Gavastan Capsule 100 mg (Gabapentin)

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 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 twice 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 a starting dose, one 300 mg capsule of this medicine 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 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 twice 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 a starting 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 must not exceed 3,600 mg of gabapentin. The total daily dose of this medicine 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. Older adults: Dose adjustment may be necessary 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: Creatinine clearance (mL/min) ≥80: Total daily dose 900∼2,400 mg/day Creatinine clearance (mL/min) 50∼79: Total daily dose 600∼1,800 mg/day Creatinine clearance (mL/min) 30∼49: Total daily dose 300∼900 mg/day Creatinine clearance (mL/min) 15∼29: Total daily dose 150b∼600 mg/day Creatinine clearance (mL/min) <15: Total daily dose 150b∼300 mg/day 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 receiving hemodialysis Initial dose: Gabapentin 300∼400 mg is recommended. Maintenance dose: Administer gabapentin 200∼300 mg after 4 hours of hemodialysis; do not administer this medicine on days when hemodialysis is not performed. Method and duration of administration Swallow this medicine whole with plenty of fluid. It 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 medicine is missed (if more than 12 hours have passed since the last dose), the physician should decide whether an additional dose should be taken to make up for the missed dose. When taken concomitantly with antacids containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. The duration of treatment with this medicine should depend on clinical need. Treatment of epilepsy generally requires long-term administration. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to abrupt discontinuation of treatment); however, 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 administered 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 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 Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years Day 1: Administer gabapentin 10 mg/kg of body weight Day 2: Administer gabapentin 20 mg/kg of body weight From Day 3 onward: Administer gabapentin 30 mg/kg of body weight If necessary, the dose may be increased to a maximum of 40 mg/kg of body weight per day. The total daily dose should be divided into 3 doses.

This medication may increase the risk of suicidal thoughts or behavior, so if any changes in mood or behavior occur during treatment, immediate consultation with a physician is required. Stopping this medication suddenly may cause seizures to worsen, so the dosage should be reduced gradually under medical supervision. Serious side effects, such as pancreatitis, may occur; hence, if persistent upper abdominal pain, nausea, or vomiting occurs, discontinue use immediately and seek medical attention. Special caution is needed for children and adolescents as emotional fluctuations, aggression, and decreased concentration may occur when taking this medication. This medication may cause central nervous system depressant effects such as drowsiness and dizziness, requiring careful attention when driving or operating machinery after use. Taking it with narcotics or other central nervous system depressants may result in respiratory depression or severe sedation, necessitating thorough monitoring by a physician. Patients with impaired kidney function should adjust the dosage, and women who are pregnant or planning to become pregnant must consult a physician before taking this medication. This medication contains lactose and should not be taken by patients with lactose intolerance. If abnormal symptoms such as weight gain, visual disturbances, or skin rashes occur during treatment, notify medical personnel immediately and seek appropriate measures. Strict compliance with prescribed dosage and administration is essential, and one should not stop or change the medication arbitrarily.

Suicidal thoughts, suicidal behavior, depression, emotional instability, hostility, abnormal thinking, hyperactivity, 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, abnormal coordination, dizziness, dysarthria, insomnia, hypersensitivity, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, fatigue, facial edema, hypertension, distention, decreased appetite, gingivitis, purpura, arthralgia, hyperactivity, increased reflexes, decreased or absent reflexes, sensory disturbances, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injuries due to accidents, cold syndrome, infection, pain, dry mouth, gait abnormalities, confusion, sensory loss, tremors, vertigo, dyspnea, rash, abnormal thoughts, chest pain, soft tissue inflammation, allergic reactions, abscess, chills, mucosal abnormalities, body odor, cysts, hernia, abnormal BUN level, neck mass, pelvic pain, sepsis, bruising-like purpura due to trauma, anemia, lymphadenopathy, thrombocytopenia, lymphadenopathy, lymphoproliferative response, decreased prothrombin, edema, gout, hypoglycemia, weight loss, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, pouchitis, contracture, confusion, depression, neurogenic hypersensitivity, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, delirium, peri-oral sensory disturbances, abnormal euphoria, hypersensitivity, reduced motor function, suicide attempts, restlessness, heightened tension, increased libido, movement disorders, fasciculation, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, nasal hemorrhage, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infection, urinary disorders, erectile dysfunction, incontinence, vulvar neuropathy, mastalgia, menstrual abnormalities, polyuria, urinary retention, cystitis, ejaculation disorders, penile enlargement, gynecomastia, nocturia, pyelonephritis, scrotal enlargement, frequent urination, urgent urination, urinary abnormalities, tongue paralysis, increased 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, systemic edema, gynecomastia, hallucinations, hepatitis, hypersensitivity reactions including systemic responses, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic dysregulation, palpitations, pancreatitis, sexual dysfunction, skin and mucosal syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, fatigue

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature. Proper storage will help preserve the efficacy and safety of the medication for a longer period.

Appearance

A hard capsule with a yellow upper part and a white lower part containing white to grayish white powder.

Package unit

30 capsules/bottle, 500 capsules/bottle