J-Gaba Capsule 50 mg (Pregabalin)

Adult dose

This medication is administered orally in divided doses of the total daily dosage, taken twice a day regardless of food. 1. Neuropathic pain 1) Peripheral neuropathic pain: Starting dose of 150 mg per day, which may be increased to 300 mg per day after 3 to 7 days, and further increased to a maximum of 600 mg per day at intervals of 7 days. 2) Central neuropathic pain: Starting dose of 150 mg per day, which may be increased to 300 mg after a week. 2. Epilepsy Adults: Starting dose of 150 mg per day, which may be increased to 300 mg after a week, and further increased to a maximum of 600 mg at intervals of 7 days if necessary. 3. Fibromyalgia The recommended dosage for this medication is 300 mg to 450 mg per day. The starting dose is 75 mg taken twice daily (150 mg per day), and based on efficacy and tolerability, it may be increased to 300 mg per day within a week. If sufficient benefit is not experienced at the dosage of 300 mg, it may be increased to 450 mg per day (225 mg taken twice daily) within a week. Clinical studies have been conducted at the dosage of 600 mg per day, but evidence of additional benefit or sufficient tolerability at this dosage is lacking. Given the potential for dose-dependent adverse reactions, doses exceeding 450 mg per day are not recommended. 4. Discontinuation Current clinical experience suggests that when discontinuing this medication, it should be done gradually over a span of at least one week. 5. Patients with impaired kidney function This medication is primarily eliminated by the kidneys in unchanged form following systemic circulation. The clearance of this medication is directly affected by creatinine clearance; thus, dosage reduction in patients with impaired kidney function should be individualized based on creatinine clearance. The creatinine clearance is determined by the following formula: Creatinine clearance (mL/min)* = [140 – age (years)] x Weight (kg) 72 x Serum creatinine concentration (mg/dL) * For females, multiply the result by 0.85. This medication is effectively removed from the blood by hemodialysis (approximately 50% within 4 hours). The daily dosage of pregabalin for dialysis patients should be adjusted based on kidney function. In addition to the daily dosage based on kidney function, an additional dose should be immediately given following every 4-hour session of hemodialysis. [Table 1] Application of Pregabalin dosing based on kidney function Creatinine clearance (CLcr), (mL/min) Pregabalin total daily dosage a Administration method Starting dose (mg/day) Maximum dose (mg/day) ≥60 150 600 BID or TID ≥30-<60 75 300 BID or TID ≥15-<30 25-50 150 QD or BID <15 25 75 QD Additional dose after hemodialysis 25 100 Single dose b TID = Total daily dosage divided into 3 doses BID = Total daily dosage divided into 2 doses QD = Administered once a day a: Total daily dosage (mg/day) should be administered as specified in the administration method. b: Additional dose indicates a quantity administered as a single additional dose. 6. Patients with impaired liver function No dosage adjustment is necessary in patients with impaired liver function. 7. Pediatric and adolescent patients Administration is not recommended for children under 12 years and adolescents aged 12-17 due to insufficient safety and efficacy data. 8. Elderly (65 years and older) In elderly patients with impaired kidney function, dose reduction may be necessary.

Child dose

Administration for children under 12 years and adolescents aged 12-17 is not recommended due to insufficient safety and efficacy data.

This medication may increase the risk of suicidal thoughts or behavior, so mood changes and symptoms of depression should be monitored closely while taking it. Patients with hypersensitivity to this medication or with genetic issues such as lactose intolerance should not take it. Diabetic patients should be cautious since weight gain from this medication may require adjustment of the dosage of blood sugar control medications. If hypersensitivity reactions such as angioedema occur, discontinue use immediately and consult medical personnel. Elderly patients may experience dizziness, drowsiness, or loss of consciousness more frequently, so special caution is needed, especially during initial use. Vision blurriness or changes in eyesight may occur, and these symptoms can improve after stopping the medication. Since there is insufficient data on discontinuing concomitant medications when switching to monotherapy, caution is warranted. Withdrawal symptoms such as insomnia, headache, and anxiety may occur upon discontinuation, so tapering should be done according to medical guidance. Due to the risk of drug abuse, patients with a history of mental disorders or substance abuse should be particularly cautious. Patients with impaired kidney function may require dosage adjustment. In patients with heart failure, this medication should be used cautiously, and caution is needed when taking it along with opioid analgesics due to an increased risk of central nervous system depression. Patients with weakened respiratory function or elderly patients may be at risk of severe respiratory depression and should have their dosage adjusted. Pregnant women are advised not to take this medication in early pregnancy due to the risk of fetal deformities and women of childbearing age should use effective contraception. Breastfeeding women should consider discontinuing either breastfeeding or the medication as it passes into breast milk. Avoid hazardous activities such as driving or operating machinery until dizziness and drowsiness completely subside. Severe skin reactions may rarely occur, so discontinue use if abnormal symptoms such as rash or swelling appear. In the event of overdose, symptoms such as mental confusion, drowsiness, and seizures may occur, requiring immediate emergency treatment, including possible hemodialysis if necessary. Keep out of reach of children and avoid transferring to other containers.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough + fever, yellowing of skin or eyes (jaundice), severe systemic lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, reduced urine output

Mild side effects

• Confusion
• disorientation
• irritability
• depression
• euphoria
• decreased libido
• insomnia
• depersonalization
• sexual dysfunction
• restlessness

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is best to store it at room temperature, between 15 degrees Celsius and 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and a white lower part containing white powder

Package unit

30 capsules/bottle