Medication info
Gabastan Capsule (Gabapentin)

Gabastan Capsule (Gabapentin)

Prescription medicationHard capsuleOral
Ingredient · strength
Gabapentin›300mg / 1 capsule
Manufacturer / importer
Korea Pavis Pharmaceutical Co., Ltd.
Appearance
A hard yellow capsule containing white or grayish powder.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 200805255 · Approved 2008.05.08 · Insurance code 621801130

Summary

Main use
Relief of neuropathic pain and treatment of partial-onset seizures
Who takes it
Adults · Children
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 take one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this medicine 2 times daily, or take two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Take one 300 mg capsule of this medicine 3 times daily, or take three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine may be taken 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 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 take one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this medicine 2 times daily, or take two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Take one 300 mg capsule of this medicine 3 times daily, or take three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine may be taken 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. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dosage adjustment may be necessary because of 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: Dosage adjustment is necessary 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) When administering 3 times daily, care should be taken to ensure that the interval between doses does not exceed 12 hours in order to prevent recurrence of seizures. 2) If a dose of this medicine 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 used concomitantly with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after administration of the antacid. 4) If treatment with this medicine is to be discontinued, or if it is to be used concomitantly with another antiepileptic drug, changes 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) The first dose on the first day of treatment should be taken at bedtime.
Child dose
Adjunctive therapy in children aged 3 years or older and 12 years or younger - Day 1: Administer 10 mg/kg of body weight of gabapentin - Day 2: Administer 20 mg/kg of body weight of gabapentin - From Day 3 onward: Administer 30 mg/kg of body weight of gabapentin The dose may be increased, if needed, to a maximum of 40 mg/kg of body weight per day. When administering this drug, divide the total daily dose into 3 doses.

Ingredients

Manufacturer
Korea Pavis Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of neuropathic pain and treatment of partial-onset seizures

  • Epilepsy
  • simple partial seizures
  • complex partial seizures
  • secondary generalized seizures
  • partial seizures
  • neuropathic pain
View approved original text

This medication is used for patients with epilepsy. It is particularly used as monotherapy in adolescents aged 13 and older and as adjunctive therapy in children aged 3 and older and adults for the treatment of partial seizures. Additionally, it is effective in the relief of neuropathic pain. It helps improve patients' symptoms and enhances their quality of life.

How to take

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 take one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this medicine 2 times daily, or take two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Take one 300 mg capsule of this medicine 3 times daily, or take three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine may be taken 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 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 take one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) - Day 2: Take one 300 mg capsule of this medicine 2 times daily, or take two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Take one 300 mg capsule of this medicine 3 times daily, or take three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine may be taken 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. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dosage adjustment may be necessary because of 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: Dosage adjustment is necessary 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) When administering 3 times daily, care should be taken to ensure that the interval between doses does not exceed 12 hours in order to prevent recurrence of seizures. 2) If a dose of this medicine 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 used concomitantly with antacids containing magnesium or aluminum, this medicine should be taken at least 2 hours after administration of the antacid. 4) If treatment with this medicine is to be discontinued, or if it is to be used concomitantly with another antiepileptic drug, changes 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) The first dose on the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years or older and 12 years or younger - Day 1: Administer 10 mg/kg of body weight of gabapentin - Day 2: Administer 20 mg/kg of body weight of gabapentin - From Day 3 onward: Administer 30 mg/kg of body weight of gabapentin The dose may be increased, if needed, to a maximum of 40 mg/kg of body weight per day. When administering this drug, divide the total daily dose into 3 doses.

Precautions

This medication is used for the treatment of epilepsy or neuropathic pain. While taking this medication, there may be symptoms of suicidal thoughts or behavior and depression, so mental status changes must be observed closely. Sudden discontinuation of this medication may increase seizure frequency or lead to status epilepticus, so it should be gradually discontinued according to a physician's instructions. Long-term usage may lead to side effects such as weight gain, dizziness, drowsiness, and coordination problems, so regular health status checks are necessary. Children, elderly patients, and those with impaired renal function require dose adjustments, as behavioral changes or neuropsychiatric reactions may occur more frequently, necessitating caution. Women who are pregnant or potentially pregnant should carefully consider the risks to the fetus before taking this medication, and those who are breastfeeding should also consult with their doctor before taking this medication. Taking this medication with central nervous system depressants, including narcotics, can cause serious side effects such as sedation and respiratory depression, so caution is needed when taken together. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, vomiting) occur during treatment, the medication should be discontinued immediately, and medical consultation should be sought. This medication can cause serious skin reactions or allergic reactions, so if symptoms such as rash, fever, difficulty breathing, or swelling appear, consumption should be immediately halted and medical assistance should be sought. Activities requiring concentration, such as driving or operating machinery, should only be done after confirming the individual's condition following the medication, and it is advised to avoid such activities if experiencing dizziness or drowsiness. In cases of overdose, decreased consciousness or coma may occur; therefore, the prescribed dosage and usage must be adhered to, and in case of overdose, contact medical facilities immediately. This medication must be stored out of the reach of children and should not be transferred to other containers from its original packaging, as that is safer.

Side effects

suicidal impulses, suicidal behaviors, depression, abnormal changes in mood and behavior, persistent seizure state, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, deep sedation, respiratory depression, coma, death, 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, speech disorders, emotional instability, insomnia, hyperreactive response, nystagmus, drowsiness, thought disorder, tremors, single convulsion, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, increased reflexes, decreased reflexes, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of warning signs, laryngeal neuralgia, sleepwalking, pseudo-croup, hoarseness, injuries due to accidents, cold syndrome, infection, pain, dry mouth, gait abnormalities, confusion, sensory loss, tremors, vertigo, dyspnea, coagulopathy, rash, hematuria, urinary disorders, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anaplasia, ejaculation abnormalities, neuropathy, decreased libido, depersonalization, hallucinations, suicide attempts, anxiety, increased tension, increased libido, movement disorders, myoclonic jerks, vestibular disturbances, increased coughing, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, increased serum creatine kinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, myotonic cramps, palpitations, pancreatitis, erectile dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture exposure. It is best to keep the medication at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

A hard yellow capsule containing white or grayish powder.

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.