Canagabentin 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 drug once daily or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this drug 2 times daily or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this drug 3 times daily or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug 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 drug once daily or one 100 mg capsule of this drug 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this drug 2 times daily or two 100 mg capsules of this drug 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this drug 3 times daily or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug 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 drug should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in increments of 100 mg. 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) 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: 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) Dose for patients on 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 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, take care that the dosing interval does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (if 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. 3) When administered with an antacid containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in bioavailability of this drug. 4) The duration of treatment with this drug should be determined according to clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in seizure frequency due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued or it is to be used concomitantly 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 the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: Day 1: administer 10 mg/kg body weight of gabapentin; Day 2: administer 20 mg/kg body weight of gabapentin; From Day 3: administer 30 mg/kg body weight of gabapentin; if necessary, the dose may be increased up to a maximum of 40 mg/kg body weight per day. When administering this medicine, the total daily dose should be divided into 3 doses.

This drug may increase the risk of suicidal thoughts or behavior, so if mood changes or behavioral abnormalities occur during treatment, medical advice should be sought immediately. Stopping this drug suddenly can exacerbate seizures, so it must be gradually reduced according to a physician's instructions. Long-term use has been associated with the potential for cancer in some animal studies, but the risk in humans is unclear. Sudden and unexpected death cases have been reported during treatment with this medication, but this is similar to levels commonly observed in epilepsy patients. If symptoms of pancreatitis such as persistent abdominal pain, nausea, and recurrent vomiting occur, the medication should be stopped immediately and a doctor consulted. Children aged 3 to 12 years old may experience neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity, so caution is needed. When taking this medication with opioids or other central nervous system depressants, severe sedation, respiratory depression, or coma may occur, so it should only be used at the minimum effective dose for short periods, with close monitoring of the patient. Patients with allergies to this drug or any of its components, acute pancreatitis patients, or those with generalized epilepsy should not take this medication. Patients with reduced kidney function, elderly patients, those with a history of mental illness, pregnant or potentially pregnant women, and breastfeeding mothers require careful monitoring and dose adjustments during treatment. Dizziness, drowsiness, confusion, or psychiatric disorders may occur, so it is advisable to avoid driving or operating hazardous machinery. This medication may cause various side effects such as weight gain, visual disturbances, skin rashes, and blood abnormalities, so regular check-ups and immediate consultation with a healthcare provider in case of unusual symptoms are necessary. Taking this medication during pregnancy may affect the fetus, so anyone planning to become pregnant or already pregnant should consult a physician and use effective contraception methods. During breastfeeding, this medication may be secreted into breast milk and its effects on infants are uncertain; therefore, either breastfeeding should be stopped or medical advice sought before taking it. Interactions with other medications or alcohol may occur during medication use, so all medications currently being taken should be disclosed to healthcare providers before adjustments are made to the medication plan. In the case of overdose, symptoms such as dizziness, drowsiness, or decreased consciousness may occur, but generally, supportive therapy leads to recovery, while severe renal impairment may require dialysis.

Suicidal ideation, suicidal behavior, depression, emotional instability, hostility, abnormal thinking, hyperactivity, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hypersensitive reaction, nystagmus, drowsiness, abnormal thinking, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, anorexia, gingivitis, arthralgia, dizziness, hyperactivity, increased or decreased reflexes, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulation abnormalities, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injury due to accident, cold syndrome, pain, xerostomia, gait abnormalities, confusion, sensory reduction, drowsiness, tremors, vertigo, dyspnea, rash, tongue paralysis, facial edema, allergic reaction, abscess, chills, chills and fever, mucosal abnormalities, syncope, palpitations, migraine, hypotension, peripheral vascular disorders, cardiovascular disorders, cerebrovascular accidents, congestive heart failure, myocardial infarction, vasodilation, angina, heart failure, increased capillary fragility, phlebitis, thrombophlebitis, varicose veins, gastroenteritis, gastrointestinal abnormalities, oral candidiasis, gastritis, tongue abnormalities, thirst, dental abnormalities, bowel abnormalities, liver function test abnormalities, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transpeptidase, gingivitis, intestinal obstruction, intestinal ulcers, melena, oral ulcers, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechiae, anemia, lymphadenopathy, decreased prothrombin, edema, gout, hypoglycemia, weight loss, arthritis, arthrosis, leg cramps, myasthenia, tibial pain, joint disorders, tendon disorders, confusion, depression, neuroasthenia, perceptual abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, nystagmus, confusion, perceptual abnormalities around the mouth, exceptional euphoria, hypersensitivity, decreased motor function, suicide attempt, restlessness, tension, increased libido, movement disorders, fasciculation, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulceration, 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, urination disorders, erectile dysfunction, urinary incontinence, vulvovaginal candidiasis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile enlargement, gynecomastia, nocturia, pyelonephritis, scrotal enlargement, frequent urination, urgency, urinary abnormalities, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensation, lethargy

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to preserve the medication's efficacy.

Appearance

A white or light gray powder or granules contained in a white hard capsule.

Package unit

30 capsules/bottle, 100 capsules/bottle