Medication info
Neurogaffin Capsule 300 mg (Gabapentin)

Neurogaffin Capsule 300 mg (Gabapentin)

Prescription medicationHard capsuleOral
Ingredient · strength
Gabapentin›300mg / 1 capsule
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a white or grayish white powder or granules inside, with a yellowish color on top and bottom.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201901590 · Approved 2019.03.15 · Insurance code 693902960

Summary

Main use
Relief of neuropathic pain; treatment of partial-onset seizures in epilepsy
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: 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: 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 decline in renal function (see table). Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis: Dosage 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 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: 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. 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, and 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 (more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. When used concomitantly with antacids containing magnesium or aluminum, administer this drug at least 2 hours after the antacid. The duration of treatment with this drug should depend on clinical need. Treatment of epilepsy generally requires long-term administration. If treatment with this drug 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. 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 the first day of treatment should be taken at bedtime.
Child dose
Adjunctive therapy for children 3 to 12 years of age To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate gradually over the first 3 days of treatment as follows: 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 per kg of body weight daily. The total daily dose of this drug should be divided into 3 doses.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of epilepsy. It is primarily used as a monotherapy in patients aged 13 years and older with simple or complex partial seizures, as well as in cases where secondary generalized symptoms occur. It is also effective as an adjunct therapy for partial seizures in children aged 3 years and older and adults. Additionally, it helps in alleviating neuropathic pain. In summary, this drug is used for 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 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 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: 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 decline in renal function (see table). Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis: Dosage 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 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: 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. 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, and 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 (more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. When used concomitantly with antacids containing magnesium or aluminum, administer this drug at least 2 hours after the antacid. The duration of treatment with this drug should depend on clinical need. Treatment of epilepsy generally requires long-term administration. If treatment with this drug 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. 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 the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy for children 3 to 12 years of age To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate gradually over the first 3 days of treatment as follows: 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 per kg of body weight daily. The total daily dose of this drug should be divided into 3 doses.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors; therefore, patients should consult a physician immediately if they experience depression or changes in mood while taking it. Suddenly discontinuing this medication can lead to more frequent or severe seizures; hence, it should be tapered off gradually under medical supervision. If symptoms of pancreatitis such as persistent abdominal pain, nausea, or recurrent vomiting occur, the medication should be stopped immediately and medical personnel should be notified. There may be neuropsychiatric adverse reactions such as emotional instability, hostility, decreased concentration, or hyperactivity in children aged 3 to 12 years, so caution is advised. Taking this medication with narcotics or central nervous system depressants may cause drowsiness, respiratory depression, or coma; always follow medical advice. Patients who are allergic to this medication, have acute pancreatitis, or generalized tonic seizures should not take it. Patients with poor kidney function or elderly individuals, those with a history of psychiatric disorders, as well as pregnant or nursing mothers should consult a physician before taking this medication. Dizziness, drowsiness, or motor coordination issues may occur while taking this drug, so care should be taken when driving or operating hazardous machinery. Taking this medication during pregnancy may affect the fetus, hence women who are capable of becoming pregnant should use effective contraceptive methods, and should consult a doctor if pregnant or planning to become pregnant. Weight gain or visual disturbances may occur while on this medication, so it is advisable to regularly check weight and eyesight. If severe skin rash, fever, difficulty breathing, or swelling of the face or lips occur during the course of taking this medication, it should be immediately discontinued and emergency treatment should be sought. Sudden discontinuation after prolonged use may lead to withdrawal symptoms such as anxiety, insomnia, tremors, and headaches; hence dosage should be adjusted according to the physician’s directives. This medication should be kept out of the reach of children and stored in its 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 disorders, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, memory loss, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, excitation, nystagmus, drowsiness, thought disorders, tremor, monoparesis, cough, pharyngitis, rhinitis, erosion, acne, pruritus, rash, amblyopia, diplopia, erectile dysfunction, asthenia, low back pain, cold syndrome, headache, infection, pain, xerostomia, distension, gait disturbance, ataxia, confusion, sensory loss, tremor, vertigo, dyspnea, coagulation abnormalities, loss of warning signs, laryngeal neuralgia, somnambulism, pseudo-croup, hoarseness, facial swelling, allergic reactions, abscess, chills, mucosal abnormalities, syncope, palpitations, migraine, hypotension, peripheral vascular disorders, cardiovascular disorders, cerebrovascular accident, congestive heart failure, myocardial infarction, vasodilation, gastroenteritis, loss of appetite, abnormal liver function tests, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, increased gamma-glutamyl transpeptidase, gingivitis, bowel obstruction, intestinal ulcer, melena, oral ulcer, rectal abnormalities, rectal bleeding, stomatitis, diabetes, petechial hemorrhage, anemia, lymphadenopathy, thrombocytopenia, edema, gout, hypoglycemia, weight loss, arthritis, arthralgia, myalgia, arthrosis, leg cramps, myasthenia gravis, dizziness, hyperesthesia, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream abnormalities, dysarthria, emotional instability, nystagmus, confusion, perioral sensory abnormalities, abnormal euphoria, hypersensitivity, decreased motor function, suicide attempt, agitation, increased tension, increased libido, movement disorders, fasciculations, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, pruritus, skin ulcer, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, abscesses, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste disturbance, hearing loss, conjunctival congestion, diabetic retinopathy, ocular pain, microhemorrhage in the fundus, retinal vein thrombosis, loss of taste, urinary tract infection, voiding disorders, erectile dysfunction, urinary incontinence, vulvovaginal syndrome, mastalgia, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, elevated serum creatine kinase, 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 with systemic involvement, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic seizures, palpitations, pancreatitis, sexual dysfunction, mucocutaneous 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 tightly sealed container. Additionally, it is best to store it at room temperature, specifically between 1 to 30 degrees Celsius, not in very cold or hot places. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

A hard capsule with a white or grayish white powder or granules inside, with a yellowish color on top and bottom.

Package unit

30 capsules/bottle, 100 capsules/bottle

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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.