Compare to: Modicon? WATSON, 937 or 938 or 939 or P
tablet , multi-colored , round round
Beveled edge7 white (937), 7 light peach (938), 7 peach (939), 7 green
Necon? 1/35
(norethindrone and ethinyl estradiol) Tablets USP
Necon? 0.5/35
(norethindrone and ethinyl estradiol) Tablets USP
Necon? 10/11
(norethindrone and ethinyl estradiol) Tablets USP
Necon? 1/50
(norethindrone and mestranol) Tablets USP
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DRUG DESCRIPTION
Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol:
Necon? 1/35: Each dark yellow tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon? 1/35 package contains only inert ingredients, as follows: micro- crystalline cellulose, lactose (anhydrous), and magnesium stearate.
Necon? 0.5/35: Each light yellow tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon? 0.5/35 package contains only inert ingredients as listed under white tablets in Necon? 1/35.
Necon? 10/11: Each light yellow tablet (10) contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Each dark yellow tablet (11) contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrys- talline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon? 10/11 package contains only inert ingredients as listed under white tablets in Necon? 1/35.
Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound mestranol:
Necon? 1/50: Each light blue tablet contains 1 mg of norethindrone and 0.05 mg of mestranol. Inactive ingredients include FD&C Blue No. 1 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon? 1/50 package contains only inert ingredients as listed under white tablets in Necon? 1/35.
INDICATIONS
Necon? 1/35, Necon? 0.5/35, Necon? 10/11, and Necon? 1/50 are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I 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, 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 section).
* Thrombophlebitis and venous thrombosis with or without embolism
* Arterial thromboembolism
* Pulmonary embolism
* Myocardial infarction
* Cerebral hemorrhage
* Cerebral thrombosis
* Hypertension
* Gallbladder disease
* Hepatic adenomas or benign liver tumors
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 abdomi- nal cramps and bloating)
* Breakthrough bleeding
* Spotting
* Change in menstrual flow
* Amenorrhea
* Temporary infertility after discontinuation of treatment
* Edema
* 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
