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desogestrel and ethinyl estradiol
Overview
What is Emoquette?
EMOQUETTE(desogestrel and ethinyl estradiol tablets USP) tablets provide an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18, 19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)- trien-20-yne-3, 17, diol). Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, povidone, polyethylene glycol, pregelatinized starch, stearic acid and vitamin E. Each light-green tablet contains the following inactive ingredients: FD&C Blue No. 2 aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and pregelatinized starch.
Emoquette meets USP Dissolution Test 2.
What does Emoquette look like?
What are the available doses of Emoquette?
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What should I talk to my health care provider before I take Emoquette?
Sorry No records found
How should I use Emoquette?
EMOQUETTE(desogestrel and ethinyl estradiol tablets USP) tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.
In a clinical trial with EMOQUETTE, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.
Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York, NY; Irvington Publishers, 1998.
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To achieve maximum contraceptive effectiveness, EMOQUETTE must be taken exactly as directed and at intervals not exceeding 24 hours. EMOQUETTE is available in the blister pack which is preset for a Sunday Start. Day 1 Start is also provided.
What interacts with Emoquette?
Sorry No Records found
What are the warnings of Emoquette?
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What are the precautions of Emoquette?
Sorry No Records found
What are the side effects of Emoquette?
Sorry No records found
What should I look out for while using Emoquette?
Oral contraceptives should not be used in women who currently have the following conditions:
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including
EMOQUETTE
, should not be used by women who are over 35 years of age and smoke.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the author’s permission). For further information, the reader is referred to a text on epidemiological methods.
What might happen if I take too much Emoquette?
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 Emoquette?
Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.EMOQUETTE (desogestrel and ethinyl estradiol tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers; each blister pack tablet dispenser contains 28 tablets. Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each light-green tablet contains inert ingredients.The white tablets are round, film-coated, imprinted with “93” on one side and “876” on the other side; the light-green tablets are round, film-coated imprinted with “93” on one side, and “743” on the other side.Blister pack tablet dispenser NDC 0603-7540-01Boxes of 3 blister pack tablet dispensers NDC 0603-7540-49Boxes of 6 blister pack tablet dispensers NDC 0603-7540-17EMOQUETTE (desogestrel and ethinyl estradiol tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers; each blister pack tablet dispenser contains 28 tablets. Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each light-green tablet contains inert ingredients.The white tablets are round, film-coated, imprinted with “93” on one side and “876” on the other side; the light-green tablets are round, film-coated imprinted with “93” on one side, and “743” on the other side.Blister pack tablet dispenser NDC 0603-7540-01Boxes of 3 blister pack tablet dispensers NDC 0603-7540-49Boxes of 6 blister pack tablet dispensers NDC 0603-7540-17EMOQUETTE (desogestrel and ethinyl estradiol tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers; each blister pack tablet dispenser contains 28 tablets. Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each light-green tablet contains inert ingredients.The white tablets are round, film-coated, imprinted with “93” on one side and “876” on the other side; the light-green tablets are round, film-coated imprinted with “93” on one side, and “743” on the other side.Blister pack tablet dispenser NDC 0603-7540-01Boxes of 3 blister pack tablet dispensers NDC 0603-7540-49Boxes of 6 blister pack tablet dispensers NDC 0603-7540-17
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Combined 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 changes in the endometrium which reduce the likelihood of implantation.
Receptor binding studies, as well as studies in animals, have shown that 3-keto-desogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with minimal intrinsic androgenicity. The relevance of this latter finding in humans is unknown.
Non-Clinical Toxicology
Oral contraceptives should not be used in women who currently have the following conditions:Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including
EMOQUETTE
, should not be used by women who are over 35 years of age and smoke.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (Adapted from refs. 2 and 3 with the author’s permission). For further information, the reader is referred to a text on epidemiological methods.
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Effects of Other Drugs on Combined Hormonal Contraceptives Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Effects of Combined Hormonal Contraceptives on Other DrugsCOCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increases with use of COCs.
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 ).
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:
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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