Europe — EMA
Monostep (Ethinylestradiol, Levonorgestrel)
GNH USA supplies Monostep (Ethinylestradiol / Levonorgestrel), a combined oral contraceptive for prevention of pregnancy. Request a quote for global supply.
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What is Ethinylestradiol, Levonorgestrel?
Ethinylestradiol / Levonorgestrel, the active ingredients in Monostep, are a combined oral contraceptive presented as tablets for oral use. The formulation combines an estrogen and a progestogen to deliver reliable contraception for women of reproductive age, preventing unintended pregnancy.
GNH USA supplies Monostep as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑controlled manufacturing, regulatory compliance, and reliable global distribution for healthcare providers. The company adheres to EU Good Manufacturing Practice and provides comprehensive documentation for import and pharmacovigilance.
What is Ethinylestradiol, Levonorgestrel used for?
Monostep, a combined oral contraceptive, is indicated for hormonal contraception to prevent pregnancy. - Contraception: prevents unintended pregnancy by inhibiting ovulation and altering cervical mucus. - Menstrual cycle regulation: helps achieve regular menstrual periods and reduces heavy bleeding. - Acne management: may improve hormonal acne associated with androgen excess.
What are the side effects of Ethinylestradiol, Levonorgestrel?
Monostep may be associated with a range of adverse reactions, varying in frequency and severity.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Breast tenderness: swelling or discomfort in the breasts. - Headache: occasional throbbing or tension‑type pain. - Spotting between periods: light vaginal bleeding.
Serious or Rare Side Effects: - Venous thromboembolism: blood clots in deep veins or lungs. - Arterial thrombosis: stroke or myocardial infarction risk. - Severe hypertension: sudden high blood pressure. - Liver tumor: benign hepatic adenoma.
What precautions apply to Ethinylestradiol, Levonorgestrel?
Before prescribing Monostep, clinicians should evaluate several safety considerations. - Assess thromboembolic risk: review personal or family history of clotting disorders. - Avoid smoking: especially in women over 35 years of age. - Monitor blood pressure: hypertension may develop during therapy. - Evaluate liver function: hepatic impairment can affect hormone metabolism. - Counsel on medication adherence: missed tablets reduce contraceptive effectiveness. - Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture.
What does Ethinylestradiol, Levonorgestrel interact with?
Monostep can interact with other medicines, altering its efficacy or safety.
Major Interactions (Avoid): - Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): reduce hormonal levels. - Rifampin or other rifamycins: decrease contraceptive effectiveness. - St. John’s wort: herbal inducer that lowers hormone concentrations.
Moderate Interactions (Monitor Closely): - Antifungal agents (e.g., ketoconazole): may increase hormone levels and side effects. - Certain antiretrovirals (e.g., protease inhibitors): can affect plasma concentrations.



