Danogen 100 Mg Capsule (10 Cap)

DANOGEN 100 MG CAPSULE

Name:

• Common Name: Danogen
• Brand Name: DANOGEN 100 MG CAPSULE (manufactured by Cipla Ltd.)

Composition: Each capsule contains Danazol 100 mg as the active ingredient.

Uses: DANOGEN 100 MG CAPSULE is a synthetic steroid primarily used to treat various conditions, including:

• Endometriosis: A disorder where tissue similar to the lining of the uterus grows outside the uterus, causing pelvic pain and other symptoms.
• Benign Fibrocystic Breast Disease: Characterized by painful breast cysts or lumps that are not malignant.
• Heavy Menstrual Bleeding (Menorrhagia).
• Painful or Irregular Periods.
• Premenstrual Tension (PMT).
• Hereditary Angioedema: An allergic condition causing episodes of swelling.

Dosage and Administration: DANOGEN 100 MG CAPSULE should be taken orally, with or without food, exactly as prescribed by your doctor. It is advised to take the capsule whole with a glass of water, without chewing, crushing, or breaking it. To achieve the best benefit, it should be taken at the same time each day. The dosage and duration of treatment depend on the medical condition being treated; for endometriosis, typical doses range from 200 to 800 mg daily in divided doses, and for fibrocystic breast disease, 100 to 400 mg daily.

Side Effects: Common side effects may include:

• Weight gain, acne, oily skin or hair, hair loss, excessive hair growth on the body or face (hirsutism).
• Changes in menstrual cycle, irregular periods, decrease in breast size, vaginal dryness and irritation.
• Sore throat, hoarse voice or voice changes.
• Stomach pain, nausea, headache, dizziness, vertigo, fatigue, sweating, flushing.
• Mood changes, nervousness, irritability.
• Skin rashes, chest pain, edema (swelling).

If side effects persist or worsen, consult your doctor.

Precautions:

• Contraindications: Do not use DANOGEN 100 MG CAPSULE if you are pregnant (Category X) or breastfeeding, allergic to danazol, or have severe liver, kidney, or heart disease. It is also contraindicated in patients with porphyria, undiagnosed vaginal bleeding, certain hormone-sensitive cancers, a history of blood clots (thrombosis), or if taking simvastatin.
• Warnings: Use effective non-hormonal contraceptives during treatment as it can cause birth defects. Avoid or limit alcohol consumption as it may cause shortness of breath or make you feel sick. This medicine may cause dizziness, vertigo, or blurred vision; therefore, avoid driving or operating heavy machinery if you experience these symptoms. Inform your doctor if you are undergoing surgery, have diabetes, migraines, or blood circulation problems. Regular monitoring of blood sugar, liver function tests, and complete blood counts is recommended during treatment.
• Overdose: Symptoms of overdose may include dark urine, severe stomach/abdominal pain, and yellowing of eyes/skin. Seek immediate medical attention if an overdose is suspected.

Storage: Store DANOGEN 100 MG CAPSULE at room temperature in an airtight container, away from direct sunlight, heat, and moisture. Keep it out of reach and sight of children.

DANOGEN 100 MG CAPSULE, containing Danazol, is a synthetic steroid primarily used to manage various gynecological conditions. It works by affecting hormone levels in the body.

What is DANOGEN 100 MG CAPSULE used for?

DANOGEN 100 MG CAPSULE is primarily used to treat endometriosis, a condition where tissue similar to the lining of the uterus grows outside it, causing pain and irregularities. It is also prescribed for benign fibrocystic breast disease, which involves painful or tender breast lumps that are not cancerous. Other uses include managing severe cyclical mastalgia (breast pain associated with hormonal variations), dysfunctional uterine bleeding, symptomatic gynecomastia, preoperative thinning of the endometrium, and hereditary angioedema (a condition causing episodes of swelling).

How does DANOGEN 100 MG CAPSULE work?

DANOGEN 100 MG CAPSULE, which contains Danazol, functions as an anterior pituitary suppressant. It works by inhibiting the output of gonadotropins (hormones like FSH and LH) from the pituitary gland, which in turn reduces the amount of estrogen produced by the ovaries. This action effectively induces a temporary menopause-like state, causing both normal and displaced endometrial tissues to become inactive and shrink. Additionally, it has some androgenic (male hormone-like) properties, can directly inhibit ovarian steroidogenesis, and affects steroid hormone carrier proteins, further contributing to its therapeutic effects.

What is the usual dosage for DANOGEN 100 MG CAPSULE?

The dosage of DANOGEN 100 MG CAPSULE varies depending on the condition being treated and individual patient response.

