Gaba 300 mg Capsule (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, instead of the above regimen, 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.) 2. 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 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, instead of the above regimen, one 300 mg capsule of this drug may be administered three times daily as the starting dose (gabapentin 900 mg/day). If needed, 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. 3. Frail patients: In frail patients with low body weight or patients after transplantation, the gabapentin dose should be increased in increments of 100 mg. 4. Elderly patients: Dose adjustment may be necessary because of 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) 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: 3 × 100 mg should be administered 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 sufficient fluid and may be administered 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 drug is missed (when more than 12 hours have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When administered 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 depend on 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 abrupt 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 it is to be used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 6) To reduce the main adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 to 12 years Titrate gradually over the first 3 days of treatment to achieve a maintenance dose of 30 mg/kg/day of gabapentin, as follows: - Day 1: Administer 10 mg/kg of body weight as gabapentin - Day 2: Administer 20 mg/kg of body weight as gabapentin - From Day 3: Administer 30 mg/kg of body weight as gabapentin The dose may be increased, if needed, up to a maximum of 40 mg/kg of body weight per day. When administering this drug, divide the total daily dose into 3 doses.

This medication may pose a risk of changes in mental health such as suicidal thoughts or behavior, or depression, therefore careful observation is needed during use. If this medication is suddenly discontinued, there may be an increase in seizures or the occurrence of status epilepticus, so it should be tapered off gradually according to a doctor's instructions. In animal studies, some potential for tumor development has been reported; however, the clinical risk in humans is not yet clear. There have been reports of unexpected sudden deaths during treatment, but these may be related to the epilepsy itself, thus caution is required. If symptoms of pancreatitis such as persistent abdominal pain, nausea, or repeated vomiting occur during treatment, the use of this medication should be stopped immediately and consultation with a physician should occur. Caution should be exercised when administering to children aged 3 to 12 years due to possible central nervous system adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity. Co-administration with central nervous system depressants such as narcotic analgesics may cause severe drowsiness, respiratory depression, or coma; therefore, it should be used at the minimum dosage for a short duration under medical supervision. This medication should not be administered to patients with hypersensitivity or acute pancreatitis, those with specific types of seizures, or patients with lactose intolerance. Patients with impaired kidney function, the elderly, those with a history of psychiatric illness, children with attention deficit or behavioral disorders, pregnant women or those of childbearing potential, and nursing mothers should use this medication with extra caution. Drowsiness, dizziness, or coordination difficulties may occur, so driving or operating machinery requires caution. During treatment with this medication, adverse reactions such as weight gain, vision changes, or skin rashes may occur, so regular monitoring of the condition is necessary, and if any unusual symptoms arise, immediate consultation with a physician is needed. Withdrawal symptoms such as anxiety, insomnia, nausea, tremors, or headaches may appear upon discontinuation; thus, the dosage should be gradually reduced according to a doctor's instructions. During early pregnancy, this medication may affect the fetus, so its use should be avoided during pregnancy, and women planning to become pregnant should use effective contraceptive measures. If breastfeeding, as this medication may be excreted in breast milk, consultation with healthcare professionals regarding its use during nursing is necessary. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or quality degradation.

suicidal thoughts, suicidal behaviors, depression, emotional instability, hostility, abnormal thinking, hyperactivity, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst or dry mouth, nausea and vomiting, leukopenia, peripheral edema, weight gain, fractures, muscle pain, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, abnormal thinking, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, double vision, erectile dysfunction, weakness, lethargy, facial edema, hypertension, distension, loss of appetite, gingivitis, arthralgia, dizziness, hyperactivity, increased reflex movements, reduction or absence, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of signs, laryngeal neuralgia, sleepwalking, pseudo-croup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory deficits, tremors, vertigo, respiratory distress, thrombocytopenia, hematuria, urinary disorders, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, anorgasmia, abnormal ejaculation, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgent urination, vaginismus, mastalgia, scrotal pain, confusion, depression, neuroexcitability, perceptual abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, nystagmus, stupor, perioral sensory disturbances, hyperesthesia, sensory motor decrease, suicide attempts, anxiety, heightened tension, increased libido, movement disorders, fasciculations, vestibular disorders, increased coughing, bronchitis, rhinitis, sinusitis, pneumonia, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinomas, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste disturbance, hearing loss, conjunctival congestion, diabetic retinopathy, ocular pain, microhemorrhage in the fundus, retinal vein thrombosis, loss of taste, urinary tract infection, urinary disorders, erectile dysfunction, urinary incontinence, vulvovaginitis, mastalgia, menstrual disorders, polyuria, urinary retention, cystitis, abnormal ejaculation, penile engorgement, gynecomastia, nocturia, pyelonephritis, scrotal engorgement, frequency of urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine kinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash accompanied by systemic symptoms, elevated liver function test results, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea-acanthocytosis, movement disorders, dystonia, myoclonic spasms, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal feeling, lethargy

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. Such storage can help to preserve the medication's effectiveness for a long time.

Appearance

A hard capsule containing white or grayish white powder or granules, with a light yellowish color on its upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle