Medication info
Gabastil Capsule 100mg (Gabapentin)

Gabastil Capsule 100mg (Gabapentin)

Prescription medicationHard capsuleOral
Ingredient · strength
Gabapentin›100mg / 1 capsule
Manufacturer / importer
Korea Hyutech Pharmaceutical Co., Ltd.
Appearance
A hard capsule with white or light gray powder inside, with a white upper and lower part.
Packaging
Bottle packaging - 30 capsules/bottle, Bottle packaging - 300 capsules/bottle
Approval status
Active

MFDS item code 201900773 · Approved 2019.01.31 · Insurance code 649104240

Summary

Main use
Relief of neuropathic pain; treatment of epilepsy (partial-onset 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 as gabapentin, titrate the dose gradually 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: 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 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.) The duration of treatment should be determined according to clinical need. Long-term treatment is generally required for epilepsy. If treatment with this drug is to be discontinued or if it is to be used in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. Neuropathic pain (Neuropathic pain) Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose gradually 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: 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this drug should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. Frail patients In frail patients with low body weight or patients who have undergone transplantation, the dose of this drug should be increased in 100 mg increments. Elderly patients Dose adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis Dosage for patients with renal impairment: ≥80 mL/min: Total daily dose 900∼2,400 mg/day 50∼79 mL/min: Total daily dose 600∼1,800 mg/day 30∼49 mL/min: Total daily dose 300∼900 mg/day 15∼29 mL/min: Total daily dose 150b∼600 mg/day <15 mL/min: Total daily dose 150b∼300 mg/day a: The total daily dose should be divided into 3 doses. b: A dose of 3 × 100 mg should be administered 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 receiving 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. Method and duration of administration 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 interval between doses does not exceed 12 hours to prevent recurrence of seizures. If a dose of this drug is missed (if more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be taken to make up for it. When used with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. The duration of treatment with this drug should be determined according to clinical need. Any dose reduction, discontinuation, or switch to another alternative drug should be carried out gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). To reduce the main adverse reactions, 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: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate the dose over the first 3 days of treatment as follows. 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. The dose may be increased, if needed, to a maximum of 40 mg per kg of body weight daily. The total daily dose of this medicine should be divided into 3 doses.

Ingredients

Manufacturer
Korea Hyutech Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of neuropathic pain; treatment of epilepsy (partial-onset seizures)

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

This medicine is used for the treatment of epilepsy, particularly effective as monotherapy for simple or complex partial seizures with or without secondary generalization in adolescents and adults aged 13 years and older. It is also helpful in treating partial seizures with or without secondary generalization as an adjunctive therapy for children aged 3 years and older and adults. Moreover, it is used for relieving neuropathic pain, improving neural-related pain symptoms. This drug is effectively applied in the treatment of epilepsy 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 as gabapentin, titrate the dose gradually 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: 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 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.) The duration of treatment should be determined according to clinical need. Long-term treatment is generally required for epilepsy. If treatment with this drug is to be discontinued or if it is to be used in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. Neuropathic pain (Neuropathic pain) Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose gradually 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: 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this drug should be divided into 3 doses. The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. Frail patients In frail patients with low body weight or patients who have undergone transplantation, the dose of this drug should be increased in 100 mg increments. Elderly patients Dose adjustment may be necessary due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis Dosage for patients with renal impairment: ≥80 mL/min: Total daily dose 900∼2,400 mg/day 50∼79 mL/min: Total daily dose 600∼1,800 mg/day 30∼49 mL/min: Total daily dose 300∼900 mg/day 15∼29 mL/min: Total daily dose 150b∼600 mg/day <15 mL/min: Total daily dose 150b∼300 mg/day a: The total daily dose should be divided into 3 doses. b: A dose of 3 × 100 mg should be administered 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 receiving 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. Method and duration of administration 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 interval between doses does not exceed 12 hours to prevent recurrence of seizures. If a dose of this drug is missed (if more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be taken to make up for it. When used with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. The duration of treatment with this drug should be determined according to clinical need. Any dose reduction, discontinuation, or switch to another alternative drug should be carried out gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). To reduce the main adverse reactions, 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: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate the dose over the first 3 days of treatment as follows. 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. The dose may be increased, if needed, to a maximum of 40 mg per kg of body weight daily. The total daily dose of this medicine should be divided into 3 doses.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so if any symptoms of depression or mood changes occur during administration, consult a physician immediately. Abruptly discontinuing the medication may worsen seizures, so dosage should be gradually adjusted according to the physician's instructions. Some potential for tumor development has been reported in animal studies, but the effects on humans are not yet clear. Reports of sudden and unexpected deaths occurred during the use of this medication; however, these are within the normal range of risk for patients with epilepsy. If symptoms of pancreatitis (persistent abdominal pain, nausea, recurrent vomiting) occur, discontinue use immediately and inform a healthcare professional. Children aged 3 years to 12 years may exhibit central nervous system adverse reactions, so if emotional instability, aggression, impaired concentration, or hyperactivity occur, consult a healthcare professional. Combining this drug with CNS depressants, including narcotics, may cause severe drowsiness, respiratory depression, or coma, so it must be taken strictly under a physician's guidance. Patients with allergies to this drug or its components, acute pancreatitis, specific seizure types, or lactose intolerance should not take this medication. Patients with impaired kidney function, elderly patients, those with a history of psychiatric disorders, pregnant women or those who may become pregnant, and nursing mothers must consult a physician before use. Drowsiness or dizziness may occur, so caution is advised while driving or operating dangerous machinery. This medication can cause various side effects, including weight gain, vision changes, and skin rashes, so it is important to inform a healthcare professional of any abnormal symptoms. During pregnancy, it may affect the fetus, so if planning pregnancy or already pregnant, consult a physician before use, and use may be restricted while nursing. There may be interactions when using this drug with other medications or alcohol, so inform a healthcare professional of any medications being taken. This medication should be kept out of the reach of children and stored in its original container to prevent misuse.

