Product Description.:
Dp, 021 or 331 or 022
tablet , multi-colored , round round
21 white, coated (021), 2 light green (331), 5 light blue, coated (022
Kariva? (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets provide an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch, stearic acid and vitamin E, followed by 2 light-green round tablets with the following inactive ingredients: FD&CBlue No. 1 Aluminum Lake, FD&CYellow No. 6 Aluminum Lake, FD&CYellow No. 10 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch. Kariva? also contains 5 light-blue round tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, FD&CBlue No. 1 Aluminum Lake, FD&CBlue No. 2 Aluminum Lake, hydroxypropyl methylcellulose, lactose mono-hydrate, polydextrose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin and vitamin E.
INDICATIONS
Kariva? (desogestrel/ethinyl estradiol and ethinyl estradiol)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 II 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 these 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 immedi-ately postpartum
* Cholestatic jaundice
* Migraine
* Rash (allergic)
* Mental depression
* Reduced tolerance to carbohydrates
* Vaginal candidiasis
* Change in corneal curvature (steepening)
* Intolerance to contact lenses
The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
* Pre-menstrual syndrome
* Cataracts
* Changes in appetite
* Cystitis-like syndrome
* Headache
* Nervousness
* Dizziness
* Hirsutism
* Loss of scalp hair
* Erythema multiforme
* Erythema nodosum
* Hemorrhagic eruption
* Vaginitis
* Porphyria
* Impaired renal function
* Hemolytic uremic syndrome
* Acne
* Changes in libido
* Colitis
* Budd-Chiari Syndrome
DRUG INTERACTIONS
Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and possibly with griseofulvin, ampicillin and tetracyclines
