Unipentin Capsule 300 mg (Gabapentin)

Adult dose

Monotherapy and adjunctive therapy for patients aged 13 years and older with epilepsy: To achieve a maintenance dose of 900 mg/day as 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 2 times 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 as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) Adults with neuropathic pain (18 years and older): To achieve a maintenance dose of 900 mg/day as 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 2 times 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 as gabapentin within one week, and the total daily dose must not exceed 3,600 mg as gabapentin. When administering this drug, the total daily dose should be divided into 3 doses. Debilitated patients: In debilitated patients with low body weight or patients after 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. Renal function, creatinine clearance (mL/min) ≥80: Total daily dosea (mg/day) 900∼2,400 Renal function, creatinine clearance (mL/min) 50∼79: Total daily dosea (mg/day) 600∼1,800 Renal function, creatinine clearance (mL/min) 30∼49: Total daily dosea (mg/day) 300∼900 Renal function, creatinine clearance (mL/min) 15∼29: Total daily dosea (mg/day) 150b∼600 Renal function, creatinine clearance (mL/min) <15: Total daily dosea (mg/day) 150b∼300 a: The total daily dose should be divided into 3 doses. b: 3 × 100 mg should be administered 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, and do not administer this drug on days when hemodialysis is not performed. This drug should be swallowed whole with an adequate amount of fluid and may be taken with or without food. When administered 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. If a dose of this drug is missed (if 12 hours or more have elapsed since the most recent dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. When this drug is used concomitantly with antacids containing magnesium or aluminum, it should be administered at least 2 hours after the antacid. The duration of treatment with this drug should depend on clinical need. Long-term treatment is generally required for epilepsy. If treatment with this drug is to be discontinued or it is to be used concomitantly 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, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day of treatment should be taken at bedtime.

Child dose

Adjunctive therapy in children aged 3 years to 12 years: To achieve a maintenance dose of 30 mg/day per kg of body weight of gabapentin, titrate gradually over the first 3 days of treatment as follows. Day 1: Administer gabapentin 10 mg/weight(kg); Day 2: Administer gabapentin 20 mg/weight(kg); From day 3: Administer gabapentin 30 mg/weight(kg). The dose may be increased, if necessary, to a maximum of 40 mg per kg of body weight daily. When administering this medicine, divide the total daily dose into 3 doses.

This medication may increase the risk of suicidal thoughts or actions; thus, patients should consult a healthcare professional if they experience any changes in mood or behavior while taking this medication. Abrupt discontinuation may exacerbate seizures; it should be tapered off slowly per doctor's advice. If symptoms of pancreatitis, including persistent abdominal pain, nausea, or vomiting occur, the medication should be stopped immediately and a hospital visit is necessary. Caution is required when administering to children as neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, or hyperactivity may occur. If this medication is taken with central nervous system depressants, including narcotics, drowsiness, respiratory depression, or coma may occur, necessitating careful monitoring. This medication should not be used in patients with certain genetic disorders, acute pancreatitis, or primary generalized epilepsy. Patients with impaired kidney function, the elderly, those with a history of mental illness, pregnant or nursing women should use this medication cautiously. While taking this medication, dizziness, drowsiness, and decreased concentration may occur; it is advisable to avoid driving or operating hazardous machinery. The medication can cause various side effects, such as weight gain, visual disturbances, or skin rashes, and any unusual symptoms should be reported to a healthcare professional. During pregnancy, it may affect the fetus; therefore, it is necessary to consult a physician if planning to become pregnant or if pregnant before taking this medication. Abrupt discontinuation may lead to withdrawal symptoms such as anxiety, insomnia, and headaches; hence, it should be tapered off gradually under the physician's guidance. This medication is approved for children aged 3 years and older, and safety for monotherapy in children under the age of 13 has not been sufficiently established. In case of overdose, symptoms such as dizziness, drowsiness, or coma may occur; hence, the prescribed dosage must be adhered to strictly, and medical attention should be sought immediately if suspected. This medication should be kept out of reach of children and stored in its original container to maintain quality.

