Medication info
Kolon Gabapentin Capsule 100mg (Gabapentin)

Kolon Gabapentin Capsule 100mg (Gabapentin)

Prescription medicationHard capsuleOral
Ingredient · strength
Gabapentin›100mg / 1 capsule
Manufacturer / importer
Kolon Pharmaceutical Co., Ltd.
Appearance
A white or off-white hard capsule containing powder or granules.
Packaging
30 capsules per bottle, 200 capsules per bottle
Approval status
Active

MFDS item code 200500583 · Notified 2005.07.29 · Insurance code 670301470

Summary

Main use
Treatment of neuropathic pain and epilepsy (partial seizures)
Who takes it
Adults · Children
Adult dose
Epilepsy, 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: 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 twice 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.) 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: 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 twice 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; 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. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dosage adjustment may be necessary due to age-related deterioration in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dosage adjustment is required based on the following table. Renal function, creatinine clearance (mL/min) ≥80: Total daily doseᵃ (mg/day) 900∼2,400 Renal function, creatinine clearance (mL/min) 50∼79: Total daily doseᵃ (mg/day) 600∼1,800 Renal function, creatinine clearance (mL/min) 30∼49: Total daily doseᵃ (mg/day) 300∼900 Renal function, creatinine clearance (mL/min) 15∼29: Total daily doseᵃ (mg/day) 150ᵇ∼600 Renal function, creatinine clearance (mL/min) <15: Total daily doseᵃ (mg/day) 150ᵇ∼300 a: The total daily dose should be divided into 3 doses. b: Administer 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. Dosage 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; do not administer this drug on days when hemodialysis is not performed. This drug should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. If a dose of this drug is missed (when more than 12 hours have elapsed since the most recent dose), the physician should determine whether an additional dose should be taken to make up for it. When coadministered with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. The duration of treatment with this drug should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the 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. The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 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
Adjunctive therapy in children aged 3 years through 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 to a maximum of 40 mg per kg of body weight daily. The total daily dose of this drug should be divided into 3 doses.

Ingredients

Manufacturer
Kolon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of neuropathic pain and epilepsy (partial seizures)

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

This medication effectively treats partial seizures in epilepsy patients, either as monotherapy or as an adjunct therapy. It is particularly used for adolescents aged 13 years and older and adults with newly diagnosed seizures, including those with secondary general symptoms. It is also utilized as adjunct therapy for children aged 3 years and older and adults with partial seizures. Additionally, it helps relieve neuropathic pain. This drug is used to improve epileptic seizures and neuropathic pain.

How to take

Adult dose

Epilepsy, 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: 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 twice 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.) 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: 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 twice 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; 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. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dosage adjustment may be necessary due to age-related deterioration in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dosage adjustment is required based on the following table. Renal function, creatinine clearance (mL/min) ≥80: Total daily doseᵃ (mg/day) 900∼2,400 Renal function, creatinine clearance (mL/min) 50∼79: Total daily doseᵃ (mg/day) 600∼1,800 Renal function, creatinine clearance (mL/min) 30∼49: Total daily doseᵃ (mg/day) 300∼900 Renal function, creatinine clearance (mL/min) 15∼29: Total daily doseᵃ (mg/day) 150ᵇ∼600 Renal function, creatinine clearance (mL/min) <15: Total daily doseᵃ (mg/day) 150ᵇ∼300 a: The total daily dose should be divided into 3 doses. b: Administer 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. Dosage 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; do not administer this drug on days when hemodialysis is not performed. This drug should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. If a dose of this drug is missed (when more than 12 hours have elapsed since the most recent dose), the physician should determine whether an additional dose should be taken to make up for it. When coadministered with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. The duration of treatment with this drug should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the 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. The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 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

Adjunctive therapy in children aged 3 years through 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 to a maximum of 40 mg per kg of body weight daily. The total daily dose of this drug should be divided into 3 doses.

Precautions

This medication is used to treat epilepsy and neuropathic pain. Patients and caregivers should report any signs of suicidal thoughts or behavior, or mental health issues such as depression that may occur during treatment. Abruptly stopping the medication can lead to worsening seizures or progression to status epilepticus; therefore, it must be discontinued according to the doctor's instructions. This medication can cause serious side effects such as pancreatitis; if persistent abdominal pain or vomiting occurs, you should stop taking it immediately and visit a hospital. In child patients, neuropsychiatric side effects such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, so caution is needed. When used with central nervous system depressants, including narcotics, there may be risks of drowsiness, respiratory depression, or coma, so it should be taken under the supervision of a physician. Patients with a history of allergic reactions or drug hypersensitivity, acute pancreatitis, or certain genetic metabolic disorders should not take this medication. Patients with diminished kidney function, the elderly, those with psychiatric disorders, pregnant or breastfeeding women should exercise special caution when using this drug, and pregnant women should consult with their physician as it may affect the fetus. Side effects such as dizziness, drowsiness, ataxia, and memory impairment may occur, and driving or operating hazardous machinery should be avoided. Additionally, various side effects such as weight gain, vision changes, skin rashes, and blood abnormalities have been reported, requiring regular health monitoring. If the medication is suddenly discontinued, withdrawal symptoms such as anxiety, insomnia, headaches, and tremors may occur, so it should be tapered off gradually according to the doctor’s instructions. During treatment, there may be potential drug interactions, so all medications being taken should be disclosed to the healthcare provider. Keep out of reach of children and store it in the original container to maintain the quality of the medication.

Side effects

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired cooperation, dizziness, speech disorders, insomnia, neurological hyperreactivity, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, fatigue, facial edema, allergies, generalized edema, weight loss, chills, feelings of strangeness, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular ectopic beats, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, cheilitis, sialadenosis, labial bleeding, esophagitis, hiatal hernia, hematemesis, rectal inflammation, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid hypertrophy, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or loss of libido, agitation, paranoia, depersonalization, altered state of ecstasy, hypersensitivity, hallucinatory states, suicidal ideation, psychiatric disorders, chorea, athetoid movements around the mouth, brain disease, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor coordination disorders, meningitis, focal muscle spasms, sensory hyperreactivity, decreased motor function, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal itching, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, subcutaneous nodules, hyperpigmentation, skin necrosis, localized swelling, hematuria, urination disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, ejaculation abnormalities, kidney pain, white discharge, genital itching, kidney stones, acute kidney injury, anuria, diabetes, nephritis, enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, orchalgia, visual disturbances, cataracts, conjunctivitis, dry eyes, eye pain, photophobia, bilateral or unilateral ptosis, subconjunctival hemorrhage, papule, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, loss of taste, taste disorders, blepharospasm, ocular fullness, itchy eyes, accommodation disorders, tympanic membrane perforation, hypersensitivity to noise, eye fixation abnormality, overflow, retinopathy, glaucoma, iritis, corneal dysfunction, lacrimal gland dysfunction, eye atrophy, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, tongue paralysis, increased serum creatine kinase levels, rhabdomyolysis, acute kidney injury, 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, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetoid movements, movement disorders, dystonia, metabolic cramping, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, apathy

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain room temperature between 1°C and 30°C. This will help keep the medication effective.

Appearance and packaging

Appearance

A white or off-white hard capsule containing powder or granules.

Package unit

30 capsules per bottle, 200 capsules per 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.