Gabapentin 800 mg Tablets (Gabapentin)

Adult dose

100 mg, 300 mg, and 400 mg capsules may be used to administer the initial dose. For maintenance dosing, 600 mg and 800 mg tablets and 300 mg and 400 mg capsules may be used; 100 mg capsules may be used in patients requiring hemodialysis. There is no difference between the capsule and tablet dosage forms in terms of therapeutic effect. The dose should be determined by the physician based on each patient’s individual tolerability and efficacy. Epilepsy — Monotherapy and adjunctive therapy in patients aged 13 years and older: This drug is effective at doses of 900～2,400 mg/day of gabapentin. Initial dose: Titrate the dose over the first 3 days of treatment to achieve a maintenance dose of 900 mg/day of gabapentin. 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 onward: 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) Maintenance dose: The initial efficacy of this drug can be assessed at doses of 900∼1,200 mg/day of gabapentin. If higher doses are required, it is recommended to administer 600 mg tablets 3 times daily for a dose of 1,800 mg/day of gabapentin, or 800 mg tablets 3 times daily for a dose of 2,400 mg/day of gabapentin. The total daily dose should not exceed 2,400 mg of gabapentin. Long-term treatment is generally required for epilepsy. If treatment with this drug is to be discontinued or it is to be administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. Neuropathic pain — Adults (18 years and older): Titrate the dose over the first 3 days of treatment to achieve a maintenance dose of 900 mg/day of gabapentin. 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 onward: 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, in addition to the method above, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (gabapentin 900 mg/day). If needed, 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 administering this drug, the total daily dose should be divided into 3 doses. The safety and efficacy of treatment with this drug for neuropathic pain for periods longer than 5 months have not been evaluated. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, the dose of this drug should be increased in 100 mg increments. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function. Patients with renal impairment (creatinine clearance 80 mL/min or less) or patients receiving hemodialysis — Dose in patients with renal impairment: ≥80 mL/min: Total daily dose 900∼2,400 mg/day 50∼79 mL/min: Total daily dose 600∼1,800 mg/day 30∼49 mL/min: Total daily dose 300∼900 mg/day 15∼29 mL/min: Total daily dose 150b∼600 mg/day <15 mL/min: Total daily dose 150b∼300 mg/day 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. Dose in 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 drug on days when hemodialysis is not performed. This drug should be swallowed whole with plenty of fluids and may be administered with or without food. When administered 3 times daily, care should be taken to ensure 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 passed since the last dose), the physician should determine whether an additional dose should be administered to make up for the missed dose. When this drug is administered concomitantly with antacids containing magnesium or aluminum, it should be administered at least 2 hours after the antacid. If the dose of this drug is reduced, treatment is discontinued, or the patient is switched to another alternative drug, this should be done gradually over at least 1 week (a longer period may be needed at the prescriber’s discretion). To reduce the main adverse reactions, including somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors and mental health issues such as depression during treatment, so mood and behavioral changes should be closely monitored. Abrupt discontinuation of this medication may result in more frequent or severe seizures, so it must be gradually discontinued according to a doctor's instructions. Although certain animal studies have reported links to cancer occurrence, the effects on humans are still unclear. There have been reports of unexpected sudden deaths during the use of this medication, but this falls within the range of risk that can generally occur in patients with epilepsy. If symptoms of pancreatitis appear, such as persistent upper abdominal pain, nausea, or repetitive vomiting, the medication should be discontinued immediately and medical advice sought. This medication may carry the risk of severe sedation, respiratory depression, coma, or death when taken with central nervous system depressants, including narcotics; therefore, it should only be taken short-term and at the minimum dose as prescribed by a physician. Patients with a history of hypersensitivity or acute pancreatitis, and patients with certain types of seizures should not take this medication. Patients with impaired renal function, elderly patients, those with a history of mental illness, pregnant or breastfeeding women should use this medication with caution, and dosage adjustments may be necessary. This medication may cause central nervous system-related side effects such as drowsiness, dizziness, memory impairment, and movement coordination disorders; therefore, driving or operating hazardous machinery should be avoided during the initial stages of treatment. During pregnancy, there may be potential risks to the fetus, so if planning to become pregnant or if already pregnant, consultation with a physician is essential; similar caution is required during breastfeeding. Abruptly stopping this medication after long-term use may result in withdrawal symptoms such as anxiety, insomnia, nausea, and tremors; therefore, the dosage should be gradually reduced according to a doctor’s instructions. Interactions with other medications may occur while taking this medication, so all current medications and alcohol consumption should be disclosed to healthcare providers for careful monitoring. When administering to children or the elderly, appropriate dosage adjustments and observation are especially necessary due to the potential for side effects. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation in quality.

suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, deep sedation, respiratory depression, coma, 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, abnormal coordination, dizziness, dysarthria, emotional instability, insomnia, neurotic reactions, nystagmus, drowsiness, cognitive abnormalities, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, bloating, loss of appetite, gingivitis, purpura, arthralgia, hyperactivity, abnormal reflexes, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual disturbances, confusion, depression, neuroticism, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, language disorders, dream abnormalities, dysarthria, emotional instability, confusion, perioral sensory disturbances, abnormal euphoria, hypersensitivity, reduced motor function, suicide attempts, agitation, increased tension, increased libido, movement disorders, myoclonus, vestibular disorders, epistaxis, dyspnea, apnea, alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, seborrheic dermatitis, psoriasis, epidermal peeling, maceration, skin nodules, subcutaneous nodules, melanosis, skin necrosis, localized swelling, hematuria, urinary disorders, frequency, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anorgasmia, ejaculation abnormalities, transient symptoms of central nervous system tongue paralysis, increased blood creatine phosphokinase, rhabdomyolysis, acute kidney failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms (DRESS), elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic cramps, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome (mucocutaneous syndrome), thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. Additionally, it is advisable to avoid extremely hot or cold places and to store it at room temperature between 1°C and 30°C.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle