Tradename
Neuroglopentin
Generic Name
Gabapentin
Category
Musculoskeletal System
Form
Capsules
Composition
Active Ingredients
Gabapentin.............100, 300, or 400 mg
Excipients
Lactose monohydrate, starch maize, talc
Description
Properties/Actions
Pharmacodynamics
Neuroglopentin
is an oral antiepileptic drug (AED). It is structurally related to the neurotransmitter GABA (gaba-aminobutyric acid) but it does not interact with GABA receptors, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. Its main site of action appears to be on T-type calcium channel function, by binding to a particular channel subunit and inhibiting the release of various neurotransmitters and modulators.

Pharmacokinetics
Gabapentin is absorbed from the gastrointestinal tract by means of a saturable mechanism.
Following multiple dosing, peak plasma concentrations are usually achieved within 2 hours of administration and steady state achieved within 1 to 2 days.
Less than 3% of gabapentin circulates bound to plasma protein.
It is widely distributed throughout the body and is distributed into breast milk.
It is not appreciably metabolized and most of the dose is excreted unchanged in the urine with the remainder appearing in the feces.
The elimination half-life has been reported to be about 5-7 hours.
In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced. It can be removed from plasma by hemodialysis.
Indications
Neuroglopentin is indicated in:
  • Treatment of neuropathic pain in adults.
  • Post-herpetic neuralgia.
  • Epilepsy: As an adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. It is also indicated as adjuntive therapy in the treatment of partial seizures in pediatric patients aged 3-12 years.
Contraindications
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of its ingredients.
Drug Interactions
The following has been noted:
  • Gabapentin is not appreciably metabolized nor does it interefere with the metabolism of commonly co-administered antiepileptic drugs such as: phenytoin, carbamazepine, valproic acid, and phenobarbital.
  • Co-administration of gabapentin with naproxen sodium appears to increase the amount of gabapentin absorbed by 12-15%. Gabapentin, on the other hand, has no effect on naproxen pharmacokinetic parameters.
  • Antacids may reduce the bioavailability of gabapentin. It is recommended that gabapentin should be taken at least 2 hours following antacid administration.
Side Effects/Adverse Effects
The most commonly reported adverse effects associated with gabapentin are:
  • Somnolence
  • Dizziness, ataxia, and fatigue.
  • Nystagmus, tremor
  • Diplopia, amblyopia
  • Pharyngitis, dysarthria,
  • Weight gain, dyspepsia
  • Amnesia, weakness, paraesthesia, arthralgia
  • Purpura
  • Leucopenia
  • Anxiety
  • Urinary tract infections
Rarely, the following events may also be experienced:
  • Pancreatitis
  • Altered liver function tests
  • Erythema multiforme
  • Stevens-Johnson syndrome
  • Rhinitis
  • Nervousness
  • Myalgia
  • Headache
  • Edema
  • Nausea and vomiting
  • Blood glucose fluctuations in diabetics
  • Confusion, depression, hallucinations and psychoses
Pregnancy & Lactation
Gabapentin should not be used during pregnancy or lactation.
Dosage & Administration
Adults with Neuropathic Pain, Post-herpetic Neuralgia
Neuroglopentin
 therapy may be initiated as a single 300 mg dose on day 1, followed by 600 mg/day on Day 2 in divided doses, and 900 mg/day on Day 3 in divided doses as well.
The dose can be subsequently titrated upwards as needed for pain relief to a daily dose of 1800 mg in divided doses.

Epilepsy
Neuroglopentin is recommended for add-on therapy in patients 3 years of age and older.
Patients >12 years of age: The effect dose is 900-1800 mg/day given in divided doses using 300 or 400 mg capsules. The starting dose is 300 mg three times daily. If necessary, the dose may be increased using 300 or 400 mg capsules, three time a day up to 1800 mg/day. Doses up to 2400 mg/day have been well tolerated in long-term clinical studies.
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 Neuroglopentin in patients 5 years of age and older is 25-33 mg/kg/day and given in divided doses.
The effective dose in pediatric patients aged 3-4 years is 40 mg/kg/day and given in divided doses.
Overdosage
Warnings
Patients should be advised neither to drive a car nor operate other complex machinery until they have gained sufficient experience on gabapentin. Patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations, therefore the dose of gabapentin or morphine should be reduced. Patients should be carefully observed for signs of CNS depression, such as somnolence.
Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency.
Notes
Storage
Store at a temperature not exceeding 30°C, in a dry place.
Packaging
Boxes of 30 capsules each in 3 strips of 10 capsules each.
Manufacturer
Global Napi Pharmaceuticals
Date Added/Updated
13th June 2012 3:14pm

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