Prescription Drug Information: Gabapentin (Page 4 of 4)

DRUG ABUSE AND DEPENDENCE

The abuse and dependence potential of Gabapentin Capsules has not been evaluated in human studies.

OVERDOSAGE

A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.

Acute oral overdoses of Gabapentin Capsules up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed. All patients recovered with supportive care.

Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.

DOSAGE & ADMINISTRATION

Gabapentin Capsules is given orally with or without food.

If Gabapentin Capsules 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, Gabapentin Capsules 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

Gabapentin Capsules 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 Gabapentin Capsules is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules 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 Gabapentin Capsules 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.) 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 Gabapentin Capsules therapy. Further, because there are no significant pharmacokinetic interactions among Gabapentin Capsules and other commonly used antiepileptic drugs, the addition of Gabapentin Capsules does not alter the plasma levels of these drugs appreciably.

If Gabapentin Capsules 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 (C_Cr ) can be reasonably well estimated using the equation of Cockcroft and Gault:

for females C_Cr =(0.85)(140 age)(weight)/[(72)(S_Cr )]for males C_Cr =(140 age)(weight)/[(72)(S_Cr )]

where age is in years, weight is in kilograms and S_Cr 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. Gabapetin Capsules Dosage Based on Renal Function.

Renal Function Creatinine Clearance (mL/min)	Total Daily Dose Range (mg/day)	Dose Regimen (mg)
a For 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).
b 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.
≥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
15a	100-300	100 QD	125 QD	150 QD	200 QD	300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis		125b	150b	200b	250b	350b

The use of Gabapentin Capsules 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

Gabapetin Capsules are available as follows:

100 mg capsules: White-White, opaque hard gelatin capsules printed with “IP 101” on both cap and body.

300 mg capsules: Buff-Buff, opaque hard gelatin capsules printed with “IP 102” on both cap and body.

400 mg capsules: Light caramel-Light caramel, opaque hard gelatin capsules printed with “IP 103” on both cap and body.

They are supplied by Keltman Pharmaceuticals Inc. as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
68387-420-30	100 mg	30 Capsules in a Plastic Bottle	WHITE	53746-101
68387-420-90	100 mg	90 Capsules in a Plastic Bottle	WHITE	53746-101
68387-420-12	100 mg	120 Capsules in a Plastic Bottle	WHITE	53746-101
68387-410-30	300 mg	30 Capsules in a Plastic Bottle	Buff-Buff	53746-102
68387-410-60	300 mg	60 Capsules in a Plastic Bottle	Buff-Buff	53746-102
68387-410-90	300 mg	90 Capsules in a Plastic Bottle	Buff-Buff	53746-102
68387-410-18	300 mg	180 Capsules in a Plastic Bottle	Buff-Buff	53746-102
68387-404-60	400 mg	60 Capsules in a Plastic Bottle	Light caramel-Light caramel	53746-103
68387-404-90	400 mg	90 Capsules in a Plastic Bottle	Light caramel-Light caramel	53746-103
68387-404-12	400 mg	120 Capsules in a Plastic Bottle	Light caramel-Light caramel	53746-103

Storage

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Rx only

Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788

Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141

This Product was Repackaged By Sandhills Packaging for:

Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GABAPENTIN gabapentin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68387-420(NDC:53746-101) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 100 mg

Product Characteristics Color WHITE (WHITE) Score no score Shape CAPSULE (HARD GELATIN) Size 16mm Flavor Imprint Code IP101 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68387-420-30 30 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None 2 NDC:68387-420-90 90 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None 3 NDC:68387-420-12 120 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078428 12/15/2009

GABAPENTIN gabapentin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68387-410(NDC:53746-102) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg

Product Characteristics Color YELLOW (Buff-Buff) Score no score Shape CAPSULE (HARD GELATIN) Size 19mm Flavor Imprint Code IP102 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68387-410-30 30 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None 2 NDC:68387-410-60 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None 3 NDC:68387-410-90 90 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None 4 NDC:68387-410-18 180 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078428 12/15/2009

GABAPENTIN gabapentin capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68387-404(NDC:53746-103) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 400 mg

Product Characteristics Color BROWN (Light caramel-Light caramel) Score no score Shape CAPSULE (HARD GELATIN) Size 21mm Flavor Imprint Code IP103 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68387-404-60 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None 2 NDC:68387-404-90 90 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None 3 NDC:68387-404-12 120 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078428 12/15/2009

Labeler — Keltman Pharmaceuticals Inc. (362861077)

Establishment
Name	Address	ID/FEI	Operations
Keltman Pharmaceuticals Inc.		362861077	repack, relabel

Revised: 02/2011 Keltman Pharmaceuticals Inc.