CLIMEN 2/1/MG FC TAB 21/TAB

Dosage & Administration

Maximum Dose

1 tablet orally once daily for 21 days per cycle (do not exceed 1 tablet/day).

Drug Interactions

Interaction Severity

Clinically significant interactions: enzyme inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St John’s wort) may reduce hormone exposure/efficacy; strong CYP3A4 inhibitors (e.g., azole antifungals, some macrolides) may increase exposure; monitor with anticoagulants (e.g., warfarin) and ciclosporin due to potential effect changes.

Special Populations

Breastfeeding

Contraindicated

Liver Impairment

Contraindicated in severe or active hepatic disease; in mild-moderate impairment use only with caution and close monitoring, and discontinue if liver function deteriorates.

Pharmacology

Mechanism of Action

Estradiol replaces endogenous estrogen to relieve menopausal symptoms; cyproterone acetate provides progestogenic activity to oppose estrogen-driven endometrial proliferation (reducing hyperplasia risk) and has anti-androgen receptor activity; together they provide cyclic HRT.

Half-Life

Cyproterone acetate: terminal half-life about 1.6-1.8 days (≈38-44 hours); Estradiol (oral): short effective half-life on the order of hours (commonly cited ~12-20 hours depending on matrix/measured analyte).

Metabolism

Estradiol is extensively metabolized in the liver (and gut) to estrone/estriol and conjugates; cyproterone acetate is hepatically metabolized (largely via CYP3A4) to hydroxylated metabolites including 15β-hydroxy-cyproterone acetate.

Excretion

Cyproterone acetate: metabolites eliminated via both feces and urine (predominantly biliary/fecal with a substantial renal fraction); Estradiol metabolites: mainly excreted in urine as sulfate/glucuronide conjugates (with some biliary/fecal elimination).

Product Information

Available Dosage Forms

Coated tablet (oral).

Composition per Dose

Each film-coated tablet: Cyproterone acetate 2mg + Estradiol valerate 1mg (equivalent to estradiol 1mg)

Hormone Type

Combined

Method

Oral

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