AbaPen 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 medication once daily, or one 100 mg capsule of this medication three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medication twice daily, or two 100 mg capsules of this medication three times daily (gabapentin 600 mg/day) From Day 3 onward: Administer one 300 mg capsule of this medication three times daily, or three 100 mg capsules of this medication three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medication may be administered three 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 medication once daily, or one 100 mg capsule of this medication three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medication twice daily, or two 100 mg capsules of this medication three times daily (gabapentin 600 mg/day) From Day 3 onward: Administer one 300 mg capsule of this medication three times daily, or three 100 mg capsules of this medication three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medication may be administered three 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 medication 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 increments of 100 mg. 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 is divided into 3 doses. b: The dose should be 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. Dosage for hemodialysis patients 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 medication on days when hemodialysis is not performed. Method and duration of administration This medication should be swallowed whole with sufficient fluid and 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 medication is missed (if more than 12 hours have elapsed since the last dose), whether to administer an additional dose to make up for the missed dose should be determined by the physician. When used concomitantly with antacids containing magnesium or aluminum, administer this medication at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medication. The duration of treatment with this medication 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 following abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medication is to be discontinued, or if it is to be 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 more than 5 months have not been evaluated. To reduce the main adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be administered at bedtime.

Child dose

Children aged 3 to 12 years (adjunctive therapy): Gradually titrate over the first 3 days of treatment to a maintenance dose of 30 mg/day of gabapentin per kg of body weight. 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 to a maximum of 40 mg/kg of body weight per day if needed. The total daily dose should be divided into 3 doses.

This medication is an antiepileptic drug, and during its use, suicidal thoughts or behaviors, changes in mental health such as depression may occur, so careful observation is required. If this medication is suddenly discontinued, there is a risk of more frequent seizures or prolonged seizure status, so it should be gradually reduced according to the doctor's instructions. Long-term use may result in side effects such as weight gain, drowsiness, dizziness, and coordination disorders, thus regular monitoring of the patient's condition is necessary. Especially women who are pregnant or planning to become pregnant must consult before taking the medication as it may affect the fetus, and caution is also needed during breastfeeding. Patients with impaired kidney function or the elderly need to adjust the dosage, and caution is required when taken with other central nervous system depressants due to potential respiratory depression or severe sedation. This medication can cause allergic reactions or serious skin reactions (such as Stevens-Johnson syndrome), so if symptoms such as skin rash, fever, or lymphadenopathy occur, the medication should be discontinued immediately and medical advice sought. If experiencing severe dizziness or drowsiness, avoid dangerous activities such as driving or operating machinery, and close observation is necessary for children and adolescents as behavioral changes may occur. Serious side effects such as hemorrhagic pancreatitis have been reported, so if symptoms like persistent abdominal pain, nausea, or vomiting occur, discontinue the medication and visit a hospital immediately. There is a risk of drug abuse or dependence, so patients with a history of substance abuse should use caution, and withdrawal symptoms such as anxiety, insomnia, or headache may occur when discontinuing the medication. This medication has not been established for safety and efficacy in children, especially those under 3 years of age, and there is insufficient experience with monotherapy in pediatric patients under 13 years of age, so caution is needed. Finally, medications should be taken strictly according to the physician's prescription, and adherence to the prescribed dosage and intervals is essential to reduce the risk of side effects and seizures.

Suicidal thoughts, suicidal behavior, depression, emotional instability, hostility, abnormal thinking, hyperactivity, hemorrhagic pancreatitis, abdominal pain, 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, impaired coordination, dizziness, dysarthria, insomnia, neural hypersensitivity response, nystagmus, drowsiness, abnormal thinking, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, anorexia, gingivitis, arthralgia, hyperactivity, reflex changes, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infection, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, blood clotting abnormalities, loss of warning signs, laryngeal neuralgia, sleepwalking, pseudo croup, hoarseness, trauma-related injury, cold syndrome, pain, dry mouth, gait abnormalities, confusion, sensory loss, tremor, vertigo, dyspnea, rash, asthenia, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular premature contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular stomatitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectal inflammation, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, goiter, low estrogen, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, increased white blood cell count, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, pouchitis, contracture, decreased or lost reflexes, increased reflexes, CNS tumor, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, anxiety, paranoia, depersonalization, euphoria, hyperesthesia, delirious state, suicidal thoughts, psychiatric disorders, chorea, athetosis, oral motor disturbances, brain disease, nerve paralysis, personality disorder, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, local focal spasms, hypersensitivity, reduced motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal deformities, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, excessive sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal shedding, maceration, skin nodules, melasma, skin necrosis, localized swelling, hematuria, micturition disorders, polyuria, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, atrophy, ejaculation abnormalities, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, dyspareunia, mastalgia, testicular pain, hearing loss, ear pain, tinnitus, otitis interna, inflammation of the ear, taste loss, taste abnormalities, eyelid twitching, conjunctival swelling, eye itching, accommodation abnormalities, tympanic membrane perforation, noise sensitivity, eye fixation abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, tear function disorders, eye degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, otitis interna, otitis externa, olfactory disturbances, urinary tract infection, micturition disorders, erectile dysfunction, urinary incontinence, vulvar neurodermatitis, mastalgia, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile engorgement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequent urination, urgent urination, urinary abnormalities, tongue paralysis, increased blood creatine kinase levels, 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, generalized edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, metabolic myoclonus, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal feelings, lethargy

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The storage temperature should be kept at room temperature between 1°C and 30°C.

Appearance

White or grayish-white powder contained in a white hard capsule

Package unit

30 capsules/bottle, 300 capsules/bottle