Manufacturer: Cipla, India
Pharmaceutical name: Cyproterone Acetate, Ethinylestradiol
Pack: 21 pills (0.035mg+2mg)
Ginette-35 is used as an oral contraceptive for women who need anti-androgen therapy. Cyproterone acetate can be combined with ethinyl estradiol to manage idiopathic hirsutism. It is also effective for treating severe acne, particularly androgen-related acne that involves inflammation, seborrhea, or the development of nodules. Each blister pack contains 21 active hormonal film-coated tablets, each containing 0.035 mg of Ethinylestradiol and 2 mg of Cyproterone Acetate, along with 7 inactive non-hormonal tablets.
Before starting Ginette-35, it is essential to conduct a thorough medical (including gynecological) examination and carefully assess the patient's medical history. Regular medical check-ups are advisable during the duration of use. Pregnancy must be ruled out.
Conditions related to the clotting system and any family history of thrombo-embolic diseases, especially at a young age, must be excluded.
Before prescribing Ginette-35 for hirsutism treatment, any androgen-producing tumors or adrenal enzyme defects should be ruled out.
For the first 14 days of the initial cycle or in case of a missed tablet, additional contraceptive measures are recommended. Spotting may occur but typically resolves on its own.
The patient should consult her healthcare provider if there are instances of prolonged and persistent bleeding. The tablet should be taken approximately at the same time each day, ensuring it does not exceed a 24-hour interval for optimal effectiveness. Taking the tablet with food may help mitigate nausea.
If a dose is missed, it should be taken as soon as possible, ideally within 12 hours, but not when the next dose is nearing. Do not take two doses at once. Resume taking the next tablet at the regular time to avoid withdrawal bleeding. Additional non-hormonal contraceptive measures should be implemented. In cases of diarrhea or vomiting, extra non-hormonal contraception should be used to prevent pregnancy.
The patient is to begin with the first tablet on the first day of the cycle (the cycle's first day corresponds to the first day of menstrual bleeding). Subsequently, one tablet should be taken daily, following the arrow sequence, at the same time until all tablets have been consumed. The first tablet should be taken from the silver section (of the calendar pack), starting on the designated day indicated on the strip.
A new pack should be initiated the day after completing the previous pack, again starting from the appropriate day within the silver section of the strip. This procedure should be adhered to as long as contraception is desired. For the management of androgen-dependent acne: the dosage is the same as for contraception.
If a dose of Ginette-35 is missed, it should be taken as soon as possible, that is within the next 12 hours at the latest, but not when the next dose is close. Avoid taking two doses simultaneously. Resume the next tablet at the usual time to prevent withdrawal bleeding, while ensuring additional non-hormonal contraceptive precautions are taken.