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Drug Catalog - Product Detail

LEVONORGESTREL/ETHINYL ESTRADIOL (MYZILRA) TB .075/.04MG,.125/.03MG,.05/.03MG 3X28

NDC Mfr Size Str Form
00603-7625-49 PAR PHARMACEUTICALS 28 50-30/75-40/125-30 MCG TABLET
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Description
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. Chemical structure of Levonorgestrel and Ethinyl Estradiol
How Supplied
HOW SUPPLIED 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.
Indications & Usage
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 consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Injectable progestogen 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2.0 Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (Female) without spermicide 5 21 Cervical cap Nulliparous women 9 20 Parous women 26 40 Vaginal sponge Nulliparous women 9 20 Parous women 20 40 Diaphragm with spermicidal cream or jelly 6 20 Spermicides alone (foam, creams, jellies, and vaginal suppositories) 6 26 Periodic abstinence (all methods) 1 to 9 Depending on method (calendar, ovulation, symptothermal, post-ovulation) 25 Withdrawal 4 19 No contraception (planned pregnancy) 85 85 NA - not available Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998.
Dosage and Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Myzilra ® Tablets—triphasic regimen must be taken exactly as directed and at intervals not exceeding 24 hours. Myzilra ® Tablets are a three-phase preparation plus 7 inert tablets. The dosage of Myzilra ® Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 beige tablets (phase 1), followed by 5 white tablets (phase 2), followed by 10 light-yellow tablets (phase 3), plus 7 light-green inert tablets, according to the prescribed schedule. It is recommended that Myzilra ® Tablets be taken at the same time each day, preferably after the evening meal or at bedtime. During the first cycle of medication, the patient should be instructed to take one Myzilra ® Tablet daily in the order of 6 beige, 5 white, 10 light-yellow tablets, and then 7 light-green inert tablets for twenty-eight (28) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) Withdrawal bleeding usually occurs within 3 days following the last light-yellow tablet. (If Myzilra ® Tablets are first taken later than the first day of the first menstrual cycle of medication or postpartum, contraceptive reliance should not be placed on Myzilra ® Tablets until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.) When switching from another oral contraceptive, Myzilra ® Tablets should be started on the first day of bleeding following the last active tablet taken of the previous oral contraceptive. The patient begins her next and all subsequent 28 day courses of Myzilra ® Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her beige tablets on the next day after ingestion of the last light-green tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of Myzilra ® Tablets is started later than the next day, the patient should be protected by another means of contraception until she has taken a tablet daily for seven consecutive days. If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if Myzilra ® Tablets are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. The risk of pregnancy increases with each active (beige, white, or light-yellow) tablet missed. For additional patient instructions regarding missed pills, see the “ WHAT TO DO IF YOU MISS PILLS ” section in the DETAILED PATIENT LABELING below. If breakthrough bleeding occurs following missed active tablets, it will usually be transient and of no consequence. If the patient misses one or more light-green tablets, she is still protected against pregnancy provided she begins taking beige tablets again on the proper day. In the nonlactating mother, Myzilra ® Tablets may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS concerning thromboembolic disease). It is to be noted that early resumption of ovulation may occur if bromocriptine mesylate has been used for the prevention of lactation.