IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE OF CHATEAL®
Chateal is a combined oral contraceptive (COC) indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
SELECTED SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
BRIEF SUMMARY: CONSULT THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION
Combination oral contraceptives, including Chateal, should not be used in women with any of the following conditions:
- Thrombophlebitis or thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebral-vascular or coronary artery disease
- Thrombogenic valvulopathies
- Thrombogenic rhythm disorders
- Diabetes with vascular involvement
- Uncontrolled hypertension
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Hepatic adenomas or carcinoma or active liver disease, as long as liver function has not returned to normal
- Cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
- Known or suspected pregnancy
- Hypersensitivity to any of the components of Chateal (levonorgestrel and ethinyl estradiol tablets, USP).
- Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
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, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, 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 certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis. Practitioners prescribing oral contraceptives should be familiar with information relating to these risks.
Risk information described in the full Prescribing Information includes:
- Thromboembolic Disorders and Other Vascular Problems
- Estimates of Mortality from Contraceptive Use
- Carcinoma of the Reproductive Organs and Breasts
- Hepatic Neoplasia
- Use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
- Ocular Lesions
- Oral Contraceptive Use Before or During Early Pregnancy
- Gallbladder Disease
- Carbohydrate and Lipid Metabolic Effects
- Elevated Blood Pressure
- Bleeding Irregularities
The most serious reactions are discussed in detail in the full product labeling and include serious cardiovascular events and smoking, vascular events and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness and headache.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, CHATEAL must be taken exactly as directed and at intervals not more than 24 hours apart.
Patients should be counseled that Chateal does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reference: Chateal® prescribing information. Charleston, SC USA, August 2017
Please see full prescribing information here.
To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.