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Ogestrel 0.5/50 Generic Name & Formulations
Legal Class
Rx
General Description
Norgestrel 0.5mg, ethinyl estradiol 50micrograms (21 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—3
Manufacturer
Ogestrel 0.5/50 Indications
Indications
Oral contraception.
Ogestrel 0.5/50 Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Not applicable.
Ogestrel 0.5/50 Contraindications
Contraindications
Thrombophlebitis or thromboembolic disorders. History of DVT, cerebrovascular or coronary artery disease. Known or suspected breast carcinoma, endometrial or other estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Ogestrel 0.5/50 Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Ogestrel 0.5/50 Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age; not recommended. Discontinue if thrombotic event, unexplained visual changes, jaundice, 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. Gallbladder disease. Obesity. Diabetes. Prediabetes. Hypertriglyceridemia. Depression. Conditions aggravated by fluid retention; monitor. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea, retinal vein thrombosis. Monitor BP. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
Ogestrel 0.5/50 Pharmacokinetics
See Literature
Ogestrel 0.5/50 Interactions
Interactions
See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Ogestrel 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).
Ogestrel 0.5/50 Adverse Reactions
Adverse Reactions
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.
Ogestrel 0.5/50 Clinical Trials
See Literature
Ogestrel 0.5/50 Note
Not Applicable
Ogestrel 0.5/50 Patient Counseling
See Literature
