Diane-35

Diane-35

cyproterone + ethinylestradiol

Manufacturer:

Bayer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Cyproterone acetate 2 mg, ethinylestradiol 35 mcg
Indications/Uses
Moderate to severe acne related to androgen-sensitivity (w/ or w/o seborrhoea) &/or hirsutism in women of reproductive age when topical therapy or systemic antibiotic treatments has failed. Hormonal contraceptive.
Dosage/Direction for Use
1 tab daily at about the same time every day for 21 consecutive days starting on the 1st day of menstrual bleeding followed by a 7-day tab-free interval.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Presence or history of venous or arterial thrombotic/thromboembolic events (eg, DVT, pulmonary embolism, MI) or CVA; prodromi of thrombosis (eg, transient ischaemic attack, angina pectoris); liver tumors (benign or malignant). High risk of venous or arterial thrombosis. History of migraine w/ focal neurological symptoms. DM w/ vascular involvement. Severe hepatic disease. Concomitant use w/ direct-acting antiviral medicinal products containing ombitasvir, paritaprevir, or dasabuvir, & combinations of these. Known or suspected sex-steroid influenced malignancies (eg, of the genital organs or breasts). Undiagnosed vag bleeding. Concomitant use w/ another hormonal contraceptive. Not for use in men. Pregnancy & lactation.
Special Precautions
Increased risk of arterial & venous thrombotic & thromboembolic diseases eg, MI, DVT, pulmonary embolism & of CVA. Venous thromboembolism manifesting as DVT &/or pulmonary embolism may occur during therapy. Consider the potential for synergistic risk of thrombosis in women who possess combination of risk factors or exhibit greater severity of an individual risk factor; the risk of thromboembolism in the puerperium. Patients that may have inherently increased CV risk eg, that associated w/ polycystic ovary syndrome. Conditions associated w/ adverse circulatory events include DM, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) & sickle cell disease. Discontinue in case of increase in frequency or severity of migraine. Consider liver tumor in differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur in women taking COCs. Women w/, or w/ a family history of, hypertriglyceridemia may be at risk of pancreatitis when using COCs. W/draw COC & treat HTN if sustained clinically significant HTN develops during use of a COC. Women w/ hereditary angioedema exogenous estrogens. Discontinue in case of acute or chronic disturbances of liver function; recurrence of cholestatic jaundice which occurred 1st during pregnancy or previous use of sex steroids. Diabetic women. Women w/ history of chloasma gravidarum; avoid exposure to the sun or UV radiation while taking COCs in women w/ tendency to chloasma. Clarify androgen-producing tumor or adrenal enzyme defect by differential diagnosis if symptoms have recently developed or increased substantially in women suffering from hirsutism. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption & patients on a lactose-free diet. Not a protection against HIV infections (AIDS) & other STD. Irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the 1st mth of use. Consider non-hormonal causes & indicate adequate diagnostic measures to exclude malignancy or pregnancy if bleeding irregularities persist or occur after previously regular cycles. Rule out pregnancy before continued COC use if COC has not been taken accordingly prior to the 1st missed w/drawal bleed or if 2 w/drawal bleeds are missed.
Adverse Reactions
Nausea, abdominal pain; increased wt; headache; depressed mood, altered mood; breast pain, breast tenderness.
Drug Interactions
Increased clearance of sex hormones & which may lead to breakthrough bleeding &/or contraceptive failure w/ drugs that induce microsomal enzymes eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, & possibly also oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's wort. Increased or decreased plasma conc w/ many HIV/HCV PIs & NNRTIs. Decreased clearance & increased plasma conc w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice; etoricoxib. May either increase (eg, cyclosporin) or decrease (eg, lamotrigine) plasma & tissue conc of certain drugs. Weak increase in plasma conc of CYP3A4 substrates (eg, midazolam) while plasma conc of CYP1A2 substrates can increase weakly (eg, theophylline) or moderately (eg, melatonin & tizanidine). Increased ALT levels w/ direct-acting antiviral medicinal products containing ombitasvir, paritaprevir, or dasabuvir, & combinations of these.
MIMS Class
Other Drugs Affecting Hormonal Regulation / Acne Treatment Preparations
ATC Classification
G03HB01 - cyproterone and estrogen ; Belongs to the class of antiandrogen preparations in combination with estrogens. Used to counter androgenic activities.
Presentation/Packing
Form
Diane-35 tab
Packing/Price
21's
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