Dyana 2 mg+0.035 mg (Tablet)

Indications

• Treatment of severe acne in women
• Unresponsive to oral antibiotic and other treatments
• Symptoms of androgenization - seborrhea, hirsutism

Composition

• Supplied in blister pack units
• Each tablet contains Cyproterone acetate 2 mg and Ethinylestradiol 0.035 mg
• 21 days on medication, 7-day off interval

Pharmacology

• Cyproterone has antiandrogenic, progestogenic, antigonadotrophic activity
• It blocks androgen receptors and reduces androgen synthesis
• Ethinylestradiol increases levels of sex hormone binding globulin (SHBG)
• Rapidly absorbed after oral administration
• Long terminal half-life leads to increased plasma levels
• Long-term therapy did not significantly influence lipid metabolism

Dosage & Administration

• 21-day course of tablets followed by 7-day off interval
• Patient compliance is essential
• Contraceptive properties are not the sole purpose of prescription
• Treatment should be continued for several months
• Instructions for missed dose

Interaction

• Concurrent use of drugs affecting efficacy and bleeding
• Altered effectiveness of various drug classes when used concurrently
• Metabolism acceleration by certain drugs leading to reduced efficacy

Contraindications

• Thrombophlebitis, thromboembolic disorders
• Cerebrovascular disorders
• Active liver disease or hepatic adenomas
• Known or suspected carcinoma of the breast
• Undiagnosed abnormal vaginal bleeding
• Pregnancy suspected or diagnosed

Side Effects

• Bleeding
• Dizziness
• Depression
• Weight gain
• Headache
• Edema
• Breast pain
• Blood clot
• Gallstones

Pregnancy & Lactation

• Fetal abnormalities reported in offspring
• Excretion of components in breast milk may affect quantity and quality
• Long-term effects on developing child not known

Precautions & Warnings

• Predisposing factors for coronary artery diseases
• Discontinue medication at earliest manifestation of certain disorders
• Caution for patients with essential hypertension
• Migraine and headache precautions
• Diabetes observation and supervision

Overdose Effects

• No reports of overdose with this tablet
• No specific antidotes - treatment should be symptomatic

Therapeutic Class

• Oral Contraceptive preparations
• Oral Hormonal preparations for Acne

Storage Conditions

• Store below 30°C and in dry place
• Protect from light
• Keep out of the reach of children

Related Brands

• Giane 2 mg+0.035 mg (Tablet) - renata-limited
• Cleo 2 mg+0.035 mg (Tablet) - nuvista-pharma-ltd