Oxymetholone
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Overview
Oxymetholone is an anabolic steroid that is FDA approved for the treatment of anaemia. Common adverse reactions include cholestatic jaundice, clitoral enlargement, menstrual irregularities,insomnia, nausea, vomiting, diarrhea, gynecomastia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Oxymetholone tablets is indicated in the treatment of anemias caused by deficient red cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond. Anadrol®-50 Tablets should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy and the appropriate use of corticosteroids.
Dosage
The recommended daily dose in adults is 1-5 mg/kg of body weight per day. The usual effective dose is 1-2 mg/kg/day but higher doses may be required, and the dose should be individualized. Response is not often immediate, and a minimum trial of three to six months should be given. Following remission, some patients may be maintained without the drug; others may be maintained on an established lower daily dosage. A continued maintenance dose is usually necessary in patients with congenital aplastic anemia.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Oxymetholone in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxymetholone in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
Oxymetholone tablets is indicated in the treatment of anemias caused by deficient red cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond. Anadrol®-50 Tablets should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy and the appropriate use of corticosteroids.
Dosage
The recommended daily dose in children is 1-5 mg/kg of body weight per day. The usual effective dose is 1-2 mg/kg/day but higher doses may be required, and the dose should be individualized. Response is not often immediate, and a minimum trial of three to six months should be given. Following remission, some patients may be maintained without the drug; others may be maintained on an established lower daily dosage. A continued maintenance dose is usually necessary in patients with congenital aplastic anemia.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Oxymetholone in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxymetholone in pediatric patients.
Contraindications
There is limited information regarding Oxymetholone Contraindications in the drug label.
Warnings
There is limited information regarding Oxymetholone Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Oxymetholone in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Oxymetholone in the drug label.
Drug Interactions
There is limited information regarding Oxymetholone Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oxymetholone in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Oxymetholone during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Oxymetholone with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Oxymetholone with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Oxymetholone with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Oxymetholone with respect to specific gender populations.
Race
There is no FDA guidance on the use of Oxymetholone with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Oxymetholone in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Oxymetholone in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Oxymetholone in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Oxymetholone in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Oxymetholone in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Oxymetholone in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Oxymetholone in the drug label.
Pharmacology
There is limited information regarding Oxymetholone Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Oxymetholone Mechanism of Action in the drug label.
Structure
There is limited information regarding Oxymetholone Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Oxymetholone in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Oxymetholone in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Oxymetholone in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Oxymetholone in the drug label.
How Supplied
Storage
There is limited information regarding Oxymetholone Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Oxymetholone in the drug label.
Precautions with Alcohol
- Alcohol-Oxymetholone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Oxymetholone Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Oxymetholone Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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