ORTHO TRI-CYCLEN LO Rx
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).
Janssen Pharmaceuticals, Inc.
Indications for ORTHO TRI-CYCLEN LO:
1 tab daily for 28 days; repeat.
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). 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.
Cigarette smoking increases risk of serious cardiovascular events.
Increased risk of cardiovascular events (eg, stroke, MI) 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. Hereditary angioedema. 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.
Progestin + estrogen.
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Ortho Tri-Cyclen Lo 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).
Headache/migraine, nausea, vomiting, breast issues, abdominal pain/distension, menstrual disorders, mood disorders, acne, vulvovaginal infection, weight increased, fatigue; hypertension, chloasma, serious thromboembolic events, liver disease.
Packs—6 (blister cards)
Clinical Pain Advisor Articles
- Serum Vitamin D Levels and Risk for Migraine
- Rimegepant Orally Dissolving Formulation Provides Rapid Relief From Acute Migraine
- Updated Evidence-Based Recommendations for Buprenorphine Treatment
- Business Degree Increasingly Useful for Doctors
- Two Screening Tools May Accurately Predict Transition From Acute to Chronic Low Back Pain
- Manual Therapy vs Opioids for Management of Shoulder, Spine Pain
- Greater Temporal Summation of Pain in HIV With Chronic Pain
- FDA Warns Two Companies About Bogus Opioid Addiction Treatment
- Prescription Digital Therapeutic Approved for Opioid Use Disorder
- A Potential Biomarker for Predicting Antibody Treatment Efficacy in Migraine