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Ortho-Cept 0.15-0.03mg Tablets 6X28 Each By J O M Pharmaceutical Services

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Ortho-Cept 0.15-0.03mg Tablets 6X28 Each By J O M Pharmaceutical Services

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Ortho-Cept 0.15-0.03mg Tablets 6X28 Each By J O M Pharmaceutical Services Item No.:This Item Requires A Valid Order From A Physician Licensed in USA. Item No.:RXD4451191/RXB10097256
NDC No. 50458019615
Generic Name:Desogestrel/Eth Estradiol
. Trade Name: Ortho-Cept
Additional Description:Dialpak
Strength: 0.15-0.03mg
Form Tabs
Size 6X28Each
Unit of Measure Each
Unit of Sale Cn
Unit Dose
Schedule No. 0
Private Label 999
Multi-Source Y
Active Status Active
Generic Ind. Bran UPC

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DESCRIPTION

ORTHO-CEPT Tablets provide an oral contraceptive regimen of 21 light orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include colloidal silicone dioxide, corn starch, ferric oxide, lactose, hypromellose, lactose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, and vitamin E. Each green tablet contains the following inactive ingredients: FD&C Blue No.1 Aluminum Lake, ferric oxide, hypromellose, lactose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

INDICATIONS AND USAGE

ORTHO-CEPT Tablets are 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 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 these methods can result in lower failure rates.

In a clinical trial with ORTHO-CEPT, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly.

CONTRAINDICATIONS

Oral contraceptives should not be used in women who currently have the following conditions:

* Thrombophlebitis or thromboembolic disorders
* A past history of deep vein thrombophlebitis or thromboembolic disorders
* Cerebral vascular or coronary artery disease (current or history)
* Valvular heart disease with complications
* Severe hypertension
* Diabetes with vascular involvement
* Headaches with focal neurological symptoms
* Major surgery with prolonged immobilization
* Known or suspected carcinoma of the breast or personal history of breast cancer
* Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
* Undiagnosed abnormal genital bleeding
* Cholestatic jaundice of pregnancy or jaundice with prior pill use
* Acute or chronic hepatocellular disease with abnormal liver function
* Hepatic adenomas or carcinomas
* Known or suspected pregnancy
* Hypersensitivity to any component of this product

WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the author's permission). For further information, the reader is referred to a text on epidemiological methods.