Danogen 50

DANOGEN 50

Name:

• Brand Name: DANOGEN 50
• Common Name: Danazol

Composition: Each capsule of DANOGEN 50 contains 50 mg of Danazol as the active ingredient.

Uses: DANOGEN 50 (Danazol) is a synthetic steroid primarily used to treat various conditions by modulating female hormones in the body. It is prescribed for:

• Endometriosis: To alleviate pain, reduce the size of endometrial implants, and manage symptoms like pelvic pain and heavy menstrual periods.
• Fibrocystic Breast Disease: To decrease pain and nodularity in swollen, tender breasts with non-cancerous lumps when other treatments are unsuccessful.
• Hereditary Angioedema: To prevent or reduce the frequency of attacks of swelling in various parts of the body.
• Other uses: May also be used for heavy menstrual bleeding, painful or irregular periods, and premenstrual tension (PMS).

Dosage and Administration: DANOGEN 50 is typically taken orally as directed by a healthcare professional. The dosage varies depending on the condition and individual response.

• Endometriosis: Mild cases may start with 200-400 mg/day divided BID, while moderate-to-severe cases may begin with 800 mg/day divided BID. Therapy is usually continued for 6 to 9 months.
• Fibrocystic Breast Disease: Doses typically range from 100-400 mg/day divided BID, with maintenance therapy for 3-6 months.
• Hereditary Angioedema: Initial dosing may be 200 mg two or three times a day, then gradually decreased. The medicine can be taken with or without food, but should be taken at the same time each day. Capsules should be swallowed whole and not crushed or chewed.

Side Effects: Common side effects can include androgen-like effects and menstrual changes.

• Common Side Effects: Weight gain, acne, oily skin or hair, flushing, sweating, nervousness, irritability, mood changes, decreased breast size, vaginal dryness/irritation/burning, changes in menstrual cycle (spotting, irregular bleeding, missed periods), hair loss, and voice changes.
• Serious Side Effects: Include blood clots, liver damage (yellowing of skin/eyes, pain in stomach area, unusual bleeding), increased pressure around the brain (severe headache, nausea, vomiting, vision problems), and changes in cholesterol levels.

Precautions:

• Pregnancy and Breastfeeding: DANOGEN 50 is contraindicated during pregnancy and breastfeeding, as it may harm the fetus and decrease the effectiveness of hormonal contraceptives. Effective non-hormonal birth control must be used.
• Medical Conditions: Use with caution in patients with a history of migraine, heart, liver, or kidney disease, seizures, stroke, blood clots, breast cancer, or porphyria. Regular monitoring of liver function and blood sugar levels is advised.
• Drug Interactions: DANOGEN 50 can interact with antidiabetic drugs (causing insulin resistance), cyclosporin, tacrolimus (increasing their renal toxicity), synthetic vitamin D analogs (increasing calcemic response), and statins like simvastatin, atorvastatin, and lovastatin (increasing risk of myopathy/rhabdomyolysis).

Storage: Store DANOGEN 50 at room temperature (between 20°C and 25°C), protected from light, in a dry place, away from heat and moisture. Keep out of reach of children and pets. Do not keep outdated medicine.

Here are frequently asked questions about DANOGEN 50 by CIPLA LTD:

What is DANOGEN 50 used for?

DANOGEN 50 (Danazol) is primarily used to treat endometriosis, a condition where tissue similar to the lining of the uterus grows outside it. It also manages fibrocystic breast disease (non-cancerous breast lumps that may be painful), hereditary angioedema (an allergic condition causing swelling), and certain menstrual problems like heavy or painful periods and premenstrual syndrome (PMS).

How does DANOGEN 50 work?

DANOGEN 50 works by decreasing the levels of certain female hormones, particularly estrogen, in the body. It does this by suppressing the activity of the ovaries and reducing the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the pituitary gland. This action induces a temporary menopause-like state, which helps to shrink displaced endometrial tissue, decrease the growth rate of abnormal breast tissue, and reduce attacks in hereditary angioedema.

What is the usual dosage for DANOGEN 50?

The dosage of DANOGEN 50 varies depending on the condition being treated and individual response. For endometriosis, adults typically take 200-800 mg daily in two divided doses for 3-6 months, or up to 9 months if necessary. For benign breast disorders, the initial dose is often 100-400 mg daily in two divided doses for 3-6 months. It should always be taken strictly as prescribed by your doctor. DANOGEN 50 can be taken with or without food, ideally at a fixed time each day.

What are the possible side effects of DANOGEN 50?

Common side effects can include acne, weight gain, fluid retention (edema), hair loss, increased body or facial hair (hirsutism), changes in voice (hoarseness, deepening), irregular menstrual cycles, decreased breast size, nausea, headache, dizziness, and oily skin. If these side effects persist or worsen, consult your doctor.

Is DANOGEN 50 safe during pregnancy or breastfeeding?

No, DANOGEN 50 is contraindicated and highly unsafe during pregnancy as it may cause birth defects. Women of childbearing potential are advised to use effective, non-hormonal contraception while taking this medicine. It is also unsafe during breastfeeding because small amounts of the drug may be excreted in breast milk and cause toxicity to the baby.

Can DANOGEN 50 be taken with other medications?

DANOGEN 50 can interact with several medications. It may increase the effect of blood thinners like warfarin, raising the risk of bleeding. It can also increase the blood levels of certain drugs such as carbamazepine, cyclosporine, tacrolimus, and alfacalcidol. DANOGEN 50 may reduce the effectiveness of medications for diabetes and high blood pressure. Concomitant use with certain cholesterol-lowering medicines (statins like simvastatin, atorvastatin, and lovastatin) can increase the risk of muscle problems. Always inform your doctor about all other medications, supplements, or herbal products you are currently taking.

What precautions should be taken while using DANOGEN 50?

Caution is advised if you have pre-existing conditions such as liver disease, kidney disease, heart problems, epilepsy, migraine, diabetes mellitus, or a history of blood clots. Alcohol consumption should be avoided or limited as it may cause shortness of breath or sickness. DANOGEN 50 may cause dizziness, vertigo, or blurred vision, so avoid driving or operating machinery if you experience these effects. Inform your doctor if you are allergic to Danazol or any other ingredients, or if you are scheduled for surgery.

What happens if a dose of DANOGEN 50 is missed?

If you miss a dose of DANOGEN 50, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

How should DANOGEN 50 be stored?

DANOGEN 50 should be stored in a cool and dry place, away from direct sunlight. Keep it out of the reach and sight of children. The recommended storage temperature is below 25°C or below 30°C. Protect it from light and moisture.