Aranelle

— THERAPEUTIC DISORDERS TREATED —
  • Contraception

Aranelle Generic Name & Formulations

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