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Levonorgestrel and Ethinyl Estradiol
Overview
What is Quasense?
QUASENSE (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 white active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, and 7 peach inert tablets (without hormones).
The structural formulas for the active components are:
Levonorgestrel
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.
Ethinyl Estradiol
Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.
What does Quasense look like?
What are the available doses of Quasense?
QUASENSE consists of 84 round, white tablets containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 round, peach inert tablets. ()
What should I talk to my health care provider before I take Quasense?
Nursing Mothers: Advise use of another contraceptive method. QUASENSE can decrease milk production. ()
How should I use Quasense?
QUASENSE (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
QUASENSE is dispensed in an Extended-Cycle Tablet Dispenser []. QUASENSE should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
Instruct patients to take QUASENSE once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, QUASENSE should be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see FDA-approved patient labeling.
What interacts with Quasense?
Sorry No Records found
What are the warnings of Quasense?
Sorry No Records found
What are the precautions of Quasense?
Sorry No Records found
What are the side effects of Quasense?
Sorry No records found
What should I look out for while using Quasense?
Do not prescribe QUASENSE to women who are known to have the following conditions:
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ()].
What might happen if I take too much Quasense?
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
How should I store and handle Quasense?
TOBI should be stored under refrigeration at 2ºC–8ºC/36ºF–46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. TOBI should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2ºC–8ºC/36ºF–46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).TOBI ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.TOBI should be stored under refrigeration at 2ºC–8ºC/36ºF–46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. TOBI should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2ºC–8ºC/36ºF–46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).TOBI ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017Nimodipine Capsules 30 mg are available as orange, opaque, oblong shape, soft gelatin capsules, imprinted with black ink. They are supplied as follows: The capsules should be stored in the manufacturer's original package.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Capsules should be protected from light and freezing.Manufactured for: Heritage Pharmaceuticals Inc.East Brunswick, NJ 088161.866.901.DRUG (3784)51U000000272US01Revised: 10/2017
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Non-Clinical Toxicology
Do not prescribe QUASENSE to women who are known to have the following conditions:Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ()].
Pharmacodynamic studies in Wilson’s disease patients failed to demonstrate drug interactions between zinc acetate (50 mg t.i.d.) and ascorbic acid (1 g daily), penicillamine (1 g daily), and trientine (1 g daily). Therefore, precautions for zinc acetate effects do not seem necessary when Wilson’s disease patients are taking vitamin C or approved chelating agents. However, no data are available to demonstrate that zinc acetate should be added to other drugs used for the treatment of Wilson’s disease patients or is safe.
Thrombotic disorders and other vascular problems: Stop QUASENSE if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. ()
Liver disease: Discontinue QUASENSE if jaundice occurs. ()
High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop QUASENSE if blood pressure rises significantly. ()
Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking QUASENSE. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ()
Headache: Evaluate significant change in headaches and discontinue QUASENSE if indicated. ()
Bleeding irregularities and amenorrhea: Evaluate irregular bleeding or amenorrhea. ()
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
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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