Suicidal ideation, suicidal behavior, depression, emotional instability, aggression, thought disorder, hyperactivity, abdominal pain, back pain, fatigue, fever, headache, viral infection, vasodilation, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysphonia, insomnia, neurogenic responses, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, erosion, acne, itching, rash, amblyopia, double vision, erectile dysfunction, weakness, lethargy, facial edema, hypertension, abdominal distension, anorexia, gingivitis, arthralgia, dizziness, hyperactivity syndrome, reflex changes, sensory abnormalities, anxiety, aggression, pneumonia, urinary tract infection, visual disturbances, viral infection, weight gain, drowsiness, aggression, emotional instability, hyperactivity syndrome, bronchitis, respiratory infection, dehydration, infectious mononucleosis, hepatitis, coagulopathy, loss of signs, laryngeal neuralgia, somnambulism, pseudocroup, hoarseness, injury due to accidents, cold syndrome, pain, dry mouth, abdominal distension, abnormal gait, confusion, tremor, vertigo, dyspnea, rash, myasthenia, back pain, headache, infection, constipation, diarrhea, nausea, vomiting, peripheral edema, weight gain, abnormal gait, amnesia, ataxia, confusion, dizziness, sensory loss, drowsiness, thought disorder, tremor, vertigo, dyspnea, pharyngitis, rash, amblyopia, suicidal ideation, suicidal behavior, depression, anxiety, hallucinations, psychosis, stupor, hallucinatory state, suicide attempt, agitation, hypertonia, movement disorders, myoclonic jerks, vestibular disorders, epistaxis, dyspnea, apnea, hair loss, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photodermatitis, leg ulcers, scalp seborrhea, psoriasis, epidermal peeling, maceration, skin nodules, melasma, skin necrosis, localized edema, hematuria, voiding dysfunction, hypoglycemia, urinary incontinence, vaginal bleeding, amenorrhea, menstrual abnormalities, menorrhagia, breast cancer, anovulation, ejaculatory dysfunction, neurogenic reactions, weight loss, edema, gout, hypoglycemia, anemia, lymphadenopathy, thrombocytopenia, petechiae, lymphadenopathy, lymphoid response, prothrombin reduction, edema, gout, hypoglycemia, weight loss, confusion, depression, dizziness, neurogenic reactions, perceptual disturbances, insomnia, neuropathy, decreased libido, anxiety, depersonalization, decreased reflexes, speech disorder, dream disturbances, dysphonia, emotional instability, nystagmus, stupor, perioral sensory disturbance, unusual euphoria, sensory hyperreactivity, reduced motor function syndrome, suicide attempt, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, hemoptysis, degeneration, itching, skin ulcers, dry skin, shingles, skin abnormalities, fungal dermatitis, furunculosis, herpes simplex, psoriasis, sweating, urticaria, vesicular rash, acne, hair abnormalities, maculopapular rash, nail abnormalities, skin carcinoma, skin discoloration, skin thickening, visual disturbances, ear pain, eye abnormalities, taste disturbances, hearing loss, conjunctival hyperemia, diabetic retinopathy, ocular pain, retinal microhemorrhage, retinal vein thrombosis, taste loss, urinary tract infection, voiding dysfunction, erectile dysfunction, urinary incontinence, vaginal miliary syndrome, mastalgia, menstrual abnormalities, polyuria, voiding dysfunction, cystitis, ejaculatory dysfunction, penile engorgement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal engorgement, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash with systemic symptoms, elevated liver function tests, erythema multiforme, falls, systemic edema, gynecomastia, hallucinations, hepatitis, systemic reactions including hypersensitivity, hyponatremia, jaundice, loss of consciousness, chorea and athetosis, movement disorders, dystonia, rhabdomyolytic syndrome, palpitations, pancreatitis, sexual dysfunction, skin and mucous membrane syndrome, thrombocytopenia, tinnitus, urinary incontinence, insomnia, nausea, pain, sweating, tremor, headache, abnormal sensations, lethargy

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

Opaque yellow hard capsules containing white or grayish powder

Package unit

30 capsules/bottle, 100 capsules/bottle