Overview
11 DESCRIPTION Norelgestromin and ethinyl estradiol transdermal system is a transdermal system with a contact surface area of 15.75 cm 2 . It contains 4.678 mg norelgestromin, USP (NGMN) and 0.53 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN and 35 mcg of EE per day.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action NGMN is the active progestin largely responsible for the progestational activity that occurs in women following application of norelgestromin and ethinyl estradiol transdermal system. NGMN is also the primary active metabolite produced following oral administration of NGM, the progestin component of some oral contraceptive products. Combination hormonal contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). 12.
Indications
- 1 INDICATIONS AND USAGE Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI)
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, norelgestromin and ethinyl estradiol transdermal system must be used exactly as directed. Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling. Norelgestromin and ethinyl estradiol transdermal system uses a 28-day (4-week) cycle. Apply a new patch to the upper outer arm, abdomen, buttock or back each week for 3 weeks (21 total days). Week 4 is patch-free. ( 2.1 , 2.3 ) Apply each new patch on the same day of the week.
Black Box Warning
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI |GTE 30 kg/m2 • Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including norelgestromin and ethinyl estradiol transdermal system, are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 ) and Warnings and...
Contraindications
- 4 CONTRAINDICATIONS Norelgestromin and ethinyl estradiol transdermal system is contraindicated in females who are known to have or develop the following conditions: ● At high risk of arterial or venous thromboembolic events. Examples include women who: ○ Smoke, if over age 35 [see Boxed Warning, and Warnings and Precautions ( 5.1 )] ○ Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] ○ Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] ○ Have cerebrovascular disease [see Warnings and Precautions ( 5.
Side Effects
- 6 ADVERSE REACTIONS The following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol transdermal system, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.
Interactions
- 7 DRUG INTERACTIONS Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs. ( 7.1 ) 7.