Medication info
Abapent Capsule 300 mg (Gabapentin)

Abapent Capsule 300 mg (Gabapentin)

Prescription medicationHard capsuleOral
Ingredient · strength
Gabapentin›300mg / 1 capsule
Manufacturer / importer
IQUR Co., Ltd.
Appearance
Light yellow hard capsule filled with white or grayish powder
Packaging
30 capsules, 300 capsules
Approval status
Active

MFDS item code 201601570 · Approved 2016.03.18

Summary

Main use
Relief of neuropathic pain; treatment of partial-onset seizures in epilepsy
Who takes it
Adults · Children
Adult dose
Monotherapy and adjunctive therapy for patients with epilepsy aged 13 years and older: To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be taken three times daily as the starting dose (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.) Adults with neuropathic pain (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be taken three times daily as the starting dose (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. When taking this drug, the total daily dose should be divided into 3 doses. Frailty: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. Older adults: Dose adjustment may be required due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. Dosage for patients with renal impairment: Renal function, creatinine clearance (mL/min) ≥80: Total daily dosea (mg/day) 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. 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 plenty of fluid and may be taken with or without food. When administered 3 times daily, take care that the dosing interval 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), whether to take an additional dose to make up for it should be determined by a physician. When used with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. If treatment with this drug is to be discontinued, or if it is to be used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. 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: To achieve a maintenance dose of gabapentin 30 mg/kg/day, titrate over the first 3 days of treatment as follows. Day 1: gabapentin 10 mg/kg body weight; Day 2: gabapentin 20 mg/kg body weight; from Day 3: gabapentin 30 mg/kg body weight. The dose may be increased as needed to a maximum of 40 mg/kg body weight per day. The total daily dose of this medicine should be divided into 3 doses.

Ingredients

Manufacturer
IQUR Co., Ltd.

Efficacy & effects

Relief of neuropathic pain; treatment of partial-onset seizures in epilepsy

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

This medication is used for the treatment of epilepsy and is effective for partial seizures in adolescents aged 13 years and older or adults when used as monotherapy. Additionally, it can also help in the treatment of partial seizures in children aged 3 years and older and adults when used as an adjunctive therapy. Furthermore, it is also used for the relief of neuropathic pain, proving effective in pain management. Thus, it improves the quality of life of patients suffering from epilepsy and neuropathic pain.

How to take

Adult dose

Monotherapy and adjunctive therapy for patients with epilepsy aged 13 years and older: To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be taken three times daily as the starting dose (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.) Adults with neuropathic pain (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: Take one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Take one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3: Take one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, one 300 mg capsule of this drug may be taken three times daily as the starting dose (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. When taking this drug, the total daily dose should be divided into 3 doses. Frailty: In frail patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. Older adults: Dose adjustment may be required due to age-related decline in renal function (see table). Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. Dosage for patients with renal impairment: Renal function, creatinine clearance (mL/min) ≥80: Total daily dosea (mg/day) 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. 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 plenty of fluid and may be taken with or without food. When administered 3 times daily, take care that the dosing interval 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), whether to take an additional dose to make up for it should be determined by a physician. When used with antacids containing magnesium or aluminum, this drug should be taken at least 2 hours after the antacid. If treatment with this drug is to be discontinued, or if it is to be used concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain for periods longer than 5 months have not been evaluated. 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: To achieve a maintenance dose of gabapentin 30 mg/kg/day, titrate over the first 3 days of treatment as follows. Day 1: gabapentin 10 mg/kg body weight; Day 2: gabapentin 20 mg/kg body weight; from Day 3: gabapentin 30 mg/kg body weight. The dose may be increased as needed to a maximum of 40 mg/kg body weight per day. The total daily dose of this medicine should be divided into 3 doses.

