Gabapentin Capsule 300 Milligrams (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 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, one 300 mg capsule of this drug may be administered three times daily as the starting dose (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin; 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 cause status epilepticus. If treatment with this drug is to be discontinued, or if it is to be used 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 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, one 300 mg capsule of this drug may be administered three times daily as the starting dose (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within one week; the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this drug should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients after transplantation, the dose of gabapentin 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, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (12 hours or more have elapsed since the last dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. 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 needed at the prescriber's discretion). 5) To reduce the main adverse effects, 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 in children aged 3 to 12 years: Administer gabapentin 10 mg/kg body weight on the first day; 20 mg/kg body weight on the second day; and 30 mg/kg body weight from the third day onward. The dose may be increased as needed up 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 drug is used to treat epilepsy and neuropathic pain and may increase the risk of suicidal thoughts or behaviors. Patients and caregivers should closely observe for these symptoms. Abruptly stopping this medication may lead to increased frequency of seizures, so the dosage should be gradually reduced according to a doctor's instruction. There have been reports of increased cancer risk in certain animal studies, but the risk to humans is not well established. While taking this medication, serious pancreatic symptoms such as hemorrhagic pancreatitis may appear, so patients should consult a doctor immediately if they experience upper abdominal pain, nausea, or repeated vomiting. Particularly in children aged 3 to 12, there may be adverse emotional reactions, including emotional instability, aggression, thought disorders, or hyperactivity, which require monitoring. This medication carries a risk of sedation, respiratory depression, coma, and even death when taken with central nervous system depressants, including narcotics, and should be used at the minimal dose for the shortest duration under a doctor's supervision. It is contraindicated in patients with a history of hypersensitivity, acute pancreatitis, or primary generalized seizures. Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, children with attention deficit disorder, women who are pregnant or planning to become pregnant, and breastfeeding mothers should use this medication with caution. During treatment, side effects such as dizziness, drowsiness, ataxia, memory loss, depression, nausea, and vomiting can occur, thus it is advisable to avoid driving or operating hazardous machinery. Taking this medication during pregnancy may affect the fetus; therefore, women of childbearing potential should use effective contraceptive methods, and breastfeeding mothers should consult a doctor before taking this medication. Withdrawal symptoms such as anxiety, insomnia, nausea, pain, sweating, tremors, headache, and depression may occur when this medication is discontinued, and it should be tapered off gradually as per a doctor's guidance. Patients must inform their doctor or pharmacist about other medications they are taking or health conditions and should seek medical advice if they experience unusual symptoms.

Suicidal thoughts, suicidal behavior, depression, emotional instability, hostility, abnormal thinking, hyperactivity, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disorders, insomnia, neuro-excitability, nystagmus, drowsiness, abnormal thinking, tremors, single muscle contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, apathy, facial edema, hypertension, bloating, decreased appetite, gingivitis, arthralgia, dizziness, hyperactivity, increased reflexes, decrease or absence of reflexes, sensory disturbances, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, viral infections, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, coagulation disorders, loss of reflexes, laryngeal neuralgia, sleepwalking, pseudo-croup, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, gait abnormalities, confusion, tremors, vertigo, dyspnea, coagulation disorders, rash, hematuria, urinary dysfunction, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, adynamia, ejaculation abnormalities, neuropathy, decreased libido, depersonalization, hallucinations, suicidal thoughts, mental disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, perspiration, urticaria, vesicular rash, visual disturbances, ear pain, eye abnormalities, taste disturbances, hearing loss, urinary tract infection, urinary dysfunction, erectile dysfunction, urinary incontinence, vaginal mycotic infection, mastalgia, menstrual abnormalities, polyuria, urinary retention, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, alopecia, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity reactions including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic cramps, palpitations, pancreatitis, sexual dysfunction, mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, perspiration, tremors, headache, abnormal sensations, apathy

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is best to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance

A light yellow hard capsule containing white to light gray powder.

Package unit

30 capsules/bottle, 200 capsules/bottle