MYZILRA- levonorgestrel and ethinyl estradiol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Par Pharmaceutical

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.05 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use Myzilra® Tablets as a method of contraception. Oral contraceptives are highly effective. TABLE I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998. Oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders. A past history of deep-vein thrombophlebitis or thromboembolic disorders. Cerebral-vascular or coronary-artery disease. Known or suspected carcinoma of the breast. Carcinoma of

Product summary:

Myzilra® (levonorgestrel and ethinyl estradiol tablets USP)—triphasic regimen is packaged in cartons of 3 and 6 blister pack tablet dispensers. Each blister pack tablet dispenser contains 28 round, film coated tablets as follows: Six beige tablets debossed “93” on one side and “680” on the other side, each containing 0.05 mg levonorgestrel and 0.03 mg ethinyl estradiol; five white tablets debossed “93” on one side and “681” on the other side, each containing 0.075 mg levonorgestrel and 0.04 mg ethinyl estradiol; ten light-yellow tablets debossed “93” on one side and “682” on the other side, each containing 0.125 mg levonorgestrel and 0.03 mg ethinyl estradiol; and seven light-green inert tablets debossed “93” on one side and “743” on the other side. Blister pack tablet dispenser NDC 0603-7625-01 Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49 Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid humid conditions and protect from light by storing tablet blister in the cardboard sleeve provided. References available upon request.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MYZILRA- LEVONORGESTREL AND ETHINYL ESTRADIOL
PAR PHARMACEUTICAL
----------
MYZILRA (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)—TRIPHASIC
REGIMEN
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Each Myzilra
cycle of 28 tablets consists of three different drug phases as
follows: Phase 1
comprised of 6 beige tablets, each containing 0.05 mg of
levonorgestrel (d(-)-13 beta-ethyl-17-alpha-
ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic
progestogen, and 0.03 mg of ethinyl
estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol);
phase 2 comprised of 5 white tablets,
each containing 0.075 mg levonorgestrel and 0.04 mg ethinyl estradiol;
and phase 3 comprised of 10
light-yellow tablets, each containing 0.125 mg levonorgestrel and 0.03
mg ethinyl estradiol; then
followed by 7 light-green inert tablets. The inactive ingredients
present are microcrystalline cellulose,
FD&C Blue 2, FD&C Red 40, FD&C Yellow 6, D&C Yellow 10, hypromellose,
iron oxide yellow,
lactose monohydrate, magnesium stearate, polyethylene glycol,
pregelatinized starch, and vitamin E.
CLINICAL PHARMACOLOGY
Combination oral contraceptives primarily 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).
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in
women who elect to use Myzilra
Tablets as a method of contraception. Oral contraceptives are highly
effective. TABLE I lists the
typical accidental pregnancy rates for users of combination oral
contraceptives and other methods of
contraception. The efficacy of these contraceptive methods, except
sterilization and the IUD, depends
upon the reliability with which they are used. Correct and consisten