Pharmagabapentin Capsule (Gabapentin)

Adult dose

1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: To achieve a maintenance dose of 900 mg/day of gabapentin, titration should be carried out over the first 3 days of treatment. Day 1: Administer one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug 3 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 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, apart from the above regimens, one 300 mg capsule of this drug 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 and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titration should be carried out over the first 3 days of treatment. Day 1: Administer one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug 3 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 3 times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, apart from the above regimens, one 300 mg capsule of this drug 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, and the total daily dose should not exceed 3,600 mg of gabapentin. The total daily dose of this drug should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, 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. Renal function, creatinine clearance (mL/min) ≥80: Total daily dose 900∼2,400 mg/day Renal function, creatinine clearance (mL/min) 50∼79: Total daily dose 600∼1,800 mg/day Renal function, creatinine clearance (mL/min) 30∼49: Total daily dose 300∼900 mg/day Renal function, creatinine clearance (mL/min) 15∼29: Total daily dose 150b∼600 mg/day Renal function, creatinine clearance (mL/min) <15: Total daily dose 150b∼300 mg/day a: The total daily dose should be divided into 3 doses. b: Should be administered as 3 × 100 mg every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to the creatinine clearance. Dosage for hemodialysis patients Starting 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration This drug 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 to ensure that the interval between doses does not exceed 12 hours in order to prevent recurrence of seizures. If a dose of this drug is missed (if more than 12 hours have elapsed since the last dose), the decision on whether to administer an additional dose to make up for the missed dose should be made by a physician. When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. The duration of treatment with this drug should depend on clinical need. Treatment of epilepsy generally requires long-term administration. If treatment with this drug is to be discontinued, or if it is to be administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 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 to 12 years: Gradually titrate over the first 3 days of treatment to a maintenance dose of gabapentin 30 mg/kg/day. Day 1: Administer gabapentin 10 mg/kg body weight Day 2: Administer gabapentin 20 mg/kg body weight From Day 3 onward: Administer gabapentin 30 mg/kg body weight The dose may be increased up to a maximum of 40 mg/kg body weight per day as needed. The total daily dose of this medicine should be divided into 3 doses.

This drug may increase the risk of suicidal thoughts or behaviors, so if symptoms of depression or mood changes occur during treatment, you should consult a doctor immediately. Abruptly stopping this medication may worsen seizures, so the dosage should be gradually reduced according to a doctor's instructions. Serious side effects such as pancreatitis may occur with this drug, so if persistent upper abdominal pain or vomiting occurs, you should stop taking the drug immediately and visit a hospital. Particularly in children, neurological and psychiatric adverse reactions such as emotional instability, aggression, and decreased concentration may occur, so caution is necessary. This medication may cause drowsiness or dizziness, so care should be taken when driving or operating machinery. Taking this drug with central nervous system depressants or narcotics may cause respiratory depression or severe sedation, so it should only be used in combination after consulting a doctor. Patients with impaired kidney function require dosage adjustments, and elderly patients should also take caution when using this medication. Women who are pregnant or planning to become pregnant should consult a doctor before taking this drug, and caution is also necessary during breastfeeding. If allergic reactions, skin rashes, or symptoms of anaphylaxis occur, the drug should be stopped immediately and medical personnel informed. This drug may lead to abuse and dependence, so patients with a history of drug use should exercise particular caution. If side effects are severe or discomfort persists during treatment, you should consult medical personnel for appropriate measures.

suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorders, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired cooperation, dizziness, dysarthria, insomnia, neurogenic reactions, nystagmus, drowsiness, thought disorders, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, myasthenia, lethargy, facial swelling, allergy, systemic edema, weight loss, chills, feeling strange, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular premature contraction, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased saliva secretion, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland hyperplasia, 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, Cushing's syndrome, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, Hodgkin's lymphoma, increased bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, abnormal dreams, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, euphoria, hypersensitivity, hallucinatory states, suicidal impulses, 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 hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal deformity, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal detachment, maceration, skin nodules, hyperpigmentation, skin necrosis, localized swelling, hematuria, urination disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation abnormalities, kidney pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, systemic symptoms associated with drug rash, elevated liver function test values, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, paroxysmal tachycardia, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, tremors, headaches, abnormal sensations, lethargy

This medication should be stored in a closed container to protect it from exposure to air or moisture. It is best stored at room temperature between 1 and 30 degrees Celsius. This way of storage helps maintain the effectiveness of the drug.

Appearance

Yellowish hard capsule containing white or grayish-white powder

Package unit

30 capsules/bottle, 500 capsules/bottle, [for export] 30 capsules (10 capsules/PTPX3)