GNH USA

Europe — EMA

Naomi (Ethinylestradiol, Levonorgestrel)

GNH USA supplies Naomi (Ethinylestradiol and Levonorgestrel), a combined estrogen‑progestogen oral contraceptive for pregnancy prevention.

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What is Ethinylestradiol, Levonorgestrel?

Ethinylestradiol, the active ingredient in Naomi, is a combined estrogen‑progestogen oral contraceptive presented as an oral tablet for oral use. It is indicated for prevention of pregnancy in women of reproductive age. GNH USA supplies Naomi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Ethinylestradiol, Levonorgestrel used for?

Naomi is a combined estrogen‑progestogen oral contraceptive that works within the hormonal birth‑control pathway. - Prevention of pregnancy: provides reliable contraception for women of child‑bearing potential. - Oral contraceptive: delivers a regulated dose of estrogen and progestogen to inhibit ovulation. - Menstrual cycle regulation: helps achieve more predictable menstrual bleeding patterns.

What are the side effects of Ethinylestradiol, Levonorgestrel?

Adverse reactions may occur with any hormonal contraceptive.

Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: swelling or discomfort of the breasts. - Spotting or irregular bleeding: breakthrough bleeding between periods. - Mood changes: irritability or emotional fluctuations.

Serious or Rare Side Effects: - Deep vein thrombosis: blood clot formation in deep veins. - Pulmonary embolism: clot migration to lung vessels. - Stroke: cerebrovascular accident due to clot or hemorrhage.

What precautions apply to Ethinylestradiol, Levonorgestrel?

Before prescribing Naomi, clinicians should evaluate individual risk factors and counsel patients accordingly. - Cardiovascular risk assessment: avoid in women with history of thromboembolic disease. - Smoking restriction: do not use in smokers over 15 cigarettes per day. - Liver disease review: contraindicated in severe hepatic impairment. - Pregnancy category: X – must not be used during pregnancy. - Blood pressure monitoring: check regularly in hypertensive patients. - Store below 25°C: keep in the original pack, protect from moisture.

What does Ethinylestradiol, Levonorgestrel interact with?

Naomi can interact with other medicines that affect hormone metabolism or clotting pathways.

Major Interactions (Avoid): - Enzyme‑inducing antiepileptics (e.g., carbamazepine): reduce contraceptive efficacy. - Rifampicin: markedly decreases hormone levels. - St. John’s wort: may lead to breakthrough bleeding.

Moderate Interactions (Monitor Closely): - Antifungal agents (e.g., ketoconazole): may increase hormone concentrations. - Selective serotonin reuptake inhibitors (SSRIs): possible alteration of bleeding pattern. - Diuretics: may affect fluid balance and blood pressure control.

Frequently asked questions

What is Naomi used for?+
Naomi is a combined estrogen‑progestogen oral tablet indicated for the prevention of pregnancy. It provides hormonal contraception by inhibiting ovulation and creating cervical mucus changes that reduce the likelihood of fertilisation.
How does ethinylestradiol work in Naomi?+
Ethinylestradiol binds to estrogen receptors and, together with levonorgestrel, suppresses the mid‑cycle surge of luteinizing hormone (LH) and follicle‑stimulating hormone (FSH). This suppression prevents ovulation and, together with progestogenic effects, makes the uterine environment less suitable for implantation.
What is the usual dose of Naomi?+
The dosing regimen for Naomi is determined by the prescribing healthcare professional. Typically, it is taken once daily as directed on the prescription label, but the exact schedule and number of tablets per pack are set by the prescriber.
Is Naomi safe to use during pregnancy or breastfeeding?+
Naomi is classified as pregnancy category X, meaning it must not be used during pregnancy because it can cause fetal harm. It is also not recommended while breastfeeding unless the benefits outweigh the risks, and a healthcare provider should be consulted.
How do I order Naomi from GNH USA?+
To order Naomi, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA supplies 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 Naomi compare with other combined oral contraceptives?+
Naomi contains the standard doses of ethinylestradiol and levonorgestrel, a widely used progestogen. Compared with pills that use newer progestins, Naomi offers a well‑characterised safety profile and efficacy, but individual tolerability may differ, so clinicians choose based on patient history and risk factors.
How should Naomi be stored and handled?+
Naomi tablets should be stored below 25 °C in their original packaging, protected from moisture and direct sunlight. Keep the container tightly closed and out of reach of children to maintain product stability and potency.
How is Naomi administered?+
Naomi is taken orally, usually once daily at the same time each day. The tablet is swallowed whole with water and should be started according to the prescriber’s instructions, often on the first day of the menstrual cycle or after a hormone‑free interval.
What are the most serious risks associated with Naomi?+
The most serious risks include thromboembolic events such as deep‑vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. Women with a history of clotting disorders, smoking more than 15 cigarettes per day, or certain cardiovascular conditions should avoid using Naomi.
Who should not use Naomi?+
Naomi is contraindicated in women who are pregnant, have a history of thromboembolic disease, uncontrolled hypertension, severe liver disease, known or suspected breast cancer, or who smoke heavily (more than 15 cigarettes per day) and are over 35 years of age.
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
Sandoz S.P.A.
Origin
EU

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