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NATAZIA
Contraception
Menorrhagia
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Drug Name:

NATAZIA Rx

Generic Name and Formulations:
Estradiol valerate 3mg (2 tabs); dienogest 2mg + estradiol valerate 2mg (5 tabs); dienogest 3mg + estradiol valerate 2mg (17 tabs); estradiol valerate 1mg (2 tabs); inert (2 tabs).

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for NATAZIA:

Oral contraception.

Adult:

BMI >30kg/m2: insufficient data. 1 tab daily for 28 days; repeat. Use Day 1 start; use non-hormonal backup method for first 9 days. Do not skip doses or delay dose >12 hours. Switching from other methods: see full labeling.

Children:

Premenarchal: not applicable.

Contraindications:

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Undiagnosed abnormal uterine bleeding. Hepatic disease or tumors. Pregnancy (Cat. X).

Warnings/Precautions:

Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age; not recommended. Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Uncontrolled hypertension. Gallbladder disease. Diabetes. Prediabetes. Depression. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Nursing mothers: not recommended.

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. May antagonize lamotrigine. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

Pharmacological Class:

Estrogen + progestin.

Adverse Reactions:

Headache, irregular uterine bleeding, mastodynia, GI upset, acne, increased weight; hypertension, transient delay of ovulation after discontinuation, edema, chloasma. Increased risk of gallbladder disease, thromboembolic disorders.

How Supplied:

Tabs—84 (3 packs)

Indications for NATAZIA:

Heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.

Adult:

BMI >30kg/m2: insufficient data. 1 tab daily for 28 days; repeat. Use Day 1 start; use non-hormonal backup method for first 9 days. Do not skip doses or delay dose >12 hours.

Children:

Premenarchal: not applicable.

Contraindications:

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Undiagnosed abnormal uterine bleeding. Hepatic disease or tumors. Pregnancy (Cat. X).

Warnings/Precautions:

Increased risk of cardiovascular events esp. in cigarette smokers >35yrs of age; not recommended. Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Uncontrolled hypertension. Gallbladder disease. Diabetes. Prediabetes. Depression. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Nursing mothers: not recommended.

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. May antagonize lamotrigine. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones.

Pharmacological Class:

Estrogen + progestin.

Adverse Reactions:

Headache, irregular uterine bleeding, mastodynia, GI upset, acne, increased weight; hypertension, transient delay of ovulation after discontinuation, edema, chloasma. Increased risk of gallbladder disease, thromboembolic disorders.

How Supplied:

Tabs—84 (3 packs)

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