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ORTHO-NOVUM 1/35–28
Contraception
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Drug Name:

ORTHO-NOVUM 1/35–28 Rx

Generic Name and Formulations:
Norethindrone 1mg, ethinyl estradiol 35micrograms (21 tabs); inert (7 tabs).

Company:
Janssen Pharmaceuticals, Inc.

Therapeutic Use:

Indications for ORTHO-NOVUM 1/35–28:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Premenarchal: not recommended.

Contraindications:

Thrombophlebitis or thromboembolic disorders. History of DVT, cerebral vascular or coronary artery disease. Valvular heart disease. Uncontrolled hypertension. Diabetes with vascular involvement. Headaches with focal neurological symptoms. Major surgery with prolonged immobilization. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Pregnancy-related jaundice or with prior pill use. Hepatic disease or tumors. Pregnancy (Cat.X). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Warnings/Precautions:

Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism, and during and after prolonged immobilization. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Gallbladder disease. Ectopic pregnancy. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. Fluid retention. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Postmenopausal women or nursing mothers: not recommended.

Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Ortho-Novum prior to starting HCV regimen and restart 2wks after completion. May be antagonized by phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John’s wort; use backup contraception. May be potentiated by atorvastatin, rosuvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice). May be affected by HIV protease inhibitors or NNRTIs. Concomitant colesevelam; give 4hrs apart. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid, lamotrigine. May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May need dose adjustment of thyroid hormones. May affect lab tests (eg, coagulation factors, triglycerides, lipids, glucose tolerance, binding proteins, hormone binding globulins, serum folate).

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

Nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, melasma, headache, intolerance to contact lenses; hypertension, serious thromboembolic events, liver disease.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

YES

How Supplied:

Packs—6 (blister cards)

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