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ORTHO-CYCLEN 28
Contraception
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Drug Name:

ORTHO-CYCLEN 28 Rx

Generic Name and Formulations:
Norgestimate 0.25mg, ethinyl estradiol 35mcg (21 tabs); inert (7 tabs).

Company:
Janssen Pharmaceuticals, Inc.

Therapeutic Use:

Indications for ORTHO-CYCLEN 28:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Premenarchal: not recommended.

Pharmacological Class:

Progestin + estrogen.

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. Known or suspected breast carcinoma, endometrial carcinoma or other estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Pregnancy-related jaundice or with prior pill use. Hepatic disease or tumors. Known or suspected pregnancy (Cat.X).

Warnings/Precautions:

Increased risk of cardiovascular events (eg, MI, stroke, DVT, VTE) esp. smokers >35 years of age. Discontinue if thrombotic event, unexplained visual changes, persistently elevated BP, 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. Cardio- or cerebrovascular diseases. Increased risk of breast cancer or hepatic neoplasia. Hypertriglyceridemia. Obesity. Diabetes. Prediabetes. Gallbladder disease. Ectopic pregnancy. Depression. Evaluate significant changes in headaches, abnormal vaginal bleeding, amenorrhea. Conditions aggravated by fluid retention; monitor. Do regular complete physical exams (eg, Pap smear, mammogram, BP). May need barrier contraception with Sunday starts or postpartum use (see full labeling). Postmenopausal women or nursing mothers: not recommended.

Interactions:

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. 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).

Adverse Reactions:

Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, melasma, headache, intolerance to contact lenses; serious cardiovascular events.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

How Supplied:

Blister—6

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