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Balziva Generic Name & Formulations
Legal Class
Rx
General Description
Norethindrone 0.4mg, ethinyl estradiol 35mcg (21 tabs); inert (7 tabs).
Pharmacological Class
Progestin + estrogen.
How Supplied
Packs—6
Manufacturer
Balziva Indications
Indications
Oral contraception.
Balziva Dosage and Administration
Adult
1 tab daily for 28 days; repeat.
Children
Not applicable.
Balziva 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).
Balziva Boxed Warnings
Not Applicable
Balziva Warnings/Precautions
Warnings/Precautions
Smokers over 35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. 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 literature). Nursing mothers: not recommended.
Balziva Pharmacokinetics
See Literature
Balziva 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.
Balziva 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.
Balziva Clinical Trials
See Literature
Balziva Note
Not Applicable
Balziva Patient Counseling
See Literature