Precautions

This medication may increase the risk of suicidal thoughts or behavior, so if any changes in mood or behavior occur during treatment, inform your doctor immediately. Suddenly stopping this medication can lead to more frequent seizures or progression to status epilepticus; therefore, it must be tapered off gradually as directed by a physician. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, or repeated vomiting occur, this medication should be stopped immediately and healthcare professionals should be consulted. Children aged 3 to 12 years taking this medication may exhibit neurological and psychiatric symptoms such as emotional instability, aggression, decreased concentration, and hyperactivity, so caution is advised. Taking this medication with central nervous system depressants, including opioids, may lead to severe drowsiness, respiratory depression, or coma; therefore, it should only be taken at the lowest effective dose for the shortest duration under close observation by healthcare professionals. This medication should not be administered to patients with hypersensitivity, acute pancreatitis, certain types of seizures, or those with hereditary lactose intolerance. Patients with impaired kidney function, elderly patients, children with a history of psychiatric conditions or attention deficit and behavioral disorders, pregnant or breastfeeding women should use this medication cautiously. Side effects may include dizziness, drowsiness, coordination problems, memory impairment, nausea, vomiting, which necessitates caution when driving or operating machinery. During pregnancy, especially in the early stages, this medication may affect the fetus, therefore its use during pregnancy should be decided in consultation with a healthcare provider, and effective contraception should be utilized by women who may become pregnant. This medication can be transferred into breast milk, so breastfeeding status should also be discussed with healthcare professionals. While taking this medication, it is important to regularly monitor weight and physical condition, and inform healthcare professionals immediately regarding any adverse reactions. Do not change the dosage of this medication arbitrarily, and take care not to exceed 12 hours between doses. Store out of reach of children, and keep in the original container to prevent misuse or degradation of quality.

