Gabapentin Capsule 100 mg (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 medicine once daily, or one 100 mg capsule of this medicine three 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 three times daily (gabapentin 600 mg/day). - From Day 3 onward: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this medicine 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.) 3) The duration of treatment should be determined according to clinical needs. Long-term treatment is generally required for epilepsy. 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 precipitate 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. 2. Neuropathic pain 1) 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 medicine once daily, or one 100 mg capsule of this medicine three 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 three times daily (gabapentin 600 mg/day). - From Day 3 onward: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this medicine 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 1 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. 2) The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. 3. Debilitated patients : In debilitated patients with low body weight or patients after transplantation surgery, the gabapentin dose should be increased in increments of 100 mg. 4. Elderly patients : Dose adjustment may be necessary due to age-related deterioration of renal function (see table). 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients undergoing hemodialysis : Dose adjustment is necessary based on the following table. 1) Dose 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) Dose 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) Swallow this medicine whole with plenty of liquid. It 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 (more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for it. 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 should be determined according to clinical needs. If the dose of this medicine is reduced, treatment is discontinued, or the patient is switched to another alternative medicine, 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 Day 1 should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years - Day 1: Administer 10 mg/kg of body weight of gabapentin - Day 2: Administer 20 mg/kg of body weight of gabapentin - From Day 3 onward: Administer 30 mg/kg of body weight of gabapentin The dose may be increased, if needed, to a maximum of 40 mg per kg of body weight per day. Divide the total daily dose of this medicine into 3 doses.

This medication may cause mood changes such as suicidal thoughts or behavior, and depression during treatment, so patients and guardians should notify healthcare professionals if these symptoms occur. Suddenly stopping the medication can lead to increased seizures or prolonged epileptic conditions, so it should be discontinued gradually under the direction of a physician. This medication may cause side effects such as weight gain, dizziness, drowsiness, and difficulty with motor coordination, so caution should be exercised when driving or operating hazardous machinery. Particularly in pediatric patients, neuropsychiatric adverse reactions such as emotional instability, aggression, abnormal thoughts, and hyperactivity may occur, necessitating observation. When taken together with narcotics or other central nervous system depressants, respiratory depression or deep sedation may occur, so careful observation and dosage adjustment are required when used concomitantly. Patients with impaired renal function should have their dosages adjusted; patients with acute pancreatitis or hypersensitivity to this medication or its components should not take it. During pregnancy, this medication may pose risks to the fetus, so women who are pregnant or planning to become pregnant must consult their healthcare provider, and nursing mothers should also exercise caution. This medication can cause serious allergic reactions such as skin rash, anaphylaxis, and angioedema; if any suspicious symptoms occur, discontinue the medication immediately and seek medical attention. Sudden discontinuation after prolonged use may result in withdrawal symptoms such as anxiety, insomnia, nausea, and tremors, so dosage adjustments should be made under the guidance of a healthcare professional. During treatment, weight and physical condition should be regularly monitored, and patients should inform healthcare professionals about any other medications being taken to be aware of potential interactions.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thinking, 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, impaired coordination, dizziness, dysarthria, insomnia, nervous hyperreaction, nystagmus, drowsiness, abnormal thinking, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial edema, allergy, generalized edema, weight loss, chills, strange sensations, lack of energy, 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 thrombosis, premature ventricular contraction, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased saliva secretion, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth 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, Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, diminished or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, abnormal sensations, partial paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, euphoric episodes, hyperestesia, hallucinatory states, suicidal urges, mental disorders, chorea, athetosis, perioral movement disorders, brain diseases, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonus, sensory hyperreactivity, motor dysfunction, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, rhinorrhea, 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, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melasma, skin necrosis, localized swelling, hematuria, urinary disorders, frequent urination, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, abnormal menstruation, menorrhagia, breast cancer, oligomenorrhea, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, dyspareunia, mastalgia, testicular pain, 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, allergic reactions including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea athetosis, movement disorders, dystonia, myotonia, palpitations, pancreatitis, sexual dysfunction, Stephens-Johnson syndrome, thrombocytopenia, tinnitus, incontinence, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy, asthenia, facial edema, allergic reactions, abscesses, chills, chills and fever, mucosal abnormalities, body odor, cysts, hernias, abnormal BUN levels, neck masses, pelvic pain, sepsis, viral infections, syncope, palpitations, congestive heart failure, vascular dilation, gastrointestinal inflammation, gastrointestinal abnormalities, oral candidiasis, gastritis, tongue abnormalities, dental abnormalities, fecal abnormalities, abnormal liver function tests, periodontal abscesses, cholecystitis, cholelithiasis, duodenal ulcers, fecal incontinence, elevated gamma-glutamyl transferase, gingivitis, intestinal obstruction, intestinal ulcers, melanotic stools, oral ulcers, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechiae, lymphoproliferative reactions, reduced prothrombin, edema, gout, hypoglycemia, weight loss, elevated alkaline phosphatase, diabetic ketoacidosis, elevated lactate dehydrogenase, arthritis, arthrosis, leg cramps, myasthenia gravis, shin pain, joint disorders, tendon disorders, confusion, depression, neuropathy, decreased libido, anxiety, depersonalization, diminished reflexes, speech disorders, dream disorders, dysarthria, emotional instability, confusion, perioral sensory disturbances, euphoric episodes, sensory hyperreactivity, motor dysfunction, suicide attempts, agitation, hypertonia, increased libido, movement disorders, myoclonus, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, fungal dermatitis, boil formation, herpes simplex, psoriasis, sweating, hives, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinomas, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste distortions, hearing loss, conjunctival injection, diabetic retinopathy, eye pain, retinal microhemorrhages, retinal vein thrombosis, taste loss, urinary tract infections, urinary disorders, erectile dysfunction, incontinence, vulvovaginal candidiasis, mastalgia, abnormal menstruation, polyuria, urinary retention, cystitis, ejaculation disorders, penile engorgement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, abnormal urination, tongue paralysis

This medication should be stored in a tightly sealed container to protect from air or moisture. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature.

Appearance

A hard capsule that is white to light gray containing powder

Package unit

30 capsules/bottle, 200 capsules/bottle