Gabapentin 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 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: 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, one 300 mg capsule of this medicine 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, 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 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: 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, one 300 mg capsule of this medicine 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 medicine must 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 receiving hemodialysis: Dose adjustment is required based on the following table. 1) Dosage in 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: The dose should be administered as 3 × 100 mg every 2 days. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage in 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 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 (if 12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be given 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. 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 cause status epilepticus. If treatment with this medicine must be discontinued or it is 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 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 Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years — Day 1: Administer gabapentin 10 mg/body weight (kg) Adjunctive therapy in children aged 3 years to 12 years — Day 2: Administer gabapentin 20 mg/body weight (kg) Adjunctive therapy in children aged 3 years to 12 years — From Day 3 onward: Administer gabapentin 30 mg/body weight (kg); the maintenance dose is gabapentin 30 mg/kg of body weight/day; the dose may be increased, as needed, up to a maximum of 40 mg/kg of body weight per day. When administering this medicine, divide the total daily dose into 3 doses.

This medication is used for the treatment of epilepsy and neuropathic pain. During treatment, mental health changes such as suicidal thoughts or behaviors and depression may occur; thus, patients and caregivers should immediately inform healthcare professionals if these symptoms arise. Sudden discontinuation of the medication may result in more frequent seizures or status epilepticus, so it should be discontinued according to a doctor's instructions. Although this medication has shown results related to certain cancers in some animal studies, its clinical significance in humans is not yet clear. If symptoms of pancreatitis appear, such as persistent abdominal pain, nausea, or vomiting, the medication should be stopped immediately and consulted with a physician. In particular, caution is needed as neuropsychiatric side effects such as emotional instability, aggression, impaired concentration, and hyperactivity may occur in children. Serious side effects may occur when co-administered with central nervous system depressants, especially narcotics, necessitating strict doctor supervision. This medication should not be administered to patients with allergic reactions to this drug or its components, or those with acute pancreatitis or generalized tonic clonic seizures. Patients with impaired kidney function, the elderly, those with a history of psychosis, women who are pregnant or planning to become pregnant, and breastfeeding mothers should use this medication with caution. Common side effects during treatment include dizziness, drowsiness, and ataxia, so it is advisable to avoid driving or operating hazardous machinery until accustomed to the drug. In the early stages of pregnancy, there is a risk of fetal malformations; therefore, women who are pregnant or planning to become pregnant must consult a physician and use effective contraception. Nursing mothers should discuss whether to discontinue breastfeeding with a physician, as this medication is secreted in breast milk. Various side effects, such as weight gain, visual disturbances, and skin rashes, may occur during treatment, necessitating regular monitoring and testing. In cases of overdose, symptoms such as dizziness, drowsiness, and coma may appear; however, recovery is generally possible with supportive care. Store out of reach of children and keep in the original container to prevent misuse.

Suicidal ideation, suicidal behavior, depression, abnormal mood and behavioral changes, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurotic responses, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, listlessness, facial swelling, allergy, generalized edema, weight loss, chills, strange sensations, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombotic venous inflammation, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular extrasystole, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, hyperemia, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastritis, 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, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, ecchymosis 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, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracerebral hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski's sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, restlessness, paranoia, depersonalization, dysphoria, hypersensitivity, hallucination state, suicidal ideation, mental disorders, chorea athetoides, orofacial movement disorders, brain diseases, neuropathy, personality disorders, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, focal myoclonus, perceptual hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, shortness of breath, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal abrasion, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, skin dryness, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal desquamation, maceration, skin nodules, subcutaneous nodules, acanthosis, skin necrosis, localized edema, hematuria, urination disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, amenorrhea, ejaculation disorders, renal pain, leukorrhea, genital itching, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, vulvodynia, mastalgia, testicular pain, vision changes, cataracts, conjunctivitis, dry eyes, ocular pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear infection, ear inflammation, taste loss, taste disturbances, blepharospasm, congestion, epistaxis, thrombocytopenia, urinary incontinence, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, 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, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea athetoides, movement disorders, dystonia, myotonic contraction syndrome, palpitations, pancreatitis, sexual dysfunction, Steven-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensation, lethargy

This medication should be stored in a tightly closed container to prevent air or moisture from entering and kept at room temperature between 1 to 30 degrees Celsius.

Appearance

Hard capsule with yellowish brown shell containing white to grayish-white powder

Package unit

30 capsules/bottle, 100 capsules/bottle