Teva Gabapentin Capsule 300 mg (Gabapentin)

Adult dose

Epilepsy — Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day). Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day). From Day 3: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin, and the total daily dose must not exceed 2,400 mg of gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day of gabapentin.) The duration of treatment should be based on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued, or if it is to be administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. Neuropathic pain — Adults (18 years and older) To achieve a maintenance dose of 900 mg/day of gabapentin, titrate the dose over the first 3 days of treatment as follows. Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day). Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day). From Day 3: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within one week, and the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this medicine should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. Frail patients In frail patients with low body weight or patients following transplant surgery, the dose of this medicine should be increased in increments of 100 mg. Elderly patients Dose adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis Dosage for patients with renal impairment: Renal function, creatinine clearance (mL/min) ≥80: Total daily dosea (mg/day) 900 ~ 2,400 Renal function, creatinine clearance (mL/min) 50 - 79: Total daily dosea (mg/day) 600 ~ 1,800 Renal function, creatinine clearance (mL/min) 30 - 49: Total daily dosea (mg/day) 300 ~ 900 Renal function, creatinine clearance (mL/min) 15 - 29: Total daily dosea (mg/day) 150b~600 Renal function, creatinine clearance (mL/min) < 15: Total daily dosea (mg/day) 150b~300 a: The total daily dose should be divided into 3 doses. b: Administer 3 × 100 mg every 2 days. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. Dosage for patients on hemodialysis Initial dose: 300~400 mg of gabapentin is recommended. Maintenance dose: Administer 200~300 mg of gabapentin after 4 hours of hemodialysis, and do not administer this medicine on days when hemodialysis is not performed. Method and duration of administration Swallow this medicine whole with plenty of fluids. It may be taken with or without food. When administered 3 times daily, ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. If a dose of this medicine is missed (12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. When administered concomitantly with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. The duration of treatment with this medicine should be based on clinical need. If the dose of this medicine is reduced, treatment is discontinued, or the medicine is switched to another alternative, the change should be made gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy for children aged 3 to 12 years: Day one: administer gabapentin 10 mg/kg of body weight Adjunctive therapy for children aged 3 to 12 years: Day two: administer gabapentin 20 mg/kg of body weight Adjunctive therapy for children aged 3 to 12 years: From day three onward: administer gabapentin 30 mg/kg of body weight; the dose may be increased as needed up to a maximum of 40 mg per kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, if there are changes in mood or behavior during treatment, immediate consultation with a doctor is required. Sudden discontinuation of this medication may result in more frequent seizures or worsen the condition, so it should be gradually reduced according to a doctor's instructions. Long-term use may result in weight gain; therefore, regular weight monitoring and dietary and exercise adjustments as necessary should be implemented. This medication may cause drowsiness, dizziness, and decreased concentration; hence, it is advisable to avoid driving or operating dangerous machinery after taking it. Particularly, if taken in conjunction with other central nervous system depressants or narcotics, serious side effects such as sedation or respiratory depression may occur, so strict monitoring by a physician is necessary. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication as it may pose a risk to the fetus, and caution is required during breastfeeding. Children and the elderly may be more sensitive to the side effects of this medication; therefore, extra caution is necessary when administering it. If symptoms of pancreatitis such as persistent abdominal pain, nausea, or vomiting occur during the use of this medication, it should be discontinued immediately and a visit to the hospital is necessary. If severe skin rashes or allergic symptoms occur, stop using the medication immediately and inform healthcare professionals. This medication may cause drug dependence or withdrawal symptoms, so it should be gradually reduced according to a doctor's instructions upon cessation.

• Suicidal impulse
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disorder
• hyperactivity
• weakness

This medication is sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 15 and 25 degrees Celsius to preserve its efficacy for an extended period.

Appearance

Orange hard gelatin capsules filled with a white or almost white powder and small lumps.

Package unit

50 capsules (10 capsules/PTPX5)