Gabapentin Capsule 300mg (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years and older To reach 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: 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 a starting 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; 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 reach 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: 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 a starting 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; 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 100 mg increments. 4. Elderly patients: Dosage 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: 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. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage 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 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, care should be taken to 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 (i.e., more than 12 hours have passed since the last dose), the physician should determine whether an additional dose should be taken to make up for it. 3) When used with antacids containing magnesium or aluminum, this drug should be administered 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. Treatment of epilepsy generally requires long-term administration. 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 drug must be discontinued, or if it is to be used in combination with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) The safety and efficacy of treatment of 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 gabapentin 10 mg/kg body weight. Adjunctive therapy in children aged 3 years to 12 years: Day 2: Administer gabapentin 20 mg/kg body weight. Adjunctive therapy in children aged 3 years to 12 years: From day 3: Administer gabapentin 30 mg/kg body weight. Adjunctive therapy in children aged 3 years to 12 years: The dose may be increased as needed to a maximum of 40 mg/kg body weight daily. The total daily dose of this medicine should be administered in 3 divided doses.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, any changes in mood or behavior during treatment should be reported to a doctor immediately. Abruptly discontinuing this medication can lead to worsening seizures or status epilepticus, so the dosage should be reduced gradually according to the doctor's instructions. Prolonged use may lead to weight gain, so regular weight monitoring is advised, and dietary and exercise management should be considered if necessary. This medication may cause central nervous system side effects like dizziness, drowsiness, and motor coordination disorders, so it is advisable to avoid driving or operating hazardous machinery during the initial period of treatment. Particularly in children aged 3 to 12 years, neuropsychiatric side effects such as emotional instability, aggression, and decreased concentration may occur, so caution is needed. When used in combination with central nervous system depressants or narcotics, respiratory depression or severe sedation may occur, requiring strict medical supervision when using such medications together. Patients with impaired kidney function may have delayed drug excretion, so dosage adjustments may be necessary. This medication may cause pancreatitis; therefore, if persistent abdominal pain, nausea, or vomiting occurs, discontinuation of the medication and consultation with a doctor are necessary. During pregnancy, it may affect the fetus, so if planning to become pregnant or if already pregnant, consultation with a doctor is essential, and caution is also required during breastfeeding. If allergic reactions such as skin rashes, fever, or lymphadenopathy occur during treatment, the medication should be discontinued immediately and medical attention sought. There is a potential for drug dependence and abuse, so patients with a history of substance abuse should take special care when using this medication. Withdrawal symptoms such as anxiety, insomnia, tremors, and headaches may occur upon discontinuation, so it is important to consult a doctor and taper off gradually.

Suicidal ideation, suicidal behavior, depression, emotional instability, hostility, thought disturbances, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, dental abnormalities, diarrhea, indigestion, increased appetite, dry mouth, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, nervous hyperreactivity, nystagmus, drowsiness, thought disturbances, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, impotence, weakness, lethargy, facial swelling, hypertension, abdominal distension, loss of appetite, gingivitis, arthralgia, hyperactivity, increased reflexes, decreased reflexes, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of prodrome, laryngeal neuralgia, sleepwalking, pseudocroup, hoarseness, injuries due to accidents, cold syndrome, pain, dry mouth, gait disturbances, confusion, sensory loss, tremors, vertigo, dyspnea, thrombocytopenia, anaphylaxis, angioedema, urticaria, hair loss, skin rash, dry skin, skin ulcers, herpes zoster, skin discoloration, skin nodules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal exfoliation, maceration, skin papules, necrosis, localized swelling, hematuria, urinary disorders, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, abnormal menstruation, menorrhagia, breast cancer, anorgasmia, ejaculation abnormalities, renal pain, leucorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginal pain, breast pain, testicular pain, visual disturbances, cataract, conjunctivitis, dry eye, ocular pain, photophobia, ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear infection, taste loss, taste disturbances, blepharospasm, fullness of ear, tongue paralysis, withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal feelings, lethargy)

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is crucial to maintain storage temperatures between 1 degree and 30 degrees Celsius. This will help ensure the drug's effectiveness.

Appearance

A hard capsule of yellowish color containing white or grayish-white powder

Package unit

30, 100, 300 capsules/bottle