Europe — EMA
Novastep (Ethinylestradiol, Levonorgestrel)
GNH USA supplies Novastep (Ethinylestradiol / Levonorgestrel), a combined estrogen-progestogen oral contraceptive for prevention of pregnancy.
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What is Ethinylestradiol, Levonorgestrel?
Ethinylestradiol / Levonorgestrel, the active ingredient in Novastep, is a combined estrogen-progestogen oral contraceptive presented as a tablet for oral use. It prevents pregnancy in women of reproductive age. GNH USA supplies Novastep as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Ethinylestradiol, Levonorgestrel used for?
Novastep, a combined estrogen‑progestogen oral contraceptive, is used for hormonal contraception and related menstrual conditions. - Prevention of pregnancy: provides reliable birth control for women of childbearing age. - Regulation of menstrual cycles: helps achieve predictable bleeding patterns and reduces dysmenorrhea. - Treatment of acne: can improve acne by decreasing androgenic activity in the skin.
What are the side effects of Ethinylestradiol, Levonorgestrel?
Novastep may cause a range of adverse reactions, most of which are mild and transient.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: swelling or discomfort. - Spotting or breakthrough bleeding: irregular light bleeding. - Mood changes: irritability or emotional fluctuations. - Weight gain: modest increase in body weight.
Serious or Rare Side Effects: - Deep vein thrombosis: blood clot formation in deep veins. - Pulmonary embolism: clot migration to lung arteries. - Stroke: cerebrovascular accident due to clot or hemorrhage. - Myocardial infarction: heart attack from reduced coronary flow. - Hepatic adenoma: benign liver tumor. - Severe allergic reaction: anaphylaxis with rash, swelling, or breathing difficulty.
What precautions apply to Ethinylestradiol, Levonorgestrel?
Before prescribing Novastep, clinicians should consider several safety factors. - Assess thrombotic risk: evaluate personal or family history of clotting disorders. - Screen for hypertension: ensure blood pressure is controlled before use. - Avoid smoking: especially in women over 35 years of age. - Monitor liver function: caution in patients with hepatic disease. - Contraindicated in pregnancy: do not use in pregnant women. - Store at ambient temperature: keep below 25°C in the original pack, protect from moisture.
What does Ethinylestradiol, Levonorgestrel interact with?
Novastep can interact with other medicines, altering its effectiveness or safety.
Major Interactions (Avoid): - Enzyme‑inducing anticonvulsants (e.g., carbamazepine): reduce contraceptive efficacy. - Rifampin: markedly decreases plasma hormone levels. - St. John’s wort: may lead to contraceptive failure.
Moderate Interactions (Monitor Closely): - Certain antibiotics (e.g., tetracycline): may slightly lower effectiveness. - Antifungal agents (e.g., ketoconazole): can increase hormone concentrations. - Selective serotonin reuptake inhibitors: may heighten risk of mood changes.



