Ginette 35: Comprehensive Hormonal Therapy for PCOS and Acne
| Product dosage: 2.035mg | |||
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Synonyms | |||
Ginette 35 is a combined oral contraceptive pill specifically formulated for the management of polycystic ovary syndrome (PCOS) and moderate to severe acne in women. It contains a balanced combination of cyproterone acetate and ethinylestradiol, offering both contraceptive and antiandrogenic benefits. This medication is prescribed under medical supervision to address underlying hormonal imbalances, regulate menstrual cycles, and improve dermatological conditions. Its dual-action profile makes it a cornerstone in endocrine therapy for appropriate patient populations.
Features
- Active ingredients: Cyproterone acetate (2 mg) and Ethinylestradiol (0.035 mg)
- Pharmaceutical form: Film-coated tablets
- Pack size: 21 tablets per blister strip
- Hormonal class: Antiandrogen and estrogen combination
- Prescription status: Rx-only medication
- Manufacturer: Standardized under international pharmaceutical guidelines
Benefits
- Effectively reduces sebum production and improves moderate to severe acne vulgaris
- Regulates menstrual cycles in women with polycystic ovary syndrome (PCOS)
- Decreases androgen-related symptoms such as hirsutism and alopecia
- Provides reliable contraception with a Pearl Index of approximately 0.5-1.0
- Helps restore hormonal balance in hyperandrogenic conditions
- May improve quality of life through comprehensive symptom management
Common use
Ginette 35 is primarily indicated for the treatment of signs of androgenization in women, such as severe acne that has proven resistant to topical treatments, seborrhea, and mild forms of hirsutism. It is also commonly prescribed for menstrual cycle regulation in polycystic ovary syndrome where other treatments have been ineffective. The antiandrogenic effects make it particularly suitable for women presenting with both dermatological and endocrine manifestations of hyperandrogenism. It is not intended as a first-line acne treatment or for cosmetic use alone.
Dosage and direction
One tablet is taken orally at approximately the same time each day for 21 consecutive days, followed by a 7-day tablet-free interval. Withdrawal bleeding usually occurs during this break. Treatment cycles are repeated continuously unless otherwise directed by a physician. Tablets should be swallowed whole with water, with or without food. Treatment duration is typically several months for acne improvement, though cycle regulation may require longer therapy. Always begin packaging as directed by your healthcare provider, following specific instructions for first-cycle initiation.
Precautions
- Not recommended for smokers over age 35 due to increased cardiovascular risk
- Requires thorough medical evaluation including blood pressure assessment before prescription
- Regular monitoring of liver function is advised during prolonged therapy
- May affect glucose tolerance; diabetic patients require careful supervision
- Caution advised in women with history of depression; monitor mood changes
- Temporary discontinuation recommended 4-6 weeks before elective surgery involving prolonged immobilization
- Reduced efficacy may occur with gastrointestinal disturbances (vomiting/diarrhea)
- Does not protect against sexually transmitted infections
Contraindications
- History of or current thrombophlebitis or thromboembolic disorders
- Known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Known or suspected pregnancy
- Active liver disease or history of hepatic tumors
- Severe diabetes with vascular involvement
- Hypertriglyceridemia or history of pancreatitis
- Hypersensitivity to any component of the medication
- Migraine with focal neurological symptoms
Possible side effects
Common (≥1/100):
- Nausea, abdominal pain
- Headache, migraine
- Breast tenderness
- Mood changes
- Breakthrough bleeding
Uncommon (≥1/1000):
- Libido changes
- Fluid retention
- Chloasma
- Contact lens intolerance
- Hypertension
Rare (<1/1000):
- Thromboembolic events
- Hepatic disorders
- Gallbladder disease
- Hearing loss
- Erythema nodosum
Drug interaction
- Antibiotics (particularly rifampicin) may reduce efficacy
- Anticonvulsants (carbamazepine, phenytoin) increase metabolism
- HIV protease inhibitors affect cytochrome P450 system
- St. John’s Wort reduces contraceptive effectiveness
- Cyclosporine levels may increase
- Laboratory test interferences with thyroid and adrenal function tests
- Anticoagulant dosage may require adjustment
Missed dose
If less than 12 hours late: Take tablet immediately and continue schedule. If more than 12 hours late: Take missed tablet immediately and next tablet at regular time (may require additional contraception for 7 days). If multiple tablets missed: Follow specific guidance based on treatment cycle week and consult healthcare provider. Use barrier contraception until professional advice obtained.
Overdose
Symptoms may include nausea, vomiting, and withdrawal bleeding. No specific antidote exists; treatment should be symptomatic. Gastric lavage may be considered if ingestion occurred within short timeframe. Medical supervision recommended even for minor overdoses due to hormonal content. Serious complications are unlikely with acute overdose but monitoring is advised.
Storage
Store below 25°C in original packaging protected from light and moisture. Keep out of reach of children. Do not use after expiration date printed on packaging. Properly dispose of unused medication through pharmacy take-back programs.
Disclaimer
This information is for educational purposes only and does not replace professional medical advice. Ginette 35 is a prescription medication that requires thorough medical evaluation before use. Individual response may vary, and not all side effects are listed here. Always follow your healthcare provider’s instructions regarding dosage, duration, and monitoring. Report any adverse effects to your physician promptly.
Reviews
Clinical studies demonstrate significant improvement in acne lesions in 70-90% of patients after 3-6 cycles. Menstrual cycle regulation achieved in approximately 85% of PCOS patients. Patient satisfaction surveys indicate high approval ratings for dermatological improvement, though some report side effects affecting continuation. Long-term studies show maintained efficacy with proper medical supervision. Real-world evidence supports its position as valuable antiandrogen therapy when prescribed appropriately.