Boryeong Gabapentin Capsule 100 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 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, a starting dose of one 300 mg capsule of this drug may be administered 3 times daily (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 of age 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, a starting dose of one 300 mg capsule of this drug may be administered 3 times daily (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. 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 who have undergone transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dosage adjustment may be necessary due to age-related decreased renal function (see table). 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dosage 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. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage for patients on 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 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. 2) If a dose of this drug is missed (when more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. 3) When taken concomitantly with antacids containing magnesium or aluminum, this drug 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 (increased 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 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. 5) The safety and efficacy of treatment for neuropathic pain for more 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 the first day of treatment should be taken at bedtime.

Child dose

1) Adjunctive therapy in children aged 3 to 12 years - 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 as needed to a maximum of 40 mg/kg body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication is used for the treatment of epilepsy and carries the risk of suicidal thoughts or behaviors, so both patients and caregivers need to monitor closely for these symptoms. Sudden discontinuation may lead to worsened seizures, so the dosage must be gradually adjusted according to the doctor's instructions. Some animal studies have reported a potential risk of certain cancers, although the risk to humans is unclear. There have been reports of unexpected sudden deaths during treatment, so caution is especially needed for epilepsy patients. If symptoms of pancreatitis occur, the medication should be stopped immediately and the doctor should be consulted. In pediatric patients, emotional instability, hostility, reduced concentration, and hyperactivity may occur, so caution is necessary. Taking this medication together with narcotics or other central nervous system depressants can lead to severe sedation, respiratory depression, coma, or death, so consult a doctor before use. Patients with hypersensitivity or acute pancreatitis, as well as certain genetic forms of lactose intolerance, should not take this medication. Patients with impaired kidney function, the elderly, those with a history of mental illness, pregnant women, and nursing mothers should use this medication carefully, as it may affect the fetus during pregnancy, requiring special attention. Side effects such as dizziness, drowsiness, and ataxia may occur, so care should be taken when driving or operating machinery. This drug has been associated with various side effects including weight gain, vision abnormalities, skin rash, and blood abnormalities; if any unusual symptoms occur, medical advice should be sought immediately. Withdrawal symptoms such as anxiety, insomnia, nausea, and tremors may occur upon discontinuation, so it should be gradually stopped according to the doctor's instructions. This drug can interact with other medications, so all drugs currently being taken should be disclosed to healthcare professionals for consultation. Store out of the reach of children and keep in the original container to prevent misuse or degradation of quality.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperkinesia, profound sedation, respiratory depression, coma, death, abdominal pain, back pain, fatigue, fever, headache, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disorder, insomnia, neurovegetative response, nystagmus, drowsiness, tremor, single muscular contraction, cough, pharyngitis, rhinitis, erosion, acne, pruritus, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, loss of appetite, gingivitis, arthralgia, dizziness, hyperkinesia, increased reflexes, decreased or absent reflexes, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual impairment, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, somnambulism, pseudo croup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory impairment, syncope, dream disorders, sensory impairment, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, muscle hypertonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, apathy, hallucinations, decreased libido, anxiety, paranoid disorder, depersonalization, abnormal euphoria, hypersensitivity, hallucinatory state, suicidal ideation, mental disorder, chorea with athetosis, perioral movement disorder, brain disease, nerve paralysis, personality disorder, increased libido, substance suppression, apraxia, subtle motor control disorder, meningitis, local focal spasms, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, rhinitis, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photodermatitis, leg ulcers, scalp seborrhea, psoriasis, epidermal desquamation, maceration, skin nodules, melasma, skin necrosis, localized swelling, hematuria, urinary disorders, oliguria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, anovulation, ejaculation disorders, renal pain, leucorrhea, genital pruritus, nephrolithiasis, acute kidney failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, dyspareunia, mastalgia, testicular pain, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, systemic symptoms associated with drug rash, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, movement disorder, muscle hypertonia, paroxysmal kinesigenic dyskinesia, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, lingual paralysis, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensation, lethargy

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness and safety.

Appearance

A hard capsule with white or light gray powder inside, with a white cap and body.

Package unit

30 capsules/bottle, 100 capsules/bottle