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Natazia Generic Name & Formulations
Legal Class
Rx
General Description
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).
Pharmacological Class
Estrogen + progestin.
How Supplied
Tabs—84 (3 packs)
Manufacturer
Natazia Indications
Indications
Oral contraception.
Natazia Dosage and Administration
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.
Natazia Contraindications
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).
Natazia Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Natazia Warnings/Precautions
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.
Natazia Pharmacokinetics
See Literature
Natazia Interactions
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.
Natazia Adverse Reactions
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.
Natazia Clinical Trials
See Literature
Natazia Note
Not Applicable
Natazia Patient Counseling
See Literature
Natazia Generic Name & Formulations
Legal Class
Rx
General Description
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).
Pharmacological Class
Estrogen + progestin.
How Supplied
Tabs—84 (3 packs)
Manufacturer
Natazia Indications
Indications
Heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.
Natazia Dosage and Administration
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.
Natazia Contraindications
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).
Natazia Boxed Warnings
Boxed Warning
Cigarette smoking increases risk of serious cardiovascular events.
Natazia Warnings/Precautions
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.
Natazia Pharmacokinetics
See Literature
Natazia Interactions
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.
Natazia Adverse Reactions
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.
Natazia Clinical Trials
See Literature
Natazia Note
Not Applicable
Natazia Patient Counseling
See Literature
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