Gabarel Capsule 100mg (Gabapentin)

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 medicine once daily, or one 100 mg capsule of this medicine three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, a starting dose of one 300 mg capsule of this medicine three times daily may be used (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.) 2. 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 medicine once daily, or one 100 mg capsule of this medicine three times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine twice daily, or two 100 mg capsules of this medicine three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, a starting dose of one 300 mg capsule of this medicine three times daily may be used (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 medicine should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, 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 ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 1) Dosage 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: Administer 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. 2) 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 medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with sufficient fluid and may be taken with or without food. When administered 3 times daily, care should be taken not to allow the interval between doses to exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medicine is missed (more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be taken to make up for it. 3) When used concomitantly with antacids containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. This can substantially reduce the decrease in bioavailability of this medicine. 4) The duration of treatment with this medicine should depend on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (increased 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 medicine 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. 5) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 6) To reduce the main adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be administered at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years In children aged 3 years to 12 years, titrate gradually over the first 3 days of treatment as follows to achieve a maintenance dose of gabapentin 30 mg/day per kg of body weight. - Children aged 3 years to 12 years, Day 1: Administer gabapentin 10 mg/body weight (kg) - Children aged 3 years to 12 years, Day 2: Administer gabapentin 20 mg/body weight (kg) - Children aged 3 years to 12 years, Day 3 onward: Administer gabapentin 30 mg/body weight (kg) In children aged 3 years to 12 years, the dose may be increased to a maximum of 40 mg per kg of body weight daily as needed. The total daily dose of this medicine should be divided into 3 doses.

This drug may increase the risk of suicidal thoughts or behaviors, so mood or behavior changes should be carefully monitored during treatment. If treatment is stopped suddenly, seizures may worsen or a prolonged state of epilepsy can occur, so the dosage must be gradually reduced according to a physician's instructions. In animal studies, some risk of cancer has been reported, but the effects on humans are not yet clear. Unexpected sudden death cases have been reported during the course of taking this drug, so patients should be regularly monitored by healthcare professionals. If symptoms of pancreatitis (upper abdominal pain, nausea, repeated vomiting) occur, it is necessary to stop taking the drug immediately and go to the hospital. Children aged over 3 and less than 12 years may experience central nervous system adverse reactions (emotional instability, aggression, decreased concentration, hyperactivity, etc.), so caution is needed. Taking this drug with narcotics or other central nervous system depressants can lead to severe drowsiness, respiratory depression, coma, or even death, so it should be taken very cautiously if combined. Patients with allergies to this drug or its components, as well as those with acute pancreatitis or generalized tonic-clonic seizures, should not take this medication. Patients with compromised kidney function, the elderly, individuals with a history of mental illness, children with attention deficit or behavioral disorders, pregnant or planning to become pregnant women, and nursing mothers should be particularly careful when taking this medication. Dizziness, drowsiness, and decreased concentration may occur during treatment, so driving or operating dangerous machinery should be avoided. This drug may cause various side effects, such as weight gain, vision changes, skin rashes, and blood abnormalities, so any unusual symptoms should be reported to healthcare providers immediately. In early pregnancy, it can affect the fetus, so it is generally advised not to take this medication during pregnancy. Effective contraception should be used while taking this drug. Breastfeeding mothers should avoid nursing while using this drug or consult a doctor. This drug should be kept out of the reach of children and stored in its original container to prevent misuse and degradation in quality.

Suicidal ideation, suicidal behavior, depression, emotional instability, hostility, abnormal thoughts, hyperactivity, hemorrhagic pancreatitis, abdominal pain, low back pain, fatigue, fever, headache, viral infection, vasodilation, 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, neuroplastic reactions, nystagmus, drowsiness, abnormal thoughts, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, pruritus, rash, amblyopia, diplopia, erectile dysfunction, weakness, fatigue, facial edema, hypertension, bloating, loss of appetite, gingivitis, arthralgia, hyperactivity, abnormal reflexes, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of prodromal signs, laryngeal neuralgia, sleepwalking, pseudo-croup, hoarseness, traumatic injury, cold syndrome, pain, xerostomia, abnormal gait, confusion, sensory loss, tremors, vertigo, dyspnea, rash, asthenia, fatigue, facial edema, allergies, generalized edema, weight loss, chills, feelings of unreality, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noises, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, salivary gland enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, confusion, depression, neuroplasticity, sensory abnormalities, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech impairment, dream abnormalities, dysarthria, emotional instability, stupor, perioral sensory abnormalities, abnormal euphoria, sensory hyperreactivity, decrease in motor function, suicide attempt, agitation, heightened tension, increased libido, movement disorders, myoclonus, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, pulmonary abnormalities, epistaxis, hemoptysis, degeneration, pruritus, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin pigmentation, skin thickening, urinary tract infection, urination disorders, erectile dysfunction, urinary incontinence, vulvovaginitis, mastalgia, menstrual disorders, polyuria, urinary retention, cystitis, ejaculatory dysfunction, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgency, urinary abnormalities, tongue paralysis, elevated 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 including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea-athetosis, movement disorders, dystonia, myotonic contractures, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, fatigue

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness for a longer period.

Appearance

White or grayish-white powder or granules in a hard capsule with a white upper and lower part.

Package unit

30 capsules/bottle, 100 capsules/bottle