NEURONTIN CAPSULE 400 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

GABAPENTIN

Available from:

VIATRIS PRIVATE LIMITED

ATC code:

N02BF01

Dosage:

400 mg

Pharmaceutical form:

CAPSULE

Composition:

GABAPENTIN 400 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Pfizer Manufacturing Deutschland GmbH

Authorization status:

ACTIVE

Authorization date:

1995-08-25

Patient Information leaflet

 
1 of 18

NEURONTIN
®
 (GABAPENTIN) CAPSULES 
NEURONTIN
®
 (GABAPENTIN) TABLETS 

1. 
NAME OF THE MEDICINAL PRODUCT 

NEURONTIN. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Gabapentin is supplied as capsules containing 300 mg and 400 mg of active drug substance 
for oral administration. 

Gabapentin is also supplied as 600 mg and 800 mg tablets. 

Gabapentin  is  a  white  to  off-white  crystalline  solid.  It  is  freely  soluble  in  water  and  both 
basic and acidic aqueous solutions. 

3. 
PHARMACEUTICAL FORM 

Capsules, tablets. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

EPILEPSY 

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 4.2 – POSOLOGY AND METHOD OF ADMINISTRATION: _Pediatric patients _
_aged 3 to 12 years_). 

NEUROPATHIC PAIN 

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. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

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GENERAL 

Gabapentin is given orally with or without food. 

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. 

EPILEPSY 

_Adults and pediatric patients older than 12 years of age _
_ _
In clinical trials, the effective dosing range was 9

Summary of Product characteristics

NEURONTIN
® (GABAPENTIN) CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
NEURONTIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin is supplied as capsules containing 300 mg and 400 mg of
active drug
substance for oral administration.
Gabapentin is a white to off-white crystalline solid. It is freely
soluble in water and
both basic and acidic aqueous solutions.
3.
PHARMACEUTICAL FORM
Capsules
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EPILEPSY
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
4.2
POSOLOGY
AND
METHOD
OF
ADMINISTRATION –
_Pediatric patients aged 3 to 12 years_
).
NEUROPATHIC PAIN
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Gabapentin is given orally with or without food.
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.
EPILEPSY
_Adults and pediatric patients older than 12 years of age_
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
schedul