Huronitin Capsule 100 mg (Gabapentin)

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 of gabapentin, titrate the dose over the first 3 days of treatment as follows. - Day 1: Administer one 300 mg capsule of this medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication 2 times daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medication 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 of age 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 medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication 2 times daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medication may be administered 3 times daily (gabapentin 900 mg/day). If needed, 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. The total daily dose of this medication 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: 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 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: 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 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 medication on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medication should be swallowed whole with an adequate amount of fluid and may be taken with or without food. When administered 3 times daily, ensure that the interval between doses is not more than 12 hours to prevent recurrence of seizures. 2) If a dose of this medication is missed (more than 12 hours have elapsed since the most recent dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When coadministered with antacids containing magnesium or aluminum, administer this medication at least 2 hours after the antacid. This can greatly reduce the decrease in the bioavailability of this medication. 4) The duration of treatment with this medication 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 this medication must be discontinued or administered in combination 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.

Child dose

2) Adjunctive therapy in children aged 3 years or older and 12 years or younger To achieve a maintenance dose of gabapentin 30 mg/kg body weight/day, titrate gradually over the first 3 days of treatment as follows: - 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 to a maximum of 40 mg/kg body weight per day if necessary. The total daily dose of this medicine should be administered in 3 divided doses.

This drug is used for the treatment of epilepsy and neuropathic pain. There is a risk of developing mental health issues such as suicidal thoughts or behavior and depression, so patients and caregivers should inform medical personnel immediately if these symptoms occur. Suddenly stopping the medication can worsen seizures or lead to a prolonged state of epilepsy, so it should be discontinued gradually according to a doctor's instructions. This drug may cause serious side effects such as pancreatitis; if symptoms like upper abdominal pain, nausea, or repeated vomiting occur, stop taking it immediately and visit a hospital. Particular caution is needed when administering this medication to children aged between 3 and 12 years, as there may be neuropsychiatric adverse reactions such as emotional instability, aggression, thought disorders, and hyperactivity. Concurrent use of this drug with central nervous system depressants, including narcotics, can lead to severe sedation, respiratory depression, and coma, so it must be administered at the lowest possible dose for a short period under a doctor's direction, with close monitoring of the patient's condition. This drug should not be administered to patients with certain genetic disorders, acute pancreatitis, or generalized absence seizures. Extra caution is required for patients with impaired renal function, elderly patients, those with a history of mental illness, pregnant women or those who may become pregnant, and breastfeeding women, and administration should be discussed with a physician. Common side effects include dizziness, drowsiness, and motor coordination difficulties, so caution is needed in activities such as driving or operating dangerous machinery. A variety of side effects including weight gain, vision problems, skin rash, and blood disorders have been reported, so if any unusual symptoms occur, consult with medical personnel immediately. There may be risks to the fetus if used during pregnancy, so consultation with a doctor is essential if planning to become pregnant or if already pregnant, and caution is also needed while breastfeeding. This drug may cause withdrawal symptoms; therefore, dosing should be tapered off gradually under a doctor's guidance when discontinuing. Drug interactions may occur with this medication, so inform the physician about all medications being taken. Store out of reach of children and in the original container to prevent misuse.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• thought disorder
• hyperactivity
• weakness

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. To maintain the drug's effectiveness, it is important to store it at room temperature between 1°C and 30°C.

Appearance

A hard capsule with white or light gray powder inside, with a white upper and lower part.

Package unit

30 capsules, 300 capsules per bottle