Chateal®


Chateal® \shah•TEEL\
(Levonorgestrel and Ethinyl Estradiol tablets USP, 0.15 mg/0.03mg)

Chateal is approved by the FDA as a generic equivalent to Nordette®, and compares to Levora®, Portia®, Altavera®, Marlissa®, and Kurvelo®.

This Afaxys product is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive for contraception.

Facilities that are eligible to become Afaxys Pharmaceuticals dispensers include: Family Planning Centers, Colleges and Universities, Reproductive Health Centers, Community Health Centers, City, County, and State Facilities, and Federal and Government Agencies in the United States.

WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. The risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes was associated with a significant increased risk) and is quite marked in women over 35. 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 venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gall bladder disease and hypertension. The risk of serious morbidity and mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity and diabetes.

Please see additional Important Safety Information below and full Prescribing Information, including Warnings, Contraindications, Drug Interactions, Precautions and Adverse Reactions to CHATEAL here.


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Prescribing Information
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CHATEAL® IMPORTANT SAFETY INFORMATION

Patients should be counseled that these products do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

CONTRAINDICATIONS
Contraindications to CHATEAL include current or past history of thrombophlebitis or thromboembolic disorders, cerebral-vascular or coronary disease, thrombogenic valvulopathies or rhythm disorders, diabetes with vascular involvement, uncontrolled hypertension, known or suspected carcinoma of the breast, 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, hepatic adenomas or carcinomas or active liver disease as long as liver function has not returned to normal, known or suspected pregnancy and hypersensitivity to any components of CHATEAL (levonorgestrel and ethinyl estradiol tablets, USP).

WARNINGS
Warnings include thromboembolic disorders and other vascular problems (myocardial infarction, thromboembolism, cerebrovascular disease, dose related risk of vascular disease, persistence of risk of vascular disease), carcinoma of the reproductive organs, hepatic neoplasia, ocular lesions (retinal thrombosis), oral contraceptive use before or during pregnancy, gall bladder disease, carbohydrate and lipid metabolic effects, hypertension, headache and bleeding irregularities.

Please see complete Important Safety Information here.