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Neurontin (Gabapentin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Postherpetic Neuralgia

Neurontin (gabapentin) is indicated for the management of postherpetic neuralgia in adults.

Epilepsy

Neurontin (gabapentin) is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Neurontin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 — 12 years.

DOSAGE AND ADMINISTRATION

Neurontin is given orally with or without food. Patients should be informed that, should they break the scored 600 or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within several days of breaking the scored tablet should be discarded.

If Neurontin dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

Postherpetic Neuralgia

In adults with postherpetic neuralgia, Neurontin therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.

Epilepsy

Neurontin is recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.

Patients >12 years of age: The effective dose of Neurontin is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours.

Pediatric Patients Age 3—12 years: The starting dose should range from 10—15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of Neurontin in patients 5 years of age and older is 25—35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatrics.) Neurontin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well-tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

It is not necessary to monitor gabapentin plasma concentrations to optimize Neurontin therapy. Further, because there are no significant pharmacokinetic interactions among Neurontin and other commonly used antiepileptic drugs, the addition of Neurontin does not alter the plasma levels of these drugs appreciably.

If Neurontin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.

Dosage in Renal Impairment

Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:

for females CCr=(0.85)(140-age)(weight)/[(72)(SCr)]

for males CCr=(140-age)(weight)/[(72)(SCr)]

where age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.

Dosage adjustment in patients ≥12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).

TABLE 6. Neurontin Dosage Based on Renal Function
Renal Function
Creatinine Clearance
(mL/min)
Total Daily Dose Range
(mg/day)
Dose Regimen
(mg)
≥60 900—3600 300 TID 400 TID 600 TID 800 TID 1200 TID
>30—59 400—1400 200 BID 300 BID 400 BID 500 BID 700 BID
>15—29 200—700 200 QD 300 QD 400 QD 500 QD 700 QD
15For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). 100—300 100 QD 125 QD 150 QD 200 QD 300 QD

Post-Hemodialysis Supplemental Dose (mg) 1

Hemodialysis 125 150 200 250 350

1 Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.

The use of Neurontin in patients <12 years of age with compromised renal function has not been studied.

Dosage in Elderly

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

HOW SUPPLIED

Neurontin (gabapentin) capsules, tablets and oral solution are supplied as follows:

100 mg capsules;

White hard gelatin capsules printed with "PD" on one side and "Neurontin/100 mg" on the other; available in:
Bottles of 100: N 0071-0803-24
Unit dose 50's: N 0071-0803-40

300 mg capsules;

Yellow hard gelatin capsules printed with "PD" on one side and "Neurontin/300 mg" on the other; available in:
Bottles of 100: N 0071-0805-24
Unit dose 50's: N 0071-0805-40

400 mg capsules;

Orange hard gelatin capsules printed with "PD" on one side and "Neurontin/400 mg" on the other; available in:
Bottles of 100: N 0071-0806-24
Unit dose 50's: N 0071-0806-40

600 mg tablets;

White elliptical film-coated scored tablets debossed with "NT" and "16" on one side; available in:
Bottles of 100: N 0071-0513-24

800 mg tablets;

White elliptical film-coated scored tablets debossed with "NT" and "26" on one side; available in:
Bottles of 100: N 0071-0401-24

250 mg/5 mL oral solution;

Clear colorless to slightly yellow solution; each 5 mL of oral solution contains 250 mg of gabapentin; available in:
Bottles containing 470 mL: N0071-2012-23

Storage (Capsules)

Store at 25C (77F); excursions permitted to 15 – 30C (59 – 86F) [see USP Controlled Room Temperature].

Storage (Tablets)

Store at 25C (77F); excursions permitted to 15 – 30C (59 – 86F) [see USP Controlled Room Temperature].

Storage (Oral Solution)

Store refrigerated, 2—8C (36—46F)

Rx only

LAB-0106-10.0
April 2009

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