Europe — EMA
Kliogest (Norethisterone Acetate, Estradiol)
GNH USA supplies Kliogest (Norethisterone Acetate/Estradiol), a combined oral contraceptive for pregnancy prevention and hormone therapy.
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What is Norethisterone Acetate, Estradiol?
Norethisterone Acetate and Estradiol, the active ingredients in Kliogest, are a combined oral contraceptive presented as a tablet for oral use. It is used to prevent pregnancy, manage menstrual disorders, and provide hormone replacement therapy for menopausal women.
GNH USA supplies Kliogest as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Norethisterone Acetate, Estradiol used for?
Kliogest, a combined estrogen‑progestogen oral contraceptive, is indicated for several hormone‑related conditions.
- Prevention of pregnancy: provides reliable contraception for women of reproductive age. - Management of menstrual disorders: reduces irregular bleeding and alleviates dysmenorrhea. - Hormone replacement therapy: supplies estrogen and progestogen to relieve menopausal symptoms.
What are the side effects of Norethisterone Acetate, Estradiol?
Kliogest may cause a range of adverse reactions. The most frequently reported events are generally mild and transient.
Common Side Effects: - Nausea - Headache - Breast tenderness - Spotting or breakthrough bleeding - Weight change - Mood swings
Serious or Rare Side Effects: - Venous thromboembolism (deep‑vein thrombosis, pulmonary embolism) - Stroke or transient ischemic attack - Myocardial infarction - Severe hypertension - Liver dysfunction or cholestasis - Allergic reactions, including anaphylaxis
What precautions apply to Norethisterone Acetate, Estradiol?
Before prescribing Kliogest, clinicians should evaluate individual risk factors and counsel patients on safe use.
- Cardiovascular assessment: screen for hypertension, smoking, or a history of thromboembolic disease. - Age and smoking: avoid use in women over 35 who smoke. - Liver function: monitor patients with hepatic impairment. - Blood pressure monitoring: check regularly during therapy. - Patient education: advise on signs of VTE, stroke, or severe headache. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Norethisterone Acetate, Estradiol interact with?
Kliogest can interact with several medicines, altering its effectiveness or increasing risk of adverse events.
Major Interactions (Avoid): - Rifampin and other strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, St. John’s wort) – may reduce contraceptive efficacy. - Certain antifungal agents (e.g., ketoconazole) – can increase hormone levels and risk of toxicity. - Griseofulvin – may diminish contraceptive protection.
Moderate Interactions (Monitor Closely): - Anticoagulants such as warfarin – may require INR monitoring. - Antidepressants (SSRIs, SNRIs) – potential for increased mood‑related side effects. - Antihypertensive drugs – may experience altered blood pressure control. - Anticonvulsants like valproate – may affect hormone metabolism. - Herbal supplements (e.g., ginseng) – possible impact on hormone levels.



