Gaba 100 mg Capsules (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years and older To reach 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 an initial 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.) 2. Neuropathic pain Adults (18 years and older): To reach 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 an initial dose, one 300 mg capsule of this drug may be administered three times daily (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 administered in 3 divided doses. 3. Debilitated patients: In debilitated patients with low body weight or patients following transplantation, the gabapentin dose should be increased in increments of 100 mg. 4. Older adults: 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) 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 administered in 3 divided 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 on 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 taken with or without food. When administered 3 times daily, care should be taken not to allow the interval between doses to exceed 12 hours in order to prevent recurrence of seizures. 2) If a dose of this drug is missed (when 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 it. 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 depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increased 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 drug must 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 more 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 of treatment should be taken at bedtime.

Child dose

1. Epilepsy 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 is an anticonvulsant used in the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behavior while taking it; therefore, patients and caregivers should closely monitor for mood changes or unusual behavior. Suddenly stopping the medication can lead to worsening seizures or the risk of status epilepticus, so it should be gradually tapered off according to a doctor's instructions. This medication may cause serious side effects such as pancreatitis; therefore, if symptoms like upper abdominal pain, nausea, or recurrent vomiting occur, it should be discontinued immediately and medical advice sought. Caution is needed when administering this medication to children aged 3 to 12 due to potential neuropsychiatric adverse reactions such as emotional instability, aggression, concentration deficits, and hyperactivity. Taking this medication with central nervous system depressants, including drugs of abuse, may result in severe drowsiness, respiratory depression, or coma; thus, if used together, it should be at the lowest effective dose for a short duration, and the patient should be closely monitored. Patients with poor kidney function or the elderly may need dosage adjustments, and women who are pregnant or may become pregnant should consult a doctor before taking this medication due to risks to the fetus. Dizziness, drowsiness, and coordination difficulties may occur during use, so it is advisable to avoid driving or operating dangerous machinery until accustomed to the medication. This medication can cause various side effects, including weight gain, vision abnormalities, and skin rash; thus, any unusual symptoms should be reported to medical personnel immediately. Pregnant or breastfeeding women should always consult with healthcare professionals both before and after administration of this medication, and its use is particularly advised against in early pregnancy. In cases of overdose, symptoms such as dizziness, drowsiness, or coma may appear, but recovery is usually achieved with supportive care; in severe instances, dialysis may be required. This medication should be stored out of the reach of children and care should be taken to not store it in a different container from the original packaging.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, lethargy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, coordination dysfunction, dizziness, dysarthria, insomnia, nervous hyperreactivity, nystagmus, drowsiness, thought disorders, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial edema, allergy, systemic edema, weight loss, chills, feelings of unfamiliarity, lassitude, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, murmurs, atrial fibrillation, heart failure, thrombophlebitis, deep thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, peptic ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, pouchitis, contracture, dizziness, hyperactivity, sensory disturbances, reduced or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, decreased proprioception, intracerebral hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, altered euphoria, hyperesthesia, hallucinatory state, suicidal ideation, mental disturbances, chorea, athetosis, perioral movement disorders, encephalopathy, neuropathy, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorder, meningitis, focal myoclonic seizures, sensory hypersensitivity, psychomotor retardation, mania, neuroses, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal picking, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, seborrheic dermatitis, psoriasis, epidermal detachment, maceration, skin nodules, subcutaneous nodules, melanosis, skin necrosis, localized edema, hematuria, urinary disorders, frequency of urination, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anorgasmia, ejaculation disorders, renal pain, leukorrhea, genital itching, renal calculi, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urgency, vaginismus, mastalgia, orchalgia, visual disturbances, cataract, conjunctivitis, dry eye, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbances, blepharospasm, fullness, eye itching, accommodation disturbances, tympanic membrane perforation, sensitivity to noise, eye focus abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroiditis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, confusion, loss of consciousness, mental disorders, suicide attempts, agitation, hypertonia, movement disorders, myoclonic seizures, increased serum creatine phosphokinase levels, rhabdomyolysis, acute renal failure, urticaria, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, drug eruption with eosinophilia and systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea athetosis, movement disorders, dystonia, syndromic muscular cramps, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance

A white or gray-white hard capsule containing powder or granules.

Package unit

30 capsules/bottle, 100 capsules/bottle