Gabatiron Capsule 100 Milligrams (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, the dose should be titrated over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product three times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this product three times daily, or three 100 mg capsules of this product three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this product 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; 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, the dose should be titrated over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this product once daily, or one 100 mg capsule of this product three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this product twice daily, or two 100 mg capsules of this product three times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this product three times daily, or three 100 mg capsules of this product three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this product may be administered three 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 product should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dosage adjustment may be necessary because of age-related decline in 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: A dose of 3 × 100 mg should be administered 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, and do not administer this product on days when hemodialysis is not performed. 6. Method and duration of administration 1) This product 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 dosing interval does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this product is missed (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. 3) When administered concomitantly with antacids containing magnesium or aluminum, this product should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this product. 4) The duration of treatment with this product 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 cause status epilepticus. If treatment with this product is to be discontinued, or if it is to be 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 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

Adjunctive therapy in children aged 3 to 12 years: To achieve a maintenance dose of 30 mg/kg/day of gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: administer 10 mg/kg of gabapentin; Day 2: administer 20 mg/kg of gabapentin; Day 3 onward: administer 30 mg/kg of gabapentin. The dose may be increased, as needed, to a maximum of 40 mg/kg per day. When administering this drug, divide the total daily dose into 3 doses.

During treatment with this medication, there may be changes in mental health, such as suicidal thoughts or behaviors, and depression, so patients and caregivers should inform medical personnel immediately if such symptoms appear. Abrupt discontinuation of this medication may increase the frequency of seizures or lead to a more severe condition, so the dosage should be decreased gradually under medical supervision. Some cancer risks have been reported in animal studies, but the risk in humans is still unclear. There have been reports of sudden and unexpected deaths during the use of this medication, so it should be used with caution under the guidance of a physician. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, and repeated vomiting, occur, the use of this medication should be discontinued immediately and medical advice sought. Particular care should be taken with pediatric patients, as they may exhibit neurological and psychiatric side effects, such as emotional instability, aggression, decreased concentration, and hyperactivity. Using this medication in combination with narcotics or other central nervous system depressants may lead to severe drowsiness, respiratory depression, or coma, and should only be used at the minimum effective dose for a short duration with strict medical supervision. Patients with a history of allergic reactions to this medication, those with acute pancreatitis, and patients with certain types of seizures should not take this medication. Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, pregnant or planning to become pregnant women, and nursing mothers should exercise additional caution when using this medication and consult a doctor. Dizziness, drowsiness, and motor coordination disorders may occur upon taking this medication, so caution should be exercised when driving or operating hazardous machinery. Weight gain may occur, so it is advisable to check weight regularly and consider dietary and exercise measures if necessary. If visual adverse effects (such as amblyopia or diplopia) occur during the use of this medication, medical personnel should be informed immediately. Severe skin reactions or serious allergic symptoms, such as anaphylaxis, should lead to immediate discontinuation of this medication and emergency treatment. This medication has potential for dependence or abuse; therefore, patients with a history of substance abuse should use it with particular caution. Sudden discontinuation can lead to withdrawal symptoms such as anxiety, insomnia, nausea, and tremors, thus careful tapering is necessary in accordance with medical advice. There may be drug interactions, so patients should inform healthcare professionals of any medications they are taking or alcohol consumption. During pregnancy, there may be risks to the fetus, so women who are pregnant or planning to become pregnant must consult a physician before taking this medication. If breastfeeding, there is a possibility that this medication may be secreted in breast milk, so it is advised to discuss its use with healthcare professionals and discontinue breastfeeding if necessary.

suicidal ideation, suicidal behavior, depression, emotional instability, hostility, thought disorder, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, dry mouth, nausea, vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, speech disorder, insomnia, neurogenic hypersensitivity, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased or decreased reflexes, sensory disturbance, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infections, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of prodrome, laryngalgia, somnambulism, pseudocroup, hoarseness, asthenia, trauma due to accident, cold syndrome, pain, dry mouth, gait disturbance, confusion, sensory deficit, tremors, vertigo, dyspnea, rash, suicide attempt, agitation, hypertonia, movement disorders, myoclonus, vestibular disorder, epistaxis, dyspnea, apnea, hair loss, dermatitis, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, exfoliative dermatitis, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, dysuria, polyuria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual disorders, menorrhagia, breast cancer, anorgasmia, ejaculation disorder, neurogenic hypersensitivity, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, language disorders, dream disturbances, speech disorders, emotional instability, confusion, perioral sensory disturbances, euphoria, perceptual hypersensitivity, decreased motor function, suicidal behavior, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, boil syndrome, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, visual disturbances, ear pain, visual disturbances, taste distortion, hearing loss, conjunctival injection, diabetic retinopathy, ocular pain, retinal microhemorrhages, retinal vein thrombosis, loss of taste, urinary tract infection, dysuria, erectile dysfunction, incontinence, vaginal atrophy, mastalgia, menstrual disorders, polyuria, urinary retention, cystitis, ejaculation disorder, penile enlargement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal edema, frequent urination, urgent urination, urinary abnormalities, tongue paralysis, elevated serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast hypertrophy, chest pain, toxic epidermal necrolysis, eosinophilia, systemic symptoms with drug rash, increased 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 dystrophy, palpitations, pancreatitis, sexual dysfunction, skin and mucosal syndrome, thrombocytopenia, tinnitus, incontinence, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, preferably at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness for a longer time.

Appearance

A hard capsule with white or grayish-white powder or granules, with the upper and lower parts being white.

Package unit

30 capsules/bottle, 100 capsules/bottle