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Low-ogestrel Generic Name & Formulations
Legal Class
Rx
General Description
Norgestrel 0.3mg, ethinyl estradiol 30micrograms (21 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—6
Manufacturer
Low-ogestrel Indications
Indications
Oral contraception.
Low-ogestrel Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Not applicable.
Low-ogestrel 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 (Cat.X).
Low-ogestrel Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Low-ogestrel Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events 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.
Low-ogestrel Pharmacokinetics
See Literature
Low-ogestrel Interactions
Interactions
Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels.
Low-ogestrel 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.
Low-ogestrel Clinical Trials
See Literature
Low-ogestrel Note
Not Applicable
Low-ogestrel Patient Counseling
See Literature
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