IMPORTANT SAFETY INFORMATION
Indication and Usage of Chateal®
Chateal is a combine 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
- 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
WARNINGS AND PRECAUTIONS
- Thrombotic and other vascular events- Stop Chateal if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries or surgeries known to have an elevated risk of thromboembolism, or if there is an unexplained loss or change of vision (Evaluate for retinal thrombosis immediately.). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
- Carcinoma of the breast- Women with current or past history of breast cancer should not use Chateal.
- Liver Disease- Discontinue Chateal if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use.
- High Blood pressure- Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use Chateal.
- Other warnings and precautions include gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.
ADVERSE REACTIONS / SIDE EFFECTS
The most serious reactions are discussed above 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.
Patients should be counseled that Chateal does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reference: Chateal® prescribing information. Charleston, SC: Afaxys, Inc. August 2015.
Please see full prescribing information
To report SUSPECTED ADVERSE REACTIONS, call
report via the FDA MedWatch Program at www.fda.gov/medwatch