PenDown Capsules 100 mg (Gabapentin)

Adult dose

Monotherapy and adjunctive therapy in patients aged 13 years and older: To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually 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 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, instead of the above regimen, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (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 gradually 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 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, instead of the above regimen, one 300 mg capsule of this drug may be administered 3 times daily as the starting dose (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. When administering this drug, the total daily dose should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients who have undergone transplantation, the gabapentin dose should be increased in 100 mg increments. Elderly patients: Dosage 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: Dosage adjustment is required based on the following table. 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 <15 mL/min, the dose should be reduced in proportion to creatinine clearance. Dosage for 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, and do not administer this drug on days when hemodialysis is not performed. This drug should be swallowed whole with sufficient 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 in order to prevent recurrence of seizures. If a dose of this drug is missed (12 hours or more have elapsed since the last dose), whether an additional dose should be taken to make up for the missed dose should be determined by the physician. When used concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. The duration of treatment with this drug should depend on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to sudden discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug must be discontinued or it is used concomitantly with another antiepileptic drug, changes 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 years to 12 years: Titrate gradually over the first 3 days of treatment to a maintenance dose of 30 mg/day of gabapentin per kg of body weight, as follows: - Day 1: Administer 10 mg/kg of body weight of gabapentin - Day 2: Administer 20 mg/kg of body weight of gabapentin - From Day 3 onward: Administer 30 mg/kg of body weight of gabapentin The dose may be increased, if needed, to a maximum of 40 mg per kg of body weight per day. Divide the total daily dose of this medicine into 3 doses.

This medication is used to treat epilepsy, and there may be an increased risk of suicidal thoughts or actions during use, so if mood changes or depression symptoms occur, consult a doctor immediately. Sudden discontinuation can increase the frequency of seizures or lead to a persistent state of epilepsy, so it should be gradually discontinued under a physician's guidance. In some animal studies, the possibility of certain cancers has been reported, but the effects on humans are still unclear. Sudden and unexpected deaths have been reported during use, but this may be related to the risks of epilepsy itself, so caution is needed. If symptoms of pancreatitis (abdominal pain, nausea, repetitive vomiting) appear, discontinue use immediately and inform healthcare professionals. Children may exhibit neuropsychiatric adverse effects such as emotional instability, aggression, decreased concentration, and hyperactivity, so close observation is necessary. When combined with narcotics or central nervous system depressants, severe drowsiness, respiratory depression, and coma may occur, so minimal dosages should be used for short durations while closely monitoring the patient. Patients with allergic reactions or hypersensitivity, acute pancreatitis, or certain hereditary lactose metabolism disorders should not use this medication. Patients with reduced renal function, the elderly, those with a history of psychosis, pregnant women or women planning to become pregnant, and nursing mothers should use this medication cautiously and may require dosage adjustments. Dizziness, drowsiness, and motor coordination issues may occur during use, so caution is advised when driving or operating machinery. Taking this medication during early pregnancy may increase the risk of congenital defects in the fetus, so it should be administered in consultation with a physician during pregnancy, and women of childbearing potential should use effective contraception. Weight gain may occur during treatment, so regular weight checks are needed, and diet and exercise should be adjusted as necessary. Overdosage may result in symptoms such as dizziness, drowsiness, and coma, but recovery generally occurs with supportive care; however, severe renal failure patients may require dialysis. This medication should be kept out of the reach of children, and stored in its original container to prevent misuse.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, abnormal thinking, hyperactivity, weakness, lethargy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurotoxic response, nystagmus, drowsiness, abnormal thinking, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, loss of appetite, gingivitis, arthralgia, dizziness, hyperactivity syndrome, increased, decreased, or absent reflexes, sensory abnormalities, anxiety, hostility, pneumonia, urinary tract infection, visual abnormalities, viral infection, fever, drowsiness, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injury due to accident, cold syndrome, pain, dry mouth, distension, abnormal walking, confusion, sensory loss, tremor, vertigo, dyspnea, thrombocytopenia, hematuria, urinary disorder, frequent urination, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual disorders, heavy menstrual bleeding, breast cancer, impotency, abnormal ejaculation, kidney pain, leucorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturia, pyuria, urgency, dyspareunia, mastalgia, testicular pain, visual impairment, cataracts, conjunctivitis, dry eye, ocular pain, photophobia, ptosis, ocular hemorrhage, chalazion, hearing loss, ear pain, tinnitus, otitis interna, ear inflammation, loss of taste, taste disturbance, blepharospasm, sensation fullness, itching eyes, abnormal focus, eustachian tube dysfunction, otitis interna, otitis externa, increased serum creatine phosphokinase, rhabdomyolysis, acute renal 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, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea athetoid, movement disorders, dystonia, myotonic crisis, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensations, lethargy, suicidal thoughts, suicidal behavior, suicide attempts

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature. This helps ensure the medication's effectiveness is preserved safely for a long time.

Appearance

White powder in a white hard capsule.

Package unit

30 capsules/bottle, 200 capsules/bottle