Sitipentene 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, the dose should be titrated as follows over the first 3 days of treatment. Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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 abrupt discontinuation of treatment), 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 used concomitantly with another antiepileptic drug, the dose should be changed 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, the dose should be titrated as follows over the first 3 days of treatment. Day 1: Administer one 300 mg capsule of this medicine once daily, or one 100 mg capsule of this medicine 3 times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this medicine 2 times daily, or two 100 mg capsules of this medicine 3 times daily (gabapentin 600 mg/day) From Day 3 onward: Administer one 300 mg capsule of this medicine 3 times daily, or three 100 mg capsules of this medicine 3 times daily (gabapentin 900 mg/day) Alternatively, as a starting dose, one 300 mg capsule of this medicine 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 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. 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 medicine should be increased in 100 mg increments. 4. Elderly patients Dose adjustment may be necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance 80 mL/min or less) 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) ≥ 80: Total daily dosea 900~2,400 (mg/day) Renal function, creatinine clearance (mL/min) 50~79: Total daily dosea 600~1,800 (mg/day) Renal function, creatinine clearance (mL/min) 30~49: Total daily dosea 300~900 (mg/day) Renal function, creatinine clearance (mL/min) 15~29: Total daily dosea 150b~600 (mg/day) Renal function, creatinine clearance (mL/min) < 15: Total daily dosea 150b~300 (mg/day) 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) Dose for patients on hemodialysis Initial dose: Gabapentin 300~400 mg is recommended. Maintenance dose: Administer gabapentin 200~300 mg after 4 hours of hemodialysis; do not administer this medicine on days when hemodialysis is not performed. 6. Method and duration of administration 1) 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 convulsions. 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 administered concomitantly with antacids containing magnesium or aluminum, this medicine should be administered at least 2 hours after the antacid. This can greatly 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 switched to another alternative, this should be done gradually over at least 1 week (a longer period may be needed at the prescriber's discretion). 5) To reduce the main adverse reactions, 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 through 12 years Day 1: Administer gabapentin 10 mg/body weight (kg) Day 2: Administer gabapentin 20 mg/body weight (kg) From day 3 onward: Administer gabapentin 30 mg/body weight (kg) Titrate over the first 3 days of treatment to achieve a maintenance dose of gabapentin 30 mg/kg/day. If necessary, the dose may be increased to a maximum of 40 mg/kg/day. The total daily dose of this medicine should be divided into 3 doses.

This medication is used as an anticonvulsant to control seizures. There is a risk of developing suicidal thoughts or behaviors, as well as mental health issues such as depression during treatment, so patients and caregivers should inform healthcare professionals immediately if these symptoms occur. Abrupt discontinuation of this medication may exacerbate seizures or result in status epilepticus, so it should be discontinued gradually under a doctor's guidance. Specific animal studies have reported a potential for certain cancers; however, the carcinogenic risk in humans is not yet clear. There have been rare reports of sudden and unexpected deaths, but these are within the risk range of epilepsy patients themselves. If symptoms of pancreatitis, such as persistent upper abdominal pain, nausea, and repeated vomiting occur, this medication should be discontinued immediately, and a doctor should be consulted. Among children aged 3 to 12 years, central nervous system adverse reactions such as emotional instability, aggression, abnormal thinking, and hyperactivity may occur, so caution is advised. This medication and CNS depressants, including narcotics, can pose a risk of profound sedation, respiratory depression, coma, and even death when taken together, so coadministration must be done with great caution, and if necessary, the minimum dose should be used for the shortest duration. Patients with a history of hypersensitivity, acute pancreatitis, patients with generalized seizures, and lactose intolerance should not take this medication. Patients with impaired kidney function, the elderly, those with a history of psychosis, children with attention deficit disorder, pregnant or nursing women should use this medication with special caution. During treatment, side effects such as drowsiness, dizziness, ataxia, memory loss, nausea, vomiting, etc., may occur, and these symptoms may impair the ability to drive or operate machinery. During pregnancy, the potential risk to the fetus necessitates consultation with a healthcare professional prior to taking this medication, and nursing mothers should also consult a doctor before use. Suddenly discontinuing this medication can result in withdrawal symptoms such as anxiety, insomnia, nausea, shaking, headaches, and depression, so dosages should be adjusted according to the doctor's instructions. This medication may interact with other drugs, so it is essential to inform healthcare providers about other medications being used or alcohol consumption. Finally, store this medication out of reach of children, and do not transfer it from its original container to another container to ensure the quality and safety of the medication.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, abdominal pain, lower back pain, fatigue, fever, headache, viral infections, vascular dilation, constipation, abnormal teeth, diarrhea, indigestion, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysarthria, insomnia, neurogenic responses, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, fatigue, facial swelling, hypertension, bloating, decreased appetite, gingivitis, purpura, arthralgia, hyperactivity, increased reflex movements, decrease or absence, sensory abnormalities, anxiety, pneumonia, urinary tract infection, visual disturbances, viral infections, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation abnormalities, loss of warning signs, laryngeal neuralgia, somnambulism, pseudo-croup, hoarseness, trauma from accidents, cold syndrome, pain, dry mouth, abnormal gait, confusion, sensory impairment, tremors, dizziness, shortness of breath, hematuria, urinary disorders, oliguria, cystitis, urinary retention, incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, heavy menstrual bleeding, breast cancer, anorgasmia, ejaculation disorders, blood coagulation abnormalities, confusion, depression, neurogenic responses, perceptual disturbance, insomnia, neuropathy, decreased libido, anxiety, depersonalization, reduced reflexes, speech disorders, dream disturbances, dysarthria, emotional instability, confusion, perioral sensory disturbance, abnormal euphoria, sensory hyperreactivity, movement dysfunction, suicide attempt, agitation, heightened tension, increased libido, movement disorders, myoclonic jerks, vestibular disorders, increased cough, bronchitis, rhinitis, sinusitis, pneumonia, asthma, lung abnormalities, epistaxis, itching, skin ulcers, dry skin, herpes zoster, 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 abnormalities, hearing loss, conjunctival injection, diabetic retinopathy, ocular pain, microhemorrhage in the fundus, retinal vein thrombosis, loss of taste, urinary tract infection, urinary disorders, erectile dysfunction, incontinence, vulvodynia, breast pain, menstrual irregularities, polyuria, urinary retention, cystitis, ejaculation disorders, penile enlargement, gynecomastia, nocturnal enuresis, pyelonephritis, scrotal enlargement, frequent urination, urgency, urinary abnormalities, tongue paralysis, increased serum creatine phosphokinase, rhabdomyolysis, acute renal failure, urticaria, allergic reactions, hair loss, anaphylaxis, angioedema, hyperglycemia, hypoglycemia, breast enlargement, chest pain, toxic epidermal necrolysis, eosinophilia, drug rash accompanied by systemic symptoms, liver function test elevation, erythema multiforme, falls, generalized edema, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea and athetosis, movement disorders, muscle tone abnormalities, myotonic dystrophy, palpitations, pancreatitis, sexual dysfunction, sicca syndrome, thrombocytopenia, tinnitus, incontinence, anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, fatigue

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness for a longer period.

Appearance

Hard capsules with off-yellow upper and lower parts containing white to light gray powder

Package unit

30 capsules/bottle, 100 capsules/bottle