Teva Gabapentin 100 mg Capsules

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients 13 years of age 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 drug once daily or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3 onward: Administer one 300 mg capsule of this drug three times daily or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered three 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.) 3) The duration of treatment should be determined according to clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may precipitate status epilepticus. If treatment with this drug must be discontinued, or if it is to be used in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) Adults (18 years of age 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 drug once daily or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3 onward: Administer one 300 mg capsule of this drug three times daily or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered three 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. When this drug is administered, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. 3. Frail patients In frail patients with low body weight or patients after transplant surgery, the dose of this drug should be increased in increments of 100 mg 4. Elderly patients Dosage adjustment may be necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis: Dosage adjustment is required based on the following table. 1) Dosage for patients with renal impairment: Renal function, creatinine clearance (mL/min) Total daily dosea (mg/day) ≥80 900 ~ 2,400 50 - 79 600 ~ 1,800 30 - 49 300 ~ 900 15 - 29 150b~600 < 15 150b~300 a: The total daily dose should be divided into 3 doses. b: Administer 3 × 100 mg every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage for patients receiving hemodialysis Initial dose: 300~400 mg of gabapentin is recommended. Maintenance dose: Administer 200~300 mg of gabapentin after 4 hours of hemodialysis; do not administer this drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug should be swallowed whole with plenty of fluid and may be taken with or without food. When administered 3 times daily, care should be taken to ensure that the interval between doses is not more than 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (when more than 12 hours have elapsed since the most recent dose), whether an additional dose should be taken to make up for it should be determined by the physician. 3) When used concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should be determined according to clinical need. If the dose of this drug is reduced, treatment is discontinued, or the patient is switched to another alternative drug, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 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; day two: administer gabapentin 20 mg/kg of body weight; 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 ideation or behavior, and if symptoms of depression or mood changes occur during treatment, immediate consultation with a doctor is necessary. Abruptly stopping this medication can worsen seizures or lead to status epilepticus, so dosage should be gradually reduced under medical supervision. Although some animal studies have reported a potential risk of cancer, the effects in humans are unclear. There have been reports of unexpected sudden deaths during treatment; however, this may be related to the risks associated with epilepsy itself, so caution is advised. If symptoms of pancreatitis, such as persistent abdominal pain, nausea, and recurrent vomiting occur, the medication should be stopped immediately and medical attention should be sought. Particularly in children aged 3 to 12 years, neuropsychiatric adverse reactions such as emotional instability, aggression, reduced concentration, and hyperactivity may occur, thus careful observation is necessary. Taking this medication with central nervous system depressants, including narcotics, may cause severe drowsiness, respiratory depression, or coma; therefore, use the minimum dosage for a short duration and monitor closely. Patients with a history of allergic reactions to this medication, acute pancreatitis, specific seizure types, or lactose intolerance should not use it. Patients with impaired renal function, older adults, those with a history of psychosis, pregnant or nursing women, and children with attention deficits or behavioral issues should use this medication with even more caution. Drowsiness, dizziness, confusion, and mental disturbances may occur during treatment; therefore, driving or operating dangerous machinery should be avoided if such symptoms are present. This medication can cause various side effects, such as weight gain, visual disturbances, skin rashes, and blood abnormalities, making it important to undergo regular check-ups and immediately inform healthcare professionals of any unusual symptoms. Using this medication during pregnancy may affect the fetus, so it is essential to consult a doctor if pregnant or planning to become pregnant. Nursing women should also consult a doctor before taking the medication. Withdrawal symptoms may occur, so sudden discontinuation should be avoided, and the dosage should be adjusted gradually following medical advice. Care should be taken with drug interactions, and other medications being taken should be reported to the doctor, especially in conjunction with antacids or central nervous system depressants. Keep this medication out of the reach of children and store it in its original container to prevent misuse.

• Suicidal ideation
• suicidal behavior
• depression
• emotional instability
• hostility
• cognitive abnormalities
• hyperactivity
• abdominal pain
• back pain
• fatigue

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to keep it at room temperature between 15 to 25 degrees Celsius.

Appearance

Gray hard gelatin capsules filled with white or almost white powder and small clumps.

Package unit

50 capsules (10 capsules/PTPX5)