Side effects

  • Suicidal impulses
  • suicidal behavior
  • depression
  • abnormal changes in mood and behavior
  • hemorrhagic pancreatitis
  • emotional instability
  • hostility
  • thought disorder
  • hyperactivity
  • lethargy
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  • apathy
  • facial swelling
  • hypertension
  • constipation
  • abnormal teeth
  • diarrhea
  • dyspepsia
  • increased appetite
  • thirst
  • nausea
  • vomiting
  • leukopenia
  • peripheral edema
  • weight gain
  • fractures
  • myalgia
  • amnesia
  • ataxia
  • confusion
  • impaired cooperation
  • dizziness
  • dysarthria
  • insomnia
  • neurogenic reactions
  • nystagmus
  • drowsiness
  • tremor
  • single contraction
  • cough
  • pharyngitis
  • rhinitis
  • erosion
  • acne
  • itching
  • rash
  • amblyopia
  • diplopia
  • erectile dysfunction
  • myasthenia
  • apathy
  • facial swelling
  • allergy
  • general edema
  • weight loss
  • chills
  • feelings of unfamiliarity
  • weakness
  • alcohol intolerance
  • hangover effects
  • hypotension
  • angina
  • peripheral vascular disorders
  • palpitations
  • tachycardia
  • migraine
  • noise
  • atrial fibrillation
  • heart failure
  • thrombotic venous inflammation
  • deep venous thrombosis
  • myocardial infarction
  • cerebrovascular accident
  • pulmonary thrombosis
  • ventricular extrasystole
  • bradycardia
  • immature atrial contraction
  • pericardial friction
  • heart block
  • pulmonary embolism
  • hyperlipidemia
  • hypercholesterolemia
  • pericardial effusion
  • pericarditis
  • anorexia
  • bloating
  • gingivitis
  • glossitis
  • gum bleeding
  • thirst
  • stomatitis
  • increased salivation
  • gastroenteritis
  • hemorrhoids
  • bloody stools
  • fecal incontinence
  • liver enlargement
  • dysphagia
  • belching
  • pancreatitis
  • gastric ulcer
  • colitis
  • stomatitis vesicles
  • dental discoloration
  • cheilitis
  • sialadenitis
  • lip bleeding
  • esophagitis
  • hiatus hernia
  • hematemesis
  • proctitis
  • irritable bowel syndrome
  • rectal bleeding
  • esophageal spasm
  • hyperthyroidism
  • hypothyroidism
  • thyroid enlargement
  • low estrogen
  • ovarian failure
  • epididymitis
  • testicular swelling
  • Cushing's syndrome
  • trauma-induced purpura
  • anemia
  • lymphadenopathy
  • thrombocytopenia
  • increased leukocyte count
  • lymphocytosis
  • non-Hodgkin lymphoma
  • prolonged bleeding time
  • arthralgia
  • tendinitis
  • arthritis
  • joint stiffness
  • joint swelling
  • benign Romberg test
  • costochondritis
  • osteoporosis
  • bursitis
  • contracture
  • dizziness
  • hyperactivity
  • sensory disturbance
  • decreased or absent reflexes
  • increased reflexes
  • anxiety
  • hostility
  • CNS tumor
  • syncope
  • dream disorder
  • aphasia
  • sensory loss
  • intracranial hemorrhage
  • hypotonia
  • abnormal sensation
  • incomplete paralysis
  • dyskinesia
  • hemiplegia
  • facial paralysis
  • confusion
  • cerebellar dysfunction
  • benign Babinski sign
  • decreased proprioception
  • intracranial hematoma
  • apathy
  • hallucinations
  • decreased or lost sexual desire
  • restlessness
  • paranoia
  • depersonalization
  • feelings of euphoria
  • hypersensitivity
  • state of hallucination
  • suicidal impulse
  • mental disorder
  • chorea
  • athetosis
  • perioral movement disorder
  • brain disease
  • nerve paralysis
