Product image of Midane (Cyproterone Acetate, Ethinylestradiol) supplied by GNH India

Midane

Active Ingredient:
Cyproterone Acetate, Ethinylestradiol
Origin:
EU

Midane (Cyproterone Acetate, Ethinylestradiol)

Cyproterone acetate and ethinylestradiol, the active ingredients in Midane, are a combined estrogen‑progestogen oral contraceptive presented as an unspecified strength/oral tablet for oral use. It provides hormonal contraception and anti‑androgen therapy for women of reproductive age, and is indicated for prevention of pregnancy and for treatment of androgen‑dependent conditions such as acne and hirsutism.

GNH India supplies Midane as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Pelpharma Handels Gmbh

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Indications & Clinical Uses

Midane, a combined estrogen‑progestogen oral contraceptive, is used in hormonal regulation pathways for several clinical indications.

  • Contraception: Prevents pregnancy by inhibiting ovulation.
  • Acne: Reduces androgen‑driven facial and trunk acne in women.
  • Hirsutism: Decreases excessive facial and body hair growth associated with androgen excess.

How It Works

  • Midane combines ethinylestradiol, a synthetic estrogen, with cyproterone acetate, a progestogen that also blocks androgen receptors. Ethinylestradiol suppresses the hypothalamic‑pituitary‑gonadal axis, lowering gonadotropin release and preventing follicular development. Cyproterone acetate further inhibits gonadotropin secretion and competitively antagonizes androgen receptors, resulting in ovulation suppression and mitigation of androgen‑mediated skin effects.

Side Effects

Midane may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Nausea: mild stomach upset often occurring early in treatment.
  • Headache: transient tension‑type or migraine‑like headaches.
  • Breast tenderness: mild swelling or discomfort of the breasts.
  • Weight change: slight increase or fluctuation in body weight.

Serious or Rare Side Effects

  • Venous thromboembolism: blood clot formation in deep veins or lungs.
  • Hepatic dysfunction: abnormal liver enzymes or jaundice.
  • Hypertensive crisis: sudden severe increase in blood pressure, especially with certain medications.

Precautions & Warnings

Before prescribing Midane, clinicians should consider several precautionary measures to ensure patient safety.

  • Contraindication: pregnancy – product is classified as Category X and must not be used.
  • Cardiovascular risk: avoid in women with a history of thromboembolic disorders, myocardial infarction or stroke.
  • Liver disease: use with caution in patients with active hepatic disease or impaired function.
  • Smoking: contraindicated in women over 35 who smoke heavily.
  • Drug interactions: review concomitant medications that may increase clot risk or affect hormone metabolism.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging and protect from moisture.

Avoid Interactions

Midane can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Combined hormonal contraceptives with other estrogen‑containing products: increased risk of thrombosis.
  • Anticoagulants (e.g., warfarin): may reduce anticoagulant effect, requiring monitoring.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may lower plasma levels of both components, reducing effectiveness.

Moderate Interactions (Monitor Closely)

  • Antiepileptics (e.g., phenytoin): may modestly decrease hormone levels.
  • Antiretrovirals (e.g., protease inhibitors): can increase hormone concentrations, raising side‑effect risk.
  • St. John’s wort: may reduce contraceptive efficacy.

Frequently Asked Questions

Midane is a prescription oral tablet that combines cyproterone acetate and ethinylestradiol. It is primarily used for hormonal contraception to prevent pregnancy, and it also treats androgen‑dependent skin conditions such as acne and hirsutism in women of reproductive age.

Ethinylestradiol suppresses the hypothalamic‑pituitary‑gonadal axis, reducing the release of gonadotropins and thereby preventing ovulation. Cyproterone acetate adds anti‑androgen activity by blocking androgen receptors and further inhibiting gonadotropin secretion, which together provide contraceptive efficacy and improve androgen‑related dermatologic conditions.

The dosing regimen for Midane is determined by the prescribing clinician based on the product label and individual patient factors. Typically, the medication is taken once daily for a defined cycle, but the exact schedule and duration should be confirmed with the healthcare provider.

Midane is classified as Pregnancy Category X, meaning it must not be used during pregnancy because it can cause fetal harm. It is also generally not recommended for breastfeeding women, as the hormones can be excreted in breast milk and may affect the infant.

To order Midane, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

Midane offers the same contraceptive efficacy as other combined estrogen‑progestogen pills but includes cyproterone acetate, which provides additional anti‑androgenic activity. This makes it particularly useful for patients who also need treatment for acne or hirsutism, a benefit not shared by all standard combined oral contraceptives.

Midane tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original blister pack or container, protect them from moisture and direct sunlight, and ensure they are out of reach of children.

Midane is taken orally as a tablet, usually once each day at the same time. It can be taken with or without food, but consistency with respect to meals helps maintain stable absorption. Patients should follow the schedule prescribed by their healthcare professional.

The most serious adverse events associated with Midane include venous thromboembolism (blood clots), hepatic dysfunction (liver enzyme abnormalities or jaundice), and hypertensive crises. Patients should seek immediate medical attention if they experience unexplained leg pain, shortness of breath, severe abdominal pain, yellowing of the skin or eyes, or a sudden, severe increase in blood pressure.

Midane should not be used by women who are pregnant, have a known clotting disorder, have a history of stroke or myocardial infarction, are over 35 years old and smoke heavily, have active liver disease, or have known hypersensitivity to any component of the formulation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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