Each study included a 7- or 8-week double-blind phase (3 or 4 weeks of titration and 4 weeks of fixed dose). Patients initiated treatment with titration to a maximum of 900 mg/day gabapentin over 3 days. Dosages were then to be titrated in 600 to 1200 mg/day increments at 3- to 7-day intervals to the target dose over 3 to 4 weeks. These pharmacokinetic data indicate that the effective daily dose in pediatric patients with epilepsy ages 3 and 4 years should be 40 mg/kg/day to achieve average plasma concentrations similar to those achieved in patients 5 years of age and older receiving gabapentin at 30 mg/kg/day [see Dosage and Administration (2.2)]. Child 6–11 years 10 mg/kg once daily (max. per dose 300 mg) on day 1, then 10 mg/kg twice daily (max. per dose 300 mg) on day 2, then 10 mg/kg 3 times a day (max. per dose 300 mg) on day 3; usual dose 25–35 mg/kg daily in 3 divided doses, some children may not tolerate daily increments; longer intervals (up to weekly) may be more appropriate, daily dose maximum to be given in 3 divided In a pharmacokinetic study of 48 children between 1 month and 12 years of age, a single gabapentin dose of 10 mg/kg resulted in peak plasma concentrations at 2-3 hours.6 Patients less than 5 years of age had a mean maximum concentration (Cmax) lower than older children (3.74 + 1.25 mcg/mL vs 4.52 + 1.19 mcg/mL, p Max dosage 3600mg if patient already on gabapentin; Taper dose > 7 days to discontinue; Pediatric Dosing Partial seizures. Adjunct for partial seizures with out secondary generalization in patients> 12yo with epilepsy; also adjunctive therapy for partial seizures in patients 3-12 years <3 years: Safety and efficacy not established dose 1-5mg PO q8h. Max 10mg PO q8h Gabapentin PO: 5-40mg/kg/day in 3 divided doses (children ≥3 years old) Neuropathic pain and enhancement of opioid analgesia. Start low and titrate. Amitriptyline PO: Start 0.15mg/kg QHS; may advance over 2-3 weeks to 0.5-2mg/kg QHS Indications: headache prophylaxis, IBS, neuropathic pain,. Can prolong QT A standard dosing regimen was used for this study starting at gabapentin 100 mg daily and increasing gradually until 300 mg 3 times daily was reached by week 5, with additional dosage increases for patients >30 kg and where the dosage of 30 mg/kg per day was not sufficient to effect change (maximum 50 mg/kg per day). 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. 2.3 Dosage Adjustment in Patients with Renal Impairment . Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing Pediatric Patients Age 3 to 11 years. The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of NEURONTIN in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided Used to treat restless legs syndrome in adults and occasionally in children/adolescents. Gradual dose increase helps to minimize sedation. May need to adjust dose in renal impairment. Space doses at least 2 hours from antacids (decreases absorption of gabapentin). Adverse effects: somnolence, ataxia, fatigue, and depression. Detailed Gabapentin dosage information for adults and children. Includes dosages for Restless Legs Syndrome, Epilepsy and Postherpetic Neuralgia; plus renal, liver and dialysis adjustments. Bioavailability of gabapentin is approximately 60%, 47%, 34%, 33%, and 27% following 900, 1200, 2400, 3600, and 4800 mg/day given in 3 divided doses, respectively. Food has only a slight effect The mean maximum dose was 23.2 ± 14.4 mg/kg/day (range, 4–62 mg/kg/day) with the median interval of every 8 hours (IQR, 8 hours). For 15 infants (22%), the maximum total daily dose was 15 mg/kg/day. The maximum dose in 1 patient was 62 mg/kg/day divided every 8 hours. Maximum dose may not be needed for maximum effect. Increased oral doses are associated with decreased bioavailability. Evidence of benefit in acute pain management in children is limited. Not effective as a mood stabilizer in bipolar disorder and should not be used as monotherapy. These pharmacokinetic data indicate that the effective daily dose in pediatric patients with epilepsy ages 3 and 4 years should be 40 mg/kg/day to achieve average plasma concentrations similar to those achieved in patients 5 years of age and older receiving gabapentin at 30 mg/kg/day [see Dosage and Administration (2.1)]. From 12 years: Initially 300mg OD for day 1, then 300mg BD for day 2, then 300mg TDS for day 3, then increase in steps of 300mg every 3 – 7 days in 3 divided doses. Max daily dose 3600mg/day. The effective dose of gabapentin in patients 5 years of age and older is 25 to 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). Infants 1 month to Children 12 years: 4.7 hours. Adults, normal: 5 to 7 hours; increased half-life with decreased renal function; anuric adult patients: 132 hours; adults during hemodialysis: 3.8 hours. <3% In CrCl <30 mL/minute, half-life is approximately 52 hours (immediate release). There are several studies of gabapentin in children with partial seizures. In 1996, Khurana and colleagues reported the results of an open-label add-on trial in 32 children (ages 2-16 years) with refractory partial seizures.4 The children were treated with gabapentin doses of 10 to 50 mg/kg/day, with an average effective dose of 26.7 mg/kg/day. Child 6–11 years 10 mg/kg once daily (max. per dose 300 mg) on day 1, then 10 mg/kg twice daily (max. per dose 300 mg) on day 2, then 10 mg/kg 3 times a day (max. per dose 300 mg) on day 3; usual dose 25–35 mg/kg daily in 3 divided doses, some children may not tolerate daily increments; longer intervals (up to weekly) may be more appropriate, daily dose maximum to be given in 3 divided
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