Onegaba

Onegaba Dosage/Direction for Use

gabapentin

Manufacturer:

Aurobindo Pharma

Distributor:

Unimed
Full Prescribing Info
Dosage/Direction for Use
300 & 400 mg: General: Gabapentin is given orally with or without food.
When in the judgement of the clinician there is a need for dose reduction, discontinuation, or substitution with an alternative medication, this should be done gradually over a minimum of one week.
Epilepsy: Adults and pediatric patients over 12 years of age: The effective dose of Gabapentin is 900 to 3600 mg/day. Therapy may be initiated by administering 300mg three times a day (TID) on Day 1, or by titrating the dose as described in Table 1. Thereafter, the dose can be increased in three equally divided doses upto a maximum dose of 3600 mg/day. Dosages upto 4800 mg/day have been well tolerated in long-term open-label clinical studies. The maximum time between doses in the three times a day (TID) schedule should not exceed 12 hours to prevent breakthrough convulsions. (See Table 1.)

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Pediatric Patients Age 3-12 years: The starting dose should range from 10-15 mg/kg/day in 3 equally divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of Gabapentin 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 aged 3 to less than 5 years is 40 mg/kg/day and given in divided doses (three times a day). Dosages upto 50 mg/kg/day have been well tolerated in longterm 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 therapy. Further, Gabapentin may be used in combination with other antiepileptic drugs without concern for alteration of the plasma concentrations of Gabapentin or serum concentrations of other antiepileptic drugs.
Neuropathic Pain in Adults: The starting dose is 900 mg/day given as three equally divided doses, and increased if necessary, based on response, upto a maximum dose of 3600 mg/day. Therapy should be initiated by titrating the dose as described in Table 1.
Dosage adjustment in Renal Impairment function for patients with Neuropathic pain or Epilepsy: Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and or those undergoing hemodialysis. (See Table 2.)

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Dosage adjustment in patients undergoing Hemodialysis: For patients undergoing hemodialysis who have never received gabapentin, a loading dose of 300 to 400mg is recommended, then 200 to 300 mg of gabapentin following each 4 hours of hemodialysis.
600 mg: Posology and method of administration: Gabapentin can be given orally with or without food. When in the judgment of the clinician there is a need for dose reduction, discontinuation, or substitution with an alternative medication, this should be done gradually over a minimum of one week. (See Table 3.)

Click on icon to see table/diagram/image

Epilepsy: Adults and Children >12years: The effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Dosages up to 4800 mg/day have been well tolerated in long–term open-label clinical studies. The maximum time interval between doses in the three times a day (TID) schedule should not exceed 12 hours to prevent breakthrough convulsions.
Children 3-12 years: The starting dose should range from 10 to 15 mg/kg/day given in equally divided doses (3 times a day), and the effective dose is reached by upward titration over a period of approximately three days. The effective dose of gabapentin in children aged 6 years and older is 25 to 35 mg/kg/day in equally divided doses (3 times a day). The effective dose of gabapentin in children aged 3 to < 5 years is 40 mg/kg/ day in equally divided doses (3 times a day). Dosages up to 50 mg/kg/day have been well tolerated in longterm 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 therapy. Further, Gabapentin may be used in combination with other antiepileptic drugs without concern for alteration of the plasma concentrations of Gabapentin or serum concentrations of other antiepileptic drugs.
Peripheral neuropathic pain: Adults: The starting dose is 900 mg/day given as three equally divided doses and increased if necessary, based on individual patient response and tolerability, the maximum dose of 3600 mg/day.
Dosage Adjustment in Impaired Renal Function fort Patients with Neuropathic pain or Epilepsy: Dosage adjustment is recommended in patients with compromised renal function as described in Table 4 and/ or those undergoing haemodialysis. (See Table 4.)

Click on icon to see table/diagram/image

Dosage adjustment in patients undergoing haemodialysis: For anuric patients undergoing haemodialysis who have never received gabapentin, a loading dose of 300 to 400 mg is recommended, then 200 to 300 mg of gabapentin following each 4 hours of haemodialysis, is recommended.
Mode of administration: Oral administration.
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