Levantin Capsule 100 mg (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, titrate the dose 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 three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered three 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.). 3) The duration of treatment should depend on clinical need. Long-term treatment is generally required for epilepsy. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment); however, sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug must be discontinued, or if it is to be administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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 drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this drug may be administered three times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within 1 week, and the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this drug should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 3. Debilitated patients: In debilitated patients with low body weight or patients who have undergone transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dose adjustment may be necessary due to age-related deterioration of 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: 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 hemodialysis patients 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 sufficient fluid and may be taken with or without food. When administered 3 times daily, ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (12 hours or more have elapsed since the most recent dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug is reduced, treatment is discontinued, or the patient is switched to another alternative medication, this should be done gradually over at least 1 week (a longer period may be necessary at the prescriber's discretion). 5) To reduce the main adverse reactions, 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 years to 12 years: To achieve a maintenance dose of gabapentin 30 mg/kg/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: administer gabapentin 30 mg/kg body weight. If necessary, the dose may be increased to a maximum of 40 mg/kg 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; therefore, if you experience any abnormal changes in mood or behavior during treatment, consult your physician immediately. Stopping this medication suddenly may lead to increased seizure frequency or prolonged epilepsy, so it should be tapered off gradually under a physician's guidance. Serious side effects such as pancreatitis may occur; if you experience upper abdominal pain, nausea, or vomiting, stop taking this medication immediately and inform your healthcare provider. Children, elderly patients, and those with reduced kidney function may be more sensitive to the side effects of this medication, so caution is warranted during administration. This medication can cause central nervous system side effects such as drowsiness, dizziness, and motor coordination issues, so it is advisable to avoid driving or operating hazardous machinery after taking it. Combining this medication with other drugs or narcotics that have central nervous system depressant effects may lead to dangerous side effects such as sedation or respiratory depression; therefore, you must inform your doctor about any other medications you are currently taking. Pregnant women or those planning to become pregnant should consult their physician prior to taking this medication, as it may affect the fetus; caution is also needed during breastfeeding. This medication can cause allergic reactions or serious skin conditions; if you develop rash, fever, or swollen lymph nodes, stop taking the medication and consult your healthcare provider immediately. Weight gain or swelling may occur during treatment, so regular weight checks should be conducted, and dietary adjustments and exercise should be implemented if necessary. When administering this medication to children, behavioral changes such as emotional instability, aggression, or decreased concentration may arise, so caregivers should observe them closely. In case of overdose, symptoms may include dizziness, drowsiness, and reduced consciousness; however, recovery is typically possible with supportive treatment. This medication should be stored in its original container and kept out of reach of children.

Suicidal thoughts, suicidal behavior, depression, 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, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, thought disorder, tremor, singular contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, double vision, erectile dysfunction, lethargy, fatigue, facial edema, hypertension, bloating, poor appetite, gingivitis, arthralgia, dizziness, hyperactivity syndrome, reflex activity changes, sensory disturbance, anxiety, hostility, pneumonia, urinary tract infection, visual disturbance, viral infection, weight gain, drowsiness, hostility, emotional instability, hyperactivity syndrome, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorder, loss of signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait disturbance, confusion, tremor, vertigo, dyspnea, thrombocytopenia, anaphylaxis, angioedema, urticaria, hair loss, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorder, dystonia, myotonic dystrophy, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensations, lethargy

Store this medication in a tightly closed container to prevent air or moisture from entering. Maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

White or grayish-white powder in white opaque hard capsules

Package unit

30 capsules/bottle, 300 capsules/bottle