Indications for: TARINA FE 1/20

Oral contraception.

Adult Dosage:

1 tab daily for 28 days; repeat. Take at the same time daily with a meal or at bedtime. Use Day 1 or Sunday start for 1st cycle; use backup method for first 7 days.

Children Dosage:

Pre-menarchal: not applicable.

TARINA FE 1/20 Contraindications:

Thrombophlebitis or thromboembolic disorders. History of DVT. Cerebral vascular or coronary artery disease. Known or suspected breast carcinoma, endometrial carcinoma or other estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Boxed Warning:

Cigarette smoking increases risk of serious cardiovascular events.

TARINA FE 1/20 Warnings/Precautions:

Increased risk of cardiovascular events (eg, MI, stroke, DVT, VTE) esp. smokers >35 years of age. Discontinue if thrombotic event, unexplained visual changes, persistently elevated BP, or jaundice 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. Increased risk of breast cancer or hepatic neoplasia. Hypertriglyceridemia. Obesity. Diabetes. Prediabetes. Gallbladder disease. Depression. Evaluate significant changes in headaches, abnormal vaginal bleeding, amenorrhea. Conditions aggravated by fluid retention; monitor. Do regular complete physical exams (eg, Pap smear, mammogram, BP). May need barrier contraception with Sunday starts or postpartum use (see full labeling). Postmenopausal women or nursing mothers: not recommended.

TARINA FE 1/20 Classification:

Progestin + estrogen.

TARINA FE 1/20 Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Tarina Fe prior to starting HCV regimen and restart 2wks after completion. May be antagonized by rifampin, phenobarbital, phenytoin, carbamazepine, troglitazone, ampicillin, tetracycline, griseofulvin, phenylbutazone, others. May be potentiated by atorvastatin, ascorbic acid, acetaminophen. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid. May potentiate cyclosporine, prednisolone, theophylline. May affect lab tests (eg, coagulation factors, triglycerides, lipids, glucose tolerance, binding proteins, hormone binding globulins, serum folate).

Adverse Reactions:

Hypertension, nausea, vomiting, breakthrough bleeding, change in menstrual flow, amenorrhea, temporary infertility after discontinuation, edema, melasma, headache, intolerance to contact lenses; serious thromboembolic events, liver disease.

How Supplied: