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Drug Catalog - Product Detail

LEVONORGESTREL/ETHINYL ESTRADIOL (ENPRESSE) TB .075/.04MG,.125/.03MG,.05/.03MG 6X28

NDC Mfr Size Str Form
00555-9047-58 TEVA PHARMACEUTICALS USA 28 50-30/75-40/125-30 MCG TABLET
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Generic Name
LEVONORGESTREL AND ETHINYL ESTRADIOL
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
Application Number
ANDA075809
Description
DESCRIPTION Each Enpresse ® (levonorgestrel and ethinyl estradiol tablets USP – triphasic regimen) cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 pink tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 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 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 orange tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 light-green inert tablets. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and pregelatinized corn starch. Coloring agents used are as follows: pink, 0.050 mg/0.030 mg tablets: D&C Yellow No. 10 Aluminum Lake and D&C Red No. 7 Calcium Lake; white, 0.075 mg/0.040 mg tablets: none; orange, 0.125 mg/0.030 mg tablets: FD&C Yellow No. 6 Aluminum Lake, 38-42%; and light-green, inert tablets: D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Levonorgestrel, USP MW: 312.45 MF: C 21 H 28 O 2 Ethinyl Estradiol, USP MW: 296.40 MF: C 20 H 24 O 2 Description: Structural Formula Description: Structural Formula 2
How Supplied
HOW SUPPLIED Enpresse ® (levonorgestrel and ethinyl estradiol tablets USP – triphasic regimen), are available in packages of six cyclic dispensers. Each cycle contains 28 round tablets as follows: six pink, round, film-coated, biconvex tablets debossed with dp on one side and 510 on the other side, each containing 0.050 mg levonorgestrel and 0.030 mg ethinyl estradiol; five white, round, film-coated, biconvex tablets debossed with dp on one side and 511 on the other side, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; ten orange, round, film-coated, biconvex tablets debossed with dp on one side and 512 on the other side, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol and seven light-green, round, inert tablets debossed with dp on one side and 519 on the other side. NDC: 0555-9047-58 References available upon request. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Brands listed are the trademarks of their respective owners. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. E 9/2022
Indications & Usage
INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product 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 Depo-Provera ® (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* 25 Withdrawal 4 19 No contraception (planned pregnancy) 85 85 NA-not available *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.
Dosage and Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Enpresse Tablets (levonorgestrel and ethinyl estradiol tablets-triphasic regimen) must be taken exactly as directed and at intervals not exceeding 24 hours. Enpresse Tablets are a three-phase preparation plus 7 inert tablets. The dosage of Enpresse Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 pink tablets (phase 1), followed by 5 white tablets (phase 2), followed by 10 orange tablets (phase 3), plus 7 light-green inert tablets, according to the prescribed schedule. It is recommended that Enpresse 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 Enpresse Tablet daily in the order of 6 pink, 5 white, 10 orange 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 orange tablet. (If Enpresse 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 Enpresse 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, Enpresse 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 Enpresse Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her pink 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 Enpresse 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 Enpresse 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 (pink, white, or orange) 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 pink tablets again on the proper day. In the nonlactating mother, Enpresse 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 postparturn 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 Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.