Eszopiclone (Eszopiclone)

Trade Name : eszopiclone

West-Ward Pharmaceuticals Corp.

TABLET

Strength 1 mg/1

ESZOPICLONE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Eszopiclone (Eszopiclone) which is also known as eszopiclone and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 1 mg/1 per ml. Read more

Eszopiclone (Eszopiclone) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Warnings and Precautions, CNS Depressant

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Eszopiclone. Some of these events may result in serious injuries, including death. Discontinue Eszopiclone immediately if a patient experiences a complex sleep behavior n
WARNING: COMPLEX SLEEP BEHAVIORS
See full prescribing information for complete boxed warning.
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Eszopiclone. Some of these events may result in serious injuries, including death. Discontinue Eszopiclone immediately if a patient experiences a complex sleep behavior (, ).

Eszopiclone Tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, Eszopiclone Tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Eszopiclone Tablets are indicated for the treatment of insomnia. Eszopiclone Tablets have been shown to decrease sleep latency and improve sleep maintenance ()

Use the lowest effective dose for the patient.

Eszopiclone tablets are available in 1 mg, 2 mg, and 3 mg strengths for oral administration.
Tablets: 1 mg, 2 mg and 3 mg tablets ()

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CNS depressant effects:
Evaluate for Comorbid Diagnoses:
Severe Anaphylactic/Anaphylactoid Reactions
Abnormal Thinking and Behavioral Changes:
Worsening of Depression or Suicidal Thinking
Withdrawal Effects:
Elderly Patients:

The following are described in more detail in the section of the label:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The premarketing development program for eszopiclone included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years. The conditions and duration of treatment with eszopiclone varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term and longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while the patient was receiving therapy following baseline evaluation.
Most commonly observed adverse reactions (incidence u22652%) were unpleasant taste, headache, somnolence, respiratory infection, dizziness, dry mouth, rash, anxiety, hallucinations, and viral infections ()

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CNS Depressants:
Rifampicin:
Ketoconazole:

No data

u2022
Pediatric Use:
8.4

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In clinical trials with eszopiclone, one case of overdose with up to 36 mg of eszopiclone was reported in which the subject fully recovered. Since commercial marketing began, spontaneous cases of eszopiclone overdoses up to 270 mg (90 times the maximum recommended dose of eszopiclone) have been reported, in which patients have recovered. Fatalities related to eszopiclone overdoses were reported only in combination with other CNS drugs or alcohol.

Eszopiclone Tablets are a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is CHClNO. Eszopiclone has a single chiral center with an ()-configuration. It has the following chemical structure:
Eszopiclone is a white to slightly yellowish powder. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).
Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone Tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and Opadry II (White). Opadry II (White) contains hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.

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Carcinogenesis
In a 2-year carcinogenicity study in mice, oral administration of racemic zopiclone (1, 10, or 100 mg/kg/day) produced increases in pulmonary carcinomas and carcinomas plus adenomas (females) and skin fibromas and sarcomas (males) at the highest dose tested. The skin tumors were due to skin lesions induced by aggressive behavior, a mechanism not relevant to humans. A carcinogenicity study of eszopiclone was conducted in mice at oral doses up to 100 mg/kg/day. Although this study did not reach a maximum tolerated dose, and was thus inadequate for overall assessment of carcinogenic potential, no increases in either pulmonary or skin tumors were seen at doses producing plasma levels of eszopiclone approximately 90 times those in humans at the MRHD of eszopiclone (and 12 times the exposure in the racemate study).
Eszopiclone did not increase tumors in a p53 transgenic mouse bioassay at oral doses up to 300u00a0mg/kg/day.
Mutagenesis
in vitro
in vitro
in vivo
()-N-desmethyl zopiclone, a metabolite of eszopiclone, was positive in chromosomal aberration assays in mammalian cells. ()-N-desmethyl zopiclone was negative in the bacterial gene mutation (Ames) assay and in an chromosomal aberration and micronucleus assay.
Impairment of Fertility

The effect of eszopiclone on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18 to 86) with chronic and transient insomnia in six placebo-controlled trials of up to 6 monthsu2019 duration. Two of these trials were in elderly patients (n=523). Overall, at the recommended adult dose (2 to 3 mg) and elderly dose (1 to 2 mg), eszopiclone significantly decreased sleep latency and improved measures of sleep maintenance (objectively measured as WASO and subjectively measured as total sleep time).

Eszopiclone Tablets are round, white, biconvex, film-coated tablets and are supplied as follows:
The 1 mg tablets are debossed with product identification u201c54u201d over u201c746u201d on one side and plain on the other side.
The 2 mg tablets are debossed with product identification u201c54u201d over u201c029u201d on one side and plain on the other side.
The 3 mg tablets are debossed with product identification u201c54u201d over u201c396u201d on one side and plain on the other side.
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]

See FDA-approved patient labeling (Medication Guide).
Inform patients and their families about the benefits and risks of treatment with eszopiclone. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with eszopiclone and with each prescription refill. Review the eszopiclone Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that eszopiclone should be taken only as prescribed.
Complex Sleep Behaviorsn- [see Boxed Warning, Warnings and Precautions ()]
CNS Depressant Effects and Next-Day Impairmentn- [see Warnings and Precautions ()]
Severe Anaphylactic and Anaphylactoid Reactionsn- [see Warnings and Precautions ()]
Suicide
Alcohol and Other Drugs
Tolerance, Abuse, and Dependence
Administration Instructions
Distr. by:n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10005923/06
Revised August 2019

Eszopiclone Tablets (ES-zoe-PIK-lone), coated CIV
Read the Medication Guide that comes with eszopiclone before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.
What is the most important information I should know about eszopiclone?
Eszopiclone may cause serious side effects, including:
Complex sleep behaviors that have caused serious injury and death.
The morning after you take eszopiclone your ability to drive safely and think clearly may be decreased. You also may experience sleepiness during the day.
Do not take eszopiclone if you:
What is eszopiclone?
Eszopiclone is a sedative-hypnotic (sleep) medicine. Eszopiclone is used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:
Eszopiclone is not for children.
Who should not take eszopiclone?
Eszopiclone may not be right for you. Before starting eszopiclone, tell your doctor about all of your health conditions, including if you:
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. n
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take eszopiclone?
What are the possible side effects of eszopiclone?
Possible serious side effects of eszopiclone include:
Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using eszopiclone.
The most common side effects of eszopiclone are:
These are not all the side effects of eszopiclone. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store eszopiclone?
General Information about eszopiclone
This Medication Guide summarizes the most important information about eszopiclone. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about eszopiclone that is written for healthcare professionals.
For product information call 1-800-962-8364.
What are the ingredients in eszopiclone?
Active Ingredient:
Inactive Ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distr. by:n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10005923/06
Revised August 2019

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Eszopiclone (Eszopiclone)

Trade Name : eszopiclone

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Eszopiclone (Eszopiclone)

Trade Name : eszopiclone

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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