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Levonorgestrel and Ethinyl Estradiol
Overview
What is Myzilra?
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.
What does Myzilra look like?
What are the available doses of Myzilra?
Sorry No records found.
What should I talk to my health care provider before I take Myzilra?
Sorry No records found
How should I use Myzilra?
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. 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.
Adapted from Hatcher RA et al, NY, NY: Ardent Media, Inc., 1998.
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 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 “” section in the 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 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 , , and 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.
What interacts with Myzilra?
Sorry No Records found
What are the warnings of Myzilra?
Sorry No Records found
What are the precautions of Myzilra?
Sorry No Records found
What are the side effects of Myzilra?
Sorry No records found
What should I look out for while using Myzilra?
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 the endometrium or other known or suspected estrogen-dependent neoplasia.Undiagnosed abnormal genital bleeding.Cholestatic jaundice of pregnancy or jaundice with prior pill use.Hepatic adenomas or carcinomas.Known or suspected pregnancy.Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see
).
What might happen if I take too much Myzilra?
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
How should I store and handle Myzilra?
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; andseven light-green inert tablets debossed “93” on one side and “743” on the other side.Blister pack tablet dispenser NDC 0603-7625-01Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17Myzilra (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; andseven light-green inert tablets debossed “93” on one side and “743” on the other side.Blister pack tablet dispenser NDC 0603-7625-01Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17Myzilra (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; andseven light-green inert tablets debossed “93” on one side and “743” on the other side.Blister pack tablet dispenser NDC 0603-7625-01Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17Myzilra (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; andseven light-green inert tablets debossed “93” on one side and “743” on the other side.Blister pack tablet dispenser NDC 0603-7625-01Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17Myzilra (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; andseven light-green inert tablets debossed “93” on one side and “743” on the other side.Blister pack tablet dispenser NDC 0603-7625-01Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17Myzilra (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; andseven light-green inert tablets debossed “93” on one side and “743” on the other side.Blister pack tablet dispenser NDC 0603-7625-01Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17Myzilra (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; andseven light-green inert tablets debossed “93” on one side and “743” on the other side.Blister pack tablet dispenser NDC 0603-7625-01Boxes of 3 blister pack tablet dispensers NDC 0603-7625-49Boxes of 6 blister pack tablet dispensers NDC 0603-7625-17
Clinical Information
Chemical Structure
No Image foundClinical 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).
Non-Clinical Toxicology
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 the endometrium or other known or suspected estrogen-dependent neoplasia.Undiagnosed abnormal genital bleeding.Cholestatic jaundice of pregnancy or jaundice with prior pill use.Hepatic adenomas or carcinomas.Known or suspected pregnancy.Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see ).Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see ).Thrombophlebitis.Arterial thromboembolism.Pulmonary embolism.Myocardial infarction.Cerebral hemorrhage.Cerebral thrombosis.Hypertension.Gallbladder disease.Hepatic adenomas or benign liver tumors.
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:Mesenteric thrombosis.Retinal thrombosis.
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related:Nausea.Vomiting.Gastrointestinal symptoms (such as abdominal pain, cramps and bloating).Breakthrough bleeding.Spotting.Change in menstrual flow.Amenorrhea.Temporary infertility after discontinuation of treatment.Edema.Melasma which may persist.Breast changes: tenderness, enlargement, secretion.Change in weight (increase or decrease).Change in cervical erosion and secretion.Diminution in lactation when given immediately postpartum.Cholestatic jaundice.Migraine.Rash (allergic).Mental depression.Reduced tolerance to carbohydrates.Vaginal candidiasis.Change in corneal curvature (steepening).Intolerance to contact lenses.
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:Congenital anomalies.Premenstrual syndrome.Cataracts.Optic neuritis.Changes in appetite.Cystitis-like syndrome.Headache.Nervousness.Dizziness.Hirsutism.Loss of scalp hair.Erythema multiforme.Erythema nodosum.Hemorrhagic eruption.Vaginitis.Porphyria.Impaired renal function.Hemolytic uremic syndrome.Budd-Chiari syndrome.Acne.Changes in libido.Colitis.Sickle-cell disease.Cerebral-vascular disease with mitral valve prolapse.Lupus-like syndromes.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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