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ZOVIA 1/35E–28
Contraception
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Drug Name:

ZOVIA 1/35E–28 Rx

Generic Name and Formulations:
Ethynodiol diacetate 1mg, ethinyl estradiol 35micrograms, 21 tabs; inert (7 tabs).

Company:
Mayne Pharma US

Therapeutic Use:

Indications for ZOVIA 1/35E–28:

Oral contraception.

Adult:

1 tab daily for 28 days; repeat.

Children:

Premenarche: not applicable.

Contraindications:

Thrombophlebitis or thromboembolic disorders. History of DVT, cerebrovascular or coronary artery disease. Known or suspected breast carcinoma, endometrial or other estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC 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.

Warnings/Precautions:

Increased risk of cardiovascular events (eg, stroke, MI) 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. Uncontrolled dyslipidemias. Hypertriglyceridemia. Depression. Fluid rentention. Monitor blood pressure. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.

See Also:

ZOVIA 1/50E–28

Pharmacological Class:

Progestin + estrogen.

Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Zovia prior to starting HCV regimen and restart 2wks after completion. May be antagonized by phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John’s wort; use backup contraception. May be potentiated by atorvastatin, rosuvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice). May be affected by HIV protease inhibitors. Concomitant colesevelam; give 4hrs apart. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid, lamotrigine. May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May need dose adjustment of thyroid hormones. May affect lab tests (eg, coagulation factors, triglycerides, lipids, glucose tolerance, binding proteins, hormone binding globulins, serum folate).

Adverse Reactions:

Nausea, vomiting, breakthrough bleeding, spotting, amenorrhea, change in menstrual flow, edema, chloasma, mastodynia, headache, migraine, intolerance to contact lenses; hypertension, serious thromboembolic events, liver disease.

How Supplied:

Packs—6

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