Aranelle Generic Name & Formulations
Legal Class
Rx
General Description
Norethindrone 0.5mg, ethinyl estradiol 35mcg (7 tabs); norethindrone 1mg, ethinyl estradiol 35mcg (9 tabs); norethindrone 0.5mg, ethinyl estradiol 35mcg (5 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—6
Manufacturer
Aranelle Indications
Indications
Oral contraception.
Aranelle Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Not applicable.
Aranelle Contraindications
Contraindications
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X).
Aranelle Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Aranelle Warnings/Precautions
Warnings/Precautions
Increased risk of cardiovascular events (eg, MI, stroke, VTE). Smokers >35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. Diabetes. Obesity. Gallbladder disease. Discontinue if jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.
Aranelle Pharmacokinetics
See Literature
Aranelle 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.
Aranelle 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.
Aranelle Clinical Trials
See Literature
Aranelle Note
Not Applicable
Aranelle Patient Counseling
See Literature