Ethinyl estradiol and Levonorgestrel/ethinyl estradiol

CAMRESE LO ® is indicated for use by females of reproductive potential to prevent pregnancy. CAMRESE LO is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

COCs prevent pregnancy primarily by suppressing ovulation.

Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. How to Start and Take CAMRESE LO Begin CAMRESE LO on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first orange tablet that day. For each 91-day course, take in the following order: Take one orange tablet daily for 84 consecutive days. Use a non-hormonal backup method of contraception (such as condoms or spermicide) until an orange tablet has been taken daily for 7 consecutive days. Then take one yellow tablet for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.

CAMRESE LO is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: Smoke, if over age 35 Have current or history of deep vein thrombosis or pulmonary embolism Have cerebrovascular disease Have coronary artery disease Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) Have inherited or acquired hypercoagulopathies Have uncontrolled hypertension or hypertension with vascular disease Have diabetes mellitus and are over age 35, diabetes mellitus with…

Boxed warning (cigarette smoking and serious cardiovascular events): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including CAMRESE LO, are contraindicated in women who are over 35 years of age and smoke. Vascular risks: Stop if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. Liver disease: Discontinue if jaundice occurs.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke Vascular events Liver disease The most common adverse reactions in clinical trials for CAMRESE LO were headaches, irregular and/or heavy uterine bleeding, dysmenorrhea, nausea and/or vomiting and back pain.

The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. No formal drug-drug interaction studies were conducted with CAMRESE LO. Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of CAMRESE LO or increase breakthrough bleeding.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).