Lyrica - Dosage PREGABALIN
Dosage & Administration
- For adult indications, begin dosing at 150 mg/day. For partial-onset seizure dosing in pediatric patients 1 month of age and older, refer to section 2.4. (2.2, 2.3, 2.4, 2.5, 2.6)
- Dosing recommendations:
| INDICATION | Dosing Regimen | Maximum Dose |
|---|---|---|
| DPN Pain (2.2) | 3 divided doses per day | 300 mg/day within 1 week |
| PHN (2.3) | 2 or 3 divided doses per day | 300 mg/day within 1 week. Maximum dose of 600 mg/day. |
| Adjunctive Therapy for Partial-Onset Seizures in Pediatric and Adult Patients Weighing 30 kg or More (2.4) | 2 or 3 divided doses per day | Maximum dose of 600 mg/day. |
| Adjunctive Therapy for Partial-Onset Seizures in Pediatric Patients Weighing Less than 30 kg (2.4) | 1 month to less than 4 years: 3 divided doses per day 4 years and older: 2 or 3 divided doses per day | 14 mg/kg/day. |
| Fibromyalgia (2.5) | 2 divided doses per day | 300 mg/day within 1 week. Maximum dose of 450 mg/day. |
| Neuropathic Pain Associated with Spinal Cord Injury (2.6) | 2 divided doses per day | 300 mg/day within 1 week. Maximum dose of 600 mg/day. |
- Dose should be adjusted in adult patients with reduced renal function. (2.7)
important administration instructions
LYRICA is given orally with or without food.
When discontinuing LYRICA, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.3)].
Because LYRICA is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see Dosage and Administration (2.7)].
neuropathic pain associated with diabetic peripheral neuropathy in adults
The maximum recommended dose of LYRICA is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see Adverse Reactions (6.1)].
postherpetic neuralgia in adults
The recommended dose of LYRICA is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate LYRICA, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1)].
adjunctive therapy for partial-onset seizures in patients 1 month of age & older
The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly.
| Age and Body Weight | Recommended Initial Dosage | Recommended Maximum Dosage | Frequency of Administration |
|---|---|---|---|
| Adults (17 years and older) | 150 mg/day | 600 mg/day | 2 or 3 divided doses |
| Pediatric patients weighing 30 kg or more | 2.5 mg/kg/day | 10 mg/kg/day (not to exceed 600 mg/day) | 2 or 3 divided doses |
| Pediatric patients weighing less than 30 kg | 3.5 mg/kg/day | 14 mg/kg/day | 1 month to less than 4 years of age: 3 divided doses 4 years of age and older: 2 or 3 divided doses |
Both the efficacy and adverse event profiles of LYRICA have been shown to be dose-related.
The effect of dose escalation rate on the tolerability of LYRICA has not been formally studied.
The efficacy of adjunctive LYRICA in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of LYRICA with gabapentin cannot be offered.
management of fibromyalgia in adults
The recommended dose of LYRICA for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see Adverse Reactions (6.1)].
neuropathic pain associated with spinal cord injury in adults
The recommended dose range of LYRICA for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate LYRICA may be treated with up to 300 mg two times a day [see Clinical Studies (14.5)].
dosing for adult patients with renal impairment
In view of dose-dependent adverse reactions and since LYRICA is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function. The use of LYRICA in pediatric patients with compromised renal function has not been studied.
Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 2. To use this dosing table, an estimate of the patient's CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation:
Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr greater than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal adjusted dose.
(For example: A patient initiating LYRICA therapy for postherpetic neuralgia with normal renal function (CLcr greater than or equal to 60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 75 mg/day pregabalin administered in two or three divided doses.)
For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 2).
| Creatinine Clearance (CLcr) (mL/min) | Total Pregabalin Daily Dose (mg/day) Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose. | Dose Regimen | |||
|---|---|---|---|---|---|
| TID= Three divided doses; BID = Two divided doses; QD = Single daily dose. | |||||
| Greater than or equal to 60 | 150 | 300 | 450 | 600 | BID or TID |
| 30–60 | 75 | 150 | 225 | 300 | BID or TID |
| 15–30 | 25–50 | 75 | 100–150 | 150 | QD or BID |
| Less than 15 | 25 | 25–50 | 50–75 | 75 | QD |
| Supplementary dosage following hemodialysis (mg) Supplementary dose is a single additional dose. | |||||
| Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg | |||||
| Patients on the 25–50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg | |||||
| Patients on the 50–75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg | |||||
| Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg | |||||
Dosage Form & Strengths
Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg
Oral Solution: 20 mg/mL
[see Description (11) and How Supplied/Storage and Handling (16)]
Overdosage
Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans
There is limited experience with overdose of LYRICA. The highest reported accidental overdose of LYRICA during the clinical development program was 8000 mg, and there were no notable clinical consequences.
Treatment or Management of Overdose
There is no specific antidote for overdose with LYRICA. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. Contact a Certified Poison Control Center for up-to-date information on the management of overdose with LYRICA.
Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).
Storage & Handling
25 mg capsules:
White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:
| Bottles of 90: | NDC 0071-1012-68 |
50 mg capsules:
White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:
| Bottles of 90: | NDC 0071-1013-68 |
| Unit-Dose Blister Packages of 100: | NDC 0071-1013-41 |
75 mg capsules:
White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:
| Bottles of 90: | NDC 0071-1014-68 |
| Unit-Dose Blister Packages of 100: | NDC 0071-1014-41 |
100 mg capsules:
Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:
| Bottles of 90: | NDC 0071-1015-68 |
| Unit-Dose Blister Packages of 100: | NDC 0071-1015-41 |
150 mg capsules:
White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:
| Bottles of 90: | NDC 0071-1016-68 |
| Unit-Dose Blister Packages of 100: | NDC 0071-1016-41 |
200 mg capsules:
Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:
| Bottles of 90: | NDC 0071-1017-68 |
225 mg capsules:
White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:
| Bottles of 90: | NDC 0071-1019-68 |
300 mg capsules:
White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:
| Bottles of 90: | NDC 0071-1018-68 |
20 mg/mL oral solution:
16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:
| 16 fluid ounce bottle | NDC 0071-1020-01 |
Storage and Handling
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).