Side effects

  • Suicidal thoughts
  • suicidal behavior
  • depression
  • abnormal changes in mood and behavior
  • hemorrhagic pancreatitis
  • emotional instability
  • hostility
  • thought disorder
  • hyperactivity
  • weakness
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  • apathy
  • facial swelling
  • hypertension
  • constipation
  • dental abnormalities
  • diarrhea
  • dyspepsia
  • increased appetite
  • thirst
  • nausea
  • vomiting
  • leukopenia
  • peripheral edema
  • weight gain
  • fractures
  • myalgia
  • amnesia
  • ataxia
  • confusion
  • impaired coordination
  • dizziness
  • dysarthria
  • insomnia
  • hyperreactivity
  • nystagmus
  • drowsiness
  • thought disorder
  • tremors
  • single contraction
  • cough
  • pharyngitis
  • rhinitis
  • abrasion
  • acne
  • itching
  • rash
  • amblyopia
  • diplopia
  • erectile dysfunction
  • asthenia
  • lethargy
  • facial swelling
  • allergy
  • generalized edema
  • weight loss
  • chills
  • feelings of detachment
  • 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 ectopy
  • bradycardia
  • immature atrial contractions
  • pericardial friction
  • heart block
  • pulmonary embolism
  • hyperlipidemia
  • hypercholesterolemia
  • pericardial effusion
  • pericarditis
  • loss of appetite
  • distension
  • gingivitis
  • glossitis
  • gum bleeding
  • thirst
  • stomatitis
  • increased saliva secretion
  • gastroenteritis
  • hemorrhoids
  • bloody stool
  • fecal incontinence
  • hepatomegaly
  • dysphagia
  • belching
  • pancreatitis
  • gastric ulcer
  • colitis
  • oral vesicles
  • tooth discoloration
  • angular cheilitis
  • sialadenosis
  • lip bleeding
  • esophagitis
  • hiatal hernia
  • hematemesis
  • proctitis
  • irritable bowel syndrome
  • rectal bleeding
  • esophageal spasm
  • hyperthyroidism
  • hypothyroidism
  • thyroid enlargement
  • low estrogen
  • ovarian failure
  • epididymitis
  • testicular swelling
  • Cushing's syndrome
  • ecchymosis due to trauma
  • anemia
  • lymphadenopathy
  • thrombocytopenia
  • leukocytosis
  • lymphocytosis
  • non-Hodgkin's lymphoma
  • increased bleeding time
  • arthralgia
  • tendinitis
  • arthritis
  • joint stiffness
  • joint swelling
  • positive Romberg test
  • costochondritis
  • osteoporosis
  • bursitis
  • contracture
  • dizziness
  • hyperactivity
  • sensory disturbance
  • decreased or lost reflexes
  • increased reflexes
  • anxiety
  • hostility
  • CNS tumor
  • syncope
  • dream disorder
  • aphasia
  • sensory loss
  • intracranial hemorrhage
  • hypotonia
  • paresthesia
  • incomplete paralysis
  • dystonia
  • hemiplegia
  • facial paralysis
  • confusion
  • cerebellar dysfunction
  • positive Babinski's sign
  • decreased proprioception
  • subdural hematoma
  • apathy
  • hallucinations
  • decreased or lost libido
  • agitation
  • paranoid disorder
  • depersonalization
  • euphoric state
  • sensitivity
  • hallucinatory state
  • suicidal thoughts
  • mental disorders
  • chorea
  • athetosis
  • oral-motor disorders
  • cerebral disease
  • neuropathy
  • personality disorders
  • increased libido
  • organic inhibition
  • apraxia
  • fine motor control disorders
  • meningitis
  • focal myoclonus
  • sensory hyperreactivity
  • decreased motor function
  • mania
  • neurosis
  • hysteria
  • antisocial reactions
  • suicidal behavior
  • pneumonia
  • nosebleeds
  • dyspnea
  • apnea
  • mucositis
  • aspiration pneumonia
  • hyperventilation
  • hiccups
  • laryngitis
  • nasal congestion
  • nasal pains
  • 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
  • hyperpigmentation
  • skin necrosis
  • localized swelling
  • hematuria
  • urination disorders
  • frequency of urination
  • cystitis
  • urinary retention
  • incontinence
  • vaginal bleeding
  • amenorrhea
  • menstrual disorders
  • menorrhagia
  • breast cancer
  • anovulation
  • ejaculation disorders
  • kidney pain
  • leukorrhea
  • genital itching
  • nephrolithiasis
  • acute kidney failure
  • anuria
  • diabetes
  • nephritis
  • nocturnal enuresis
  • pyuria
  • urgency
  • dyspareunia
  • mastalgia
  • orchalgia
  • vision disturbances
  • cataracts
  • conjunctivitis
  • eye dryness
  • eye pain
  • photophobia
  • bilateral or unilateral ptosis
  • subconjunctival hemorrhage
  • pinguecula
  • hearing loss
  • ear pain
  • tinnitus
  • labyrinthitis
  • ear inflammation
  • taste loss
  • taste disturbances
  • eyelid twitching
  • ocular fullness
  • itchy eyes
  • accommodation disturbance
  • tympanic membrane perforation
  • sensitivity to noise
  • abnormal ocular focus
  • overflow tears
  • retinopathy
  • glaucoma
  • iritis
  • corneal disorders
  • tear production dysfunction
  • eye degeneration
  • blindness
  • retinal degeneration
  • mydriasis
  • choroiditis
  • strabismus
  • Eustachian tube dysfunction
  • labyrinthitis
  • outer ear infection
  • olfactory disturbances
  • tongue paralysis
  • weakness
  • lethargy
  • facial swelling
  • hypertension
  • constipation
  • dental abnormalities
  • diarrhea
  • dyspepsia
  • increased appetite
  • thirst
  • nausea
  • vomiting
  • leukopenia
  • peripheral edema
  • weight gain
  • fractures
  • myalgia
  • amnesia
  • ataxia
  • confusion
  • impaired coordination
  • dizziness
  • dysarthria
  • insomnia
  • hyperreactivity
  • nystagmus
  • drowsiness
  • thought disorder
  • tremors
  • single contraction
  • cough
  • pharyngitis
  • rhinitis
  • abrasion
  • acne
  • itching
  • rash
  • amblyopia
  • diplopia
  • erectile dysfunction
  • viral infection
  • fever
  • weight gain
  • fatigue
  • drowsiness
  • hostility
  • emotional instability
  • hyperactivity
  • bronchitis
  • respiratory infection
  • dehydration
  • infectious mononucleosis
  • hepatitis
  • blood coagulation disorders
  • loss of symptoms
  • laryngeal neuralgia
  • sleepwalking
  • pseudo croup
  • hoarseness
  • tongue paralysis
  • anxiety
  • insomnia
  • nausea
  • pain
  • sweating
  • trembling
  • headache
  • abnormal sensations
  • lethargy
  • suicidal thoughts
  • suicidal behavior
  • depression
  • hallucinations
  • confusion
  • loss of consciousness
  • mental disorders
  • withdrawal symptoms
  • movement disorders
  • dystonia
  • paroxysmal tachycardia
  • pancreatitis
  • sexual dysfunction
  • Stevens-Johnson syndrome
  • thrombocytopenia
  • tinnitus
  • urinary incontinence

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 exposure to air or moisture, and the storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. This is an important storage method to maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Light yellow hard capsule filled with white or grayish powder

Package unit

30 capsules, 300 capsules

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.