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Levonorgestrel and Ethinyl Estradiol
Overview
What is Enpresse?
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 ((-)-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 starch. Coloring agents used are as follows: pink, 0.050mg/0.030mg tablets: D&C Yellow No. 10 Aluminum Lake and D&C Red No. 7 Calcium Lake; white, 0.075mg/0.040mg tablets: none; orange, 0.125mg/0.030mg 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: CHO
Ethinyl Estradiol, USP MW: 296.41 MF: CHO
What does Enpresse look like?
What are the available doses of Enpresse?
Sorry No records found.
What should I talk to my health care provider before I take Enpresse?
Sorry No records found
How should I use Enpresse?
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
Adapted from Hatcher RA et al, , NY, NY: Ardent Media, Inc., 1998.
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 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 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 “”, “”, and “” 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.
What interacts with Enpresse?
- Oral contraceptives should not be used in women with any of the following conditions:
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What are the warnings of Enpresse?
Sorry No Records found
What are the precautions of Enpresse?
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
1. Physical Examination And Follow-Up
A periodic history and physical examination is appropriate for all women, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
2. Lipid Disorders
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. (See “,” 1d.)
3. Liver Function
If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.
4. Fluid Retention
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
5. Emotional disorders
Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternative method of contraception in an attempt to determine whether the symptom is drug related. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
6. Contact Lenses
Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
7. Drug Interactions
Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation
Do not co-administer Enpresse (levonorgestrel and ethinyl estradiol tablets – triphasic regimen) with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to 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.
8. Interactions With Laboratory Tests
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Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:
9. Carcinogenesis
See “” section.
10. Pregnancy
Pregnancy Category X.
See “” and “” sections.
11. Nursing Mothers
Small amounts of oral-contraceptive steroids have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral-contraceptives but to use other forms of contraception until she has completely weaned her child.
12. Pediatric Use
Safety and efficacy of Enpresse (levonorgestrel and ethinyl estradiol tablets – triphasic regimen) have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and users 16 and older. Use of this product before menarche is not indicated.
What are the side effects of Enpresse?
An increased risk of the following serious adverse reactions has been associated with the use of oral- contraceptives (see “” section):
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 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.
What should I look out for while using Enpresse?
Oral contraceptives should not be used in women with any of the following conditions:
What might happen if I take too much Enpresse?
Sorry No Records found
How should I store and handle Enpresse?
StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ ]. StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ ]. 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: 0555-9047-58References available upon request.Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.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: 0555-9047-58References available upon request.Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.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: 0555-9047-58References available upon request.Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.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: 0555-9047-58References available upon request.Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Combination oral contraceptives 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:Caution should be exercised when propranolol hydrochloride extended-release capsules are administered with drugs that have an affect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see in ).
Alcohol when used concomitantly with propranolol, may increase plasma levels of propranolol.
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 “” section):
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 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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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