Generic Name and Formulations:
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).

Company:
Teva Pharmaceuticals

 

Indications for ARANELLE:

Oral contraception.

Adult Dose for ARANELLE:

1 tab daily for 28 days; repeat.

Children's Dose for ARANELLE:

Not applicable.

Pharmacological Class:

Progestin + estrogen.

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).

Warnings/Precautions:

Smokers over 35 years of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. 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 literature). Nursing mothers: not recommended.

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