norelgestromin + ethinylestradiol




Zuellig Pharma
Concise Prescribing Info
Norelgestromin 6 mg, ethinyl estradiol 600 mcg
Dosage/Direction for Use
Apply 1 patch at a time for 7 days. Replace each used patch on day 8 & 15 of the cycle. The 4th wk is patch-free starting on day 22.
Hypersensitivity. Known or past history of thrombophlebitis, thromboembolic disorders; thrombophilic conditions; cerebrovascular or CAD; valvular heart disease w/ complications; persistent BP of ≥160 mmHg systolic or ≥100 mmHg diastolic; diabetes w/ vascular involvement; migraine w/ focal aura; known or suspected breast carcinoma; endometrium carcinoma or other estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice w/ prior hormonal contraceptive use; acute or chronic hepatocellular disease w/ abnormal hepatic function; hepatic adenomas or carcinomas. Concomitant use w/ ombitasvir/paritaprevir/ritonavir & dasabuvir. Known or suspected pregnancy.
Special Precautions
Rule out malignancy in undiagnosed, persistent or recurrent abnormal vag bleeding. Not to be used by smoking women >35 yr. Increased risk of thromboembolic & vascular disorder complications; risk factors for arterial disease; DM; history of or w/ severe depression; presence or history of cholelithiasis; chronic idiopathic jaundice; Rotor or Dubin-Johnson syndrome; HTN. Increased risk of developing hepatocellular carcinoma, breast cancer, cervical intraepithelial neoplasia; decreased glucose tolerance; persistent hypertriglyceridemia; severe migraine w/ or w/o focal aura; bleeding irregularities; history of chloasma gravidum; ALT elevations. Monitor BP regularly. Avoid sun or UV radiation exposure. Body wt ≥90 kg. Not to be placed in breasts, red, irritated or cut skin. Renal & hepatic impairment. Not to be used during pregnancy & lactation.
Adverse Reactions
Application site reaction, breast symptoms (including breast discomfort & engorgement, female breast pain), nausea, headache, emotional lability.
Drug Interactions
Decreased effectiveness w/ CYP3A4-inducing drugs or herbal products. Increased plasma ethinyl estradiol levels w/ acetaminophen, ascorbic acid, CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice), etoricoxib, HIV PIs (eg, atazanavir, indinavir), HMG-CoA reductase inhibitors (eg, 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. Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir.
ATC Classification
G03AA13 - norelgestromin and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Evra transdermal patch
3 × 1's
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