Europe — EMA
Oedien (Dienogest, Ethinylestradiol | Lactose Monohydrate)
Dienogest, the active ingredient in Oedien, is a progestin presented as a combined oral tablet for systemic use. It is used in hormonal contraceptive regimens and for the management of certain estrogen‑dependent…
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What is Dienogest, Ethinylestradiol | Lactose Monohydrate?
Dienogest, the active ingredient in Oedien, is a progestin presented as a combined oral tablet for systemic use. It is used in hormonal contraceptive regimens and for the management of certain estrogen‑dependent conditions in women of reproductive age. GNH USA supplies Oedien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
GNH USA supplies Oedien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Dienogest, Ethinylestradiol | Lactose Monohydrate used for?
Oedien combines dienstrogest and ethinylestradiol to treat conditions that are managed through hormonal modulation.
- Contraception: provides reliable, reversible birth control for women seeking oral hormonal contraception. - Endometriosis: reduces pelvic pain and lesion progression associated with endometriosis. - Menstrual disorders: helps regulate irregular menstrual cycles and associated symptoms.
What are the side effects of Dienogest, Ethinylestradiol | Lactose Monohydrate?
Adverse reactions may occur with any combined oral contraceptive and vary in frequency.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like. - Breast tenderness: temporary swelling or discomfort. - Weight gain: mild fluid retention. - Mood changes: irritability or mild depressive symptoms. - Spotting: breakthrough bleeding between periods.
Serious or Rare Side Effects: - Venous thromboembolism: deep vein thrombosis or pulmonary embolism. - Stroke: ischemic or hemorrhagic events. - Myocardial infarction: heart attack in susceptible individuals. - Severe hypertension: sudden, uncontrolled high blood pressure. - Hepatic adenoma: benign liver tumor development. - Allergic reaction: anaphylaxis or severe skin rash.
What precautions apply to Dienogest, Ethinylestradiol | Lactose Monohydrate?
When prescribing Oedien, clinicians should evaluate patient history and risk factors.
- Smoking status: avoid use in women over 35 who smoke regularly. - Cardiovascular risk: assess for hypertension, clotting disorders, or history of stroke. - Liver function: monitor in patients with hepatic impairment. - Migraine history: caution in those with migraine with aura. - Pregnancy and lactation: contraindicated during pregnancy and breastfeeding. - Store at ambient temperature: keep below 25°C, in original packaging, protected from moisture.
What does Dienogest, Ethinylestradiol | Lactose Monohydrate interact with?
Oedien may interact with several medication classes; careful review is recommended.
Major Interactions (Avoid): - Anticoagulants: increased risk of thrombotic events. - Certain pharmacokinetic inducers: CYP 3‑5 A5 ?. - Antiretroviral drugs: potentially ?? . - Herbal ?? . - Antibi ?? .
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