Citygaba Capsule 300mg (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 gradually 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, instead of the above regimen, a starting dose of one 300 mg capsule of this medicine three times daily may be administered (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 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, instead of the above regimen, a starting dose of one 300 mg capsule of this medicine three times daily may be administered (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. The total daily dose of this medicine should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients after 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 in patients with renal impairment: ≥80 mL/min: 900∼2,400 mg/day 50∼79 mL/min: 600∼1,800 mg/day 30∼49 mL/min: 300∼900 mg/day 15∼29 mL/min: 150b∼600 mg/day <15 mL/min: 150b∼300 mg/day The total daily dose should be divided into 3 doses. 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. Dosage in patients on 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. Method and duration of administration This medicine should be swallowed whole with plenty of 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 medicine is missed (12 hours or more have elapsed since the last dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. When taken with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. The duration of treatment with this medicine should depend on clinical need. Treatment of epilepsy generally requires long-term administration. Abrupt 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. The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. To reduce the main adverse effects, including somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 to 12 years Day 1: Administer gabapentin 10 mg/kg of body weight Day 2: Administer gabapentin 20 mg/kg of body weight From Day 3: Administer gabapentin 30 mg/kg of body weight The dose may be increased, as needed, up 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 may increase the risk of suicidal thoughts or behavior; therefore, if mood changes or unusual behavior occurs during treatment, immediate consultation with a doctor is necessary. Sudden discontinuation of this medication may lead to increased seizure frequency or a severe state of epilepsy, so it should be gradually reduced according to a doctor's instructions. While some potential for cancer has been reported in animal studies, the effects in humans are still unclear. There have been reports of sudden and unexpected deaths during treatment; thus, caution is particularly necessary for epilepsy patients. If symptoms of pancreatitis appear, such as persistent abdominal pain, nausea, or vomiting, discontinue the medication immediately and consult a doctor. Children aged between 3 and 12 may experience neuropsychiatric side effects such as emotional instability, aggression, decreased concentration, and hyperactivity, so careful observation is required. Using this medication with narcotics or central nervous system depressants may lead to severe drowsiness, respiratory suppression, or coma; therefore, concurrent use must be under a doctor's supervision. Patients with allergies to this medication or its components, those with acute pancreatitis, or specific types of seizure disorders should not take this medication. Those with poor kidney function, the elderly, individuals with a history of mental illness, pregnant women, or nursing mothers should exercise extra caution when taking this medication. Dizziness, drowsiness, and coordination disorders may occur; thus, caution is advised when driving or operating machinery. This medication may cause various side effects including weight gain, vision changes, skin rashes, and blood abnormalities, requiring regular check-ups and symptom monitoring. Taking this medication during pregnancy may affect the fetus, so consult a doctor if you are planning to become pregnant or are pregnant. If nursing, this medication may pass into breast milk and affect the baby, so consult a doctor before taking it. Sudden discontinuation may lead to withdrawal symptoms such as anxiety, insomnia, and headache; adjustments to dosage should follow a doctor's instructions. There may be interactions with other medications, so inform your doctor of any other medications or alcohol consumption during treatment. This medication must be kept out of the reach of children and stored in its original container to prevent misuse or quality degradation.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fracture, myalgia, amnesia, ataxia, confusion, coordination dysfunction, dizziness, dysarthria, insomnia, neuro-excitable reactions, nystagmus, drowsiness, tremor, monoplegia, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lethargy, facial swelling, allergy, generalized edema, weight loss, chills, feeling of unfamiliarity, lethargy, alcohol intolerance, hangover effects, hypotension, angina, peripheral vascular disorders, palpitations, tachycardia, migraine, bruit, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary thrombosis, ventricular extrasystole, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, hematochezia, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenitis, 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, increased white blood cell count, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, pouchitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disturbances, aphasia, sensory loss, intracranial hemorrhage, hypotonia, dysesthesia, incomplete paralysis, dystonia, hemiparesis, facial paralysis, confusion, cerebellar dysfunction, positive Babinski's sign, reduced proprioception, subdural hematoma, apathy, hallucinations, decreased or lost libido, restlessness, paranoia, depersonalization, altered states of euphoria, hyperesthesia, states of hallucination, suicidal ideation, mental disorders, chorea, athetosis, perioral motor dysfunction, brain disease, neuropathy, personality disorders, increased libido, mood stabilization, apraxia, fine motor coordination disorders, meningitis, focal myoclonus, perceptual hypersensitivity, diminished motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal obstruction, bronchospasm, hypoventilation, pulmonary edema, alopecia, eczema, skin dryness, increased sweating, urticaria, hirsutism, seborrhea, cyst, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal shedding, maceration, skin nodules, necrosis, localized swelling, hematuria, dysuria, scanty urination, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, heavy menstrual bleeding, breast cancer, anovulation, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute kidney injury, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urgency, vaginismus, mastalgia, testicular pain, visual disturbances, cataracts, conjunctivitis, dry eyes, eye pain, photophobia, bilateral or unilateral ptosis, retinal hemorrhage, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear infection, loss of taste, taste distortion, eye spasm, ocular fullness, itching eyes, accommodation disorders, tympanic membrane perforation, sensitivity to noise, abnormal eye fixation, overflow, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, ocular degeneration, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory abnormalities, dehydration, infectious mononucleosis, hepatitis, coagulation disorders, loss of signs, laryngeal neuritis, somnambulism, pseudo croup, hoarseness, accidental injuries, cold syndrome, infection, pain, dry mouth, bloating, gait abnormalities, confusion, sensory loss, tremor, vertigo, dyspnea, bronchitis, rash, increased blood creatine phosphokinase, rhabdomyolysis, acute kidney injury, urticaria, allergic reactions, alopecia, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, eosinophilia, drug eruption with systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, feminization of breasts, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, palpitations, pancreatitis, sexual dysfunction, skin mucosal syndrome, thrombocytopenia, tinnitus, incontinence, tongue paralysis, insomnia, nausea, pain, sweating, tremor, headache, abnormal feeling, lethargy

This medication must be stored in a tightly sealed container to prevent air and moisture exposure and should be kept at room temperature between 1 degree and 30 degrees Celsius. This storage method will help maintain the medication's efficacy for a longer duration.

Appearance

A hard capsule containing white or grayish-white powder or granules, with light yellow upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle