Europe — EMA
Orindille (Drospirenone, Ethinylestradiol)
GNH USA supplies Orindille (Drospirenone/Ethinylestradiol), a combined oral contraceptive for prevention of pregnancy and menstrual regulation.
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What is Drospirenone, Ethinylestradiol?
Drospirenone, the active ingredient in Orindille, is a combined oral contraceptive presented as a tablet for oral use, together with ethinylestradiol. It prevents unintended pregnancy in women of reproductive age.
GNH USA supplies Orindille as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Drospirenone, Ethinylestradiol used for?
Orindille, a combined oral contraceptive, is indicated for the following clinical uses: - Contraception: Prevents unintended pregnancy by inhibiting ovulation and altering cervical mucus. - Menstrual cycle regulation: Provides regular, predictable menstrual bleeding. - Acne vulgaris: Reduces inflammatory acne lesions in women who also require contraception.
What are the side effects of Drospirenone, Ethinylestradiol?
Orindille may cause a range of adverse reactions, which are generally categorized by frequency and severity.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: swelling or discomfort. - Weight gain: mild fluid retention.
Serious or Rare Side Effects: - Venous thromboembolism: blood clots in deep veins or lungs. - Hypertensive crisis: severe increase in blood pressure. - Liver dysfunction: jaundice or abnormal liver enzymes.
What precautions apply to Drospirenone, Ethinylestradiol?
Before prescribing Orindille, clinicians should consider the following precautions: - Smoking: avoid in women over 35 who smoke, due to increased thrombotic risk. - Cardiovascular disease: contraindicated in patients with history of stroke, myocardial infarction, or uncontrolled hypertension. - Migraine with aura: avoid because of elevated stroke risk. - Liver disease: use with caution in severe hepatic impairment. - Pregnancy: discontinue immediately if pregnancy is confirmed. - Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture and light.
What does Drospirenone, Ethinylestradiol interact with?
Orindille can interact with several medicines, affecting its efficacy or safety.
Major Interactions (Avoid): - Combined hormonal contraceptives with enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may reduce contraceptive effectiveness. - Rifampicin or other strong CYP3A4 inducers: significantly decrease plasma levels of drospirenone and ethinylestradiol. - Anticoagulants (e.g., warfarin): may increase risk of thrombosis.
Moderate Interactions (Monitor Closely): - Antidepressants (SSRIs, SNRIs): may increase risk of bleeding when combined with NSAIDs. - Antifungals (ketoconazole, itraconazole): may increase hormone levels, requiring monitoring. - Herbal supplements containing St. John’s wort: may reduce contraceptive efficacy.



