GABAPENTIN- gabapentin capsule
1 INDICATIONS & USAGE
Gabapentin is indicated for:
- Management of postherpetic neuralgia in adults
- Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
2 DOSAGE & ADMINISTRATION
2.1 Dosage for Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin may be initiated on Day 1 asa single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and onDay 3 as 900 mg/day (300 mg three times a day). The dose can subsequently betitrated up as needed for pain relief to a dose of 1800 mg/day (600 mg threetimes a day). In clinical studies, efficacy was demonstrated over a range ofdoses from 1800 mg/day to 3600 mg/day with comparable effects across the doserange; however, in these clinical studies, the additional benefit of usingdoses greater than 1800 mg/day was not demonstrated.
2.2 Dosage for Epilepsy with Partial Onset Seizures
Patients 12years of age and above
The startingdose is 300 mg three times a day. The recommended maintenance dose of gabapentin is 300 mg to 600 mg threetimes a day. Dosages up to 2400 mg/day have been well tolerated in long-termclinical studies. Doses of 3600 mg/day have also been administered to a smallnumber of patients for a relatively short duration, and have been welltolerated. Administer gabapentinthree times a day using 300 mg or 400 mg capsules. The maximum time betweendoses should not exceed 12 hours.
PediatricPatients Age 3 to 11 years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in threedivided doses, and the recommended maintenance dose reached by upward titrationover a period of approximately 3 days. The recommended maintenance dose of gabapentin in patients 3 to 4 years ofage is 40 mg/kg/day, given in three divided doses. The recommended maintenancedose of gabapentin in patients 5to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divideddoses. Gabapentin may beadministered as the oral capsule. Dosages up to 50 mg/kg/day have been welltolerated in a long-term clinical study. The maximum time interval betweendoses should not exceed 12 hours.
2.3 Dosage Adjustment in Patients with Renal Impairment
Dosageadjustment in patients 12 years of age and older with renal impairment orundergoing hemodialysis is recommended, as follows (see dosing recommendationsabove for effective doses in each indication):
TABLE 1. Gabapentin Dosage Based on Renal Function
|Renal Function Creatinine Clearance (mL/min)||Total Daily Dose Range (mg/day)||Dose Regimen (mg)|
|≥ 60||900 to 3600||300 TID 400 TID 600 TID 800 TID 1200 TID|
|> 30 to 59||400 to 1400||200 BID 300 BID 400 BID 500 BID 700 BID|
|> 15 to 29||200 to 700||200 QD 300 QD 400 QD 500 QD 700 QD|
|15 a||100 to 300||100 QD 125 QD 150 QD 200 QD 300 QD|
|Post-Hemodialysis Supplemental Dose (mg) b|
|Hemodialysis||125 b 150 b 200 b 250 b 350 b|
TID = Threetimes a day; BID = Two times a day; QD = Single daily dose
a For patients with creatinine clearance <15mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patientswith a creatinine clearance of 7.5 mL/min should receive one-half the dailydose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receivemaintenance doses based on estimates of creatinine clearance as indicated inthe upper portion of the table and a supplemental post-hemodialysis doseadministered after each 4 hours of hemodialysis as indicated in the lowerportion of the table.
Creatinine clearance (CLCr) is difficult to measure in outpatients. Inpatients with stable renal function, creatinine clearance can be reasonablywell estimated using the equation of Cockcroft and Gault:
The use of gabapentinin patients less than 12 years of age with compromised renal function has notbeen studied.
2.4 Dosage in Elderly
Because elderly patients are more likely to havedecreased renal function, care should be taken in dose selection, and doseshould be adjusted based on creatinine clearance values in these patients.
2.5 Administration Information
Administer gabapentin orally with or without food.
Gabapentin capsules should be swallowedwhole with water.
If the gabapentin dose isreduced, discontinued, or substituted with an alternative medication, thisshould be done gradually over a minimum of 1 week (a longer period may beneeded at the discretion of the prescriber).
3 DOSAGE FORMS & STRENGTHS
· 100 mg: Whitehard gelatin capsules imprinted “216” on body with blue ink.
· 300 mg:Yellow hard gelatin capsules imprinted “215” on body with blue ink.
· 400 mg: Orange hard gelatin capsules imprinted “214” on body with blueink.
Gabapentin is contraindicated in patients who havedemonstrated hypersensitivity to the drug or its ingredients.
5 WARNINGS AND PRECAUTIONS
5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
Drug Reactionwith Eosinophilia and Systemic Symptoms (DRESS), also known as multiorganhypersensitivity, has occurred with gabapentin. Some of these reactions havebeen fatal or life-threatening. DRESS typically, although not exclusively,presents with fever, rash, and/or lymphadenopathy, in association with otherorgan system involvement, such as hepatitis, nephritis, hematologicalabnormalities, myocarditis, or myositis sometimes resembling an acute viralinfection. Eosinophilia is often present. This disorder is variable in itsexpression, and other organ systems not noted here may be involved.
It is important to note that early manifestations of hypersensitivity,such as fever or lymphadenopathy, may be present even though rash is notevident. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin shouldbe discontinued if an alternative etiology for the signs or symptoms cannot beestablished.
5.2 Anaphylaxis and Angioedema
Gabapentin can cause anaphylaxis and angioedema after the first dose or at anytime during treatment. Signs and symptoms in reported cases have includeddifficulty breathing, swelling of the lips, throat, and tongue, and hypotensionrequiring emergency treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should theyexperience signs or symptoms of anaphylaxis or angioedema.
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