Newbatin 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 as gabapentin, titrate the dose over the first 3 days of treatment as follows. - 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 2 times 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, instead of the above regimen, 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 as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows. - 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 2 times 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, instead of the above regimen, 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. When administering this drug, the total daily dose 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 increments of 100 mg. 4. Elderly patients: Dose adjustment may be necessary due to the decline in renal function associated with age (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 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: 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 the creatinine clearance. 2) Dosage for 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, and do not administer this drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug should be swallowed whole with sufficient fluid and may be administered 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. 2) If a dose of this drug 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 this drug is administered concomitantly with antacids containing magnesium or aluminum, it should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increased frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If this drug is to be discontinued or administered 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 periods exceeding 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 administered at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years: To achieve a maintenance dose of 30 mg/day per kg of body weight as gabapentin, titrate gradually over the first 3 days of treatment as follows. Children aged 3 to 12 years - Day 1: Administer 10 mg/kg of body weight as gabapentin Children aged 3 to 12 years - Day 2: Administer 20 mg/kg of body weight as gabapentin Children aged 3 to 12 years - From Day 3: Administer 30 mg/kg of body weight as gabapentin Children aged 3 to 12 years - If necessary, the dose may be increased up to a maximum of 40 mg per kg of body weight per day. When administering this medicine, divide the total daily dose into 3 doses.

This medication may increase the risk of suicidal thoughts or behaviors, so mood changes or unusual behaviors should be closely monitored during treatment. Abrupt discontinuation may worsen seizures or lead to status epilepticus, so the dosage should be gradually reduced under a doctor's guidance. In animal studies, some instances of tumor growth have been reported, but the effects in humans are not yet clear. There have been reports of sudden and unexpected deaths during treatment with this medication, which can fall within the common risk range for epilepsy patients. If symptoms of hemorrhagic pancreatitis occur, the medication should be stopped immediately and medical consultation should be sought. Especially in pediatric patients, neuropsychiatric adverse reactions such as emotional instability, aggression, reduced concentration, and hyperactivity may occur. Taking this medication with central nervous system depressants like narcotics may result in severe drowsiness, respiratory depression, and coma, so caution is needed when using them together. If allergic reactions or severe skin reactions occur, the medication should be stopped immediately and medical personnel should be informed. During pregnancy, fetal effects may occur, so if planning to become pregnant or if pregnant, consult with a physician. Breastfeeding women should consult with a physician before taking this medication, as it may be excreted in breast milk, and breastfeeding may need to be discontinued if necessary. Elderly patients or those with decreased kidney function may require dosage adjustments, and drowsiness or dizziness may occur during the use of this medication, so caution for falls is advised. It is recommended to avoid driving or operating hazardous machinery until familiar with the effects of this medication. When taking this medication, it should be taken as prescribed, and inform the attending physician about other medications or health conditions. In the event of an overdose, symptoms such as dizziness, drowsiness, and decreased consciousness may occur, but generally, supportive treatment leads to recovery. This medication should be kept out of reach of children and stored in its original container to prevent misuse.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, 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, neurotic reactions, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial swelling, hypertension, abdominal distension, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity disorder, increased, decreased, or absent reflex movements, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual abnormalities, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injury due to accident, cold syndrome, infection, pain, dry mouth, gait abnormalities, confusion, sensory reduction, tremors, vertigo, dyspnea, hematuria, urination disorders, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, adynamia, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute kidney failure, anuria, diabetes, nephritis, nocturia, pyuria, urinary urgency, vaginismus, mastalgia, testicular pain, visual disturbances, cataracts, conjunctivitis, dry eyes, eye pain, photophobia, ptosis, ocular hemorrhage, papilloma, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, eyelid twitching, ear fullness, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin pigmentation, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, subcutaneous nodules, melanosis, skin necrosis, localized swelling, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensation, lethargy, suicide attempt, nervousness, increased tension, movement disorders, myoclonic jerks, vestibular disorders, hemoptysis, degeneration, itching, skin ulcers, fungal skin infections, carbuncle, hair abnormalities, papulovesicular rash, nail abnormalities, skin carcinoma, skin thickening, conjunctival hyperemia, diabetic retinopathy, eye pain, microhemorrhage in the fundus, retinal vein thrombosis, taste loss, urinary tract infection, urination disorders, erectile dysfunction, urinary incontinence, vaginismus, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile engorgement, gynecomastia, nocturia, pyelonephritis, scrotal edema, frequency, urgency, urinary abnormalities, tongue paralysis, elevated serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast hypertrophy, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, metabolic myoclonus, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, withdrawal symptoms

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature to preserve its efficacy and safety for a prolonged period.

Appearance

A hard capsule with yellowish-brown outer and containing a white or grayish-white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle