Ginette

Description

Ginette Tablet (Cyproterone Acetate 2mg + Ethinylestradiol 0.035mg)

Indications:

• Acne
• Hirsutism
• Contraception (in women being treated for androgen-dependent conditions)
• Prostatic Carcinoma (though this is typically for higher doses of cyproterone acetate alone)
• (Note: “Libido” and “Hot flushes” are not direct indications for this combination product, but rather potential effects or symptoms related to hormonal balance. For clarity, this re-write focuses on the primary approved indications.)

Dosage and Administration:

• Adults (Oral):
  • Contraception; Hirsutism; Acne: 1 tablet daily (containing 2 mg cyproterone acetate and 35 mcg ethinylestradiol) for 21 consecutive days of the menstrual cycle. The first treatment course should be started on the first day of menstruation. Subsequent courses are started after 7 medication-free days following the preceding course. Treatment should be withdrawn 3 or 4 cycles after the condition has resolved.
• Children: Not indicated for use in youths <18 years.
• Renal Impairment: Contraindicated in severe renal impairment.

Method of Administration: Should be taken with food, preferably after meals, to reduce gastrointestinal discomfort.

Contraindications:

• Markedly impaired liver function or cholestasis.
• Dubin-Johnson or Rotor syndrome.
• Hepatic adenoma.
• Malignant or wasting diseases.
• Severe chronic depression.
• Severe diabetes with vascular changes.
• Sickle-cell anemia.
• History of thromboembolic disorders.
• Renal impairment.
• Youths under 18 years of age.
• Hypersensitivity to any component of the formulation.

Precautions:

• Use with caution in patients with prostate cancer (though this specific formulation is typically for female indications), hepatic impairment, diabetes mellitus, history of depression, familial defects in lipoprotein metabolism, and cardiovascular diseases.
• Monitor liver function tests (LFTs), adrenocortical function, LDL and HDL levels, and red blood cell count during treatment.
• In women: Interrupt treatment if persistent or recurrent bleeding occurs to exclude the possibility of organic diseases.
• May increase the risk of thromboembolic diseases.
• Ineffective for male hypersexuality in chronic alcoholism.
• May impair the ability to drive or operate machinery.

Pregnancy and Lactation:

• Pregnancy: Contraindicated.
• Lactation: Unknown whether the drug is excreted in milk; use with caution.

Interactions:

• Metabolism: May be reduced by inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clotrimazole, ritonavir). Inducers of CYP3A4 (e.g., rifampicin, phenytoin) may reduce the levels of cyproterone.
• Ethinylestradiol: CYP1A2 and CYP3A4 inducers such as aminoglutethimide, carbamazepine, phenobarbital, and rifampin may decrease the effects of estradiol.
• May enhance the effects of hydrocortisone and prednisolone when used together.
• Altered anticoagulant effect when used with dicoumarol.
• Potentially Fatal:
  • Antibiotics (ampicillin, tetracycline, sulfonamides, and chloramphenicol) can cause intermenstrual bleeding or failure of contraception.
  • Reduced efficacy of antihypertensives or hypoglycemic drugs.

Adverse Effects:

• In men (if applicable to cyproterone acetate alone): Inhibits spermatogenesis, reduces volume of ejaculate, causes infertility, produces abnormal spermatozoa, gynecomastia, and enlargement of mammary glands.
• Common: Galactorrhea, benign nodules, depressive mood changes, alterations in hair pattern, skin reactions, fatigue and lassitude, breathlessness, weight changes.

Mechanism of Action:

• Cyproterone Acetate: A progestogen with anti-androgenic properties. It inhibits androgen receptors, reducing the effects of male hormones in the body.
• Ethinylestradiol: A synthetic estrogen that mimics the actions of estradiol, the major estrogen in pre-menopausal women. It is responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. It also inhibits the anterior pituitary by negative feedback effect, contributing to its contraceptive action. It can cause capillary dilation, fluid retention, and protein anabolism.

Notes: Ginette 2mg + 0.035mg Tablet is manufactured by Cipla Ltd. Its generic name is Cyproterone Acetate + Ethinylestradiol. Ginette is available in Nepal.

Disclaimer: This information is not intended for diagnosis, medical advice, or treatment and should not be considered a substitute for the exercise of professional judgment by a qualified healthcare provider