Gavaron Capsule 300 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 as 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 2 times 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, as a starting 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 as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as 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 2 times 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, as a starting 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. When taking this drug, the total daily dose should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients after transplant surgery, the gabapentin dose should be increased in 100 mg increments. Elderly patients: 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 necessary 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: The dose should be administered as 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 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 drug on days when hemodialysis is not performed. This drug should be swallowed whole with an adequate amount of fluid and may be taken with or without food. When administered 3 times daily, care should be taken not to allow more than 12 hours between doses to prevent recurrence of seizures. If a dose of this drug is missed (if more than 12 hours have elapsed since the last dose), the decision whether to administer an additional dose to make up for it should be made by the physician. When used concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. If treatment with this drug is to be discontinued, or if concomitant treatment with another antiepileptic drug is to be initiated, the change should be made gradually over at least 1 week. The safety and efficacy of treatment for longer than 5 months have not been evaluated for neuropathic pain. The first dose on the first day should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years and older and 12 years and younger Day 1: Administer 10 mg/kg body weight of gabapentin Day 2: Administer 20 mg/kg body weight of gabapentin From Day 3 onward: Administer 30 mg/kg body weight of gabapentin The dose may be increased as needed up to a maximum of 40 mg/kg body weight per day. When administering this medicine, divide the total daily dose into 3 doses.

This medication has a risk of inducing mental changes such as suicidal thoughts, suicidal behavior, and depression in patients taking it; therefore, careful observation for these symptoms is essential during treatment. Sudden discontinuation of this drug may lead to more frequent seizures or severe epilepsy status; hence, it must be tapered off gradually under the direction of a physician. Animal studies have reported the possibility of cancer, but there is currently no definitive evidence that this medication causes cancer in humans. There have been reports of sudden and unexpected deaths during the administration of this medication; however, these events are within the general risk range that might be observed in patients with epilepsy. If symptoms of pancreatitis, such as persistent abdominal pain, nausea, or recurrent vomiting occur, the medication should be stopped immediately and the medical staff notified. Particularly in children aged 3 to 12 years, increased emotional instability or psychiatric adverse reactions such as aggressive behavior, reduced concentration, and hyperactivity may occur; caution is necessary. This medication can cause drowsiness, respiratory depression, or coma when taken with narcotics or central nervous system depressants; therefore, it is important to use the minimum effective dose for a short duration only when absolutely necessary. This medication should not be used in patients with hypersensitivity or acute pancreatitis, specific types of seizures, or lactose intolerance. Patients with compromised renal function, the elderly, those with a history of psychiatric disorders, pregnant or breastfeeding women, or children with attention deficit disorder should use this medication with extra caution. During treatment, dizziness, drowsiness, or impaired motor control may occur, so it is advisable to avoid driving or operating dangerous machinery. During pregnancy, this medication may pose risks to the fetus; thus, women who are pregnant or planning to become pregnant must consult with a physician before taking it and should use effective contraceptive methods. This medication is also excreted in breast milk; therefore, breastfeeding women should consult with a physician to determine whether to use it. Weight gain may occur during treatment; regular weight checks should be conducted, and if obesity is a concern, dietary control and exercise should be combined. If symptoms of hypersensitivity such as rash, fever, or lymphadenopathy appear during the administration of this medication, it should be stopped immediately and the medical staff informed. Withdrawal symptoms may occur upon discontinuation; therefore, it is essential to taper off under a physician’s direction. There may be interactions between this medication and others, so patients should accurately inform the healthcare provider about the medications they are taking and their health conditions.

• Suicidal thoughts
• suicidal behavior
• depression
• emotional instability
• hostility
• abnormal thoughts
• hyperactivity
• abdominal pain
• lower back pain
• fatigue

This medication may be sensitive to air or moisture; therefore, it should be stored in a sealed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. This will help preserve the medication's effectiveness and safety for a long time.

Appearance

Hard capsules with yellow upper and lower parts containing a white or grayish powder

Package unit

For domestic use: 30 capsules/bottle, 200 capsules/bottle For export: 100 capsules/bottle, 100 capsules (10 capsules/PTP x 10)