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PRODUCT
Gabapron cap.
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product information
Gabapron cap.
| Classification | Ethical the Counter(ETC) |
|---|---|
| Major Ingredients | Gabapentin |
| Efficacy/Effectiveness | Treatment of epilepsy, relieve neuropathic pain |
| Appearance |
product information
Details
1) Composition
Gabapentin------------300mg
2) Indications
Postherpetic Neuralgia
Gabapron (gabapentin) is indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapron (gabapentin) is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapron is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.
3) Dosage & Administration
Postherpetic Neuralgia
In adults with postherpetic neuralgia, Gabapron 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
Gabapron 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 Gabapron is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 or 800 mg tablets 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 Gabapron 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) Gabapron may be administered as the oral solution, capsule, or tablet, or 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.
It is not necessary to monitor gabapentin plasma concentrations to optimize Gabapron therapy. Further, because there are no significant pharmacokinetic interactions among Gabapron and other commonly used antiepileptic drugs, the addition of Gabapron does not alter the plasma levels of these drugs appreciably.
If Gabapron is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
4) Package
30T, 200T
Gabapentin------------300mg
2) Indications
Postherpetic Neuralgia
Gabapron (gabapentin) is indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapron (gabapentin) is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapron is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.
3) Dosage & Administration
Postherpetic Neuralgia
In adults with postherpetic neuralgia, Gabapron 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
Gabapron 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 Gabapron is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 or 800 mg tablets 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 Gabapron 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) Gabapron may be administered as the oral solution, capsule, or tablet, or 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.
It is not necessary to monitor gabapentin plasma concentrations to optimize Gabapron therapy. Further, because there are no significant pharmacokinetic interactions among Gabapron and other commonly used antiepileptic drugs, the addition of Gabapron does not alter the plasma levels of these drugs appreciably.
If Gabapron is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
4) Package
30T, 200T