Kumho Gabapentin Capsule 300 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, titrate the dose over the first 3 days of treatment as follows. - Day 1: Take 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: Take 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: Take 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, apart from the method above, one 300 mg capsule of this medicine may be taken 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, titrate the dose over the first 3 days of treatment as follows. - Day 1: Take 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: Take 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: Take 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, apart from the method above, one 300 mg capsule of this medicine may be taken 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 taking this medicine, the total daily dose should be divided into 3 doses. 3. Frail patients: In frail patients with low body weight or patients following transplant surgery, 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 of 80 mL/min or less) 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: 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 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, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medicine is missed (more than 12 hours have elapsed since the last dose), whether to take an additional dose to make up for it should be determined by the physician. 3) When used with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in bioavailability of this medicine. 4) The duration of treatment with this medicine should be determined according to clinical need. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to abrupt discontinuation of treatment), but abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine 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 longer 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 Day 1 should be taken at bedtime.

Child dose

1) Adjunctive therapy in children aged 3 to 12 years - 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 up to a maximum of 40 mg/kg body weight per day. The total daily dose should be divided into 3 doses.

This medication is used for the treatment of epilepsy and neuropathic pain. During treatment, the risk of mental health issues such as suicidal thoughts or behaviors and depression may increase; therefore, patients and caregivers should immediately inform healthcare professionals if such symptoms occur. Abrupt discontinuation of the drug can worsen seizures or lead to status epilepticus, so dose adjustments should always be made according to the doctor's guidance. In some animal studies, pancreatic carcinoma was reported, but the effects on humans are not yet clear. Additionally, sudden and unexpected deaths have been reported during the course of treatment, but this may also be related to the risks associated with epilepsy itself. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, repeated vomiting) occur during treatment, discontinue the medication immediately and consult a doctor. Care should be taken as neuropsychiatric adverse reactions like emotional instability, aggression, cognitive disturbances, and excessive motor activity may occur, especially in children aged 3 to 12 years. This medication can cause profound sedation, respiratory depression, coma, and in severe cases, death when taken in conjunction with central nervous system depressants, particularly narcotics, and must be used at the minimum dose for a short duration and patients should be closely monitored. Patients who are allergic to this medication or its components, those with acute pancreatitis, patients with generalized tonic-clonic seizures or similar seizures, and individuals with genetic lactose absorption issues should not take this medication. Patients with impaired renal function, elderly individuals, those with a history of mental illness, children with attention deficit or behavioral disorders, pregnant women or those planning to become pregnant, and breastfeeding mothers should consult their doctor before use. Side effects such as dizziness, drowsiness, ataxia, fatigue, nausea, vomiting may occur, and it is advisable to avoid driving or operating hazardous machinery if such symptoms are experienced. Weight gain and visual disturbances may also occur, thus regular monitoring is necessary. Upon discontinuing the medication, withdrawal symptoms such as anxiety, insomnia, headache, and tremors may occur, so it should be reduced gradually as directed by healthcare professionals. Moreover, this medication may affect the fetus in early pregnancy, so caution is advised during pregnancy, and women of childbearing potential should use effective contraception. Breastfeeding women should avoid breastfeeding or consult their doctor when taking this medication. This medication should be stored out of reach of children and in its original container to prevent misuse or degradation in quality.

Suicidal impulse, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, deep sedation, respiratory depression, coma, death, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, abnormal coordination, dizziness, dysphonia, insomnia, neurogenic hypersensitivity, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial swelling, hypertension, abdominal distention, anorexia, gingivitis, purpura, arthralgia, hyperactivity, increased reflexes, decreased reflexes, lack of reflexes, sensory distortion, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of symptoms, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, trauma-related injury, cold syndrome, pain, dry mouth, gait abnormalities, confusion, trembling, vertigo, dyspnea, rash, weakness, thought disorder, chest pain, soft tissue inflammation, cervical pain, allergic reaction, abscess, chills, mucosal abnormalities, body odor, cyst, hernia, abnormal BUN levels, cervical mass, pelvic pain, sepsis, weight loss, edema, gout, hypoglycemia, increased alkaline phosphatase, diabetic ketoacidosis, increased lactate dehydrogenase, syncope, palpitations, migraine, hypotension, peripheral vascular disorders, cardiovascular disorders, cerebral vascular accidents, congestive heart failure, myocardial infarction, vasodilation, angina pectoris, heart failure, increased capillary fragility, phlebitis, thrombophlebitis, varicose veins, gastroenteritis, gastrointestinal abnormalities, oral moniliasis, gastritis, tongue abnormalities, dental abnormalities, stool abnormalities, abnormal liver function tests, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transferase, gingivitis, bowel obstruction, intestinal ulcer, melena, oral ulcer, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechiae, anemia, lymphadenopathy, reduced prothrombin, lethargy, arthritis, arthrosis, leg cramps, myasthenia gravis, tibial pain, joint disorders, tendon disorders, confusion, depression, neurogenic hypersensitivity, perceptual distortions, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream disturbances, dysphonia, emotional instability, confusion, perioral sensory abnormalities, abnormal euphoria, hypersensitivity, decreased motor function, suicide attempt, restlessness, increased 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, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infection, urinary dysfunction, erectile dysfunction, urinary incontinence, vaginal moniliasis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile engorgement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequency of urination, urgency of urination, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reaction, 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, metabolic cramps, palpitations, pancreatitis, sexual dysfunction, mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensations, lethargy

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it should be kept at room temperature between 1 to 30 degrees Celsius.

Appearance

A hard capsule containing white or grayish-white powder or granules, with a yellowish tint on the upper and lower parts.

Package unit

30 capsules/bottle, 200 capsules/bottle