Drug Name:
LOW-OGESTREL Rx
Generic Name and Formulations:
Norgestrel 0.3mg, ethinyl estradiol 30micrograms (21 tabs); inert (7 tabs).
Company:
Mayne Pharma US
Therapeutic Use:
Indications for LOW-OGESTREL:
Oral contraception.
Adult:
1 tab daily for 28 days; repeat.
Children:
Not applicable.
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).
Boxed Warning:
Cigarette smoking increases risk of serious cardiovascular events.
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.
Pharmacological Class:
Progestin + estrogen.
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.
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.
How Supplied:
Packs—6
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