GNH USA

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.

Frequently asked questions

What is Novastep used for?+
Novastep is a prescription oral tablet that combines ethinylestradiol and levonorgestrel to provide hormonal contraception. It is primarily used to prevent pregnancy in women of reproductive age and may also help regulate menstrual cycles and improve acne.
How does ethinylestradiol / levonorgestrel work?+
The combination suppresses the hypothalamic‑pituitary‑ovarian axis, preventing the luteinising hormone surge that triggers ovulation. Levonorgestrel thickens cervical mucus and alters the endometrium, while ethinylestradiol stabilises the uterine lining, together reducing the chance of fertilisation and implantation.
What is the usual dose of Novastep?+
The dosing regimen for Novastep is determined by the prescribing clinician based on the product’s labeling and the patient’s individual needs. Patients should follow the prescriber’s instructions and take the tablet at the same time each day.
Is Novastep safe to use during pregnancy or breastfeeding?+
Novastep is classified as pregnancy category X, meaning it must not be used during pregnancy because it can cause fetal harm. Its safety during breastfeeding has not been established; women should consult their healthcare provider before using it while nursing.
How do I order Novastep from GNH USA?+
To order Novastep, 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 Novastep compare with other combined oral contraceptives?+
Novastep contains the same active ingredients as many other combined oral contraceptives, offering comparable efficacy and safety profiles. Differences among products usually relate to hormone dose, tablet composition, and brand‑specific excipients, which may affect tolerability for individual patients.
What are the storage and handling requirements for Novastep?+
Novastep tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack to protect them from moisture and light. Keep the medication out of reach of children and do not use if the packaging is damaged.
How is Novastep administered?+
Novastep is taken orally, usually once daily, at the same time each day. The typical regimen involves a 21‑day active tablet sequence followed by a 7‑day hormone‑free interval, during which withdrawal bleeding occurs.
What are the most serious risks associated with Novastep?+
Serious risks include venous thromboembolism, pulmonary embolism, stroke, myocardial infarction, hepatic adenoma, and severe allergic reactions. Patients should seek immediate medical attention if they experience symptoms such as sudden leg pain, shortness of breath, chest pain, severe headache, or signs of anaphylaxis.
Who should not use Novastep?+
Novastep is contraindicated in women who are pregnant, have a history of thromboembolic disorders, uncontrolled hypertension, certain liver diseases, known or suspected breast cancer, or who are smokers over the age of 35. It should also be avoided in individuals with known hypersensitivity to any component of the tablet.
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
Ethinylestradiol, Levonorgestrel
Route
Oral Use
Manufacturer
Jenapharm Gmbh & Co Kg
Origin
EU

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