Levapentin Capsule 300 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 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 twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3: 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 a starting dose, one 300 mg capsule of this medicine may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased up 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. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine is to be discontinued, or if it is to be used in combination 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 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 twice daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3: 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 a starting 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. The total daily dose of this medicine 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. Frail patients: In frail patients with low body weight or patients after transplant surgery, the dose of this medicine 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) Dose 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 : 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) Dose 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 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, ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medicine is missed (if more than 12 hours have elapsed since the most recent dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can greatly reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine should depend on clinical need. If the dose of this medicine is reduced, treatment is discontinued, or it is switched to another alternative medicine, this should be done gradually over at least 1 week (a longer period may be required 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

2) Adjunctive therapy in children aged 3 to 12 years: Day 1: Administer gabapentin 10 mg/body weight (kg) 2) Adjunctive therapy in children aged 3 to 12 years: Day 2: Administer gabapentin 20 mg/body weight (kg) 2) Adjunctive therapy in children aged 3 to 12 years: From day 3 onward: Administer gabapentin 30 mg/body weight (kg) Ages 3 to 12 years: The dose may be increased, if necessary, 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 a medication used for the treatment of epilepsy and has a risk of inducing serious mental health issues such as suicidal thoughts or behaviors; therefore, mood changes or behavioral abnormalities should be carefully monitored during treatment. Discontinuing the medication suddenly may lead to more frequent seizures or a prolonged state of epilepsy, so it should be tapered off gradually according to a doctor's instructions. Some cases of tumor formation were reported in animal studies, but there is no clear evidence that this drug causes cancer in humans. There have been reports of sudden and unexpected deaths while taking this medication, particularly due to the risk of seizures in epileptic patients. If serious pancreatic symptoms such as hemorrhagic pancreatitis occur, the medication should be discontinued immediately and medical consultation sought. Children aged 3 to 12 years may exhibit neuropsychiatric adverse reactions such as emotional instability, aggression, reduced concentration, and hyperactivity while taking this medication, so caution is needed. Taking this drug in combination with narcotics or central nervous system depressants may lead to severe drowsiness, respiratory depression, or coma; hence, it should only be used at minimal doses for short periods when absolutely necessary. Patients who are allergic to this drug or its components, have acute pancreatitis, suffer from generalized partial seizures, or have genetically inherited lactose intolerance should not take this medication. Patients with impaired kidney function, the elderly, those with a history of mental illness, children with attention deficit disorder, and women who are pregnant or breastfeeding should use this medication cautiously, and women of childbearing potential should use effective contraception concurrently. During treatment, symptoms such as dizziness, drowsiness, and ataxia may occur, so it is advisable to avoid driving or operating machinery. This drug can cause various side effects such as weight gain, visual disturbances, skin rashes, and blood abnormalities; therefore, it is essential to immediately inform healthcare professionals of any unusual symptoms. Withdrawal symptoms such as anxiety, insomnia, nausea, and tremors may occur upon discontinuation, so it is crucial to taper off slowly as per a doctor's guidance. This drug may interact with other medications, so it is necessary to inform healthcare providers about all medications being taken. During pregnancy, it may affect the fetus, so it is generally advisable to avoid use unless special circumstances arise, and caution should be exercised during breastfeeding as well. Keep this medication out of reach of children and store it in its original container to prevent misuse or deterioration.

Suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbances, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurogenic reactions, nystagmus, drowsiness, thought disturbances, tremors, single contractions, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, apathy, facial swelling, hypertension, bloating, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased reflex movements, decrease or absence, sensory disturbances, anxiety, pneumonia, urinary tract infections, visual disturbances, viral infections, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, gait disturbances, confusion, sensory loss, tremor, vertigo, dyspnea, rash, thought disturbances, chest pain, soft tissue infection, cervical pain, allergic reactions, abscess, chills, mucosal abnormalities, body odor, cysts, hernia, abnormal BUN level, cervical masses, pelvic pain, sepsis, viral infections, syncope, palpitations, migraines, hypotension, peripheral vascular disorders, cardiovascular disorders, cerebrovascular accidents, congestive heart failure, myocardial infarction, vasodilation, gastroenteritis, gastrointestinal abnormalities, oral moniliasis, gastritis, tongue abnormalities, thirst, dental abnormalities, stool abnormalities, abnormal liver function tests, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcers, fecal incontinence, increased gamma-glutamyl transpeptidase, gingivitis, intestinal obstruction, intestinal ulcers, melena, oral ulcers, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechiae, lymphadenopathy, decreased prothrombin, edema, gout, hypoglycemia, weight loss, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, confusion, depression, hyperirritability, paresthesia, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, stupor, perioral paresthesia, ecstatic states, hypersensitivity, decreased motor function, suicide attempts, agitation, tension, increased libido, movement disorders, fasciculations, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, hives, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin malignancy, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste disturbances, hearing loss, conjunctival hyperemia, diabetic retinopathy, ocular pain, microhemorrhage in the fundus, retinal vein thrombosis, loss of taste, urinary tract infections, urination disorders, erectile dysfunction, urinary incontinence, vaginal moniliasis, breast pain, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile enlargement, gynecomastia, nocturia, pyelonephritis, scrotal enlargement, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, hives, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic spasms, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, apathy

This medication is prone to moisture and air exposure, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

A hard capsule with a pale yellow outer and inner shell containing a white or grayish-white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle