The Ortho Tri-Cyclen Lo brand name has been discontinued.

Indicated for use by females of reproductive potential to prevent pregnancy.

ORTHO TRI-CYCLEN Lo is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use.

Ortho Tri-Cyclen Lo has not been studied for and is not indicated for use in emergency contraception.

Use of this product before menarche is not indicated.

Do not prescribe ORTHO TRI-CYCLEN Lo to women who are known to have the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35; have deep vein thrombosis or pulmonary embolism now or in the past; have inherited or acquired hypercoagulopathies; have cerebrovascular disease; have coronary artery disease; have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation); have uncontrolled hypertension; have diabetes mellitus with vascular disease; have headaches with focal neurological symptoms or migraine headaches with aura; women over age 35 with any migraine headache

• Liver tumors, benign or malignant, or liver disease

• Undiagnosed abnormal uterine bleeding 

• Pregnancy, because there is no reason to use COCs during pregnancy  

• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past

• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

No studies with Ortho Tri-Cyclen Lo have been conducted in women with renal or hepatic impairment.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users.

Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease.

Consider alternative contraception for women with uncontrolled dyslipidemia.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

Carefully observe women with a history of depression and discontinue ORTHO TRI-CYCLEN Lo if depression recurs to a serious degree.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking ORTHO TRI-CYCLEN Lo.

If feasible, stop ORTHO TRI-CYCLEN Lo at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization.

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of COCs include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant and products containing St. John’s wort.

Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of ethinyl estradiol (EE).

CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations.

COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs.

ORTHO TRI-CYCLEN Lo is not recommended for use in lactating women.

GoToSource

• Use before menarche. GoToSource

• Increase bone mineral density in women with hypothalamic amenorrhea and osteopenia. GoToSource

• Acne. GoToSource

• Premenstrual dysphoric disorder and polycystic ovarian syndrome. GoToSource

• Dysmenorrhea. GoToSource

Gallbladder disease. GoToSource

Depression. GoToSource

Increased risk of breast cancer. GoToSource

Myocardial infarction, stroke, venous thromboembolism (pulmonary embolism and deep venous thrombosis), hepatocellular adenoma (liver tumor), migraines and cervical cancer. GoToSource

Lawsuits filed for pseudotumor cerebri.