GNH USA

Europe — EMA

Madeleine

GNH USA supplies Madeleine (Drospirenone/Ethinylestradiol), a combined oral contraceptive for pregnancy prevention. Request a quote for global supply.

Drospirenone, Ethinylestradiol

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What is Drospirenone, Ethinylestradiol?

Drospirenone/Ethinylestradiol, the active ingredient in Madeleine, is a combined oral contraceptive presented as a tablet for oral use. It works by inhibiting ovulation and altering cervical mucus, providing effective pregnancy prevention for women of reproductive age.

GNH USA supplies Madeleine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring consistent quality, regulatory compliance, and reliable logistics for global healthcare providers while adhering to stringent manufacturing standards.

What is Drospirenone, Ethinylestradiol used for?

Madeleine, a combined oral contraceptive, is indicated for contraception, a hormonal pathway that prevents pregnancy.

- Pregnancy prevention: provides reliable contraception for women of childbearing potential. - Moderate acne treatment: reduces acne lesions by regulating hormonal influence on the skin. - Premenstrual dysphoric disorder (PMDD) management: alleviates emotional and physical symptoms associated with the menstrual cycle.

What are the side effects of Drospirenone, Ethinylestradiol?

Common Side Effects: - Nausea: mild to moderate stomach upset, often transient. - Breast tenderness: swelling or discomfort in the breast tissue. - Headache: varying intensity, may improve with continued use. - Breakthrough bleeding: spotting between periods, especially during the first cycles. - Weight gain: modest fluid retention or appetite changes. - Mood changes: irritability or mild mood swings.

Serious or Rare Side Effects: - Venous thromboembolism: deep vein thrombosis or pulmonary embolism, requiring immediate medical attention. - Arterial thrombosis: stroke or myocardial infarction, particularly in high‑risk individuals. - Severe hypertension: sudden increase in blood pressure, potentially leading to organ damage. - Liver disorders: jaundice or hepatic dysfunction. - Severe allergic reactions: rash, swelling, or anaphylaxis.

What precautions apply to Drospirenone, Ethinylestradiol?

Before starting Madeleine, consider the following precautions: - Contraindication: history of venous or arterial thromboembolism, or known clotting disorders. - Pregnancy: not to be used during pregnancy; effective contraception is required. - Smoking: avoid if over 35 years old and smoking more than 15 cigarettes per day. - Liver disease: use with caution in severe hepatic impairment. - Migraine with aura: contraindicated due to increased stroke risk. - Store at ambient temperature: keep below 25 °C, retain in the original packaging, and protect from moisture.

What does Drospirenone, Ethinylestradiol interact with?

Madeleine may interact with other medicines as follows:

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort): may markedly reduce contraceptive effectiveness. - Potent antifungal agents (e.g., ketoconazole, itraconazole): can increase hormone levels, raising the risk of adverse effects.

Moderate Interactions (Monitor Closely): - Certain antibiotics (e.g., macrolides, tetracyclines): may slightly lower efficacy; monitor for breakthrough bleeding. - Selective serotonin reuptake inhibitors (SSRIs): potential for increased bleeding tendency. - Antihypertensives (e.g., beta‑blockers, ACE inhibitors): may require blood‑pressure monitoring due to possible interaction.

Frequently asked questions

What is Madeleine used for?+
Madeleine is a combined oral contraceptive tablet used to prevent pregnancy in women of reproductive age. It works by suppressing ovulation and creating conditions in the cervix and uterus that are unfavorable for fertilization and implantation.
How does drospirenone/ethinylestradiol work?+
Drospirenone/ethinylestradiol binds to progesterone and estrogen receptors, inhibiting the release of luteinizing hormone and follicle‑stimulating hormone from the pituitary gland. This blocks ovulation, thickens cervical mucus, and stabilizes the endometrial lining, collectively preventing conception.
What is the usual dose of Madeleine?+
The dosing regimen for Madeleine is determined by the prescribing clinician. Typically, it involves taking one tablet daily at the same time each day, following the specific cycle schedule indicated on the prescription label.
Is Madeleine safe to use during pregnancy or breastfeeding?+
Madeleine is contraindicated during pregnancy and should not be started by women who are already pregnant. While limited data exist for breastfeeding, most guidelines advise caution; the prescriber will assess the risk‑benefit ratio for each individual.
How do I order Madeleine from GNH USA?+
To order Madeleine, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.
How does Madeleine compare with other combined oral contraceptives?+
Madeleine contains drospirenone, a progestin with anti‑aldosterone activity, which may offer a lower risk of water retention compared with some other progestins. Its efficacy in preventing pregnancy is comparable to other combined oral contraceptives, while its side‑effect profile may differ slightly based on the hormonal components.
How should Madeleine be stored and handled?+
Store Madeleine at ambient temperature, preferably below 25 °C. Keep the tablets in the original blister pack, protect them from moisture and direct sunlight, and keep them out of reach of children.
How is Madeleine administered?+
Madeleine is taken orally as a tablet. The usual practice is to swallow one tablet each day, preferably at the same time, with or without food, following the cycle schedule prescribed by the healthcare provider.
What are the most serious risks associated with Madeleine?+
The most serious risks include venous thromboembolism (deep‑vein thrombosis or pulmonary embolism), arterial thrombosis (stroke or myocardial infarction), severe hypertension, and liver disorders. Prompt medical attention is required if symptoms such as sudden chest pain, shortness of breath, severe headache, or abdominal pain occur.
Who should not use Madeleine?+
Madeleine should not be used by women with a history of blood‑clotting disorders, active or past venous/arterial thrombosis, known or suspected breast cancer, uncontrolled hypertension, severe liver disease, or migraine with aura. It is also contraindicated during pregnancy and in smokers over 35 years of age who smoke more than 15 cigarettes per day.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Drospirenone, Ethinylestradiol
Route
Oral Use
Manufacturer
Sandoz Pharmaceuticals D.D.
Origin
EU

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