COMPOSITION :
Gabatin® Capsule 300 mg, each capsule contains : Gabapentin 300 mg.
DESCRIPTIONS :
Gabatin® with Gabapentin as active ingredient is available in capsule 300 mg.
INDICATIONS :
Epilepsy :
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children age 3 years and older.
Neuropathic pain :
Gabapentin is indicated for the treatment of neuropathic pain in adults age 18 years and older.
DOSAGE AND ADMINISTRATIONS :
General :
Gabapentin is given orally with or without food. When in the judgement 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 :
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 2400 mg/day. The maximum time between doses in the three times a day schedule should not exceed 12 hours to prevent breakthrough convulsions.
TABLE 1
DOSING CHART – INITIAL TITRATION
| Dose | Day 1 | Day 2 | Day 3 |
| 900 mg | 300 mg QDa | 300 mg BIDb | 300 mg TIDc |
a QD = Once a day (in the evening)
b BID = Two times a day (in the morning and evening)
c TID = Three times a day (in the morning, at noon and in the evening)
Pediatric patients aged 3 – 12 years :
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 age 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). The maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor Gabapentin plasma concentrations to optimize Gabapentin therapy. Further, Gabapentin may be used in combination with other antiepileptic drugs without concern for alteration of the plasma concentrations of Gabapentin or serum concentrations of other antiepileptic drugs.
Neuropathic pain in adults :
Gabapentin should be titrated to a maximum dose of 1800 mg per day. Titration to an effective dose can be progress rapidly and can be accomplished over a few days by administering 300 mg once a day on day 1, 300 mg twice a day on day 2 and 300 mg three times a day on day 3, (TABLE 1).
Thereafter, the dose can be increased using increments of 300 mg per day given in three divided doses to a maximum of 1800 mg per day.
Dose adjustment in impaired renal function in patients with neuropathic pain or epilepsy :
Dose adjustment is recommended in patients with compromised renal function (TABLE 2) and/or those undergoing hemodialysis.
TABLE 2
MAINTENANCE DOSE OF GABAPENTIN IN ADULTS WITH REDUCED RENAL FUNCTION
| Renal Function Creatinine Clearance
(ml/minute) |
Total Daily Dosea (mg/day)
NORMAL DOSE |
||
| ≥ 80 | 900 | 1200 | 2400 |
| 50 – 79 | 600 | 600 | 1200 |
| 30 – 49 | 300 | 300 | 600 |
| 15 – 29 | 150b | 300 | 300 |
| < 15 | 150b | 150b | 150b |
a Total daily dose should be administered as a three times a day regimen. Doses used to treat patients with normal renal function (creatinine clearance ≥ 80 ml/minute) range from 900 mg/day to 2400 mg/day. Reduced doses are for patients with renal impairment (creatinine clearance < 79 ml/minute).
b To be administered as 300 mg every other day.
Dose adjustment in patients undergoing hemodialysis :
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. On dialysis-free days there should be no treatment with Gabapentin. If Gabapentin discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
Method and duration of administration :
Gabapentin capsules should be swallowed whole with sufficient fluid intake. Administration may be made during or between meals. In three-times daily administration, care should be taken that the interval between two single doses does not exceed 12 hours.
Whether a missed dose of Gabapentin (this means more than 12 hours passed since the last administration) should be made up for by taking an additional dose of Gabapentin later or not is at the physician’s discretion.
In concurrent treatment with Magnesium or Alumunium containing antacids, Gabapentin should be taken at least 2 hours after administration of the antacid. This largely avoids a reduction in Gabapentin bioavailability.
The duration of administration depends on the clinical requirements. In the treatment of epilepsy, usually, long term therapy is required.
If therapy with Gabapentin capsules should be discontinued, the dose reduced or switched to another drug, this should be done gradually over a minimum of one week, although there is no evidence of a rebound phenomenon (increased occurrence of epileptic seizures following abrupt withdrawal of therapy).
OVERDOSAGE :
- Acute, life-threatening toxicity has not been observed with Gabapentin overdoses of up to 49 grams. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, loss of consciousness, lethargy and mild diarrhea. All patients recovered fully with supportive care. Reduced absorption of Gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimize toxicity from overdoses.
- Although Gabapentin can be removed by hemodialysis, based on prior experience it is usually not required. However, in patients with severe renal impairment, hemodialysis may be indicated.
CONTRAINDICATIONS :
- Hypersensitive to Gabapentin or components of the drugs.
- Patients with acute pancreatitis.
- Gabapentin is not effective against primarily generalized seizures, such as absences.
- Gabapentin capsules are not to be administered to patients with galactosemia (galactose intolerance) due to their lactose content.
WARNINGS AND PRECAUTIONS :
- General :
Although there is no evidence of rebound seizures with Gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus (see DOSAGE AND ADMINISTRATIONS).
Gabapentin is generally not considered effective in the treatment of absence seizures.
Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall). There have also been post-marketing reports of confusion, loss of consciousness and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
Patients who require concomitant treatment with Opioids may experience increases in Gabapentin concentrations. Patients should be carefully observed for signs of Central Nervous System (CNS) depression, such as somnolence, sedation and respiratory depression and the dose of Gabapentin or Opioids should be reduced appropriately (see DRUG INTERACTIONS).
- Abuse and dependance : Cases of abuse and dependence have been reported with Gabapentin. As with any CNS active drug, carefully evaluate patients for a history of drug abuse and observed them for possible signs of Gabapentin abuse.
- Drug rash with eosinophilia and systemic symptoms : Severe, life threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in patient taking antiepileptic drugs including Gabapentin. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
- Information for patients :
To assure safe and effective use of Gabapentin, the following information and instructions should be given to patients :
-
- You should inform your physician about any prescription or nonprescription medications, alcohol or drugs you are now taking or are planning to take during your treatment with Gabapentin.
- You should inform your physician if you are pregnant or if you are planning to become pregnant, or if you become pregnant while you are taking Gabapentin.
- Gabapentin is excreted in human milk and the effect on the nursing infant is unknown. You should inform your physician if you are breast feeding an infant.
- Gabapentin may impair your ability to drive a car or operate potientally dangerous machinery. Until it is known that this medication does not affect your ability to engage in these activities, do not drive a car or operate potentially dangerous machinery.
- You should not allow more than 12 hours between Gabapentin doses to prevent breakthrough convulsions.
- Prior to initiation of treatment with Gabapentin, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity such as fever or lymphadenopathy may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
PRESENTATION :
Gabatin® Capsule 300 mg Box, 10 strips @ 10 capsules Reg. No. DKL1702354901A1
STORAGE :
STORE BELOW 25°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
