Gabarex 600 mg (Gabapentin)

Adult dose

For administration of the initial dose, 100 mg, 300 mg, and 400 mg capsules may be used. For administration of the maintenance dose, 600 mg and 800 mg tablets and 300 mg and 400 mg capsules may be used; 100 mg capsules may be used for patients requiring hemodialysis. There is no difference between the capsule and tablet formulations in terms of therapeutic effect. The dose should be determined by the physician based on each patient's tolerability and efficacy. 1. Epilepsy Monotherapy and adjunctive therapy in patients aged 13 years and older: This medicine is effective at doses of 900～2,400 mg/day of gabapentin. The dose may be increased relatively quickly, both during titration to the initial maintenance dose and thereafter as needed. Initial dose: 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 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Maintenance dose: Initial efficacy of this medicine can be assessed at doses of 900∼1,200 mg/day of gabapentin. If higher doses are required, it is recommended to administer a 600 mg tablet 3 times daily for a gabapentin dose of 1,800 mg/day, or an 800 mg tablet 3 times daily for a gabapentin dose of 2,400 mg/day. The total daily dose should 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 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medicine 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 should not exceed 3,600 mg of gabapentin. When this medicine is administered, the total daily dose should be divided into 3 doses. 4. Debilitated patients In debilitated patients with low body weight or patients following transplantation, the dose of this medicine should be increased in 100 mg increments. 5. Elderly patients Dosage adjustment may be necessary due to age-related decline in renal function (see table). 6. 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. 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 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 medicine on days when hemodialysis is not performed. 7. Method and duration of administration 1) This medicine should be swallowed whole with plenty of fluid and may be taken with or without food. When administered 3 times daily, care should be taken to ensure that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medicine is missed (if more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for it. 3) When taken with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in bioavailability of this medicine. 4) The duration of administration of this medicine should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the 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 in combination with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 6) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

When administered as adjunctive therapy to children aged 3 years to 12 years, the lower-strength 100 mg, 300 mg, or 400 mg capsules may be used instead of the high-strength tablet formulation of this medicine.

This medication may increase the risk of suicidal thoughts or behaviors, so if symptoms of depression or mood changes occur during treatment, healthcare providers should be notified immediately. Discontinuing this medication suddenly can lead to exacerbation of seizures or status epilepticus, so it should be tapered off gradually under medical instruction. Some potential for cancer development has been reported in animal studies, but the effects in humans remain unclear. Sudden and unexpected deaths have been reported during this medication use, though these are within the general risk range seen in epilepsy patients. If symptoms of pancreatitis such as persistent upper abdominal pain, nausea, or repeated vomiting occur, discontinue the medication and consult a healthcare provider immediately. Combining this drug with narcotics or central nervous system depressants can cause severe drowsiness, respiratory depression, and coma; caution is advised when used together, with minimal doses and shortest duration used as necessary. It should not be administered to patients with hypersensitivity to this medication or acute pancreatitis, or those with generalized tonic-clonic seizures. Patients with impaired kidney function, the elderly, those with a history of psychiatric disorders, children with attention deficit disorders, pregnant and nursing women should use this medication cautiously. During treatment, dizziness, drowsiness, and coordination disorders may occur, so driving or operating hazardous machinery should be avoided to reduce the risk of falls. During pregnancy, especially in the first trimester, it may pose risks to the fetus, so women who could become pregnant should discuss usage with their doctor beforehand and employ effective contraception during treatment. Nursing mothers should note that this drug is excreted in breast milk, thus should decide whether to discontinue breastfeeding or consult a healthcare provider about usage. This medication can cause various side effects such as weight gain, visual disturbances, skin rashes, and blood disorders, so any unusual symptoms should be reported to healthcare providers immediately. Abruptly stopping the drug after long-term use may cause withdrawal symptoms such as anxiety, insomnia, nausea, and tremors, so gradual discontinuation under medical advice is essential. There may be interactions with other medications, so inform healthcare providers of any current medications or alcohol consumption. Store out of the reach of children, and retain in the original container to prevent misuse and degradation of quality.

Suicidal ideation, suicidal behavior, depression, seizures, persistent seizure state, hemorrhagic pancreatitis, deep sedation, respiratory depression, coma, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, emotional instability, insomnia, neural hyperreactivity, nystagmus, drowsiness, abnormal thinking, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, apathy, facial swelling, hypertension, abdominal distention, decreased appetite, gingivitis, purpura, arthralgia, hyperactivity, reflex abnormality, sensory abnormality, anxiety, hostility, pneumonia, urinary tract infection, visual disturbance, myasthenia, accidental injury, cold syndrome, pain, dry mouth, gait abnormality, confusion, sensory loss, tremor, dizziness, dyspnea, rash, tongue paralysis, myasthenia, apathy, facial swelling, allergy, generalized edema, weight loss, chills, strange sensation, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, murmur, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary embolism, 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, 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, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, increased leukocyte count, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, pouchitis, contracture, hyperactivity, decreased or absent reflexes, increased reflexes, CNS tumor, syncope, dream abnormality, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, euphoria, hypersensitivity, hallucination state, suicidal ideation, psychiatric disorder, chorea, athetosis, oral motor disorder, brain disease, nerve paralysis, personality disorder, increased libido, organic inhibition, apraxia, fine motor control disorder, meningitis, focal myoclonus, sensory hyperreactivity, diminished motor function, mania, neurosis, hysteria, antisocial response, suicidal behavior, nosebleed, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccup, laryngitis, nasal congestion, nasal ulcer, 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, subcutaneous nodules, acanthosis, skin necrosis, localized swelling, hematuria, urinary disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularity, menorrhagia, breast cancer, amenorrhea, ejaculation abnormality, kidney pain, leukorrhea, genital itching, kidney stones, acute kidney failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, dyspareunia, mastalgia, testicular pain, visual disturbances, cataracts, conjunctivitis, eye dryness, eye pain, photophobia, bilateral or unilateral ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labrynthitis, ear inflammation, taste loss, taste disturbance, eye twitching, intumescence, eye itching, accommodation abnormality, tympanic membrane perforation, sound sensitivity, ocular fixation abnormality, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye atrophy, blindness, retinal degeneration, pupillary dilation, choroiditis or retinitis, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbance, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reaction, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorder, dystonia, myotonia, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensation, apathy

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is best kept at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the drug's effectiveness for a longer period.

Appearance

White oval film-coated tablets

Package unit

30 tablets, 90 tablets