- Approval Id
- 7c8dd3cac3a6c2e2
- Drug Name
- ALPENTIN CAPSULE 300MG
- Product Name
- ALPENTIN CAPSULE 300MG
- Approval Number
- SIN16697P
- Approval Date
- 2023-02-15
- Registrant
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Licence Holder
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
<strong>General</strong><br>
Gabapentin is given orally with or without food.</p>
<p>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 1 week.</p>
<p><strong>Epilepsy</strong><br>
<em><u>Adults and pediatric patients older than 12 years of age</u></em><br>
In clinical trials, the effective dosing range was 900 mg/day to 1800 mg/day. Therapy may be initiated by administering 300 mg three times a day on Day 1, or by titrating the dose (Table 1). Thereafter, the dose can be increased in three equally divided doses up to a maximum dose of 1800 mg/day. Doses up to 2400 mg/day have been well tolerated in long-term open-label clinical studies. Doses up to 3600 mg/day have 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 three times a day schedule should not exceed 12 hours to prevent breakthrough convulsions.</p>
<img src="/TGIF/Alpentin-Table1.png" alt="Alpentin Dosage Table 1" /><br><br>
<p><em><u>Pediatric patients aged 3 to 12 years</u></em><br>
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 3 days. The effective dose of gabapentin in pediatric patients aged 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 aged 3 to less than 5 years is 40 mg/kg/day given in equally divided doses (three times a day). Doses 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.</p>
<p>It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, gabapentin may be used in combination with other anti-epileptic drugs without concern for alteration of the plasma concentrations of gabapentin or serum concentrations of other anti-epileptic drugs.</p>
<p><strong>Neuropathic pain in adults</strong><br>
The starting dose is 900 mg/day given in three equally divided doses, and increased if necessary, based on response, up to a maximum dose of 3600 mg/day. Therapy should be initiated by titrating the dose (Table 1).</p>
<p><strong>Dose adjustment in impaired renal function in patients with neuropathic pain or epilepsy</strong><br>
Dose adjustment is recommended in patients with compromised renal function (Table 2) and/or in those undergoing hemodialysis.</p>
<img src="/TGIF/Alpentin-Table2.png" alt="Alpentin Dosage Table 2" /><br><br>
<p><strong>Dose adjustment in patients undergoing hemodialysis</strong><br>
For patients undergoing hemodialysis who have never received gabapentin, a loading dose of 300 mg to 400 mg is recommended, and then 200 mg to 300 mg of gabapentin following each 4 hours of hemodialysis.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
<u><strong>Epilepsy</strong></u><br>
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 3 years and older. Safety and effectiveness for adjunctive therapy in pediatric patients younger than 3 years have not been established (see Section <strong>4.2 – Posology and method of administration:</strong> <u><em>Pediatric patients aged 3 to 12 years</em>).</u></p>
<p><u><strong>Neuropathic pain</strong></u><br>
Gabapentin is indicated for the treatment of neuropathic pain which include diabetic pain, post-herpetic neuralgia and trigeminal neuralgia. Safety and effectiveness in patients younger than 18 years have not been established.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
Gabapentin is contraindicated in patients who are hypersensitive to gabapentin or the product’s components.</p>
- Atc Code
- N03AX12
- Atc Item Name
- xn 03 ax 12
- Pharma Manufacturer Name
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
