Nelson Gabapentin Capsule 100 mg

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 methods, a starting dose of one 300 mg capsule of this drug 3 times daily may be administered (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 methods, a starting dose of one 300 mg capsule of this drug 3 times daily may be administered (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; 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 who have undergone 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. 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 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 drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) This drug should be swallowed whole with sufficient liquid and may be taken with or without food. When administered 3 times daily, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (if 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 coadministered with antacids containing magnesium or aluminum, administer this drug 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. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued or if it is to be administered 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 periods exceeding 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

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

This medication may increase the risk of suicidal thoughts or behaviors. Therefore, any changes in mood or behavior during treatment must be reported to the doctor immediately. Abruptly stopping the medication may exacerbate seizures or lead to status epilepticus, so it must be reduced gradually under medical supervision. This medication can cause severe side effects such as pancreatitis, so if you experience persistent upper abdominal pain or vomiting, you should immediately stop taking it and go to the hospital. Particular attention is required in children aged 3 to 12 years, as they may exhibit psychiatric adverse reactions such as emotional instability, aggressiveness, decreased concentration, and hyperactivity. Taking this medication in combination with narcotics or central nervous system depressants may lead to drowsiness, respiratory depression, or coma. Therefore, it should only be used in minimal doses for a short period after consulting a doctor. Patients with hypersensitivity to this drug, acute pancreatitis, specific types of seizures, or lactose intolerance should not take it. Patients with impaired kidney function, elderly patients, those with a history of mental illness, pregnant women or those planning to become pregnant, and nursing mothers should use this medication with caution. Adverse effects such as dizziness, drowsiness, memory impairment, and motor control disorders may occur, so caution is advised when driving or operating dangerous machinery. Various side effects such as weight gain, visual impairment, and skin rash have been reported. Consult a medical professional immediately if any abnormal symptoms occur. During pregnancy, it may affect the fetus, so women of childbearing age must use effective contraception during treatment and consult a doctor in case of pregnancy. For nursing mothers, it is important to consult with a doctor regarding breastfeeding, as this medication may be secreted in breast milk. This medication may cause withdrawal symptoms, so do not stop suddenly and gradually reduce under a doctor's guidance. Interactions with other medications or alcohol may occur, so it is crucial to inform health care professionals about any medications currently being taken or alcohol consumption. Keep out of reach of children and store in the original container for safety.

Suicidal ideation, suicidal behavior, depression, emotional instability, hostility, thought disturbance, 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, delirium, impaired coordination, dizziness, dysarthria, insomnia, neurogenic hypersensitivity reaction, nystagmus, drowsiness, thought disturbance, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, decreased appetite, gingivitis, purpura, arthralgia, hyperactivity, abnormal reflex movements, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodromal symptoms, laryngeal neuralgia, sleepwalking, false croup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory loss, tremors, vertigo, dyspnea, rash, thought disturbance, chest pain, soft tissue inflammation, cervical pain, allergic reactions, abscess, chills, body odor, cysts, hernia, abnormal BUN levels, pelvic pain, sepsis, weight loss, gout, hypoglycemia, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, pouchitis, contractures, CNS tumors, syncope, dream disturbances, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioceptive sensation, subdural hematoma, apathy, hallucinations, decreased libido, restlessness, paranoid disorder, depersonalization, abnormal euphoria, hyperesthesia, hallucinatory state, suicide attempt, chorea, athetosis, perioral dyskinesia, brain disorders, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, local clonic seizures, tactile hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal sores, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, cutaneous papules, photodermatosis, leg ulcers, scalp seborrhea, psoriasis, epidermal loss, maceration, skin nodules, melanoma, skin necrosis, localized swelling, hematuria, urinary disorders, frequent urination, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, amenorrhea, ejaculation abnormalities, kidney pain, white discharge, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency for urination, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste disturbances, blepharospasm, ear fullness, conjunctival hyperemia, diabetic retinopathy, eye pain, retinal microhemorrhages, retinal vein thrombosis, taste loss, urinary tract infection, urinary disorders, erectile dysfunction, urinary incontinence, vulvar dysesthesia, mastalgia, menstrual disorders, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency for urination, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, systemic symptoms accompanied by drug rash, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic cramps, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule with white or grayish-white powder inside, both ends white.

Package unit

30 capsules/bottle, 300 capsules/bottle