Irova Capsule 300 mg (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 drug once daily, or one 100 mg capsule of this drug 3 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 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered 3 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 drug must be discontinued, or if it is 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 drug once daily, or one 100 mg capsule of this drug 3 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 3 times daily (gabapentin 600 mg/day) - From Day 3: Administer one 300 mg capsule of this drug 3 times daily, or three 100 mg capsules of this drug 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within 1 week, and 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. 2) The safety and efficacy of treatment for neuropathic pain for longer than 5 months have not been evaluated. 3. Frail patients In frail patients with low body weight or patients after transplant surgery, the dose of this drug should be increased in increments of 100 mg. 4. Elderly patients Dose adjustment may be required due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 1) Dose 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: The dose should be administered as 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) Dose 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. Do not administer this drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) 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. 2) If a dose of this drug is missed (if 12 hours or more have elapsed since the last dose), whether to administer an additional dose to make up for it should be determined by the physician. 3) When used 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. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug is reduced, treatment is discontinued, or the drug is switched to another alternative, the change should be made 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

2) 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 onward: Administer gabapentin 30 mg/kg of body weight The dose may be increased, as needed, 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 drug is used for the treatment of epilepsy and neuropathic pain. During administration, there may be changes in mental health such as suicidal thoughts or behavior and depression, so patients and guardians should closely monitor for these symptoms. Suddenly stopping this medication may increase the severity of seizures or risk progressing to status epilepticus, therefore it should be discontinued gradually as directed by a physician. Long-term or high-dose use may result in various side effects such as weight gain, drowsiness, dizziness, and impaired motor function, so regular assessments of the patient's condition should be conducted. If symptoms of pancreatitis (upper abdominal pain, nausea, vomiting) appear, the medication should be discontinued immediately and medical advice sought. Caution should be exercised especially in children aged 3 to 12 years due to the potential for neuropsychiatric adverse reactions such as emotional instability, aggression, decreased attention span, and hyperactivity. Taking this medication together with central nervous system depressants including narcotics may lead to severe sedation, respiratory depression, or state of coma; thus, it should be used at the minimum effective dose for the shortest possible duration, and the patient should be closely monitored. Particular caution is required when administering this medication to patients with impaired renal function, the elderly, individuals with a history of psychiatric illness, pregnant women or those who might become pregnant, and breastfeeding mothers. Taking this medication during pregnancy can be harmful to the fetus; therefore, those planning to become pregnant or already pregnant should consult a physician. This medication may cause drowsiness and dizziness; hence, it is advisable to avoid driving or operating dangerous machinery at the beginning of treatment or upon changing the dose. In case of overdose, symptoms such as decreased consciousness, drowsiness, dizziness, or double vision may appear, but most cases can recover with supportive care. Also, this medication should be stored out of the reach of children and kept in its original container to prevent misuse.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disturbances, hyperactivity, lethargy, fatigue, facial swelling, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neuroexcitable reactions, nystagmus, drowsiness, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, asthenia, lumbago, cold syndrome, infection, pain, dry mouth, abdominal distension, abnormal gait, ataxia, confusion, sensory deficit, trembling, vertigo, dyspnea, pneumonia, nosebleed, dyspnea, apnea, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, hematuria, urinary dysfunction, frequency, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anorgasmia, ejaculation abnormalities, neurological adverse reactions, tongue paralysis, urticaria, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function test results, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea, athetosis, movement disorders, dystonia, myotonic contractions, palpitations, pancreatitis, sexual dysfunction, mucocutaneous syndrome, thrombocytopenia, tinnitus, urinary incontinence, anxiety, insomnia, nausea, pain, sweating, trembling, headache, abnormal sensation, fatigue

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the medication remains effective over time.

Appearance

A hard capsule with a yellowish exterior containing a white to grayish white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle