INTROVALE Rx

Indications for INTROVALE:

Oral contraception.

Adult:

1 tab daily for 91 days; repeat. Use Sunday start for first cycle.

Children:

Pre-menarchal: not recommended.

Contraindications:

Thrombophlebitis or thromboembolic disorders. Cerebrovascular or coronary artery disease. Valvular heart disease with thrombogenic complications. Uncontrolled hypertension. Diabetes with vascular involvement. Headaches with focal neurological symptoms. Major surgery with prolonged immobilization. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy (Cat.X).

Warnings/Precautions:

Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Pregnancy-related cholestasis. Depression. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Do regular complete physical exams. Nursing mothers: not recommended.

Pharmacological Class:

Progestin + estrogen.

Interactions:

May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate); use backup contraception. May be affected by protease inhibitors, NNRTIs, atorvastatin, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

Adverse Reactions:

Headache, nausea, vomiting, bleeding irregularities, dysmenorrhea, weight change, mastodynia, acne, abdominal pain, anxiety, depression; angioedema, chloasma, others (see literature).

How Supplied:

Pack—3