Each film coated tablet (caplet) contains 300 or 600mg Gabapentin.
MECHANISM OF ACTION:
Gabapentin is an anticonvulsant structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but it does not interact with GABA receptors.
New-Gab is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above.
New-Gab is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Peripheral Neuropathic Pain:
New-Gab is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post herpetic neuralgia in adults.
It can be taken with or without food.
Children aged 6-12 years: The starting dose should range from 10 to 15mg/kg/day and the effective dose is reached by upward titration over a period of approximately 3 days. The effective dose of New-Gab is 25-35mg/Kg/day given in divided doses (3 times a day). Dosages up to 50mg/kg/day have been well tolerated in long term clinical study.
Adults and children aged over 12: The anti-epileptic effect of New-Gab generally occurs at 900-3600mg/day.
Titration to an effective dose can progress rapidly and can be accomplished over a few days by administering 300mg once a day on day /1/, 300mg twice a day on day /2/ and 300mg three times a day on day /3/. Thereafter, the dose can be increased using increments of 300mg/day given in three equally divided doses to a maximum dose of 3600mg/day. The maximum time interval between doses should not exceed 12 hours.
If the product is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of one week.
Peripheral Neuropathic Pain:
Adults (over the age of 18): Titration to an effective dose can progress rapidly and can be accomplished over a few days by administering 300mg once a day on day /1/, 300mg twice a day on day /2/ and 300mg three times a day on day /3/. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300mg/day increments every 2-3 days up to a maximum of 3600mg/day. The minimum time to reach a dose of 1800mg/day is one week, and to reach 3600mg/day is a total of 3 weeks.
Elderly patients (over 65 years of age): Elderly patients may require dosage adjustment because of declining renal function with age.
patients with renal impairment:
Creatinine Clearance (ml/minute)
Total daily dose (mg/day)
150-600 To be administered as 300mg every other day.
150-300 To be administered as 300mg every other day.
The daily dose should be reduced in proportion to creatinine clearance.
Patients undergoing haemodialysis:
For patients undergoing haemodialysis who have never received gabapentin, a loading dose of 300 to 400mg, then 200 to 300mg following each 4 hours of haemodialysis, is recommended. On dialysis-free days, there should be no treatment with gabapentin.
New-Gab has been evaluated as well tolerated. Rarely it occurs: Viral infection, urinary tract infection, leucopenia, anorexia, increased appetite, hostility, anxiety, emotional lability, nervousness and thinking abnormally, somnolence, dizziness, ataxia, hyperkinesias, dysarthria, amnesia, tremor, insomnia, paraesthesia, amblyopia, diplopia, vertigo, hypertension, vasodilatation, dyspnea, bronchitis, pharyngitis, cough, nausea, vomiting, diarrhea, abdominal pain, dyspepsia, dry mouth, facial oedema, purpura, rash, pruritus, arthralgia, myalgia, twitching, incontinence, fatigue, fever, peripheral or generalized oedema, abnormal gait, asthenia, pain.
Hypersensitivity to the active substance or to any of the excipients.
No interaction between New-Gab and phenobarbital, phenytoin, valproic acid, or carbamazepine has been observed.
Co-administration of New-Gab with oral contraceptives containing norethindrone and/or ethinyl estradiol, does not influence the steady state pharmacokinetics of either component.
Co-administration with antacids containing aluminum and magnesium, reduces gabapentin bioavailability up to 24%. It is recommended that New-Gab be taken earliest two hours following antacid administration.
Anti-epileptic drugs should not be abruptly discontinued because of the possibility of rebound seizures. When, in the judgment of the clinician, there is a need for dose reduction, discontinuation or substitution of alternative anticonvulsant medication, this should be done gradually over a minimum of one week.
Gabapentin is not considered effective against primary generalized seizures such as absence and may aggravate these seizures in some patients. Therefore, gabapentin should be with caution in patients with mixed seizures including absences.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
As with all anti-convulsants, gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms.
Individual experience with the drug must be established.
USE IN PREGNANCY OR LACTATION:
Pregnancy: Pregnancy category C. Safe use in human pregnancy has not been established.
Lactation: The product is excreted in human milk, but the effect on the nursing infant is unknown. Because of the potential for serious adverse reactions in nursing infants from gabapentin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Absorption: Following oral administration, peak plasma gabapentin concentrations are observed within 2–3 hours. Gabapentin bioavailability tends to decrease with increasing dose. Absolute bioavailability of a 300mg is approximately 60%.
Distribution: Gabapentin has not bound to plasma proteins and has a volume of distribution equal to 57.7 liters.
Metabolism: There is no evidence of gabapentin metabolism in humans.
Elimination: Gabapentin is eliminated unchanged solely by renal excretion. The elimination half-life of gabapentin is independent of dose and averages 5 to 7hours.
In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced.
Gabapentin is removed from plasma by hemodialysis.