Evra

Norelgestromin 6 mg, ethinylestradiol 600 mcg

Female contraception.

Use 1 patch at a time, applied & worn for 1 full wk (7 days). On change day (day 8 & 15 of the cycle) remove used patch & immediately replace w/ a new one. 4th wk is patch-free starting on day 22. New cycle begins the next day following patch-free wk.

Hypersensitivity. Thrombophlebitis or thromboembolic disorders; history of DVT or thromboembolic disorders; known thrombophilic conditions; cerebrovascular or CAD; valvular heart disease w/ complications; persistent BP values of ≥160 mmHg systolic or ≥100 mmHg diastolic; diabetes w/ vascular involvement; migraine w/ focal aura; known or suspected breast carcinoma; endometrial carcinoma & other suspected estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice w/ prior hormonal contraceptive use. Concomitant use w/ paritaprevir/ritonavir, ombitasvir, &/or dasabuvir due to potential for ALT elevations. Acute or chronic hepatocellular disease w/ abnormal liver function; hepatic adenomas or carcinomas. Pregnancy.

Discontinue treatment immediately if thromboembolic disorders (thrombophlebitis, VTE including pulmonary embolism, cerebrovascular disorders & retinal thrombosis) occur. Discontinue treatment at least 4 wk prior & 2 wk after elective surgery due to increased risk of thromboembolism & during & following prolonged immobilization; in case of suspected thromboses; if there is unexplained partial or complete loss of vision, onset of proptosis or diplopia, papilledema or retinal vascular lesions; if significant persistent BP elevation (≥160 mmHg systolic or ≥100 mmHg diastolic) occurs & cannot be adequately controlled; if onset or exacerbation of migraines w/ or w/o focal aura or headaches w/ new pattern that is recurrent, persistent or severe develops. Not to be used by smoking women >35 yr; in patients w/ history of liver tumors. Increased risk of arterial thromboses (stroke, MI) w/ predisposing factors eg, smoking, HTN, hypercholesterolemia, obesity, diabetes, history of pre-eclamptic toxemia & increasing age; thromboembolic & thrombotic disease; post-op thromboembolic complications; benign hepatocellular carcinoma. Gallbladder disease; increased BP; benign hepatic adenoma; decreased glucose tolerance; persistent hypertriglyceridemia; breakthrough bleeding, spotting &/or amenorrhea during 1st 3 mth; chloasma especially those w/ history of chloasma gravidarum. Possible increased risk of breast cancer, cervical intraepithelial neoplasia. Rule out malignancy in case of undiagnosed, persistent or recurrent abnormal vag bleeding. Avoid exposure to sun or UV radiation in patients w/ tendency to chloasma. Prolonged immobilization or major surgery, leg surgery or leg cast, family history of thromboembolic disease; smoking, hyperlipidemia, HTN (persistent BP values ≥140 mmHg systolic or ≥90 mmHg diastolic), obesity; severe migraine w/o aura; DM; presence or history of severe depression & cholelithiasis; chronic idiopathic jaundice; family history of cholestatic jaundice (eg, Rotor, Dubin-Johnson Syndrome). Pre-existing amenorrhea or oligomenorrhea. Patients weighing ≥90 kg. Control HTN before starting therapy. Regularly monitor BP throughout therapy. Renal impairment. Not to be used during lactation. Not indicated for use before menarche. Not intended for use by post-menopausal women.

Increased wt; headache, dizziness, migraine; nausea, abdominal pain & distension, vomiting, diarrhea; acne, pruritus, skin irritation; muscle spasms; vag yeast infection; application site disorder, fatigue, malaise; breast symptoms, dysmenorrhea, vag bleeding & menstrual disorders, uterine spasm, vag discharge; mood, affect & anxiety disorders. Increased BP, lipid disorders; pulmonary embolism; chloasma, contact dermatitis, erythema; fluid retention; cholecystitis; galactorrhea, genital discharge, premenstrual syndrome, vulvovag dryness; insomnia, decreased & increased libido.

Decreased effectiveness w/ some anti-epileptics (eg, carbamazepine, eslicarbazepine acetate, felbamate, oxcarbazepine, phenytoin, rufinamide, topiramate), (fos)aprepitant, barbiturates, bosentan, griseofulvin, some combinations of HIV PIs (eg, nelfinavir, ritonavir, ritonavir-boosted PIs), modafinil, some NNRTIs (eg, nevirapine), rifampin & rifabutin, St. John's wort. Increased ethinylestradiol plasma levels w/ acetaminophen, ascorbic acid, CYP3A4 inhibitors (including itraconazole, ketoconazole, voriconazole, fluconazole & grapefruit juice), etoricoxib; some HIV PIs (eg, atazanavir, indinavir), HMG-CoA reductase inhibitors (including atorvastatin & rosuvastatin), some NNRTIs (eg, etravirine). Increased plasma levels of cyclosporine, omeprazole, prednisolone, selegiline, theophylline, tizanidine, voriconazole. Decreased plasma levels of acetaminophen, clofibric acid, lamotrigine, morphine, salicylic acid, temazepam. Potential for ALT elevations w/ drug combinations containing paritaprevir/ritonavir, ombitasvir &/or dasabuvir. Altered lab tests eg, increased prothrombin time & factors VII, VIII, IX, & X; decreased anti-thrombin III; decreased protein S; increased norepinephrine (noradrenaline)-induced platelet aggregability; increased thyroid binding globulin; elevated serum binding proteins; increased sex hormone-binding globulins; slightly increased HDL-C, total cholesterol, LDL-C & triglycerides; decreased glucose tolerance; depressed serum folate levels.

Other Contraceptives

G03AA13 - norelgestromin and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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