Widerpentin Capsule 100 mg (Gabapentin)

Adult dose

1. Epilepsy 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 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 a starting 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 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 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 a starting dose, one 300 mg capsule of this medication may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as 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 who have undergone transplantation, the gabapentin dose should be increased in increments of 100 mg. 4. Elderly patients: Dose adjustment may be required due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance 80 mL/min or less) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 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: 3 × 100 mg should be administered every 2 days. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 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, and do not administer this medication on days when hemodialysis is not performed. 6. Method and duration of administration This medication should be swallowed whole with plenty of fluid and may be taken with or without food. When administering 3 times daily, care should be taken to ensure that the dosing interval does not exceed 12 hours to prevent recurrence of seizures. If a dose of this medication is missed (12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be taken to make up for it. When taking this medication concomitantly 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. The duration of treatment with this medication should depend on clinical need. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), but sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medication is to be discontinued or if it is to be used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. To reduce the main adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be administered at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: To reach a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate over the first 3 days of treatment as follows. 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, as needed, up 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 medication may increase the risk of suicidal thoughts or behaviors, so mood and behavioral changes should be carefully monitored during treatment. Abruptly stopping this medication may increase the frequency of seizures or put patients at risk for severe epileptic status, so the dosage should be gradually reduced according to a doctor's instructions. Animal studies have reported an increased risk of certain cancers; however, the effects in humans are still unclear. Unexpected sudden deaths have been reported during treatment with this medication; thus, patients with epilepsy must be managed with caution. If symptoms of pancreatitis (persistent abdominal pain, nausea, repeated vomiting) occur, the medication should be immediately discontinued, and consultation with a physician is advised. During treatment with this medication, emotional instability, aggression, decreased concentration, and hyperactivity may appear in children aged over 3 years to under 12 years, thus caution is required. Co-administration with central nervous system depressants or narcotics may cause severe drowsiness, respiratory depression, or coma, so it should only be used at the minimum dose for a short period after consulting a doctor. Patients with hypersensitivity to this medication, those with acute pancreatitis, patients with certain types of seizures, and individuals with lactose intolerance should not take this medication. Patients with renal impairment, elderly individuals, those with a history of mental illness, children with attention deficit disorder, pregnant women or those who may become pregnant, and nursing mothers should use this medication with caution. Drowsiness, dizziness, confusion, and decreased consciousness may occur during treatment, so it is advisable to avoid driving or operating dangerous machinery. Weight gain and visual disturbances (amblyopia, diplopia, etc.) may occur, so regular monitoring of the condition is essential. If severe skin reactions or anaphylaxis symptoms occur, take this medication immediately and seek emergency treatment. This medication poses a risk of dependency or misuse, so patients with a history of substance abuse should use it with particular care. Abruptly discontinuing treatment may cause withdrawal symptoms such as anxiety, insomnia, nausea, and tremors, so it should be gradually reduced according to a doctor's instructions. It may interact with other medications; therefore, inform the healthcare provider of any other medications being taken or alcohol consumption. During pregnancy, there may be risks to the fetus; thus, women who are pregnant or planning to become pregnant must consult with their physician before use. If breast-feeding, the need for this medication and whether to continue breastfeeding should be decided in consultation with a physician. Keep out of reach of children, and store in the original container to prevent misuse or degradation of quality.

Suicidal thoughts, suicidal behavior, depression, emotional instability, hostility, thought disorder, hyperactivity, abdominal pain, lower back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, dry mouth, nausea, vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hypersensitivity reaction, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, loss of appetite, gingivitis, arthralgia, dizziness, hyperactivity disorder, abnormal reflexes, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorder, loss of sensation, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, traumatic injury, cold syndrome, pain, dry mouth, gait abnormality, confusion, sensory reduction, tremor, vertigo, dyspnea, blood coagulation disorder, rash, hematuria, urinary disorder, empty bladder, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, indifference, ejaculation disorder, increased serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reaction, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, systemic reaction including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, metabolic muscle spasms, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensation, lethargy

This medication should be stored in a sealed container to prevent air or moisture from entering. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve its efficacy.

Appearance

A white or grayish-white powder or granules in a white hard capsule of upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle