Danazol 50 mg/1
Danazol · CAPSULE · Chartwell RX, LLC.
Danazol is a capsule containing danazol at 50 mg/1, taken oral. Manufactured by Chartwell RX, LLC..
Key Facts
- Brand Name
- Danazol
- Generic Name
- Danazol
- NDC Code (Product)
62135-475- Manufacturer
- Chartwell RX, LLC.
- Strength
- 50 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077246
- Drug Class
- Androgen [EPC]
- Marketing Start
- 04/19/2007
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema. Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
Dosage & Administration
DOSAGE AND ADMINISTRATION Endometriosis. In moderate to severe disease, or in patients infertile due to endometriosis, a starting dose of 800 mg given in two divided doses is recommended. Amenorrhea and rapid response to painful symptoms is best achieved at this dosage level. Gradual downward titration to a dose sufficient to maintain amenorrhea may be considered depending upon patient response. For mild cases, an initial daily dose of 200 mg to 400 mg given in two divided doses is recommended and may be adjusted depending on patient response. Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with danazol capsules (see CONTRAINDICATIONS and WARNINGS ). It is essential that therapy continue uninterrupted for 3 to 6 months but may be extended to 9 months if necessary. After termination of therapy, if symptoms recur, treatment can be reinstituted. Hereditary Angioedema. The dosage requirements for continuous treatment of hereditary angioedema with danazol capsules should be individualized on the basis of the clinical response of the patient. It is recommended that the patient be starte…
Contraindications
CONTRAINDICATIONS Danazol capsules should not be administered to patients with: Undiagnosed abnormal genital bleeding. Markedly impaired hepatic, renal, or cardiac function. Pregnancy (see WARNINGS ). Breast feeding. Porphyria-Danazol capsules can induce ALA synthetase activity and hence porphyrin metabolism. Androgen-dependent tumor. Active thrombosis or thromboembolic disease and history of such events. Hypersensitivity to danazol.
Adverse Reactions
ADVERSE REACTIONS The following events have been reported in association with the use of danazol capsules: Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare. Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with danazol capsules, persistent amenorrhea has occasionally been reported. Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy. Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in …
Frequently Asked Questions
What is Danazol used for?
Danazol contains Danazol. It is a capsule taken oral. Consult your doctor for specific uses.
Is Danazol a controlled substance?
Danazol is not classified as a controlled substance by the DEA.
What is the generic name for Danazol?
The generic name for Danazol is Danazol. There are no other listed brand versions of Danazol.
What is the NDC code for Danazol 50 mg/1?
The NDC (National Drug Code) for Danazol 50 mg/1 is 62135-475, listed by Chartwell RX, LLC..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)