  • personality disorder
  • increased sexual desire
  • substance inhibition
  • apraxia
  • fine motor dysfunction
  • meningitis
  • focal myoclonus
  • perception hypersensitivity
  • decreased motor function
  • mania
  • neurosis
  • hysteria
  • antisocial reactions
  • suicidal behavior
  • pneumonia
  • nosebleeds
  • dyspnea
  • apnea
  • mucositis
  • aspiration pneumonia
  • hyperventilation
  • hiccups
  • laryngitis
  • nasal congestion
  • nasal obstruction
  • bronchospasm
  • hypoventilation
  • pulmonary edema
  • 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 peeling
  • maceration
  • skin nodules
  • melasma
  • skin necrosis
  • localized swelling
  • hematuria
  • urinary dysfunction
  • frequent urination
  • cystitis
  • urinary retention
  • urinary incontinence
  • vaginal bleeding
  • amenorrhea
  • menstrual irregularities
  • menorrhagia
  • breast cancer
  • amenorrhea
  • ejaculation disorder
  • kidney pain
  • leukorrhea
  • genital itching
  • nephrolithiasis
  • acute renal failure
  • anuria
  • diabetes
  • nephritis
  • nocturia
  • pyuria
  • urinary urgency
  • vaginal pain
  • breast pain
  • testicular pain
  • vision abnormalities
  • cataracts
  • conjunctivitis
  • dry eyes
  • eye pain
  • photophobia
  • bilateral or unilateral ptosis
  • ocular hemorrhage
  • chalazion
  • hearing loss
  • ear pain
  • tinnitus
  • inner ear infection
  • ear inflammation
  • taste loss
  • taste abnormalities
  • eyelid spasm
  • eye pressure
  • eye itching
  • control disorder
  • tympanic membrane perforation
  • noise sensitivity
  • ocular fixation anomalies
  • overflow tears
  • retinopathy
  • glaucoma
  • iritis
  • corneal disorders
  • lacrimal gland dysfunction
  • eye degeneration
  • blindness
  • retinal degeneration
  • mydriasis
  • chorioretinitis
  • strabismus
  • Eustachian tube dysfunction
  • inner ear inflammation
  • outer ear inflammation
  • olfactory disturbances
  • urinary tract infection
  • urinary dysfunction
  • erectile dysfunction
  • urinary incontinence
  • vulvodynia
  • breast pain
  • menstrual irregularities
  • polyuria
  • urinary retention
  • cystitis
  • ejaculation disorder
  • penile swelling
  • gynecomastia
  • nocturnal enuresis
  • pyelonephritis
  • scrotal swelling
  • frequent urination
  • urgency in urination
  • abnormal urination
  • tongue paralysis
  • increased serum creatine phosphokinase
  • rhabdomyolysis
  • acute renal failure
  • urticaria
  • allergic reactions
  • hair loss
  • 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 reactions
  • hyponatremia
  • jaundice
  • loss of consciousness
  • chorea
  • athetosis
  • movement disorders
  • dyskinesia
  • palpitations
  • pancreatitis
  • sexual dysfunction
  • sicca 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 or moisture, so it should be stored in a sealed container. It is best to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature to ensure the medication's effect remains safely over a long period.

Appearance and packaging

Appearance

A hard capsule with white or light gray powder inside, with a white upper and lower part.

Package unit

Bottle packaging - 30 capsules/bottle, Bottle packaging - 300 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.

Questions about this medicine

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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.