Gunspenitin 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 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 onward: 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, 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 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, the dose should be titrated 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 onward: 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, 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 of gabapentin within one week, and the total daily dose must not exceed 3,600 mg of gabapentin. When administering this drug, the total daily dose should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dosage 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: 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 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 plenty of 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 to prevent seizure recurrence. 2) If a dose of this drug is missed (when 12 hours or more have elapsed since the most recent dose), the decision on whether to administer an additional dose to make up for it should be made by the physician. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can greatly 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 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 it is to be used in combination 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, including somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be administered at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years and older through 12 years - Day 1: Administer 10 mg/kg of body weight of gabapentin - Day 2: Administer 20 mg/kg of body weight of gabapentin - From day 3 onward: Administer 30 mg/kg of body weight of gabapentin The dose may be increased up to a maximum of 40 mg per kg of body weight daily, if necessary. When administering this medicine, divide the total daily dose into 3 doses.

This medication can cause mental health issues such as suicidal thoughts, suicidal behavior, and depression during treatment; hence, patients and caregivers should inform healthcare professionals if these symptoms occur. Abrupt discontinuation of this drug may result in more frequent seizures or prolonged status epilepticus, so the dosage should be gradually reduced under medical supervision. Weight gain may occur with long-term use, so regular weight monitoring and dietary and exercise adjustments are recommended if necessary. This drug may cause drowsiness, dizziness, decreased concentration, and therefore it is advised to avoid driving or operating hazardous machinery until adequately cautious. Particularly, when administered to children aged 3 to 12 years, symptoms such as emotional instability, hostility, decreased concentration, and hyperactivity may occur, so careful observation is essential. Patients with reduced kidney function should have their dosage adjusted, and older adults should use this medication cautiously as they may experience a higher likelihood of side effects. This medication is not to be given to patients with acute pancreatitis, certain types of seizures, or those with lactose intolerance. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication, and breastfeeding women should also take caution. Moreover, concurrent use of this medication with CNS depressants, including narcotics, may result in severe drowsiness, respiratory depression, or coma, so it must be taken strictly under medical supervision. If serious allergic reactions occur while taking this medication, such as skin rash, fever, difficulty in breathing, swelling of the face or neck, it is crucial to stop taking it immediately and seek medical attention. Withdrawal symptoms such as anxiety, insomnia, nausea, tremors, and headaches may appear upon abrupt cessation; therefore, sudden discontinuation should be avoided, and dosage adjustments should be discussed with a physician. This medication must be stored out of children's reach and kept in its original container to prevent misuse or quality degradation.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormality, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, abnormal cooperation function, dizziness, dysarthria, insomnia, neurogenic response, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, anorexia, gingivitis, purpura, arthralgia, hyperactivity syndrome, increased, decreased or absence of reflex movements, sensory disturbance, anxiety, pneumonia, urinary tract infection, visual disturbance, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormality, loss of signs, laryngeal neuralgia, sleepwalking, pseudo-croup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait abnormality, confusion, sensory reduction, thought disorder, tremor, dizziness, shortness of breath, rash, tongue paralysis, confusion, loss of consciousness, mental disorder, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash, elevated liver function tests, polycyclic erythema, falls, generalized edema, gynecomastia, hallucination, hepatitis, hypersensitivity including systemic symptoms, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorder, dystonia, myotonic cramps, palpitations, pancreatitis, sexual dysfunction, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensation, lethargy

This medication must be stored in a tightly sealed container to protect it from air and moisture, and it should be kept at room temperature between 1 and 30 degrees Celsius. Thus, avoid excessively hot or cold places, and it is advisable to keep it in a cool area away from direct sunlight.

Appearance

White hard capsule containing white or grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle