Neurosantin

Neurosantin Dosage/Direction for Use

gabapentin

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Dosage/Direction for Use
Gabapentin is 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.
Epilepsy: Adults and pediatric Patients Over 12 Years of Age: The effective dosing range was 900 to 1800 mg/day.
Therapy may be initiated by administering 300 mg (TID) on Day 1, or by titrating the dose as described in Table 2. Thereafter, the dose can be increased in three equally divided doses up to a maximum dose of 2400 mg/day. The maximum time between doses in the three times a day (TID) schedule should not exceed 12 hours to prevent breakthrough convulsions.


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Pediatric patients Age 3-12 Years: The starting dose should range from 10 to 15 mg/kg/day given in equally divided doses (three times a day), and the effective dose reached by upward titration over a period of approximately three days. The effective dose of Gabapentin in pediatric patients age 5 years and older is 25 to 35 mg/kg/day given in equally divided doses (three times a day). The effective dose in pe­diatric patients ages 3 to less than 5 years is 40 mg/kg/day given in equally divided doses (three times a day). 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 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: NEUROSANTIN should be titrated to a maximum dose of 1800 mg per day. Titration to an effective dose can be progress rapidly and can be accomplished over a few days by administering 300 mg once a day on day l. 300 mg twice a day on day 2 and 300 mg three times a day on day 3, as described in Table 3.
Thereafter, the dose can be increased using increments of 300 mg per day given in three divided doses to a maximum of 1800 mg per day.
Dosage Adjustment in Impaired Renal function for Patients with Neuropathic Pain or Epilepsy: Dosage adjustment is recommended in patients with compromised renal function as described in Table 3 and/or those undergoing hemodialysis.


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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 400 mg is recommended, then 200 to 300 mg of Gabapentin following each 4 hours of hemodialysis. On dialysis-free days there should be no treatment with NEUROSAN­TIN.
If NEUROSANTIN discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
Method and duration of administration: NEUROSANTIN capsules should be swallowed whole with sufficient fluid intake. Administration may be made during or between meals. In three-times daily admin­istration, care should be taken that the interval between two single doses does not exceed 12 hours.
Whether a missed dose of NEUROSANTIN (this mean more than 12 hours passed since the last administration) should be made up for by taking an additional dose of NEUROSANTIN later or not is at the physician's dis­cretion.
In concurrent treatment with magnesium or aluminium containing antacids, NEUROSANTIN should be taken at least 2 hours after administration of the antacid. This largely avoids a reduction in Gabapentin bioavai­lability.
The duration of administration depends on the clinical requirements.
In the treatment of epilepsy, usually long-term therapy is required.
If therapy with NEUROSANTIN capsules should be discontinued, the dose reduced, or switched to another drug, this should be done gradually over a minimum of one week, although there is no evidence of a rebound phenomenon (increased occurrence of epileptic sei­zures following abrupt withdrawal of therapy).
In the treatment of neuropathic pain, efficacy and safety has not been examined in clinical studies for treatment periods longer than 5 months.
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