Drug Catalog - Product Detail
ESZOPICLONE TAB 2MG 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 33342-0300-11 | MACLEODS PHARMACEUTICALS | 100 | 2MG | TABLET |
PACKAGE FILES
Generic Name
ESZOPICLONE
Substance Name
ESZOPICLONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202929
Description
11 DESCRIPTION Eszopiclone, USP is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1carboxylate. Its molecular weight is 388.81, and its empirical formula is C 17 H 17 C l N 6 O 3 . Eszopiclone, USP has a single chiral center with an (S)-configuration. It has the following chemical structure: Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone, USP is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone, USP and the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2. eszopiclone-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Eszopiclone tablets, USP 3 mg are dark blue, round, biconvex, film coated tablet, debossed with "L 36" on one side and plain on other side. NDC 76420-027-10 bottle of 10 tablets (repackaged from NDC 33342-301-11) NDC 76420-027-20 bottle of 20 tablets (repackaged from NDC 33342-301-11) NDC 76420-027-30 bottle of 30 tablets (repackaged from NDC 33342-301-11) NDC 76420-027-60 bottle of 60 tablets (repackaged from NDC 33342-301-11) NDC 76420-027-90 bottle of 90 tablets (repackaged from NDC 33342-301-11) NDC 76420-027-01 bottle of 100 tablets (relabeled from from NDC 33342-301-11) Eszopiclone tablets, USP 2 mg are white, round, biconvex, film coated tablet, debossed with "L 35" on one side and plain on other side. NDC 76420-024-10 bottle of 10 tablets (repackaged from NDC 33342-300-11) NDC 76420-024-20 bottle of 20 tablets (repackaged from NDC 33342-300-11) NDC 76420-024-30 bottle of 30 tablets (repackaged from NDC 33342-300-11) NDC 76420-024-60 bottle of 60 tablets (repackaged from NDC 33342-300-11) NDC 76420-024-90 bottle of 90 tablets (repackaged from NDC 33342-300-11) NDC 76420-024-01 bottle of 100 tablets (relabeled from from NDC 33342-300-11) Eszopiclone tablets, USP 1 mg are light blue, round, biconvex, film coated tablet, debossed with "L 34" on one side and plain on other side. NDC 76420-026-10 bottle of 10 tablets (repackaged from NDC 33342-299-11) NDC 76420-026-20 bottle of 20 tablets (repackaged from NDC 33342-299-11) NDC 76420-026-30 bottle of 30 tablets (repackaged/relabeled from NDC 33342-299-11/33342-299-07) NDC 76420-026-60 bottle of 60 tablets (repackaged from NDC 33342-299-11) NDC 76420-026-90 bottle of 90 tablets (repackaged from NDC 33342-299-11) NDC 76420-026-01 bottle of 100 tablets (relabeled from from NDC 33342-299-11) Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Preserve in tight containers.
Indications & Usage
1 INDICATIONS & USAGE 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 has been shown to decrease sleep latency and improve sleep maintenance ( 1 )
Dosage and Administration
2 DOSAGE & ADMINISTRATION Use the lowest effective dose for the patient. · Use the lowest dose effective for the patient ( 2 ) · Recommended initial dose is 1 mg, immediately before bedtime, with at least 7-8 hours remaining before the planned time of awakening. May increase dose if clinically indicated, to a maximum of 3 mg ( 2.1 ) · Geriatric or debilitated patients: Dose should not exceed 2 mg ( 2.2 ) · Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg ( 2.3 ) · Do not take with or immediately after a meal ( 2.5 ) 2.1 Dosage in Adults The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone tablets following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [ see Warnings and Precautions ( 5.1 ) ]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [ see Warnings and Precautions ( 5.6 ) ]. 2.2 Geriatric or Debilitated Patients The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients. 2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors In patients with severe hepatic impairment, or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [ see Warnings and Precautions ( 5.7 ) ]. 2.4 Use with CNS Depressants Dosage adjustments may be necessary when eszopiclone tablets are combined with other central nervous system (CNS) depressant drugs because of the potentially additive effects [see Warnings and Precautions ( 5.1 )]. 2.5 Administration with Food Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology ( 12.3 )] .