Gveza

Drospirenone 3 mg, ethinylestradiol 0.03 mg

OC.

1 tab daily starting on the 1st day of menstruation for 21 consecutive days. Each subsequent pack is started after a 7-day tab-free interval.

May be taken with or without food.

Hypersensitivity. Known or suspected pregnancy, undiagnosed abnormal genital bleeding, diplopia or any ocular lesion arising from ophth vascular disease, classical migraine, active liver disease, or history of cholestatic jaundice w/ pregnancy or w/ prior use of OCs. Lactation & in women who have or have had thrombophlebitis or thromboembolic disorders, cerebrovascular or CAD (including MI), severe HTN, diabetes w/ vascular involvement, known or suspected carcinoma of the breast, estrogen-dependent neoplasia (eg, endometrial carcinoma) or benign or malignant liver tumor that developed during OC or other estrogen use. Women w/ renal impairment, hepatic tumors or disease, adrenal insufficiency, high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, history of breast or other estrogen- or progestin-sensitive cancer, & in pregnancy.

Increased risk of thromboembolism, arterial thrombosis (eg, stroke, MI), liver tumor, gallbladder disease, visual disturbances, fetal abnormalities, & HTN. Cigarette smoking increases the risk of serious adverse CV; women >35 yr smoker, & w/ ischemic heart disease or a history of the disease. CV disease risk factors. Discontinue use if an arterial or venous thrombotic event occurs during therapy. Not indicated before menarche. Women ≥65 yr.

Arterial thromboembolism, cerebral hemorrhage & thrombosis, coronary thrombosis, focal nodular hyperplasia of the liver, gallbladder disease, hepatic adenomas or benign liver tumors, HTN, mesenteric thrombosis, MI, pulmonary embolism, ruptured cyst, thrombophlebitis & venous thrombosis w/ or w/o embolism, uterine leiomyoma; dizziness, headache, mental depression, migraine; melasma, allergic rash; breast pain, tenderness, enlargement, secretion, diminution in lactation; abdominal cramps, bloating, cholestatic jaundice, nausea & vomiting; amenorrhea, BTB, spotting, change in menstrual flow; cervical erosion & secretions, invasive cervical cancer, temporary infertility after discontinuation, vag candidiasis; change in corneal curvature, contact lens intolerance, neuro-ocular lesions (eg, retinal thrombosis, optic neuritis); edema, reduced carbohydrate tolerance, wt change (increase/decrease), increased prevalence of cervical chlamydia trachomatis.

May decrease pharmacologic effects w/ griseofulvin, penicillins or tetracyclines. May increase hepatic metabolism w/ aprepitant, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, HIV PIs, hydantoins, modafinil, oxcarbazepine, phenytoin, rifamycins, rufinamide, St. John's wort, topiramate. May decrease therapeutic efficacy w/ fluconazole. Increased AUC w/ atorvastatin. Decreased serum conc w/ thiazolidinediones eg, pioglitazone. Increased risk of thrombotic events w/ tranexamic acid. May decrease efficacy of anticoagulants; lamotrigine. May decrease hepatic metabolism of TCAs, β-blockers, caffeine, corticosteroids, theophyllines. May increase clearance of benzodiazepines eg, lorazepam, oxazepam, temazepam. May inhibit hepatic mixed function oxidase w/ alprazolam, chlordiazepoxide, diazepam & triazolam. May increase pharmacologic effects of corticosteroids. May inhibit metabolism of cyclosporine. May increase metabolism of lamotrigine. May increase conc of selegiline. May decrease plasma conc & pharmacodynamics effects of valproic acid.

Oral Contraceptives

G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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