Nausea, vomiting, changes in skin color, or ankle swelling.

Geriatric Use

Oxandrolone, 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 received Oxandrolone 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 CLINICAL PHARMACOLOGY ). Based on greater sensitivity to drug-induced fluid retention and transaminase elevations, a lower dose is recommended in the elderly (see DOSAGE AND ADMINISTRATION ).

Laboratory Tests

Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of therapy (see WARNINGS ).

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

Anticoagulants

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.

Warfarin

A multidose study of Oxandrolone, given as 5 or 10 mg bid in 15 healthy subjects concurrently treated with warfarin, resulted in a mean increase in S-warfarin half-life from 26 to 48 hours and AUC from 4.55 to 12.08 ng∙hr/mL; similar increases in R-warfarin half-life and AUC were also detected. Microscopic hematuria and gingival bleeding (1/15) were also observed. A 5.5-fold decrease in the mean warfarin dose from 6.13 mg/day to 1.13 mg/day (approximately 80 to 85% reduction of warfarin dose), was necessary to maintain a target INR of 1.5. When Oxandrolone therapy is initiated in a patient already receiving treatment with warfarin, the INR or prothrombin time (PT) should be monitored closely and the dose of warfarin adjusted as necessary until a stable target INR or PT has been achieved.

Furthermore, in patients receiving both drugs, careful monitoring of the INR or PT, and adjustment of the warfarin dosage if indicated are recommended when the Oxandrolone dose is changed or discontinued. Patients should be closely monitored for signs and symptoms of occult bleeding.

Oral Hypoglycemic Agents

Oxandrolone may inhibit the metabolism of oral hypoglycemic agents.

Adrenal Steroids or ACTH

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 T₄ serum levels and increased resin uptake of T₃ and T₄. Free thyroid hormone levels remain unchanged. In addition, a decrease in PBI and radioactive iodine uptake may occur.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal Data

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 were shown.

Human Data

Liver cell tumors have been reported in patients receiving long-term therapy with androgenic anabolic steroids in high doses (see WARNINGS ). 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

.

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 WARNINGS ).

ADVERSE REACTIONS

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:

Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis with long-term therapy (see WARNINGS ). 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: Phallic enlargement and increased frequency or persistence of erections.

Postpubertal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, and bladder irritability.

In Females

Clitoral enlargement, menstrual irregularities.

CNS: Habituation, excitation, insomnia, depression, and changes in libido.

Hematologic: Bleeding in patients on concomitant oral anticoagulant therapy.

Breast: Gynecomastia.

Larynx: Deepening of the voice in females.

Hair: Hirsutism and male pattern baldness in females.

Skin: Acne (especially in females and prepubertal males).

Skeletal: Premature closure of epiphyses in children (see PRECAUTIONS, Pediatric Use ).

Fluid and Electrolytes: Edema, retention of serum electrolytes (sodium chloride, potassium, phosphate, calcium).

Metabolic/Endocrine: Decreased glucose tolerance (see PRECAUTIONS, Laboratory Tests ), increased creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Masculinization of the fetus. Inhibition of gonadotropin secretion.

OVERDOSAGE

No symptoms or signs associated with overdosage have been reported. It is possible that sodium and water retention may occur.

The oral LD₅₀ of Oxandrolone in mice and dogs is greater than 5,000 mg/kg. No specific antidote is known, but gastric lavage may be used.

DOSAGE AND ADMINISTRATION

Therapy with anabolic steroids is adjunctive to and not a replacement for conventional therapy. The duration of therapy with Oxandrolone Tablets will depend on the response of the patient and the possible appearance of adverse reactions. Therapy should be intermittent.

Adults

The response of individuals to anabolic steroids varies. The daily adult dosage is 2.5 mg to 20 mg given in 2 to 4 divided doses. The desired response may be achieved with as little as 2.5 mg or as much as 20 mg daily. A course of therapy of 2 to 4 weeks is usually adequate. This may be repeated intermittently as indicated.

Children

For children the total daily dosage of Oxandrolone Tablets is ≤0.1 mg per kilogram body weight or ≤0.045 mg per pound of body weight. This may be repeated intermittently as indicated.

Geriatric Use

Recommended dose for geriatric patients is 5 mg bid.

HOW SUPPLIED

Oxandrolone Tablets, USP 2.5 mg are oval, white, scored, uncoated tablets, debossed with "2.5" on one side and "U" to the left and "S" to the right of the score on the other side. Oxandrolone Tablets, USP are available in bottles of 100 tablets (NDC 0245-0271-11), bottles of 1000 tablets (NDC 0245-0271-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0245-0271-01).

Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.

Keep out of reach of children.

Manufactured for

UPSHER-SMITH LABORATORIES, LLC

Maple Grove, MN 55369

by: Pharmaceutics International, Inc.

Hunt Valley, MD 21031

Revised 0617

NDC 0245-0271-11

Oxandrolone

Tablets, USP

2.5 mg

CIII

100 Tablets

Rx only

UPSHER-SMITH

Oxandrolone pharmaceutical active ingredients containing related brand and generic drugs:

• Oxandrolone

Oxandrolone available forms, composition, doses:

	Price
Oxandrin 10 mg tablet	27.02 USD
Oxandrin 2.5 mg tablet	8.08 USD
Oxandrolone 10 mg tablet	18.31 USD
Oxandrolone 100% powder	9.54 USD
Oxandrolone 2.5 mg tablet	5.53 USD
Tablets; Oral; Oxandrolone 10 mg
Tablets; Oral; Oxandrolone 2.5 mg

Oxandrolone destination | category:

• Human:
• Anabolic steroids

Oxandrolone Anatomical Therapeutic Chemical codes:

• A14AA08 - Oxandrolone

Oxandrolone pharmaceutical companies:

• Atlantis, Mexico
• Bio-Technology General
• Biotechnology General Israel
• CSL
• DSM Pharmaceuticals
• Kali Laboratories
• Pfizer
• Roxane Laboratories
• Sandoz
• Savient Pharmaceuticals
• Upsher-Smith Laboratories

References

1. Dailymed."OXANDROLONE TABLET [UPSHER-SMITH LABORATORIES, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."OXANDROLONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "OXANDROLONE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Oxandrolone?

Depending on the reaction of the Oxandrolone after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Oxandrolone not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Oxandrolone addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Oxandrolone, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Oxandrolone consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology