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ORTHO TRI-CYCLEN 28
Acne
Contraception
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Drug Name:

ORTHO TRI-CYCLEN 28 Rx

Generic Name and Formulations:
Norgestimate 0.18mg, ethinyl estradiol 35micrograms (7 tabs); norgestimate 0.215mg, ethinyl estradiol 35micrograms (7 tabs); norgestimate 0.25mg, ethinyl estradiol 35micrograms (7 tabs); inert (7 tabs).

Company:
Janssen Pharmaceuticals, Inc.

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. 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. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. 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 Tri-Cyclen 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. 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:

Headache/migraine, breast pain/discharge/enlargement, vaginal infection, abdominal/GI pain, mood disorders, genital discharge, weight changes; hypertension, chloasma, serious thromboembolic events, liver disease.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

YES

How Supplied:

Packs—6 (blister cards)

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. 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. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. 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 Tri-Cyclen 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. 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:

Headache/migraine, breast pain/discharge/enlargement, vaginal infection, abdominal/GI pain, mood disorders, genital discharge, weight changes; hypertension, chloasma, serious thromboembolic events, liver disease.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

YES

How Supplied:

Packs—6 (blister cards)

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