Cabapent 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 as 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 three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine three times daily or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered three times daily as the starting dose (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 medicine once daily or one 100 mg capsule of this medicine three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine three times daily or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this medicine may be administered three times daily as the starting dose (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; the total daily dose must not exceed 3,600 mg as gabapentin. When administering this medicine, the total daily dose should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, 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 ≤80 mL/min) 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: The dose should be administered as 3 × 100 mg every 2 days. In patients with creatinine clearance <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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with sufficient fluid and may be administered with or without food. When administered 3 times daily, care should be taken not to allow the dosing interval to exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medicine is missed (if 12 hours or more have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When administered with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine 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 abrupt 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 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

1. Epilepsy 2) Adjunctive therapy in children aged 3 to 12 years - Day 1: Administer gabapentin 10 mg/body weight (kg) - Day 2: Administer gabapentin 20 mg/body weight (kg) - From day 3 onward: Administer gabapentin 30 mg/body weight (kg) 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 administered in 3 divided doses.

This medication may increase the risk of suicidal thoughts or behavior. Patients should inform healthcare providers immediately if any changes in mood or behavior occur during use. Suddenly stopping this medication can lead to increased frequency of seizures or a serious condition called status epilepticus, so the dosage must be gradually reduced under a doctor's guidance. Serious side effects like pancreatitis may occur; therefore, if there are symptoms like persistent upper abdominal pain or vomiting, stop taking it immediately and visit a hospital. Particularly in child patients, neuropsychiatric adverse reactions such as emotional instability, aggressive behavior, decreased concentration, and hyperactivity may occur, requiring careful monitoring. When taken with central nervous system depressants or narcotics, the risk of drowsiness, respiratory depression, and coma may increase. Use the minimum dose for a short period under medical supervision if necessary. Patients with allergy to this medication, those with acute pancreatitis, specific types of seizure disorders, and lactose intolerance should not take it. Patients with impaired kidney function, elderly individuals, those with a history of psychiatric disorders, pregnant women, or women of childbearing potential should use this medication cautiously and consult a physician if necessary before use. Side effects including drowsiness, dizziness, and reduced motor function can commonly occur, so it is advisable to avoid driving or operating dangerous machinery during initial use or dosage increases. Suddenly stopping after long-term use can lead to withdrawal symptoms like anxiety, insomnia, nausea, and tremors, so the dosage should be gradually reduced following doctor's instructions when discontinuing use. Using this medication during pregnancy may impact the fetus, so women who are pregnant or planning to become pregnant should definitely consult a doctor before deciding on use. Breastfeeding mothers should discuss with healthcare providers whether to breastfeed or take this medication, as it can be secreted in breast milk and affect infants. Side effects such as weight gain, visual disturbances, and skin rashes may occur, necessitating regular check-ups and monitoring of conditions. During the use of this medication, be careful not to combine it with other medications or alcohol, and inform healthcare providers about any other medications being taken.

Suicidal thoughts, suicidal behavior, depression, emotional instability, hostility, abnormal thinking, hyperactivity, abdominal pain, 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, memory loss, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, hyperreactivity, nystagmus, drowsiness, abnormal thinking, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, distention, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity disorder, increased reflex, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorder, loss of alertness, laryngeal neuralgia, sleepwalking, pseudo-croup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory loss, tremors, vertigo, shortness of breath, thrombocytopenia, hematuria, urination disorders, polyuria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, agnosia, dys ejaculation, kidney pain, leukorrhea, genital pruritus, nephrolithiasis, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, vaginal pain, mastalgia, testicular pain, cataract, conjunctivitis, dry eyes, ocular pain, photophobia, ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste disturbance, blepharospasm, tympanism, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal desquamation, maceration, skin nodules, subcutaneous nodules, melasma, skin necrosis, localized swelling, hematuria, urination disorders, erectile dysfunction, incontinence, vaginal molluscum, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile swelling, gynecomastia, nocturia, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy, confusion, loss of consciousness, mental disorders, suicide attempts, agitation, hypertonia, hypersexuality, movement disorders, myoclonic jerks, vestibular disorders, acute renal failure, urticaria, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, 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 disorders, dystonia, myotonia, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, withdrawal symptoms

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should ideally remain between 1 to 30 degrees Celsius at room temperature.

Appearance

A hard capsule with white or grayish powder or granules inside, the upper and lower parts of which are pale yellow.

Package unit

30 capsules/bottle, 100 capsules/bottle