Usual Adult Dose for Diabetic Neuropathy

Immediate-release:
Initial dose: 50 mg orally 3 times a day

• Dose may be increased to 100 mg orally 3 times a day within 1 week based on efficacy and tolerability

Maximum dose: 300 mg per day

Extended-release:
Initial dose: 165 mg orally once a day after the evening meal

• Dose may be increased to 330 mg orally once a day within 1 week based on efficacy and tolerability

Maximum dose: 330 mg per day

Conversion from Immediate-release to Extended-release:

• On the day of the switch, take morning dose as prescribed and initiate extended-release therapy after the evening meal. See dose adjustment section for equivalent doses.

Comment:

• Doses of 600 mg per day have been studied and do not appear to confer additional significant benefit; treatment with doses above 300 mg per day (immediate-release) or 330 mg per day (extended-release) are not recommended due to dose-dependent adverse reactions.

Use: Management of neuropathic pain associated with diabetic peripheral neuropathy

Usual Adult Dose for Postherpetic Neuralgia

Immediate-release:
Initial dose: 150 to 300 mg orally per day in 2 or 3 divided doses

• Dose may be increased to 300 per day in 2 or 3 divided doses within 1 week based on efficacy and tolerability
• If, after 2 to 4 weeks of therapy at 300 mg per day, there is insufficient pain relief and patient is tolerating therapy, dose may be increased up to 600 mg per day in 2 or 3 divided doses

Maximum dose: 600 mg per day

Extended-release:
Initial dose: 165 mg orally once a day after the evening meal

• Dose may be increased to 330 mg orally once a day within 1 week based on efficacy and tolerability
• If, after 2 to 4 weeks of therapy at 330 mg per day, there is insufficient pain relief and patient is tolerating therapy, dose may be increased up to 660 mg per day

Maximum dose: 660 mg per day

Conversion from Immediate-release to Extended-release:

• On the day of the switch, take morning dose of immediate release pregabalin as prescribed and initiate extended-release therapy after the evening meal. See dose adjustment section for equivalent doses.

Comment:

• Treatment with doses above 300 mg per day (immediate-release) or 330 mg per day (extended-release) should be reserved for patients with on-going pain who have demonstrated tolerability at lower doses due to the high rate of discontinuation from adverse reactions at higher doses.

Use: Management of postherpetic neuralgia

Usual Adult Dose for Epilepsy

Initial dose: 150 mg orally per day in 2 or 3 divided doses

• Dose may be increased weekly based on clinical response and tolerability

Maintenance dose: 150 to 600 mg per day in divided doses 2 or 3 times a day
Maximum dose: 600 mg per day

Comments:

• Both the efficacy and adverse event profile of this drug have been shown to be dose dependent; the effect of dose escalation rate on tolerability of this drug has not been formally studied.
• Dosing recommendations for use of this drug in combination with gabapentin have not been evaluated and cannot be offered.

Use: Adjunctive therapy for treatment of partial onset seizures

Usual Adult Dose for Fibromyalgia

Initial dose: 75 mg orally twice a day

• Increase dose to 150 mg orally twice a day within 1 week based on efficacy and tolerability; the dose may be further increased to 225 mg orally twice a day

Maintenance dose: 300 to 450 mg per day in divided doses
Maximum dose: 450 mg per day

Comments:

• This drug has been studied at 600 mg per day, however, as there was no evidence of additional benefit and due to dose-dependent adverse reactions, treatment with doses above 450 mg per day is not recommended.

Use: Management of fibromyalgia

Usual Adult Dose for Neuropathic Pain

Initial dose: 75 mg orally twice a day

• Increase dose to 150 mg orally twice a day within 1 week based on efficacy and tolerability; for insufficient pain relief after 2 to 3 weeks, may be increase dose up to 300 mg orally 2 times a day as tolerated

Maintenance dose: 150 to 600 mg per day in divided doses
Maximum dose: 600 mg per day

Use: Management of neuropathic pain associated with spinal cord injury

Usual Pediatric Dose for Epilepsy

1 month to less than 4 years and weight less than 30 kg:
Initial dose: 3.5 mg/kg orally per day in 3 divided doses
Maintenance dose: 3.5 to 14 mg/kg per day in 3 divided doses

1 month to less than 4 years and weight 30 kg or greater:
Initial dose: 2.5 mg/kg orally per day in 2 or 3 divided doses
Maintenance dose: 2.5 to 10 mg/kg per day in 2 or 3 divided doses

4 years or older and weight less than 30 kg:
Initial dose: 3.5 mg/kg orally per day in 2 or 3 divided doses
Maintenance dose: 3.5 to 14 mg/kg per day in divided doses 2 or 3 times a day

4 years or older and weight 30 kg or greater:
Initial dose: 2.5 mg/kg orally per day in 2 or 3 divided doses
Maintenance dose: 2.5 to 10 mg/kg per day in divided doses 2 or 3 times a day
Maximum dose: 600 mg per day

17 years or older:
Initial dose: 150 mg orally per day in 2 or 3 divided doses
Maintenance dose: 150 to 600 mg per day in divided doses 2 or 3 times a day
Maximum dose: 600 mg per day

Comments:

• Doses may be increased weekly based on clinical response and tolerability.
• Both the efficacy and adverse event profile are dose dependent; the effect of dose escalation rate on the tolerability of this drug has not been formally studied.
• Dosing recommendations for use of this drug in combination with gabapentin have not been evaluated and cannot be offered.

