Medication info
Neurontin Capsule 100mg (Gabapentin)

Neurontin Capsule 100mg (Gabapentin)

Prescription medicationHard capsuleOral
Ingredient · strength
Gabapentin›100mg / 1 capsule
Manufacturer / importer
Medica Korea Co., Ltd.
Appearance
A hard capsule that contains white or grayish powder, with a white upper and lower part.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201604529 · Approved 2016.07.22 · Insurance code 646004290

Summary

Main use
Relief of neuropathic pain; treatment of epilepsy (partial 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: 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 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, 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.). 3) The duration of treatment should depend on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures following sudden discontinuation of treatment), sudden 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 administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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: 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, and the total daily dose must not exceed 3,600 mg of gabapentin. When this drug is administered, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment of neuropathic pain for periods longer than 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients who have undergone transplantation, 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 of 80 mL/min or less) or patients undergoing 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: 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. 2) Dose 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 administered with or without food. When administered 3 times daily, care should be taken not to allow an interval of more than 12 hours between doses to prevent recurrence of seizures. 2) If a dose of this drug is missed (if 12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug is reduced, treatment is discontinued, or the drug is replaced with another alternative, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) 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 for children aged 3 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) If necessary, the dose may be increased to a maximum of 40 mg per kg of body weight per day. The total daily dose of this drug should be divided into 3 doses.

Ingredients

Manufacturer
Medica Korea Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of partial seizures in patients with epilepsy. It is effective when used alone in adolescents aged 13 years and older and in adults, or as an adjunct therapy in children aged 3 years and older. It also helps relieve neuropathic pain. In summary, this drug is used for epilepsy and neuropathic pain.

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: 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 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, 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.). 3) The duration of treatment should depend on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures following sudden discontinuation of treatment), sudden 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 administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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: 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, and the total daily dose must not exceed 3,600 mg of gabapentin. When this drug is administered, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment of neuropathic pain for periods longer than 5 months have not been evaluated. 3. Frail patients: In frail patients with low body weight or patients who have undergone transplantation, 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 of 80 mL/min or less) or patients undergoing 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: 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. 2) Dose 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 administered with or without food. When administered 3 times daily, care should be taken not to allow an interval of more than 12 hours between doses to prevent recurrence of seizures. 2) If a dose of this drug is missed (if 12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug is reduced, treatment is discontinued, or the drug is replaced with another alternative, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) 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 for children aged 3 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) If necessary, the dose may be increased to a maximum of 40 mg per kg of body weight per day. The total daily dose of this drug should be divided into 3 doses.

Precautions

This medication may increase the risk of suicidal thoughts and behaviors, so if mood changes or depression symptoms occur during use, you should promptly inform your healthcare provider. Abruptly stopping this medication can worsen seizures or lead to a continuous state of epilepsy, so it should be gradually reduced under medical supervision when discontinuing. Long-term use may lead to weight gain, so regular weight monitoring and dietary and exercise management may be necessary. This medication may cause central nervous system side effects such as drowsiness, dizziness, and loss of motor control, so it is advised to avoid driving or operating dangerous machinery during the initial stages of treatment. Particularly in children, behavioral changes such as emotional instability, aggression, hyperactivity, and decreased concentration can occur, therefore careful observation by guardians is necessary. If symptoms of pancreatitis (persistent upper abdominal pain, nausea, repeated vomiting) occur, you should immediately stop taking the medication and consult a doctor. Taking this medication in combination with narcotics or other central nervous system depressants may lead to respiratory depression or severe sedation, so strict medical monitoring is necessary if taken together. Patients with impaired kidney function should adjust their dosage, and the elderly should also take caution when using this medication. This medication may pose a risk to the fetus, especially in the first trimester of pregnancy, so women who are pregnant or planning to become pregnant should consult a doctor. Breastfeeding women should consult healthcare providers regarding whether this medication can be excreted in breast milk. If allergic reactions or severe skin rashes, respiratory difficulties, or swelling in the face or neck occur, the medication should be discontinued immediately and emergency treatment should be sought. This medication may lead to drug dependence or withdrawal symptoms, so it should be gradually reduced as directed by a healthcare provider upon discontinuation. When taking other medications or alcohol concurrently, interactions may occur, so you should inform your doctor of all medications you are taking. Particular caution and regular monitoring are necessary for specific patient groups such as children, the elderly, and those with diminished kidney function. This medication should be stored in its original container and kept out of reach of children.

