Medication info
Citigaba Capsule 100 mg (Gabapentin)

Citigaba Capsule 100 mg (Gabapentin)

Prescription medicationHard capsuleOral
Ingredient · strength
Gabapentin›100mg / 1 capsule
Manufacturer / importer
CTC Bio Co., Ltd.
Appearance
A hard capsule of white or gray-white color containing powder or granules.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201801845 · Approved 2018.04.30 · Insurance code 669502310

Summary

Main use
Relief of neuropathic pain; treatment of epilepsy (partial seizures)
Who takes it
Adults · Children
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 drug once daily, or one 100 mg capsule of this drug three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered three times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin; 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 drug once daily, or one 100 mg capsule of this drug three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug 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 drug should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients following transplant surgery, 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 undergoing 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. Method and duration of administration This drug 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 drug is missed (if more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for it. When taken concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can greatly 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. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to abrupt discontinuation of treatment); however, abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued, or if it is to be used in combination with another antiepileptic drug, the dosage should be changed gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain lasting 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 the first day of treatment should be administered 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.

Ingredients

Manufacturer
CTC Bio Co., Ltd.

Efficacy & effects

Relief of neuropathic pain; treatment of epilepsy (partial seizures)

  • Epilepsy
  • simple partial seizures
  • complex partial seizures
  • secondary generalized symptoms
  • partial seizures
  • neuropathic pain.
View approved original text

This medicine is primarily used for the treatment of epilepsy. It can be used alone in adolescents or adults aged 13 years or older for simple or complex partial seizures, with or without secondary generalized symptoms. Additionally, it is effective as an adjunctive therapy for partial seizures in children aged 3 years and older. Furthermore, it is helpful in alleviating neuropathic pain. Therefore, this medication is used for the treatment of various seizure types in epilepsy and neuropathic pain.

How to take

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 drug once daily, or one 100 mg capsule of this drug three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered three times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin; 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 drug once daily, or one 100 mg capsule of this drug three 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 three times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug 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 drug should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients following transplant surgery, 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 undergoing 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. Method and duration of administration This drug 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 drug is missed (if more than 12 hours have elapsed since the last dose), the physician should determine whether an additional dose should be administered to make up for it. When taken concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can greatly 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. There is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to abrupt discontinuation of treatment); however, abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this drug is to be discontinued, or if it is to be used in combination with another antiepileptic drug, the dosage should be changed gradually over at least 1 week. The safety and efficacy of treatment for neuropathic pain lasting 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 the first day of treatment should be administered 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.

Precautions

This medicine may cause mood and behavioral changes such as suicidal thoughts or actions and depression, so if such symptoms occur during treatment, medical personnel should be informed immediately. Discontinuing the medication suddenly may worsen seizures or lead to a prolonged seizure state, so dosage adjustments should be made gradually under a doctor's guidance. In animal studies, certain potential cancer risks were reported, but the risk in humans is not yet clear. If symptoms of pancreatitis appear, such as persistent upper abdominal pain, nausea, or repeated vomiting, the medication should be stopped immediately and medical attention sought. When administered to children, careful monitoring is required, as neuropsychiatric side effects like emotional instability, aggression, decreased concentration, and hyperactivity may occur. Taking this medication with central nervous system depressants, including narcotics, may lead to severe drowsiness, respiratory depression, and coma, therefore it should only be taken under a doctor's guidance. This medication should not be given to patients with certain genetic problems, those with acute pancreatitis, patients with generalized epilepsy, or to anyone with confirmed hypersensitivity. Patients with reduced kidney function, the elderly, individuals with a history of psychiatric disorders, pregnant women or those planning to become pregnant, and nursing mothers should use this medication with special caution. Drowsiness or dizziness may occur during treatment, so caution is advised when driving or operating machinery. Weight gain or vision disturbances may also occur, necessitating regular evaluations of the patient's condition. When discontinuing this medication, withdrawal symptoms (anxiety, insomnia, nausea, sweating, tremors, etc.) may appear, so dosages should be reduced gradually according to the doctor's instructions. Taking this medication during pregnancy may affect the fetus, so women of childbearing potential should use effective contraception during treatment, and nursing mothers should consult their physician before taking it. The safety of this medication has not been established in children under the age of 3, and there is insufficient experience in monotherapy in children under 13, so caution is advised. In the event of an overdose, symptoms such as dizziness, drowsiness, and decreased consciousness may occur, but generally recovery occurs with supportive therapy, and patients with renal failure may require hemodialysis. Keep this medication out of reach of children, and it is safest not to transfer it to another container from the original one.

Side effects

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, indigestion, increased appetite, thirst or dryness of the mouth, nausea and vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, memory loss, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitability, nystagmus, drowsiness, tremors, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, apathy, facial swelling, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effect, hypotension, angina pectoris, peripheral vascular disorders, palpitations, tachycardia, migraine, bruit, atrial fibrillation, heart failure, thrombophlebitis, deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism, premature ventricular contractions, bradycardia, immature atrial contractions, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, anorexia, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, blood in stool, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, dental discoloration, angular cheilitis, sialadenosis, lip bleeding, esophagitis, hiatal hernia, hematemesis, rectitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, hypoe estrogenism, ovarian failure, epididymitis, testicular swelling, cushingoid appearance, ecchymoses due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin lymphoma, prolonged bleeding time, arthralgia, tendinitis, arthritis, joint stiffness, joint swelling, benign Romberg test, costochondritis, osteoporosis, bursitis, contracture, dizziness, hyperactivity, sensory abnormalities, decreased or lost reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorders, aphasia, sensory deficits, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, dystonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, benign Babinski sign, proprioceptive loss, subdural hematoma, euphoria, hallucinations, decreased or lost libido, agitation, schizophrenia, depersonalization, derealization, heightened sensitivity, hallucination state, suicidal thoughts, mental disorders, chorea, athetoid movements, oral motor dysfunction, brain disease, nerve paralysis, personality disorders, increased libido, organic inhibition, apraxia, fine motor control disorders, meningitis, focal myoclonic seizures, sensory hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal polyps, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, herpes zoster, skin discoloration, papules, photosensitivity, leg ulcers, scalp seborrhea, psoriasis, epidermal exfoliation, maceration, skin nodules, melasma, skin necrosis, localized swelling, hematuria, urinary disorders, emptiness, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute kidney failure, anuria, diabetes, nephritis, nocturia, pyuria, urinary urgency, vaginismus, mastalgia, testicular pain, hyperglycemia, hypoglycemia, gynecomastia, chest pain, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, elevated liver function tests, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, movement disorders, dystonia, idiopathic torsion dystonia, palpitations, pancreatitis, sexual dysfunction, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, incontinence, tongue paralysis, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, apathy

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly closed container to avoid exposure to air or moisture. It is crucial to maintain a storage temperature between 1 to 30 degrees Celsius to ensure the medicine's efficacy is safely preserved.

Appearance and packaging

Appearance

A hard capsule of white or gray-white color containing powder or granules.

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.