Ethynodiol Diacetate And Ethinyl Estradiol Tablets

INDICATIONS AND USAGE Zovia 1/35 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. (A) Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS ): ● Thrombophlebitis and thrombosis ● Arterial thromboembolism ● Pulmonary embolism ● Myocardial infarction and coronary thrombosis ● Cerebral hemorrhage ● Cerebral thrombosis ● Hypertension ● Gallbladder disease ● Benign and malignant liver tumors, and other hepatic lesions There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: ● Mesenteric thrombosis ● Neuro-ocular lesions (e.g., retinal thrombosis and optic neuritis) The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-re...

WARNING SIGNALS If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately: ● Sharp chest pain, coughing up blood, or sudden shortness of breath (indicating a possible blood clot in the lung). ● Pain in the calf (indicating a possible blood clot in the leg). ● Crushing chest pain or heaviness in the chest (indicating a possible heart attack). ● Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, or numbness in an arm or leg (indicating a possible stroke). ● Sudden partial or complete loss of vision (indicating a possible blood clot in the blood vessels of the eye). ● Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast). CONTRAINDICATIONS Oral contraceptives should not be used in women who have the following conditions: ● Thrombophlebitis or thromboembolic disorders ● A past history of deep vein thrombophlebitis or thromboembolic disorders ● Cerebral vascular disease, myocardial infarction, or coronary artery disease, or a past history of these conditions ● Known or suspected carcinoma of the breast, or a history...