Side effects

  • Suicidal ideation
  • suicidal behavior
  • depression
  • emotional instability
  • hostility
  • thought disorder
  • hyperactivity
  • abdominal pain
  • back pain
  • fatigue
Show 331 more
  • fever
  • headache
  • viral infection
  • vasodilation
  • constipation
  • dental abnormalities
  • diarrhea
  • indigestion
  • increased appetite
  • thirst
  • nausea
  • vomiting
  • leukopenia
  • peripheral edema
  • weight gain
  • fractures
  • myalgia
  • amnesia
  • ataxia
  • confusion
  • impaired cooperation
  • dizziness
  • dysarthria
  • insomnia
  • hypersensitivity reaction
  • nystagmus
  • drowsiness
  • thought disorder
  • tremor
  • single contraction
  • cough
  • pharyngitis
  • rhinitis
  • erosion
  • acne
  • itching
  • rash
  • amblyopia
  • diplopia
  • erectile dysfunction
  • weakness
  • lethargy
  • facial edema
  • hypertension
  • abdominal distension
  • appetite loss
  • gingivitis
  • purpura
  • arthralgia
  • hyperactivity syndrome
  • increased
  • decreased
  • or absent reflexes
  • sensory disturbances
  • anxiety
  • pneumonia
  • urinary tract infection
  • visual disturbances
  • viral infections
  • bronchitis
  • respiratory infections
  • dehydration
  • infectious mononucleosis
  • hepatitis
  • coagulopathy
  • loss of symptoms
  • laryngeal neuralgia
  • sleepwalking
  • pseudocroup
  • hoarseness
  • injuries due to accidents
  • cold syndrome
  • pain
  • dry mouth
  • gait abnormalities
  • confusion
  • sensory impairment
  • tremors
  • vertigo
  • dyspnea
  • rash
  • tongue paralysis
  • weakness
  • fatigue
  • facial edema
  • allergy
  • systemic edema
  • weight loss
  • chills
  • strange sensations
  • lethargy
  • alcohol intolerance
  • hangover effects
  • hypotension
  • angina
  • peripheral vascular disorders
  • palpitations
  • tachycardia
  • migraine
  • noise
  • atrial fibrillation
  • heart failure
  • thrombotic phlebitis
  • deep vein thrombosis
  • myocardial infarction
  • cerebrovascular accident
  • pulmonary embolism
  • premature ventricular contractions
  • bradycardia
  • immature atrial contractions
  • pericardial friction
  • heart block
  • pulmonary embolism
  • hyperlipidemia
  • hypercholesterolemia
  • pericardial effusion
  • pericarditis
  • glossitis
  • gum bleeding
  • thirst
  • stomatitis
  • increased salivation
  • gastroenteritis
  • hemorrhoids
  • bloody stools
  • fecal incontinence
  • hepatomegaly
  • dysphagia
  • belching
  • pancreatitis
  • gastric ulcer
  • colitis
  • oral vesicles
  • dental discoloration
  • cheilitis
  • salivary gland hypertrophy
  • lip bleeding
  • esophagitis
  • hiatal hernia
  • hematemesis
  • rectal inflammation
  • irritable bowel syndrome
  • rectal bleeding
  • esophageal spasm
  • hyperthyroidism
  • hypothyroidism
  • thyroid enlargement
  • hypoestrogenism
  • ovarian failure
  • epididymitis
  • testicular swelling
  • Cushingoid appearance
  • anemia
  • lymphadenopathy
  • thrombocytopenia
  • leukocytosis
  • lymphocytosis
  • non-Hodgkin's lymphoma
  • prolonged bleeding time
  • tendinitis
  • arthritis
  • joint stiffness
  • joint swelling
  • benign Romberg test
  • costochondritis
  • osteoporosis
  • baggy skin
  • contracture
  • decreased or absent reflexes
  • CNS tumors
  • syncope
  • dream disorders
  • aphasia
  • sensory impairment
