Tebagabapentin 400 mg Capsule (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 three 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 three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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.) 3) The duration of treatment should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medicine must be discontinued, or if it is to be used in combination with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain 1) 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 three 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 three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this medicine three times daily, or three 100 mg capsules of this medicine three times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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. When administering this medicine, the total daily dose should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 3. Frail patients In frail patients with low body weight or patients after transplantation, the dose of this medicine should be increased in 100 mg increments. 4. Elderly patients Dosage adjustment may be necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis: Dosage adjustment is necessary 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. In 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) Swallow this medicine whole with plenty of fluid. It may be taken with or without food. When administering 3 times daily, take care that the interval between doses does not exceed 12 hours 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 with an antacid containing magnesium or aluminum, administer this medicine at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medicine. 4) The duration of treatment with this medicine should depend on clinical need. If the dose of this medicine is reduced, treatment is discontinued, or the medicine is changed to another alternative, this should be done gradually over at least 1 week (a longer period may be required at the prescriber's discretion). 5) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy for children aged 3 to 12 years: On day one, administer gabapentin 10 mg/kg of body weight; on day two, administer gabapentin 20 mg/kg of body weight; from day three onward, administer gabapentin 30 mg/kg of body weight; the dose may be increased as needed up to a maximum of 40 mg per kg of body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication is an antiepileptic drug, and during treatment, there may be changes in mood and behavior, such as suicidal thoughts or actions and depression; if such symptoms occur, the physician must be informed immediately. Sudden discontinuation of this medication can worsen seizures or lead to continuous seizure status; therefore, it must be gradually reduced as directed by a physician. While some potential for cancer was observed in animal studies, its effect on humans is not yet clear. There have been reports of sudden and unexpected deaths during the use of this medication, but this is within a range of risks that can commonly occur in epilepsy patients. Patients on this medication may develop hemorrhagic pancreatitis, so if persistent upper abdominal pain, nausea, or repeated vomiting occurs, the patient should stop taking the medication immediately and consult a doctor. Particularly in children aged 3 to 12, caution is required as adverse CNS reactions such as emotional instability, aggression, thought disorders, and excessive hyperactivity may manifest. Caution is needed when this medication is used in conjunction with narcotics and central nervous system depressants, as this can lead to severe sedation, respiratory depression, coma, and the risk of death; strict medical supervision and minimum dosing are necessary when combined. This medication should not be used in individuals with hypersensitivity to it, acute pancreatitis, generalized tonic-clonic seizures, or lactose intolerance. Patients with renal impairment, elderly individuals, those with a history of psychosis, children with ADHD, and women who are pregnant or breastfeeding should use this medication with caution. While taking this medication, side effects such as dizziness, drowsiness, ataxia, memory impairment, nausea, and vomiting can occur; patients should avoid driving or operating hazardous machinery if they experience these symptoms. Additionally, this medication can cause weight gain and vision disturbances; regular check-ups on weight and eye condition are recommended. This medication may pose risks to the fetus during early pregnancy; hence, women who are pregnant or planning to become pregnant must consult a physician, and caution is also necessary for breastfeeding mothers. During treatment, there may be interactions with other drugs or alcohol; all medications and alcohol consumption should be disclosed to a doctor. Excessive dosages may lead to dizziness, drowsiness, and decreased consciousness, but generally, supportive care is sufficient for recovery; in severe renal failure cases, hemodialysis might be required. This medication should be stored out of reach of children and kept in its original container to prevent misuse or degradation.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, facial swelling, hypertension, 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, neurotic responses, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, feelings of strangeness, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, murmur, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, premature ventricular contraction, bradycardia, immature atrial contraction, 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, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, salivary gland enlargement, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian insufficiency, epididymitis, testicular swelling, Cushingoid appearance, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, 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 disorders, aphasia, sensory loss, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, positive Babinski sign, reduced proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, agitation, paranoia, depersonalization, dysphoria, hypersensitivity, hallucinatory state, suicidal thoughts, psychiatric disorders, chorea, athetosis, perioral movement disorders, brain diseases, neuropathy, personality disorders, increased libido, somnolence, apraxia, fine motor control disorders, meningitis, focal myoclonic seizures, hypersensitivity, functional impairment of motor skills, mania, neurosis, hysteria, antisocial responses, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyps, bronchospasm, hypopnea, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melanosis, skin necrosis, localized swelling, hematuria, urination disorders, polyuria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, amenorrhea, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vaginal pain, mastalgia, testicular pain, vision disturbances, cataracts, conjunctivitis, dry eye, ocular pain, photophobia, bilateral or unilateral ptosis, retinal hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear infection, taste loss, taste disorders, blepharospasm, occlusion, eye itching, accommodation disorders, tympanic membrane rupture, sensitivity to noise, eye fixation disorders, epiphora, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, eye degeneration, blindness, retinal degeneration, miosis, choroiditis, strabismus, Eustachian tube dysfunction, inner ear inflammation, otitis externa, olfactory dysfunction, drowsiness, hyperactivity disorder, hostility, viral infections, fever, nausea, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of symptoms, laryngeal neuralgia, sleepwalking, pseudo croup, hoarseness, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, 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, athetosis, movement disorders, dystonia, muscular cramps, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. The storage temperature should be maintained between 15 to 25 degrees Celsius at room temperature. This practice helps preserve the efficacy and safety of the medication for a longer time.

Appearance

Brown hard gelatin capsule filled with white or almost white powder and small clumps.

Package unit

50 capsules (10 capsules/PTPX5)