NIKP-Zolpidem Mechanism of Action

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Action

Pharmacology: Pharmacokinetics: Bioequivalence Study: When a single oral dose of one tablet of NIKP-Zolpidem tablet 10 mg or one tablet of the reference product (both tablets contain 10 mg of zolpidem tartrate) was given to healthy male adults during fasting with a cross-over method, the plasma concentrations of zolpidem were measured. In a statistical analysis for the obtained pharmacokinetic parameters (AUC and C_max), calculation results of 90% confidence intervals for the parameters were within a range between log (0.8) and log (1.25), demonstrating the bioequivalence of the two formulations. (See Table 1 and figure.)

Click on icon to see table/diagram/image

Click on icon to see table/diagram/image

Dissolution Profile: This drug has been shown to meet the dissolution specification for zolpidem tartrate tablets set forth in the Official Monographs of the Japanese Pharmacopoeia.

NIKP-Zolpidem Mechanism of Action

zolpidem

Manufacturer:

Nichi-Iko

Distributor:

DKSH