ORTHO TRI-CYCLEN 28 Rx

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ORTHO TRI-CYCLEN 28

Acne
Contraception
Only 4 drugs may be compared at once

Generic Name and Formulations:

Norgestimate 0.18mg, ethinyl estradiol 35mcg (7 tabs); norgestimate 0.215mg, ethinyl estradiol 35mcg (7 tabs); norgestimate 0.25mg, ethinyl estradiol 35mcg (7 tabs); inert (7 tabs).

Select therapeutic use:

Indications for ORTHO TRI-CYCLEN 28:

Moderate acne vulgaris in females ≥15yrs of age, who have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche.

Adult:

1 tab daily for 28 days; repeat.

Children:

Premenarchal: not recommended.

Contraindications:

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, 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). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy.

Warnings/Precautions:

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. Pregnancy-related cholestasis. Hypertriglyceridemia. Obesity. Diabetes. Prediabetes. Gallbladder disease. Depression; discontinue if recurs to serious degree. Evaluate significant changes in headaches, abnormal vaginal bleeding, amenorrhea. 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).

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

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

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

YES

How Supplied:

Blister—6

Indications for ORTHO TRI-CYCLEN 28:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Premenarchal: not recommended.

Contraindications:

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, 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). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy.

Warnings/Precautions:

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. Pregnancy-related cholestasis. Hypertriglyceridemia. Obesity. Diabetes. Prediabetes. Gallbladder disease. Depression; discontinue if recurs to serious degree. Evaluate significant changes in headaches, abnormal vaginal bleeding, amenorrhea. 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).

Pharmacological Class:

Progestin + estrogen.

Adverse Reactions:

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

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

YES

How Supplied:

Blister—6