Gabapentin Capsule 300 mg

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients 13 years of age 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 twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: 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, one 300 mg capsule of this medicine may be administered 3 times daily as the starting dose (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 of age 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 twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: 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, one 300 mg capsule of this medicine may be administered 3 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 medicine should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, the gabapentin dose 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 of 80 mL/min or less) 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, and 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, ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medicine is missed (when 12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine should depend on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (an increase in the 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 medicine 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. 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, including somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

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

This drug may increase the risk of suicidal thoughts or behavior, so any unusual mood or behavior changes during treatment should be reported to healthcare professionals immediately. Suddenly stopping this medication may worsen seizures or lead to a prolonged state of epilepsy, so cessation should be done gradually under a doctor’s guidance. Animal studies have observed a potential risk for cancer, but the risk in humans is not yet clear. If unexplained abdominal pain, nausea, vomiting, etc., occur during use, pancreatitis may be suspected, and immediate consultation with a physician is required. Careful monitoring is necessary when administering this drug to children aged 3 to 12, as they may exhibit behavioral changes, emotional instability, aggression, and decreased concentration. Taking this medication along with central nervous system depressants, including narcotics, can cause severe drowsiness, respiratory depression, and coma; therefore, it should only be prescribed at the minimum effective dose for the shortest period necessary. This drug should not be used in patients with hypersensitivity to it, those with acute pancreatitis, or those with certain types of seizures. Patients with impaired kidney function, elderly patients, those with a history of psychiatric disorders, and pregnant or breastfeeding women, and children with attention deficit or behavioral issues should use this medication cautiously. Dizziness, drowsiness, or ataxia may occur with this medication, so caution is advised while driving or operating hazardous machinery. During pregnancy, may affect the fetus, so those planning to become pregnant or who are pregnant should consult healthcare professionals, and caution is also necessary during lactation. Various side effects such as weight gain, visual disturbances, skin rashes, blood disorders have been reported; any unusual symptoms should be communicated to healthcare providers promptly. Withdrawal symptoms such as anxiety, insomnia, tremors, headaches may occur upon discontinuation; thus, it should be reduced gradually according to a physician's instructions. This drug can interact with other medications, so all prescribed drugs should be reported to the healthcare professional, especially when taken with antacids or central nervous system depressants. Store this medication out of reach of children and keep it in its original container to prevent misuse.

suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbances, hyperactivity, weakness, lethargy, 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, speech disorders, insomnia, neuro-excitability, nystagmus, drowsiness, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, double vision, erectile dysfunction, asthenia, lassitude, facial swelling, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular ectopy, 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, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenitis, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasms, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, traumatic purpura, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, diminished or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream abnormalities, aphasia, sensory reduction, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, restlessness, paranoia, depersonalization, altered ecstasy, hyperesthesia, hallucinatory state, suicidal impulses, mental disorders, chorea-athetosis, perioral movement disorders, brain diseases, neuropathy, personality disorders, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, local focal seizures, hypersensitivity, diminished motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal obstruction, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, hives, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photodermatitis, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urinary disorders, incontinence, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, adrenal insufficiency, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, loss of taste, taste abnormalities, blepharospasm, eye itching, accommodation abnormalities, tympanic membrane perforation, sensitivity to noise, ocular fixation abnormalities, overflow tears, retinal diseases, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye atrophy, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory abnormalities, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodromes, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, tongue paralysis, increased serum creatine phosphokinase activity, rhabdomyolysis, acute renal failure, hives, allergic reactions, hair loss, 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 with systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, macrocytic myoclonus, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headaches, abnormal sensations, lethargy

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius. This will help to preserve the drug's effectiveness for a longer period.

Appearance

Hard capsules with light yellow to yellowish color containing white or off-white powder

Package unit

30 capsules/bottle, 100 capsules/bottle