Overview
11 DESCRIPTION CAMRESE LO (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are: Levonorgestrel C 21 H 28 O 2 MW: 312.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action COCs prevent pregnancy primarily by suppressing ovulation. 12.2 Pharmacodynamics No pharmacodynamic studies were conducted with CAMRESE LO. 12.3 Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of CAMRESE LO in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability nearly 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the systemic bioavailability of ethinyl estradiol is approximately 43%.
Indications
- 1 INDICATIONS AND USAGE 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. ( 1 )
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 2.1 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.
Black Box Warning
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 [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning.
Contraindications
- 4 CONTRAINDICATIONS 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 [see Boxed Warning and Warnings and Precautions ( 5.1 )] Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ( 5.1 )] Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] Have coronary artery disease [see Warnings and Precautions ( 5.
Side Effects
- 6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] 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.
Interactions
- 7 DRUG INTERACTIONS 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.