ORTHO TRI-CYCLEN LO Rx

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ORTHO TRI-CYCLEN LO

Contraception
Only 4 drugs may be compared at once

Generic Name and Formulations:

Norgestimate 0.18mg, ethinyl estradiol 25micrograms (7 tabs); norgestimate 0.215mg, ethinyl estradiol 25micrograms (7 tabs); norgestimate 0.25mg, ethinyl estradiol 25micrograms (7 tabs); inert (7 tabs).

Select therapeutic use:

Indications for ORTHO TRI-CYCLEN LO:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Not applicable.

Contraindications:

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Undiagnosed abnormal uterine bleeding. Breast or other estrogen- or progestin-sensitive neoplasms. Hepatic disease or tumors. Pregnancy.

Warnings/Precautions:

Increased risk for serious cardiovascular events in women >35yrs who smoke. Discontinue if thrombotic events, unexplained visual changes, jaundice, persistent elevated BP, or headache/migraine 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. Hypertriglyceridemia. Obesity. Diabetes. Prediabetes. Gallbladder disease. Ectopic pregnancy. Depression. Hereditary angioedema. Conditions aggravated by fluid retention; monitor. Hepatic neoplasia. Cholasma gravidarum. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. 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, rifampin, topiramate), 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. Concomitant thyroid replacement may need to increase thyroid dose. May affect lab tests (eg, coagulation factors, triglycerides, lipids, glucose tolerance, binding proteins, hormone binding globulins, serum folate).

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

Headache. migraine, nausea, vomiting, breast issues, abdominal pain or distension, menstrual disorders, mood disorders, acne, vulvovaginal infection, weight increased, fatigue.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

YES

How Supplied:

Blister cards—6 X 28

ORTHO TRI-CYCLEN LO 28 tablets packages (Qty:1)

appx. price $161.00