Danazol200 mg

Danazol 200 mg is a synthetic androgen derivative used for:

• Treatment of endometriosis amenable to hormonal management, in patients with pain and/or infertility
• Symptomatic relief of fibrocystic breast disease with significant nodularity, pain, and tenderness that has not responded to simpler measures
• Prevention of attacks of hereditary angioedema (cutaneous, abdominal, and laryngeal) in males and females

Danazol 200 mg is generally reserved for moderate to severe cases of these conditions, after simpler or first-line treatments have been tried or are not suitable.

Contains Danazol 200 mg as the active ingredient, available as oral capsules, commonly in 50 mg, 100 mg, and 200 mg strengths.

Danazol 200 mg is a synthetic steroid derived from ethisterone, with weak androgenic (male hormone-like) activity, used to treat endometriosis and fibrocystic breast disease by suppressing ovarian hormone production, and to prevent attacks of hereditary angioedema by increasing levels of a protein (C1 esterase inhibitor) that is deficient in this condition. Its androgenic activity means it commonly causes masculinizing side effects such as acne, increased body hair, and voice changes, which can be more pronounced with prolonged or higher-dose use; it is strictly contraindicated in pregnancy, given a well-documented risk of causing genital abnormalities in a female fetus.

Therapeutic Class: Synthetic Androgen (Antigonadotropic Agent)

Danazol 200 mg suppresses the pituitary-ovarian axis by inhibiting pituitary output of gonadotropins (LH and FSH), through a combination of reduced hypothalamic-pituitary response to lowered oestrogen, altered sex steroid metabolism, and direct interaction with sex hormone receptors. This pituitary-suppressive action is reversible after stopping the drug. Danazol 200 mg is lipophilic and readily partitions into cell membranes and can induce ALA synthetase activity, relevant to its contraindication in porphyria.

• Taken orally, usually twice daily, with or without food - choose one approach and stick with it consistently for each dose
• A sensitive pregnancy test is recommended immediately before starting therapy in women of childbearing potential
• Non-hormonal contraception should be used during treatment, since Danazol 200 mg's own hormonal effects can make hormonal methods less reliable and pregnancy must be strictly avoided

The following interactions require careful assessment, since Danazol 200 mg is a moderate inhibitor of CYP3A4 and P-glycoprotein:

• Simvastatin: Danazol 200 mg significantly increases simvastatin levels, raising the risk of rhabdomyolysis (severe muscle breakdown); this combination is contraindicated.
• Warfarin: Danazol 200 mg can significantly enhance the anticoagulant effect of warfarin; closer INR monitoring and dose adjustment are typically needed.
• Carbamazepine: Danazol 200 mg can increase carbamazepine blood levels, increasing toxicity risk.
• Insulin and oral antidiabetic medicines: Danazol 200 mg can worsen glucose tolerance, potentially requiring adjustment of diabetes treatment.
• Cyclosporine and tacrolimus: Danazol 200 mg may increase blood levels of these immunosuppressants; monitoring is advisable.
• Other CYP3A4-metabolized medicines (including certain benzodiazepines and some other statins): Danazol 200 mg can raise their blood levels; discuss all current medicines with your doctor before starting Danazol 200 mg.

Common side effects

• Weight gain
• Acne, oily skin
• Menstrual irregularities, including amenorrhoea (absent periods)
• Hot flushes
• Mood changes
• Muscle cramps

Androgenic (virilizing) effects, particularly with prolonged use

• Hirsutism (increased body/facial hair)
• Voice deepening, which can be irreversible even after stopping the medicine - report any voice changes to your doctor promptly
• Clitoral enlargement

Serious side effects (seek urgent medical attention)

• Signs of liver problems: yellowing of the skin or eyes, dark urine, unusual fatigue, upper abdominal pain - Danazol 200 mg has been associated with liver enzyme elevation and, rarely, more serious liver toxicity or benign liver tumours (peliosis hepatis, hepatic adenoma) with long-term use.
• Signs of a blood clot: leg swelling and pain, chest pain, sudden shortness of breath.
• Signs of raised intracranial pressure (pseudotumor cerebri): severe headache, visual disturbances, nausea, vomiting.
• Signs of a severe allergic reaction: rash, swelling, difficulty breathing.

Pregnancy

Danazol 200 mg is strictly contraindicated in pregnancy. It can cause virilization of a female fetus, including urogenital sinus abnormalities, fused labia, and clitoral enlargement, particularly with exposure from around the eighth week of pregnancy onward. A sensitive pregnancy test is required immediately before starting therapy, and effective, reliable non-hormonal contraception must be used throughout treatment. Discontinue immediately and consult a doctor if pregnancy occurs during treatment.

Breastfeeding

Danazol 200 mg is contraindicated during breastfeeding.

• Absolute pregnancy contraindication: confirm a negative pregnancy test before starting, and use effective non-hormonal contraception throughout treatment.
• Virilizing effects: voice changes (deepening, hoarseness) can be irreversible; report any voice changes to your doctor immediately, and consider stopping treatment if they occur, since continuing may lead to permanent changes.
• Liver monitoring: periodic liver function testing is recommended, particularly with prolonged use, given the risk of enzyme elevation and rare but serious liver complications.
• Thrombosis risk: avoid in patients with a history of blood clots or active thromboembolic disease.
• Use with caution in patients with epilepsy, migraine, cardiac or renal dysfunction, or diabetes, given Danazol 200 mg's potential to cause fluid retention and affect glucose tolerance.
• Monitor closely during dose adjustments for hereditary angioedema, especially in patients with airway involvement.

Limited data exist on acute Danazol 200 mg overdose; excessive or prolonged dosing is more likely to result in exaggerated androgenic and hepatic effects rather than acute life-threatening toxicity from a single overdose. Suspected significant overdose should be evaluated by a healthcare professional; treatment is generally supportive.

Store at room temperature, protected from moisture and light, as directed on the product label. Keep out of reach of children.

• Women of reproductive potential: Require a confirmed negative pregnancy test before starting and effective non-hormonal contraception throughout treatment, given the absolute pregnancy contraindication.
• Elderly: No specific age-related dosing problems have been documented, though appropriate studies in this population are limited.
• Hepatic, renal, or cardiac impairment: Contraindicated in marked impairment of any of these organs; frequent monitoring is recommended if used in milder impairment.
• Men treated for hereditary angioedema: Also require monitoring for virilizing-type effects (such as changes in libido) and liver function, though feminizing/virilizing concerns specific to female patients do not apply.

For endometriosis, Danazol 200 mg is typically used for 3 to 9 months. For hereditary angioedema, it may be needed long-term, with the dose gradually reduced to the lowest level that prevents attacks once initial control is achieved. For fibrocystic breast disease, duration depends on symptom response, as determined by the treating physician.

Drug Class: Synthetic steroid derived from ethisterone, with androgenic and antigonadotropic activity

In endometriosis and fibrocystic breast disease, Danazol 200 mg suppresses the pituitary's release of the hormones that normally stimulate the ovaries, reducing the body's production of oestrogen and creating a low-hormone ("pseudomenopause") state that shrinks endometrial tissue and reduces breast tissue stimulation. In hereditary angioedema, Danazol 200 mg works through a different mechanism, increasing the liver's production of C1 esterase inhibitor, the protein that is deficient or dysfunctional in this condition, which helps prevent the swelling attacks characteristic of the disease.

Use and dosing of Danazol 200 mg in children must be determined by a specialist physician; it is used only in specific circumstances, such as certain cases of hereditary angioedema, with dosing and monitoring individualized based on the child's age, weight, and clinical need, given the significant hormonal effects of this medicine.