Lipz/Lipz ED

Drospirenone 3 mg, ethinylestradiol 0.03 mg, 7 placebo tab (Lipz ED only)

OCs used to prevent pregnancy.

1 tab daily starting on 1st day of menstruation, follow direction of arrows until all 21 active tab + 7 tab-free days (Lipz) or 21 active tab + 7 placebo tab (Lipz ED) have been taken. Alternatively, may start 1 tab on 1st Sunday after menstrual bleeding w/ alternative contraceptive method for the next 7 days. Take at the same time each day.

May be taken with or without food.

Hypersensitivity. History of or current thromboembolic disorders (eg, valvular heart disease w/ thrombogenic complications, DVT, or pulmonary embolism); history of CAD or cerebral vascular disease (eg, MI or stroke), or uncontrolled HTN. Undiagnosed abnormal vag bleeding; heavy smoking (at least 15 cigarettes daily) & women >35 yr; headaches w/ focal neurological symptoms characterized by visual symptoms, speech disability, or weakness in any part of body; diabetes w/ vascular complications; known or suspected breast or endometrial carcinoma, estrogen-dependent neoplasia; hepatic adenomas or carcinomas, or active liver disease; major surgery w/ prolonged immobility. Coadministration w/ any antivirals containing or combination of ombitasvir, paritaprevir, or dasabuvir. Severe kidney insufficiency or acute kidney failure. Cholestatic jaundice of pregnancy or jaundice w/ prior pill use. Known or suspected pregnancy.

Discontinue treatment if arterial or venous thrombotic event occurs during therapy; at least 4 wk before & 2 wk after surgery, & during & following prolonged immobilization. Hypertriglyceridemia, HTN, fluid retention & decreased glucose tolerance. Benign & malignant hepatic adenomas. Increased risk of thromboembolism, arterial thrombosis (eg, stroke, MI), liver tumor, gallbladder disease, fetal abnormalities & HTN; serious adverse CV effects w/ heavy smoking (≥15 cigarettes daily) & women >35 yr; post-surgery thromboembolic complications by 2 to 4-fold. Not to be used in women >35 yr who smoke; w/ current or history of ischemic heart disease, breast, endometrial, ovarian & cervical cancer; conditions predisposing to hyperkalemia (eg, renal & adrenal insufficiency, hepatic dysfunction). Signs or symptoms of thromboembolic or thrombotic disorders including sudden severe headache or vomiting & shortness of breath, speech & visual disturbance, sudden partial or complete loss of vision, dizziness or faintness, weakness or numbness in extremity, sharp or crushing chest pain, unexplained cough, hemoptysis, calf pain, or chest heaviness; severe abdominal pain or mass (indicating possible liver tumor), jaundice, severe mental depression, edema, or unusual bleeding. Irregular or heavy vag bleeding (spotting or breakthrough bleeding) between periods. Consider another contraceptive method in women w/ history of HTN, HTN-related diseases, or renal diseases. Perform annual clinical surveillance including medical history & physical exam, breast radiographic or mammographic findings, pap smear & relevant lab tests. Check serum K level during 1st treatment cycle in women receiving daily, long-term treatment for chronic conditions or diseases w/ medications increasing serum K. Not to be used during lactation.

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

May decrease levels/effects w/ antibiotics (griseofulvin, penicillins, or tetracyclines), aprepitant, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, HCV & HIV PIs, hydantoins, modafinil, NNRTIs (eg, efavirenz), oxcarbazepine, phenytoin, rifamycins, rufinamide, St. John's wort, topiramate & thiazolidinediones; fluconazole. May decrease levels/effects of lamotrigine & valproic acid. May increase levels/effects w/ atorvastatin, tranexamic acid. May increase levels/effects of TCAs, β-blockers, caffeine, corticosteroids, theophylline, cyclosporine & selegiline. Increased/decreased therapeutic efficacy of anticoagulants. May increase clearance of benzodiazepines eg, lorazepam, oxazepam, temazepam. May prolong t_½ of benzodiazepines eg, alprazolam, chlordiazepoxide, diazepam, triazolam.

Oral Contraceptives

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

D