Giane 35 Tablet
Cyproterone Acetate + Ethinylestradiol
2mg + 35mcg
Renata PLC.
| Pack size | 21 's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 9.50 AED |
Indications
Giane 35 Tablet is used for:
Acne, Contraception, Hirsutism, Prostatic carcinoma, Libido, Hot flushes
Adult Dose
Oral
Acne, Contraception, Hirsutism
Treatment of women with severe acne, with associated symptoms of androgenization, including seborrhea and mild hirsutism.
Adult: 2 mg daily (with 35 mcg of ethinylestradiol daily) for 21 days of the menstrual cycle.
Start 1st treatment course on the 1st day of menstrual cycle; subsequent courses are started after 7 medication-free days following the preceding course.
Withdraw treatment 3 or 4 cycles after the condition has resolved.
Cyproterone Acetate + Ethinylestradiol should not be prescribed for the purpose of contraception alone. However, when taken as recommended Cyproterone Acetate + Ethinylestradiol will provide reliable contraception in patients treated for the above clinical conditions.
Child Dose
Renal Dose
Renal Impairment
Cyproterone Acetate + Ethinylestradiol has not been specifically studied in renally impaired patients. Available data do not suggest a change in treatment in this patient population.
Administration
Should be taken with food. Take after meals.
Contra Indications
History of or actual thrombophlebitis or thromboembolic disorders;
History of or actual cerebrovascular disorders;
History of or actual myocardial infarction or coronary arterial disease;
Active liver disease;
Previous or existing liver tumours (benign or malignant);
History of cholestatic jaundice;
Use with the Hepatitis C virus combination drug regimen ombitasvir, paritaprevir, ritonavir, with or without dasabuvir
Known or suspected carcinoma of the breast;
Known or suspected estrogen-dependent neoplasia;
Undiagnosed abnormal vaginal bleeding;
Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or a defect in visual fields;
Concomitant use with other estrogen/progestogen combinations or estrogens or progestogens alone;
When pregnancy is suspected or diagnosed;
Severe diabetes with vascular changes;
A history of otosclerosis with deterioration during pregnancy;
Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
Precautions
Prostate cancer, hepatic impairment, DM, history of depression, familial defects in lipoprotein metabolism, CV diseases.
In women: Interrupt treatment if persistent or recurrent bleeding occurs to exclude the possibility of organic diseases.
May increase risk of thrombo-embolic diseases. Ineffective for male hypersexuality in chronic alcoholism.
May impair ability to drive or operate machinery.
Pregnancy, lactation.
Monitor LFT, adrenocortical function, LDL and HDL levels, and RBC count during treatment.
Pregnancy-Lactation
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.
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, sulphonamides and chloramphenicol) can cause intermenstrual bleeding or failure of contraception. Reduced efficacy of antihypertensives or hypoglycaemic drugs.
Adverse Effects
Side effects of Cyproterone Acetate + Ethinylestradiol :
Nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10 per cent or fewer of patients during the first cycle.
Arterial and venous thromboembolism
Cerebral hemorrhage
Cerebral thrombosis
Congenital anomalies
Gallbladder disease
Hepatic tumours
Hypertension
Mesenteric thrombosis
Myocardial infarction
Neuro-ocular lesions (eg, retinal thrombosis and optic neuritis)
Pulmonary embolism
Thrombophlebitis
Mechanism of Action
Cyproterone is a progestogen with anti-androgenic properties.Oestradiol is the major oestrogen in pre-menopausal women.
Ethinylestradiol has similar actions as oestradiol. It is responsible for the development and maintenance of female reproductive system and secondary sexual characteristics. It also inhibits anterior pituitary by negative feedback effect and causes capillary dilation, fluid retention and protein anabolism.
Note
Giane 35 2mg + 35mcg Tablet manufactured by Renata PLC.. Its generic name is Cyproterone Acetate + Ethinylestradiol. Giane 35 is availble in Bangladesh.
Farmaco BD drug index information on Giane 35 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.