Product Description.:
93, 740 or C71 or 742 or 743
tablet , film-coated , multi-colored , round round
7 white (740), 7 light-pink (C71), 7 pink (742), 7 light-green (743)
ORTHO-NOVUM?
(norethindrone/ethinyl estradiol) Tablets
and
MODICON?
(norethindrone/ethinyl estradiol) Tablets
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DRUG DESCRIPTION
COMBINATION ORAL CONTRACEPTIVES
Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol.
ORTHO-NOVUM?7/7/7 Tablets: Each white tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include lactose, magnesium stearate and pregelatinized corn starch. Each light peach tablet contains 0.75 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each green tablet contains only inert ingredients, as follows: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch.
ORTHO-NOVUM?1/35 Tablets: Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each green tablet contains only inert ingredients, as listed under green tablets in ORTHO-NOVUM 7/7/7.
INDICATIONS
ORTHO-NOVUM 7/7/7, ORTHO-NOVUM 1/35, and MODICON Tablets 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, the IUD, and the NORPLANT System 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
There is evidence of an association between the following conditions and the use of oral contraceptives:
* Mesenteric thrombosis
* Retinal thrombosis
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
* 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 and 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
