Gaba Pro Capsule 100 mg (Gabapentin)

Adult dose

1. Epilepsy 1) 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 medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication twice daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medication 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.) 3) The duration of treatment should be determined according to clinical need. Long-term treatment is generally required for epilepsy. If this medication must be discontinued or administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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 medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication twice daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medication 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 1 week, and the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this medication should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for periods exceeding 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients following transplantation, the dose of this medication should be increased in 100 mg increments. 4. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 1) Dose 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) Dose 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 medication on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this medication whole with an adequate amount of fluid. 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. 2) If a dose of this medication is missed (more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for it. 3) When administered concomitantly with antacids containing magnesium or aluminum, this medication should be taken at least 2 hours after the antacid. 4) The duration of treatment with this medication should be determined according to clinical need. If the dose of this medication is reduced, treatment is discontinued, or the patient is switched to another alternative medication, this should be done gradually over at least 1 week (a longer period may be necessary at the prescriber's discretion). 5) 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

2) Adjunctive therapy in children aged 3 to 12 years - Day 1: Administer gabapentin 10 mg/kg body weight - Day 2: Administer gabapentin 20 mg/kg body weight - From day 3 onward: Administer gabapentin 30 mg/kg body weight If necessary, the dose may be increased to a maximum of 40 mg/kg body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication, as an antiepileptic drug, can increase the risk of suicidal thoughts or behavior, hence it is important to closely monitor for symptoms of depression or mood changes while taking it. Abrupt discontinuation may worsen seizures or lead to status epilepticus, so the dosage should be tapered slowly according to a doctor’s instructions. Severe side effects such as pancreatitis may occur during the use of this medication, so any persistent upper abdominal pain, nausea, or vomiting should be immediately reported to a healthcare professional. This medication may affect the central nervous system, causing dizziness, drowsiness, or ataxia; therefore, it is advisable to avoid driving or operating machinery during the initial use. Particularly in children, the elderly, and patients with impaired kidney function, the dosage of this medication needs adjustment, and caution should be exercised in patients with a history of psychiatric disorders. When taken with central nervous system depressants, including narcotics, this medication may cause respiratory depression or profound sedation, so it must be discussed with a doctor before concurrent use. Pregnant women or those planning to become pregnant should consult a doctor before use due to risks to the fetus, and caution is also needed during breastfeeding. This medication can cause allergic reactions or severe skin reactions; if symptoms such as rash, fever, or lymphadenopathy occur, it should be stopped immediately, and a doctor should be consulted. Various side effects such as weight gain, visual disturbances, and memory impairment may occur during treatment, hence regular checks on health status are important. Additionally, there is a risk of misuse and dependence, so accurate dosing as per a doctor’s prescription and avoidance of arbitrary discontinuation or dose increase is crucial.

• Suicidal thoughts
• suicidal behavior
• depression
• emotional instability
• hostility
• thought disorder
• hyperactivity
• abdominal pain
• low back pain
• fatigue

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture, maintaining a storage temperature between 1 to 30 degrees Celsius is important. Maintaining proper temperature and container conditions can help preserve the medication's effectiveness over time.

Appearance

A white or light gray powder contained in a hard capsule with a white top and bottom.

Package unit

Bottle - 30 capsules/bottle, Bottle - 300 capsules/bottle