  • intracranial hemorrhage
  • hypotonia
  • dysesthesia
  • incomplete paralysis
  • dystonia
  • hemiplegia
  • facial paralysis
  • confusion
  • cerebellar dysfunction
  • benign Babinski sign
  • decreased proprioception
  • subdural hematoma
  • apathy
  • hallucinations
  • decreased or lost libido
  • anxiety
  • delusional disorder
  • depersonalization
  • dysphoria
  • hypersensitivity
  • hallucinatory state
  • suicidal ideation
  • psychiatric disorders
  • chorea
  • athetosis
  • orofacial movement disorder
  • brain disease
  • neuropathy
  • personality disorders
  • increased libido
  • substance suppression
  • apraxia
  • fine motor coordination disturbances
  • meningeal disease
  • focal myoclonus
  • sensory hypersensitivity
  • decreased motor function
  • mania
  • neurosis
  • hysteria
  • antisocial behavior
  • suicidal behavior
  • nosebleeds
  • dyspnea
  • apnea
  • mucositis
  • aspiration pneumonia
  • hyperventilation
  • hiccups
  • laryngitis
  • nasal congestion
  • nasal ulceration
  • bronchospasm
  • hypoventilation
  • pulmonary edema
  • hair loss
  • eczema
  • dry skin
  • increased sweating
  • urticaria
  • hirsutism
  • seborrhea
  • cysts
  • herpes simplex
  • shingles
  • skin hyperpigmentation
  • skin papules
  • photosensitivity
  • leg ulcers
  • scalp seborrhea
  • psoriasis
  • epidermal desquamation
  • maceration
  • skin nodules
  • melanosis
  • skin necrosis
  • localized swelling
  • hematuria
  • urination disorders
  • polyuria
  • cystitis
  • urinary retention
  • urinary incontinence
  • vaginal bleeding
  • amenorrhea
  • menstrual irregularities
  • menorrhagia
  • breast cancer
  • anovulation
  • abnormal ejaculation
  • kidney pain
  • leukorrhea
  • genital itching
  • kidney stones
  • acute renal failure
  • anuria
  • diabetes
  • nephritis
  • nocturia
  • pyuria
  • urinary urgency
  • dyspareunia
  • mastalgia
  • testicular pain
  • hearing loss
  • ear pain
  • tinnitus
  • inner ear inflammation
  • ear inflammation
  • taste loss
  • taste disturbances
  • eyelid twitching
  • conjunctival congestion
  • eye itching
  • accommodative disorders
  • tympanic membrane perforation
  • noise sensitivity
  • eye focal point abnormalities
  • lacrimal dysfunction
  • eye degeneration
  • blindness
  • retinal degeneration
  • miosis
  • choroiditis
  • strabismus
  • Eustachian tube dysfunction
  • inner ear inflammation
  • outer ear inflammation
  • olfactory disturbances
  • urinary tract infections
  • urination disorders
  • erectile dysfunction
  • urinary incontinence
  • vulvar dystrophy
  • mastalgia
  • menstrual irregularities
  • polyuria
  • urinary retention
  • cystitis
  • abnormal ejaculation
  • penile swelling
  • gynecomastia
  • nocturia
  • pyelonephritis
  • scrotal swelling
  • frequent urination
  • urgent urination
  • urinary abnormalities
  • tongue paralysis
  • insomnia
  • nausea
  • pain
  • sweating
  • tremors
  • headache
  • abnormal sensations
  • lethargy

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

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to preserve its effectiveness.

Appearance and packaging

Appearance

A hard capsule that contains white or grayish powder, with a white upper and lower part.

Package unit

30 capsules/bottle, 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.