Label: ESZOPICLONE- eszopiclone tablet, film coated
- NDC Code(s): 61919-991-90
- Packager: DirectRX
- This is a repackaged label.
- Source NDC Code(s): 68462-382
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIV
- Marketing Status: Abbreviated New Drug Application
Updated December 2, 2015
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- Indications and Usage
- Dosage and Administration
Use the lowest effective dose for the patient.
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 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 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 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 tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone 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 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)].Close
- Dosage forms and strengths
Eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)].Close
- Warnings and Precautions
- Adverse Reactions
- Drug Interactions
- Use in Specific Populations
- Drug abuse and Dependence
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- Information for Patients
- Medication Guide
- Package Label
- INGREDIENTS AND APPEARANCE
eszopiclone tablet, film coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-991(NDC:68462-382) Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE) ESZOPICLONE 1 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color blue (light blue) Score no score Shape ROUND Size 6mm Flavor Imprint Code 382;G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-991-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091166 12/01/2015 Labeler - DirectRX (079254320) Establishment Name Address ID/FEI Business Operations DirectRX 079254320 repack(61919-991)