Uses
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Seizure Disorders
Management (in combination with other anticonvulsants) of partial seizures in adults.
Neuropathic Pain
Management of postherpetic neuralgia in adults.
Management of pain associated with diabetic peripheral neuropathy in adults.
Dosage and Administration
General
- If pregabalin discontinued, gradually taper dosage over ≥1 week. (See Discontinuance of Pregabalin under Cautions.)
Administration
Oral Administration
Administer orally without regard to meals.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Efficacy and adverse effects dose related, although effect of dosage escalation rate on tolerability not studied.
Adults
Seizure Disorders
Partial Seizures
Oral
Initially, 75 mg twice daily or 50 mg 3 times daily (initial dosage not to exceed 150 mg daily). Increase dosage up to a maximum of 600 mg daily, based on individual patient response and tolerability.
Effective maintenance dosage is 150–600 mg daily, administered in 2 or 3 divided doses.
Dosage recommendations for use of pregabalin in conjunction with gabapentin not available, since such regimens not evaluated in controlled clinical studies.
Neuropathic Pain
Postherpetic Neuralgia
Oral
Initially, 150 mg daily (75 mg twice daily or 50 mg 3 times daily). Increase dosage to 300 mg daily within 1 week based on efficacy and tolerability.
Recommended maintenance dosage is 150–300 mg daily in 2 or 3 divided doses.
May increase dosage up to 600 mg daily (administered in 2 or 3 divided doses) in those who tolerate the drug but do not experience adequate pain relief following 2–4 weeks of treatment with pregabalin 300 mg daily.
Because of risk for dose-dependent adverse effects and higher rates of treatment discontinuance secondary to adverse effects, reserve dosages exceeding 300 mg daily for those who have continuing pain and are tolerating the 300-mg daily dosage.
Diabetic Neuropathy
Oral
Initially, 150 mg daily in 3 divided doses (50 mg 3 times daily); increase dosage within 1 week up to a maximum of 300 mg daily (administered in 3 divided doses), based on efficacy and tolerability.
Higher pregabalin dosages (i.e., dosages exceeding 600 mg daily) provide no additional benefit, but may increase risk of adverse effects.
Prescribing Limits
Adults
Seizure Disorders and Neuropathic Pain
Oral
Maximum 600 mg daily.
Special Populations
Dosage in Renal Impairment
Modify dosage of pregabalin in adults with renal impairment (Clcr <60 mL/minute) based on Clcr.
Table 1: Pregabalin Dosage Adjustment in Patients with Renal Impairment
| Usual Dosage Regimen (for Patients with Creatinine Clearances of ≥60 mL/min) |
Creatinine Clearance (mL/min) |
Adjusted Dosage Regimen |
| 150 mg daily given in 2 or 3 divided doses |
30–60 |
75 mg daily given in 2 or 3 divided doses |
| |
15–30 |
25–50 mg daily given as a single dose or in 2 divided doses |
| |
<15 |
25 mg once daily |
| 300 mg daily given in 2 or 3 divided doses |
30–60 |
150 mg daily given in 2 or 3 divided doses |
| |
15–30 |
75 mg daily given as a single dose or in 2 divided doses |
| |
<15 |
25–50 mg once daily |
| 600 mg daily given in 2 or 3 divided doses |
30–60 |
300 mg daily given in 2 or 3 divided doses |
| |
15–30 |
150 mg daily given as a single dose or in 2 divided doses |
| |
<15 |
75 mg once daily |
Patients undergoing hemodialysis should receive a supplemental dose immediately following each 4-hour dialysis session. Individuals receiving the 25-mg once-daily dosage regimen should receive a supplemental dose of 25 or 50 mg, those receiving the 25- to 50-mg once-daily dosage regimen should receive a supplemental dose of 50 or 75 mg, and those receiving the 75-mg once-daily dosage regimen should receive a supplemental dose of 100 or 150 mg.
Geriatric Patients
Adjust dosage for geriatric patients with renal impairment. (See Dosage Adjustment in Patients with Renal Impairment under Dosage and Administration.)
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