Gabapentin Capsule 300 mg (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years or 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 medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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.) 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 medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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 one week, and the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this medicine should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in increments of 100 mg. 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 undergoing 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: 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 undergoing 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine 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 not to allow more than 12 hours between doses to prevent recurrence of seizures. 2) If a dose of this medicine is missed (if 12 hours or more 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 taken concomitantly with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of administration of this medicine should depend on clinical need. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), but sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued or it is to be used concomitantly with another antiepileptic drug, changes 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 reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

1. Epilepsy 2) Adjunctive therapy in children aged 3 to 12 years To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate gradually over the first 3 days of treatment as follows: - Day 1: 10 mg/kg of body weight as gabapentin - Day 2: 20 mg/kg of body weight as gabapentin - From Day 3: 30 mg/kg of body weight as gabapentin The dose may be increased, if necessary, to a maximum of 40 mg/kg of body weight per day. The total daily dose should be divided into 3 doses.

This drug may increase the risk of suicidal thoughts or behaviors; therefore, during treatment, careful monitoring for signs of depression, mood changes, or abnormal behavior is needed. Sudden discontinuation of this drug can lead to more frequent seizures or the risk of a prolonged seizure state, so it must be tapered off gradually under a doctor's guidance. Long-term use has been reported to be associated with certain tumors in some animals, but the cancer risk in humans is not yet clear. Sudden and unexpected death cases have been reported during this medication use; however, this may be related to the risks of epilepsy itself, hence caution is required. If symptoms of acute pancreatitis, such as persistent upper abdominal pain, nausea, and repeated vomiting occur, immediate discontinuation of this medication and consultation with healthcare professionals is necessary. For children aged 3 to 12 years, emotional instability, aggression, decreased concentration, and hyperactivity may occur, necessitating careful monitoring. Co-administration of this drug with central nervous system depressants, including narcotics, may lead to sedation, respiratory depression, coma, and, in severe cases, death. Therefore, it should be used at minimal doses for a short period, with close monitoring of the patient. This medication should not be administered to patients with allergic reactions to this drug or its components, acute pancreatitis, certain types of seizure disorders, or lactose intolerance. Patients with reduced kidney function, the elderly, individuals with a history of psychiatric disorders, children with attention deficit or behavioral disorders, pregnant or potentially pregnant women, and nursing mothers should use this drug cautiously; regular monitoring is required during long-term treatment. This medication may cause a variety of side effects, including dizziness, drowsiness, ataxia, memory impairment, headache, nausea, vomiting, weight gain, etc., so any abnormal symptoms should be reported to healthcare professionals immediately. During pregnancy, it may affect the fetus; therefore, pregnant women or those planning to become pregnant must consult a doctor before taking the medication and use effective contraception during treatment. This drug may be excreted in breast milk, so nursing mothers should discuss the use of this medication with their doctor and, if necessary, discontinue breastfeeding during treatment. For children and the elderly, the safety and potential for side effects may be different, so appropriate dosage adjustments and caution are necessary. Caution is required when performing tasks requiring concentration such as driving or operating machinery while taking this medication, and it is advisable to avoid such activities until the patient is accustomed to the symptoms during initial treatment. In case of overdose, symptoms like dizziness, drowsiness, and coma may occur, but generally recover with supportive treatment; however, patients with severe renal failure may require dialysis. This medication should be kept out of reach of children and stored in its original container to prevent misuse or deterioration of quality.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbance, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, nervous hyperreactivity, nystagmus, drowsiness, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, malaise, facial swelling, allergy, generalized edema, weight loss, chills, strange feelings, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disease, palpitations, tachycardia, migraine, murmurs, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular ectopic beats, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, distension, gingivitis, glossitis, gingival bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hyperplasia, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, paresthesia, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiparesis, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, decreased positional sense, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, personality disorder, increased libido, organic inhibition, apraxia, fine motor control disorders, meningoencephalitis, localized focal seizures, hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal irritation, bronchospasm, hypoventilation, pulmonary edema, alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, exfoliative dermatitis, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urinary disorders, oliguria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, precocious puberty, ejaculation disorders, kidney pain, leukorrhea, genital pruritus, nephrolithiasis, acute kidney injury, anuria, diabetes, nephritis, nocturia, pyuria, urgency, vaginismus, mastalgia, testicular pain, vision abnormalities, cataract, conjunctivitis, dry eye, ocular pain, glare, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, auditory loss, ear pain, tinnitus, inner ear inflammation, ear infection, taste loss, taste disturbance, eyelid twitching, fullness in the ear, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodromal symptoms, laryngeal neuralgia, sleepwalking, pseudo croup, hoarseness, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug eruption with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, bilateral gynecomastia, hallucinations, hepatitis, systemic responses including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myoclonus, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, malaise

This medication should be stored in a tightly closed container to protect it from air and moisture. It is also advisable to keep the drug at room temperature, ideally between 1 degree and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

A hard capsule with a yellowish upper and lower part containing white or grayish powder or granules.

Package unit

30 capsules/bottle, 100 capsules/bottle