Product Description.:
WATSON 383 or WATSON, blank or P
tablet , multi-colored , round round
21 light pink (WATSON 383), 7 white (WATSON)
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DRUG DESCRIPTION
Zovia 1/35E-28. Each light pink tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose (anhydrous), magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Zovia 1/35E-28 package is a placebo containing no active ingredients and the inactive ingredients include lactose (anhydrous), magnesium stearate and micro-crystalline cellulose.
Zovia 1/50E-28. Each pink tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol, and the inactive ingredients include lactose (anhydrous), magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Zovia 1/50E-28 package is a placebo containing no active ingredients, and the inactive ingredients include lactose (anhydrous), magnesium stearate and microcrystalline cellulose.
INDICATIONS
Zovia 1/35E and Zovia 1/50E are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Zovia 1/50E, which contain 50 mcg of estrogen, should not be used unless medically indicated.
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.
SIDE EFFECTS
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-related:
* Nausea
* Vomiting
* Gastrointestinal symptoms (such as abdominal cramps and bloating)
* Breakthrough bleeding
* Spotting
* Change in menstrual flow
* Amenorrhea during or after use
* Temporary infertility after discontinuation of use
* Edema
* Chloasma or melasma, which may persist
* Breast changes: tenderness, enlargement, secretion
* Change in weight (increase or decrease)
* Change in cervical erosion or secretion
* Diminution in lactation when given immediately postpartum
* Cholestatic jaundice
* Migraine
* Rash (allergic)
* Mental depression
* Reduced tolerance to carbohydrates
* Vaginal candidiasis
* Change in corneal curvature (steepening)
* Intolerance to contact lenses
