desogestrel + ethinylestradiol


Renata Limited


Concise Prescribing Info
Desogestrel 0.15 mg, ethinylestradiol 0.03 mg
Dosage/Direction for Use
1 tab daily starting on 1st day of menstruaton w/o interruption for 21 days, followed by 7 tab-free days.
May be taken with or without food.
Hypersensitivity. History of or current thrombophlebitis or venous thromboembolic disorders (eg, DVT, PE), active or recent arterial thromboembolic disorder (eg, stroke, MI), cerebral vascular disease, CAD, valvular heart disease w/ complications, severe HTN, DM w/ vascular involvement, severe headache w/ focal neurological symptoms, known or suspected breast carcinoma, endometrial cancer, estrogen-dependent neoplasms, undiagnosed abnormal genital bleeding, hepatic dysfunction or tumor, cholestatic jaundice of pregnancy, jaundice w/ prior combination hormonal contraceptive use, major surgery w/ prolonged immobilization, heavy smoking (>35 yr). Pregnancy.
Special Precautions
Discontinue if any sign of thromboembolic process occur. Patients using estrogen-containing prep, severe varicose veins, hepatic cell adenomas, chloasma gravidarum. Monitor latent or overt cardiac failure, renal dysfunction, HTN, epilepsy or migraine. Estrogen-sensitive gynaecological disorders eg, uterine fibromyomata. Lactation.
Adverse Reactions
Arterial thromboembolism, cerebral hemorrhage & thrombosis, edema; depression, dizziness, headache, migraine, nervousness, premenstrual syndrome, stroke; acne, erythema multiforme & nodosum, melasma, rash; amenorrhea, breakthrough bleeding, breast enlargement, secretion & tenderness, decreased lactation, decreased glucose tolerance, libido changes, spotting, nausea, vomiting, wt gain or loss; cervical erosion & secretion changes, cystitis-like syndrome, vag candidiasis, vaginitis.
Drug Interactions
Interfered effect of microdosed progestin-containing prep w/ acitretin. Reduced efficacy w/ aminoglutethimide, anticonvulsants, troglitazone. Increased or decreased coumarin derivatives effects. Inhibited metabolism of cyclosporine, theophylline & TCAs.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA09 - desogestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
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