Epiven

Epiven

gabapentin

Manufacturer:

Prosweal Healthcare

Distributor:

Prosweal Healthcare
Full Prescribing Info
Contents
Gabapentin.
Description
Each capsule contains: Gabapentin 300 mg.
Action
Pharmacology: Pharmacokinetics: Gabapentin is absorbed from the gastrointestinal tract by means of a saturable mechanism. After multiple dosing peak plasma concentrations are usually achieved within 2 to 3 hours of a dose and steady state achieved within 1 to 2 days. Gabapentin is not appreciably metabolized and most of a dose is excreted unchanged in the urine with the remainder appearing in the faeces. Gabapentin is widely distributed throughout the body but binding to plasma proteins is minimal. The elimination half-life has been reported to be about 5 to 7 hours. Gabapentin is distributed into breast milk.
Indications/Uses
For the treatment of partial seizures with or without secondary generalization, hemopathic pain, and adjunctive therapy in patients unresponsive to or intolerant of standard anticonvulsants.
Dosage/Direction for Use
The initial oral dose of gabapentin for the treatment of epilepsy is 300 mg on the first day of treatment, 300 mg twice daily on the second day, and 300 mg three times daily on the third day; thereafter the dose may be increased in increments of 300 mg every 2 to 3 days until effective antiepileptic control is achieved, which is usually within the range of 0.9 to 3.6 g daily. Higher doses up to a maximum of 4.8 g daily have been reported to be well tolerated. The total daily dose should be taken in three equally divided doses and the maximum dosage interval should not exceed 12 hours. In the treatment of neuropathic pain, doses should be titrated to a usual maximum of 1.8 g daily in three divided doses, in a similar manner to that recommended above for the treatment of epilepsy. Higher doses have sometimes been given.
Administration in children: For the treatment of partial seizures with or without secondary generalization, gabapentin is licensed for use as adjunctive therapy in children aged 6 years and over and as monotherapy in those aged 12 years and over. As adjunctive therapy, gabapentin may be given in an initial oral dose of 10 to 15 mg/kg daily, titrated over a period of about 3 days until effective antiepileptic control is achieved, which is usually within the range 25 to 35 mg/kg daily. Higher doses up to a maximum of 50 mg/kg daily have been reported to be well tolerated. Although not licensed for use in younger children, the BNFC suggests that similar initial doses may be used in those aged 2 to 12 years; maintenance doses of 10 to 20 mg/kg 3 times daily (up to 900 mg daily for children weighing 36 kg or under, or 1.2 g daily for those over 36 kg) are also recommended. Older children may be given the usual adult dosage regimen (see previously) titrated to a maximum of 2.4 g daily. When used as monotherapy, the usual adult dosage regimen is given.
Administration in renal impairment: Reduced doses of gabapentin are recommended for patients with renal impairment or those undergoing haemodialysis. Licensed UK product information recommends the following maintenance doses based on creatinine clearance (CC) and given as 3 divided doses: CC 50 to 79 mL/minute: 600 to 1800 mg daily.
CC 30 to 49 mL/minute: 300 to 900 mg daily.
CC 15 to 29 mL/minute: 300 mg on alternate days to 600 mg daily.
CC less than 15 mL/minute: 300 mg on alternate days to 300 mg daily.
For those undergoing haemodialysis who have never received gabapentin, the recommended loading dose is 300 to 400 mg followed by 200 to 300 mg after each 4 hours of haemodialysis. On dialysis-free days no doses of gabapentin should be given.
Overdosage
Acute oral overdose of Gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed. All patients recovered with supportive care.
Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient's clinical state or in patients with significant renal impairment.
Contraindications
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Special Precautions
Gabapentin should be used with caution in patients with renal impairment and in those undergoing haemodialysis. False positive readings have been reported with some urinary protein tests in patients taking gabapentin. Care is required whey withdrawing gabapentin therapy.
Use on Driving or Machine Operation: Driving by patients with epilepsy is generally regulated and restricted to those whose seizures are adequately controlled. Also, antiepileptic drugs may produce CNS-related adverse effects, including dizziness and drowsiness, that could impair a patient's ability to drive a vehicle or operate machinery, particularly during the initial stages of therapy.
Use in Pregnancy & Lactation: Gabapentin is actively transported across the placenta and accumulates in the fetus although its effect was unclear. All the deliveries, including one preterm, were uneventful and all of the infants were healthy, apart from one who became cyanosed and mildly hypotonic 8 hours after birth. The distribution of gabapentin into breast milk was extensive and neonates were found to have a lower capacity to eliminate gabapentin than adults, with an elimination half-life of about 14 hours. However, the plasma concentrations in the breast-fed infants appeared to be low and the relative infant dose was estimated to be 1.3 to 3.8% of the mothers' weight-adjusted dose at 0.2 to 1.3 mg/kg daily. No adverse effects were reported in the infants, and the authors considered that gabapentin was generally safe during breast feeding.
Use In Pregnancy & Lactation
Gabapentin is actively transported across the placenta and accumulates in the fetus although its effect was unclear. All the deliveries, including one preterm, were uneventful and all of the infants were healthy, apart from one who became cyanosed and mildly hypotonic 8 hours after birth. The distribution of gabapentin into breast milk was extensive and neonates were found to have a lower capacity to eliminate gabapentin than adults, with an elimination half-life of about 14 hours. However, the plasma concentrations in the breast-fed infants appeared to be low and the relative infant dose was estimated to be 1.3 to 3.8% of the mothers' weight-adjusted dose at 0.2 to 1.3 mg/kg daily. No adverse effects were reported in the infants, and the authors considered that gabapentin was generally safe during breast feeding.
Adverse Reactions
The most commonly reported adverse effects associated with gabapentin are somnolence, dizziness, ataxia and fatigue. Nystagmus, tremor, diplopia, amblyopia, pharyngitis, rhinitis, dysarthria, nausea and vomiting, weight gain, oedema, dyspepsia, amnesia, weakness, paraesthesia, arthralgia, purpura, leucopenia, anxiety and urinary-tract infection may occur less frequently. Rarely, pancreatitis, altered liver function tests, erythema multiforme, Stevens-Johnson syndrome, myalgia, headache and blood glucose fluctuations in diabetics have been reported. Common psychiatric effects include confusion, depression, and nervousness, and more rarely, hallucinations and psychoses. Other adverse effects include acute renal failure, allergic reactions, alopecia, angioedema, chest pain, hepatitis, jaundice, movement disorders such as choreoathetosis, dyskinesia and dystonia, palpitations, thrombocytopenia and tinnitus.
Drug Interactions
The absorption of gabapentin from the gastrointestinal tract is reduced by antacids containing aluminum with magnesium; it is recommended that gabapentin is taken at least 2 hours after any such antacid. Morphine has been reported to reduce the clearance of gabapentin; patients receiving both drugs should be monitored for signs of CNS depression and doses should be reduced accordingly. Cimetidine has also been reported to reduce the renal clearance of gabapentin but licensed product information does not consider this to be of clinical importance.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
N03AX12 - gabapentin ; Belongs to the class of other antiepileptics.
Presentation/Packing
Cap 300 mg x 30's.
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