JOLIVETTE- norethindrone tablet
Actavis Pharma, Inc.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, modified corn starch, and povidone.
Meets USP Dissolution Test 2
Jolivette® progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.
Jolivette Indications and Usage
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.
|% of Women Experiencing an Unintended Pregnancy within the First Year of Use||% of Women Continuing Use at One Year *|
|Method(1)||Typical Use †(2)||Perfect Use ‡(3)||(4)|
|Adapted from Hatcher et al, 1998, Ref. # 1.Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.¶Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.|
|Norplant® and Norplant-2®||0.05||0.05||88|
Jolivette ® Tablets have not been studied for and are not indicated for use in emergency contraception.
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