Garotin Capsule 300 mg (Gabapentin)

Adult dosage

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, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day). - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day). - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this medicine may be administered 3 times daily (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, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day). - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day). - From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day). Alternatively, as an initial dose, one 300 mg capsule of this medicine may be administered 3 times daily (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 must not exceed 3,600 mg of gabapentin. When administering this medicine, the total daily dose should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients following 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 ≤80 mL/min) or patients undergoing 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: Administer 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 undergoing 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with plenty of fluid 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 medicine is missed (i.e., more than 12 hours have elapsed since the most recent dose), the physician should decide whether an additional dose should be taken to make up for it. 3) When this medicine is administered with antacids containing magnesium or aluminum, administer it at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine should depend on clinical need. Epilepsy generally requires long-term treatment. Although there is no evidence of a rebound phenomenon (increased seizure frequency due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine must be discontinued or it is to be used 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 should be taken at bedtime.

Children's dosage

1) Adjunctive therapy in children aged 3 to 12 years To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer 10 mg of gabapentin per kg of body weight - Day 2: Administer 20 mg of gabapentin per kg of body weight - From Day 3 onward: Administer 30 mg of gabapentin per kg of body weight The dose may be increased as needed to a maximum of 40 mg per kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This drug is used as an anticonvulsant to control seizures. There is a risk of worsening mental health states such as suicidal thoughts, behaviors, and depression during treatment, so patients and caregivers should monitor for these changes closely. Abrupt discontinuation of this medication may lead to an increased frequency of seizures and could result in serious epilepsy status, hence it should be discontinued gradually under a doctor's guidance. This medication can have serious side effects such as pancreatitis, therefore, if continuous upper abdominal pain, nausea, or vomiting occurs, the patient should immediately discontinue use and consult a healthcare professional. Special caution is needed when administered to children aged 3 to 12 due to the risk of neuropsychiatric side effects such as emotional instability, aggression, decreased concentration, and hyperactivity. Taking this drug in conjunction with narcotics or other central nervous system depressants can cause severe drowsiness, respiratory depression, and coma; hence, consultation with healthcare professionals and monitoring of dosage is necessary when using these medications together. Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, and women who are pregnant or breastfeeding require special caution when using this drug. Symptoms such as dizziness, drowsiness, and ataxia may occur during treatment, so it is best to avoid driving or operating dangerous machinery. Additionally, potential side effects such as weight gain, vision changes, skin rash, and allergic reactions may occur, and any abnormal symptoms should be promptly reported to a healthcare provider. There may be drug interactions with other medications or alcohol, so all medications currently being taken and health conditions should be accurately communicated to healthcare professionals. Lastly, store this medication out of reach of children and keep it in its original container to prevent misuse or degradation of quality.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, aggression, thought disorder, hyperactivity, deep sedation, respiratory depression, coma, abdominal pain, low back pain, fatigue, fever, headache, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysphonia, insomnia, neuroexcitable reactions, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased reflex movement, decrease or lack of reflexes, sensory abnormalities, anxiety, pneumonia, urinary tract infection, vision impairment, viral infection, drowsiness, aggression, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, trauma due to accident, cold syndrome, infection, pain, dry mouth, abnormal gait, confusion, sensory loss, thought disorder, tremor, vertigo, dyspnea, coagulopathy, rash, thrombocytopenia, anaphylaxis, angioedema, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, drug rash (DRESS), elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic convulsions, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, tinnitus, urinary incontinence, anxiety, insomnia, pain, sweating, tongue paralysis

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, and it is best to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way will help preserve its efficacy and prevent deterioration.

Appearance

Hard capsules with light yellow and beige color containing white or light gray powder

Package unit

30 capsules/bottle, 100 capsules/bottle