Overview
11 DESCRIPTION Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: • 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium • 4 light orange tablets each containing 0.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation. 12.2 Pharmacodynamics Drospirenone is a spironolactone analogue with anti-mineralocorticoid and antiandrogenic activity. The estrogen in Drospirenone/Ethinyl Estradiol/Levomefolate Calcium is ethinyl estradiol (EE). Contraception No specific pharmacodynamic studies were conducted with Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium. Two studies evaluated the effect of 3 mg DRSP / 0.02 mg EE combinations on the suppression of ovarian activity as assessed by measurement of follicle size via transvaginal ultrasound and serum hormone (progesterone and estradiol) analyses during two treatment cycles (21-day active tablet period plus 7-day...
Indications
- 1 INDICATIONS AND USAGE Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: • Prevent pregnancy. ( 1.1 ) • Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.
Common Doses
- 0.4 mg
- 400 mcg
Dosage
2 DOSAGE AND ADMINISTRATION • Take one tablet daily by mouth at the same time every day. ( 2.1 ) • Tablets must be taken in the order directed on the blister pack. ( 2.1 ) 2.1 How to Take Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium must be taken as directed, in the order directed on the blister pack.
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 should not be used by women who are over 35 years of age and smoke [see Contraindications ( 4 )] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning.
Contraindications
- 4 CONTRAINDICATIONS Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is contraindicated in females who are known to have or develop the following conditions: • Renal impairment • Adrenal insufficiency • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • 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 cerebrovascular 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 ( 5.4 )] • The most frequent adverse reactions (≥ 2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). ( 6.
Interactions
- 7 DRUG INTERACTIONS Consult the labeling of all 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 COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. ( 7.1 ) 7.