• For endometriosis, a starting dose of 800 mg per day, typically divided into two doses, may be recommended, then titrated downwards to a dose sufficient to maintain amenorrhea (absence of menstruation). Treatment usually lasts for 6 to 9 months.
• For fibrocystic breast disease, the total daily dosage can range from 100 mg to 400 mg, given in two divided doses. Maintenance therapy usually continues for 3 to 6 months.
• For hereditary angioedema, an initial dose of 200 mg two or three times a day is common, which may then be decreased by 50% at intervals of at least 1-3 months.

Always take this medicine exactly as prescribed by your doctor.

What are the possible side effects of DANOGEN 100 MG CAPSULE?

Many common side effects are associated with DANOGEN 100 MG CAPSULE due to its hormonal effects. These can include weight gain, acne, oily skin or hair, flushing, sweating, hair loss, and changes in voice (such as hoarseness or deepening of pitch). Other common side effects include abnormal growth of body hair (hirsutism), vaginal dryness, irritation, burning or itching, decreased breast size, water retention or bloating, depression, irritability, mood changes, and alterations in the menstrual cycle (spotting, irregular bleeding, or missed periods). Sore throat, stomach pain, nausea, headache, and feeling tired are also possible.

More serious side effects, though less common, require immediate medical attention. These include swelling of your hands and feet, severe dizziness, trouble breathing, and serious eye symptoms like sudden vision loss, blurred vision, or eye pain. You should also seek urgent medical care if you experience symptoms of blood clots (e.g., warm, red, swollen, or tender leg; chest pain, trouble breathing, sudden severe headache, sudden vision changes) or liver damage (e.g., yellowing of the skin or eyes, pain in the stomach area, extreme tiredness, unusual bleeding or bruising, dark urine, light-colored stools).

Is DANOGEN 100 MG CAPSULE safe during pregnancy or breastfeeding?

No, DANOGEN 100 MG CAPSULE is considered highly unsafe during pregnancy and is contraindicated for use in breastfeeding women. It can cause birth defects if taken during pregnancy. Women who can become pregnant must use effective, non-hormonal contraception throughout treatment with DANOGEN 100 MG CAPSULE. Small amounts of Danazol may also be excreted in breast milk, posing potential risks to a breastfed infant.

Can DANOGEN 100 MG CAPSULE be taken with other medications?

DANOGEN 100 MG CAPSULE can interact with several medications, potentially increasing their effects or causing serious side effects. It may increase the effect of blood thinners like warfarin, epilepsy medications such as carbamazepine, and immunosuppressants like cyclosporine and tacrolimus. Concomitant use with statins (e.g., simvastatin, atorvastatin, lovastatin) is particularly cautioned as it can increase the risk of myopathy and rhabdomyolysis; simvastatin is contraindicated with Danazol. DANOGEN 100 MG CAPSULE may also increase the effect of alfacalcidol (a form of vitamin D) and certain anesthetics. Conversely, DANOGEN 100 MG CAPSULE may decrease the effectiveness of medicines used for diabetes (as it can cause insulin resistance), high blood pressure, and hormonal contraceptives (birth control pills, patches, rings, implants, or injections). Always inform your doctor about all medications, supplements, and herbal products you are taking.

What precautions should be taken while taking DANOGEN 100 MG CAPSULE?

Several important precautions should be observed when taking DANOGEN 100 MG CAPSULE. It is crucial not to take this medicine if you are pregnant or breastfeeding, and to use effective non-hormonal birth control during treatment. Inform your doctor if you have any pre-existing conditions such as liver, kidney, or heart problems, high blood pressure, diabetes, epilepsy, migraines, polycythemia, unusual vaginal bleeding that hasn't been diagnosed, or a history of blood clots or hormone-sensitive cancers.

Avoid consuming alcohol while on this medication, as it may cause shortness of breath or make you feel sick. DANOGEN 100 MG CAPSULE can cause dizziness, a spinning feeling (vertigo), or blurred vision, so avoid driving or operating heavy machinery if you experience these symptoms. Your doctor may recommend regular blood tests to monitor your liver, kidney, and thyroid function, as well as blood cell counts, during treatment. If you are scheduled for any surgery, inform your doctor that you are taking this medicine, as it may affect certain anesthetics. Do not stop taking DANOGEN 100 MG CAPSULE without consulting your doctor.

What happens if a dose of DANOGEN 100 MG CAPSULE is missed?

If you miss a dose of DANOGEN 100 MG CAPSULE, 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 compensate for the missed one.

How should DANOGEN 100 MG CAPSULE be stored?

DANOGEN 100 MG CAPSULE should be stored at room temperature, ideally between 68°F and 77°F (20°C and 25°C). It can tolerate brief exposures to temperatures between 59°F and 86°F (15°C and 30°C), for instance, during transport. Keep the medicine in a cool, dry place.