PenDown Capsules (Gabapentin)

Adult dose

1. Epilepsy 1) 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 onward: 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, one 300 mg capsule of this medicine 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, but 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.) 2. 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 onward: 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, one 300 mg capsule of this medicine 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, and the total daily dose must not exceed 3,600 mg of gabapentin. When taking this medicine, the total daily dose should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients after transplantation, the gabapentin dose should be increased in increments of 100 mg. 4. Elderly patients: Dosage adjustment may be necessary due to age-related reduction in renal function (see table). 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dosage adjustment is required based on the following table. 1) 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. For patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) 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; do not administer this medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medicine should be swallowed whole with plenty of fluid and may be taken with or without food. When administering 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. 2) If a dose of this medicine is missed (if 12 hours or more have elapsed since the most recent dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When used concomitantly with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can significantly reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If this medicine must be discontinued or administered concomitantly with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 6) 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 and older and 12 years and younger: To achieve a maintenance dose of 30 mg/day of gabapentin per kg of body weight, titrate gradually over the first 3 days of treatment as follows. Day 1: administer 10 mg/kg of body weight as gabapentin; Day 2: administer 20 mg/kg of body weight as gabapentin; From Day 3: administer 30 mg/kg of body weight as gabapentin. If necessary, the dose may be increased to a maximum of 40 mg/kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication is used for the treatment of epilepsy and neuropathic pain; it may increase the risk of suicidal thoughts or behaviors during treatment, so patients and guardians should inform healthcare professionals immediately if such symptoms occur. Abrupt discontinuation of this medication may lead to more frequent seizures or progress to status epilepticus, so the dosage should be gradually reduced as directed by a physician. Long-term use may cause side effects such as weight gain, drowsiness, dizziness, and ataxia, so it is important to regularly monitor the condition. Special caution should be taken in children aged 3 years to 12 years as they may exhibit neuropsychiatric adverse reactions such as emotional instability, aggression, thought disturbances, and hyperactivity. Concomitant use of this medication with narcotics or central nervous system depressants can increase the risk of respiratory depression, deep sedation, coma, and death, so it must be used at minimal doses for a short duration under close medical supervision. Patients with hypersensitivity or acute pancreatitis, generalized tonic-clonic seizures, or lactose intolerance should not use this medication. Patients with impaired renal function, the elderly, individuals with a history of mental illness, pregnant women, and breastfeeding mothers should use this medication with caution, and it should only be used during pregnancy if absolutely necessary due to the risk to the fetus. This medication can cause serious allergic reactions such as anaphylaxis or angioedema, so if symptoms such as difficulty breathing or swelling of the face, lips, or throat occur, administration should be stopped immediately and a medical institution should be visited. During treatment, avoid dangerous tasks such as driving or operating machinery, and ensure that the intervals between doses are not more than 12 hours. This medication may lead to withdrawal symptoms, so do not abruptly stop taking it and consult with a healthcare provider to gradually reduce the dosage. Keep out of reach of children and store it in its original container to prevent misuse or deterioration of quality.

Suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, persistent status epilepticus, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, memory loss, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, thought disorder, tremors, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, myasthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, weakness, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, ventricular premature contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, decreased appetite, abdominal distension, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, burping, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, hypersensitivity, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushingoid appearance, bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, arthralgia, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory disturbances, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbance, aphasia, sensory loss, intracranial hemorrhage, hypotonia, abnormal sensations, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, reduced or lost libido, agitation, depersonalization, dysphoria, hypersensitivity, suicidal impulses, mental disturbances, chorea, athetoid movements, perioral movement disorders, brain disease, neuropathy, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonic seizures, hypersensitivity, motor function reduction, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal obstruction, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, cutaneous nodules, subcutaneous nodules, melasma, skin necrosis, localized swelling, hematuria, dysuria, frequency, bladder inflammation, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, irregular menstruation, menorrhagia, breast cancer, anovulation, ejaculation abnormalities, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, dyspareunia, mastalgia, testicular pain, visual disturbances, cataracts, conjunctivitis, dry eyes, eye pain, photophobia, bilateral or unilateral ptosis, retinal hemorrhage, chalazion, hearing loss, ear pain, tinnitus, labyrinthitis, ear inflammation, taste loss, taste alteration, blepharospasm, filling sensation, itchy eyes, accommodation disorders, tympanic membrane perforation, sensitivity to noise, eye focus abnormalities, overflow tears, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, labyrinthitis, otitis externa, olfactory disturbances, drowsiness, hyperactivity disorder, hostility, viral infections, fever, nausea, bronchitis, respiratory infections, pharyngitis, upper respiratory infections, headache, rhinitis, convulsions, diarrhea, decreased appetite, cough, otitis media, dehydration, infectious mononucleosis, hepatitis, blood clotting disorders, loss of signs, laryngeal neuralgia, sleepwalking, pseudo croup, hoarseness, weakness, lethargy, facial swelling, allergic reactions, abscess, chills, chills and fever, mucosal abnormalities, body odor, cysts, fever, hernia, abnormal BUN levels, cervical mass, pelvic pain, sepsis, viral infections, syncope, palpitations, migraine, congestive heart failure, myocardial infarction, vasodilation, increased capillary fragility, phlebitis, varicose veins, gastroenteritis, increased appetite, gastrointestinal abnormalities, oral candidiasis, gastritis, tongue abnormalities, thirst, dental abnormalities, stool abnormalities, decreased appetite, abnormal liver function tests, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, fecal incontinence, gamma-glutamyl transferase increase, gingivitis, intestinal obstruction, intestinal ulcer, melena, oral ulcers, rectal abnormalities, rectal bleeding, stomatitis, diabetes, purpura, anemia, lymphadenopathy, lymphoproliferative response, prothrombin decrease, edema, gout, hypoglycemia, weight loss, alkaline phosphatase increase, diabetic ketoacidosis, lactate dehydrogenase increase, arthritis, arthralgia, myalgia, arthrosis, leg cramps, myasthenia, shinbone pain, joint disorders, tendon disorders, confusion, depression, neuro-excitability, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, confusion, perioral perceptual disturbances, dysphoria, hypersensitivity, motor function reduction, suicide attempts, agitation, hypertonia, increased libido, movement disorders, myoclonic seizures, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, herpes zoster, skin abnormalities, fungal dermatitis, carbuncle, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, papular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, urinary tract infections, voiding dysfunction, erectile dysfunction, urinary incontinence, vaginal candidiasis, mastalgia, abnormal menstruation, polyuria, urinary retention, cystitis, ejaculation abnormalities, penile swelling, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal swelling, frequency, urgency, 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 eruption with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity reaction including systemic response, hyponatremia, jaundice, loss of consciousness, chorea, athetoid movements, movement disorders, dystonia, paroxysmal tachycardia, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy, apathy

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain room temperature between 1 degree and 30 degrees.

Appearance

A hard capsule with an upper part orange-yellow and filled with white powder

Package unit

30 capsules/bottle, 200 capsules/bottle