Danamet Capsule

Introduction

Danamet Capsule 100 mg is an orally active synthetic derivative of testosterone. It is marketed as a prophylactic treatment of endometriosis, fibrocystic breast disease, and hereditary angioedema (HAE). It is used in women and men to treat symptoms of hormone-related conditions, such as endometriosis, Fibrocystic Breast Disease (FBD), and angioedema.

Uses

Danamet Capsule 100 mg is used to treat:

Endometriosis, a condition where cells from the lining of the uterus migrate outside of the uterus and attach to other parts inside the body
Fibrocystic breast disease, a condition where benign lumps are formed in the breasts
Hereditary angioedema (HAE), a rare condition that causes the swelling of the face, tongue and other body parts
Uterine fibroids, non-cancerous tumors in the uterus

Brand Name	Danamet
Type	Capsule
Weight	100 mg
Generic	Danazol
Manufacturer	Eskayef Pharmaceuticals Ltd.
Available in	English বাংলা

Mechanism of Action

Danamet Capsule 100 mg works by blocking the action of hormones responsible for the development of endometriosis, fibrocystic breast disease, and angioedema. It also blocks the production of gonadotropins and decreases the production of ovarian androgens. As a result, danazol reduces the symptoms associated with these conditions.

How Long Does It Take to Work?

The effects of danazol may be noticed in as little as a few days, but the full effects typically take 4 to 6 weeks to appear. It is important to note that danazol does not cure endometriosis, fibrocystic breast disease, or hereditary angioedema. It only controls the symptoms while taking the medication. When treatment is discontinued, the symptoms may return.

Absorption

Danamet Capsule 100 mg is absorbed rapidly and completely after oral administration. Its bioavailability (i.e., absorption) is about 95%.

Route of Elimination

Danamet Capsule 100 mg is eliminated mainly via the urine and small amounts are also eliminated in the feces.

Dosage

Usually given in up to 4 divided doses; in women of child-bearing potential, treatment should start during menstruation, preferably on first day.

Endometriosis: 200-800 mg daily in up to 4 divided doses, adjusted to achieve amenorrhoea, usually for 6 months (up to 9 months in some cases).

Menorrhagia: In menorrhagia daily doses of 100-200 mg have been found effective but 200 mg daily for 3 months is usually sufficient to reduce menstrual blood flow to acceptable levels.

Severe cyclical mastalgia: 100-400 mg daily usually for 3-6 months.

Benign breast cysts: 300 mg daily usually for 3-6 months.

Gynaecomastia: 400 mg daily in up to 4 divided doses for 6 months (adolescents 200 mg daily, increased to 400 mg daily if no response after 2 months).

For pre-operative thinning of endometrium: 400 mg-800 mg daily in up to 4 divided doses for 3-6 weeks.

Children: Danazol is not used in children.

Danamet Capsule 100 mg is available as a tablet or capsule in the following strengths: 50 mg, 100 mg and 200 mg. Depending on the condition being treated, your doctor may prescribe 100 mg to 400 mg of danazol per day in divided doses.

Administration

Danamet Capsule 100 mg is typically taken with meals or at bedtime. To reduce the risk of side effects, take it with food or a full glass of water. Do not crush, chew or break the tablets, as this can lead to an increased risk of side effects.

Side Effects

Common side effects associated with danazol include:

Headache
Drowsiness
Weight change
Nausea
Difficulty sleeping
Increased facial hair growth
Tenderness and enlargement of male breast tissue
Abnormal vaginal bleeding or spotting
Decreased sex drive

Toxicity

High doses of danazol can cause serious toxicity, including liver and kidney toxicity. The symptoms of danazol toxicity include fatigue, jaundice, nausea, abdominal pain, dark urine, itching and rash.

Precaution

Danamet Capsule 100 mg should not be used in individuals who have had a hypersensitivity or allergic reaction to danazol or any of its components. People with liver disease, kidney disease or diabetes should discuss the use of danazol with their doctor before starting treatment. Danamet Capsule 100 mg can cause female birth defects if taken during pregnancy. Therefore, danazol should not be taken by women who are pregnant or trying to become pregnant. Women taking danazol should also use effective contraception to prevent pregnancy.

Interaction

Danamet Capsule 100 mg may interact with other medicines, vitamins, herbs or supplements. Examples of medicines that may interact with danazol include oral contraceptives, warfarin, amiodarone, cimetidine, phenytoin, carbamazepine, rifampin and St. John's wort. Herbal supplements, such as ginkgo biloba and garlic, may also interact with danazol. It is important to tell your doctor about all medicines and supplements you are taking before starting danazol.

Disease interaction

Danamet Capsule 100 mg can interact with chronic illnesses like diabetes, heart disease, liver disease, and kidney disease. It is important to talk to your doctor about any chronic illness you have before starting danazol.

Drug Interactions

It is important to tell your doctor about any other medications you are taking, especially if they are oral contraceptives. Danamet Capsule 100 mg can also interact with other drugs like warfarin, amiodarone, cimetidine, phenytoin, carbamazepine, and rifampin.

Food Interactions

Danamet Capsule 100 mg should not be taken with or after a high-fat meal as it can reduce its absorption. It can also interact with grapefruit juice as it can increase the amount of the drug in the body.

Pregnancy Use

Danamet Capsule 100 mg should not be used by women who are pregnant as it can cause female birth defects. Women of childbearing age should use effective contraception while taking danazol. Danamet Capsule 100 mg can pass into breastmilk and may harm a nursing infant. Therefore, danazol should not be used if you are pregnant, breastfeeding, or planning to become pregnant.

Lactation Use

Danamet Capsule 100 mg is not recommended for use in breastfeeding women due to the risk of adverse effects on the infant. Danamet Capsule 100 mg can pass into breastmilk and may harm a nursing infant. Therefore, danazol should not be used if you are breastfeeding or planning to become pregnant.

Acute Overdose

The symptoms of an acute overdose of danazol may include nausea, vomiting, stomach pain, diarrhea, fatigue, rash, dizziness, or drowsiness. If you or anyone else has taken too much danazol, contact your doctor or poison control center immediately.

Contraindication

Danamet Capsule 100 mg is contraindicated in individuals who have had a hypersensitivity or allergic reaction to danazol or any of its components. It is also contraindicated in women who are pregnant or breastfeeding.

Use Direction

Danamet Capsule 100 mg should be taken with food or a full glass of water. Do not crush, chew or break the tablets, as this can lead to an increased risk of side effects. The dose should be taken at the same time each day to maintain an even level of the drug in the body.

Storage Condition

Danamet Capsule 100 mg should be stored at room temperature, away from moisture and heat. Do not store in the bathroom or near sources of heat or moisture. Keep the medication in the original container and away from children and pets.