Use: Adjunctive therapy for treatment of partial onset seizures

Renal Dose Adjustments

ADULTS:
Immediate-release:

• CrCl 60 mL/min or greater: No adjustment recommended
• CrCl 30 to 60 mL/min: Reduce dose by 50%; dose range: 75 to 300 mg per day in 2 or 3 divided doses
• CrCl 15 to 30 mL/min: Reduce dose by approximately 75%; dose range: 25 to 150 mg orally per day in 1 to 2 divided doses
• CrCl less than 15 mL/min: Reduce dose by approximately 87.5%; dose range: 25 to 75 mg per day; see dialysis section for supplemental dose recommendations

Extended-release:

• CrCl 60 mL/min or greater: No adjustment recommended
• CrCl 30 to 60 mL/min: Reduce dose by 50%; dose range 82.5 to 330 mg per day
• CrCl less than 30 mL/min: Not recommended; use immediate-release formulation

PEDIATRICS: The use of this drug in patients with renal impairment has not been studied.

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Elderly: Dose should be adjusted based on renal function; renal function monitoring is recommended.

Conversion from Immediate-release (IR) to Extended-release (CR):

• On the day of the switch, take morning dose of IR pregabalin as prescribed and initiate ER therapy after the evening meal:
• For IR total daily dose of 75 mg: CR dose is 82.5 mg/day
• For IR total daily dose of 150 mg: CR dose is 165 mg/day
• For IR total daily dose of 225 mg: CR dose is 247.5 mg/day
• For IR total daily dose of 300 mg: CR dose is 330 mg/day
• For IR total daily dose of 450 mg: CR dose is 495 mg/day
• For IR total daily dose of 600 mg: CR dose is 660 mg/day

Extended-release tablets are indicated for neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia; efficacy has not been established for the management of fibromyalgia or as an adjunct for partial onset seizures.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to active substance or any product components; angioedema and hypersensitivity reactions have occurred

Safety and efficacy of immediate-release in patients with partial onset seizures have not been established in patients younger than 1 month.
Safety and efficacy of immediate-release in patients with fibromyalgia, neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuropathic pain associated with spinal cord injury have not been established in patients younger than 18 years.
Safety and efficacy of controlled-release have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule V

Dialysis

Immediate-release formulation only:
For patients undergoing hemodialysis, adjust the daily dose based on renal function; in addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment:

• Patients on the 25 mg/day regimen: take one supplemental dose of 25 mg or 50 mg
• Patients on the 25 to 50 mg/day regimen: take one supplemental dose of 50 mg or 75 mg
• Patients on the 50 to 75 mg/day regimen: take one supplemental dose of 75 mg or 100 mg
• Patients on the 75 mg/day regimen: take one supplemental dose of 100 mg or 150 mg

Other Comments

Administration advice:
Immediate-release:

• Take orally with or without food
• Missed dose: The missed dose should be taken as soon as remembered unless it is time for the next dose, if it is time for the next dose, skip the missed dose and take the next dose at the regularly scheduled time; do not take 2 doses at the same time

Extended-release:

• Swallow whole; do not split, crush or chew
• Take at the same time each day, preferably after evening meal
• Missed dose: If a dose is missed after the evening meal, take at bedtime following a snack or if missed until the following morning, take the missed dose following the morning meal. If missed dose is not taken with the morning meal, skip the missed dose and take usual dose following the evening meal.

Monitor:

• Monitor for the symptoms of depression or any unusual changes in mood or behavior, thoughts of suicide or self-harm.
• Monitor for weight gain, especially in patients concomitantly taking thiazolidinedione antidiabetic agents or those for whom weight gain may increase risk of heart failure.

Patient Advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients/caregivers should be instructed to discontinue therapy and seek immediate medical assistance for signs or symptoms of angioedema or hypersensitivity.
• Patients/caregivers should be informed that this drug may cause drowsiness, blurred vision, and dizziness; patients should avoid driving or operating machinery until they determine how this drug affects them.
• Patients should be instructed to avoid alcohol or other CNS depressants as this may potentiate CNS side effects.
• Patients/caregivers should be instructed not to abruptly discontinue therapy; discontinuation should be gradual, over a minimum of 1 week.
• Patients/caregivers should be instructed to report emergence of depression or any unusual changes in mood or behavior, thoughts of suicide or self-harm.
• Patients/caregivers should be instructed to report any visual disturbances, unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever.
• Patients should speak to their healthcare provider if they are pregnant, planning on becoming pregnant or breastfeeding.

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