Please read the instructions carefully and use under the guidance of a physician.
[Drug name]
English name: Pregabalin Capsules

[Ingredients]
The active ingredient of this product is pregabalin. Its chemical name is (S)-3-(aminomethyl)-5-methylhexanoic acid.

Chemical structural formula:
Molecular formula: C₈H₁₇NO₂
Molecular weight: 159.23

[Description]This product is a capsule containing white or off-white powder.

[Indications]This product is indicated for:
Postherpetic neuralgia (PHN)
Fibromyalgia
Adjunctive therapy for partial-onset seizures in adults

[Specification]75mg，150mg

[Dosage and Administration]

This product may be taken with or without food.

For the treatment of postherpetic neuralgia:

The recommended dosage is 75 mg or 150 mg twice daily, or 50 mg or 100 mg three times daily.

The starting dose may be 75 mg twice daily (150 mg/day), or 50 mg three times daily (150 mg/day). Based on efficacy and tolerability, the dose may be increased to 150 mg twice daily (300 mg/day) within one week. As this product is primarily eliminated by renal excretion, dose adjustment is recommended in patients with reduced renal function. The above recommended doses apply to patients with creatinine clearance ≥60 mL/min.用于肌酐清除率≥60mL/min的患者。

In patients who do not experience adequate pain relief after 2 to 4 weeks of treatment with this product at 300 mg/day, the dose may be increased to 300 mg twice daily (600 mg/day) or 200 mg three times daily (600 mg/day), if tolerated. As adverse reactions are dose-dependent and may lead to higher discontinuation rates, doses exceeding 300 mg/day should only be used in patients with persistent pain who have tolerated the 300 mg/day dose (see [Adverse Reactions]).

For the treatment of fibromyalgia:

The recommended dose of this product for the treatment of fibromyalgia is 300 to 450 mg/day. The starting dose should be 75 mg twice daily (150 mg/day) and may be increased to 150 mg twice daily (300 mg/day) within one week based on efficacy and tolerability. Patients who do not achieve sufficient benefit at 300 mg/day may be increased to 225 mg twice daily (450 mg/day). Although a dose of 600 mg/day has been studied in clinical trials, there is no evidence that this dose provides additional significant efficacy, and it is less well tolerated. Due to the dose-dependent nature of adverse reactions, doses exceeding 450 mg/day are not recommended (see [Adverse Reactions]). As this product is primarily eliminated by renal excretion, dose adjustment is recommended in patients with reduced renal function (see [Dosage and Administration]).

For adjunctive therapy of partial-onset seizures in adults:

The effective dose is 150 to 600 mg/day, administered in two or three divided doses. The recommended starting dose is 150 mg/day. The daily dose may be increased up to a maximum of 600 mg based on individual patient response and tolerability. The efficacy and adverse reactions of this product are dose-related.

If pregabalin is to be discontinued, it is recommended that the dose be gradually reduced over a period of at least one week.