Aripiprazole tablets

Aripiprazole has a high affinity for dopamine D2, D3, 5-HT1A and 5-HT2A receptors, and a moderate affinity for D4, 5-HT2c, 5-HT7, a1, H1 receptors and 5-HT reabsorption sites. Aripiprazole produces its anti-schizophrenia effect through partial agonism of D2 and 5-HT1A receptors and antagonism of 5-HT2A receptors.

Aripiprazole.

The 5 mg tablet is blue; the 10 mg tablet is pink; and the 15 mg tablet is yellow.

1. For the treatment of schizophrenia. 2. The efficacy of aripiprazole in the treatment of schizophrenia has been established in short-term (4-week and 6-week) controlled trials in patients with schizophrenia. Physicians who choose aripiprazole for long-term treatment should regularly re-evaluate the long-term efficacy of the drug for individual patients.

Take orally once a day, with an initial dose of 5 mg/day in the first week and an increase to 10 mg/day in the second week. After 2 weeks of medication, the dose can be increased to 15 mg/day based on individual efficacy and tolerance. The maximum daily dose should not exceed 30 mg.

1. In short-term placebo-controlled trials, adverse events occurred in aripiprazole-treated patients at an incidence of 2% and above that of placebo. 2. Dose-related adverse events Four fixed-dose (2, 10, 15, 20, and 30 mg/day) aripiprazole-placebo controlled trials evaluated the dose-effect relationship of the incidence of adverse events during treatment. This stratified analysis by study indicated that the only adverse event that may have a dose-effect relationship and was most significant only at 30 mg was somnolence (7.7% for placebo, 8.7% for 15 mg, 7.5% for 20 mg, and 15.3% for 30 mg). 3. Extrapyramidal symptoms In short-term placebo-controlled trials, the incidence of EPS reported in aripiprazole-treated patients was 6% and that in placebo was 6%, showing no difference between aripiprazole and placebo. The exception was the Bames Akathisia Rating Scale (0.08 for aripiprazole and -0.05 for placebo). Similarly, in long-term (26 weeks) placebo-controlled trials, no differences were shown between aripiprazole and placebo. 4. Laboratory Abnormalities 4--Intergroup comparisons in the 6-week placebo-controlled trials showed that there were no clinically significant differences between aripiprazole and placebo in the proportion of subjects with changes in routine blood biochemistry, blood routine, or urine routine parameters. Similarly, there was no difference between aripiprazole/placebo in the discontinuation rate caused by this. In long-term (26 weeks) placebo-controlled trials, there were no clinically significant differences in the mean changes from baseline in prolactin, fasting blood glucose, triglycerides, HDL, LDI, and total cholesterol between aripiprazole and placebo treatments. 5. Increase In short-term trials, there was a slight difference in the mean weight gain between aripiprazole and placebo treatments (0.7kg and -0.05kg, respectively), and there was also a difference in the percentage of patients who met the weight gain criteria (weight gain of 7%): 8% for aripiprazole and 3% for placebo. 6.ECG: ChangesPooled comparisons of placebo-controlled trials showed no significant differences between aripiprazole and placebo in the proportion of patients experiencing important changes in FCG parameters; in fact, aripiprazole slightly shortened the QTc interval over the dose range of 10 to 30 mg/day. The mean increase in heart rate was 4 beats/min for aripiprazole-treated patients and 1 beat/min for placebo-treated patients. 7.Other Findings Observed in Clinical Trials (Adverse Events with an Incidence of 2%)7.1 Adverse events are systematically classified and listed in order of decreasing frequency using the following frequency definitions: Common adverse events are those occurring in at least 1/100 patients (listed here are only those adverse reactions not listed in the table in placebo-controlled trials); Uncommon adverse events are those occurring in 1/100-1/1000 patients; Rare adverse events are those occurring in fewer than 1/1000 patients. 7.2 Systemic: Common - influenza syndrome, peripheral edema, chest pain, neck pain, stiff neck; Uncommon - pelvic pain, suicidal tendency, facial edema, malaise, photosensitivity, arm stiffness, jaw pain, chills, bloating, tight jaw, enlarged abdomen, chest tightness; Rare - sore throat, tight back, heavy head, candidiasis, tight throat, stiff legs, tight neck, Mendelson's syndrome, heat stroke. 7.3 Cardiovascular system: Common - hypertension, tachycardia, hypotension, bradycardia; Uncommon - palpitations, hemorrhage, myocardial infarction, QT interval prolongation, cardiac arrest, atrial fibrillation, heart failure, AV block, myocardial ischemia, phlebitis, deep vein thrombosis, angina pectoris, extrasystoles: Rare - vasovagal reaction, cardiomegaly, atrial flutter, thrombophlebitis. 7.4 Digestive system: Common - anorexia, nausea and vomiting: Uncommon - increased appetite, gastroenteritis, dysphagia, flatulence, gastritis, caries, gingivitis, hemorrhoids, gastroesophageal reflux, gastrointestinal bleeding, periodontal abscess, tongue edema, fecal incontinence, colitis, rectal bleeding, stomatitis, oral ulcer, cholecystitis, fecal impaction, oral candidiasis, cholelithiasis, heating, intestinal obstruction. Peptic ulcer; Rare - esophagitis, gingival bleeding, glossitis, hematemesis, melena, duodenal ulcer, cheilitis, hepatitis, hepatomegaly. Pancreatitis, intestinal perforation. 7.5 Endocrine system: Uncommon - hypothyroidism: Rare - goiter, hyperthyroidism. Blood/Lymphatic System: Common - ecchymoses, anemia: Uncommon - hypochromic anemia, leukopenia, leukocytosis, lymphadenopathy, thrombocytopenia; Rare - eosinophilia, thrombocytosis, megaloblastic anemia. 7.6 Metabolic and Nutritional Disorders: Common - weight loss, increased creatine phosphokinase: Uncommon - dehydration, edema, hypercholesterolemia, hyperglycemia, hypokalemia, increased urine sugar, increased alanine aminotransferase, hyperlipidemia, hypoglycemia, thirst, increased urea nitrogen, hyponatremia, increased aspartate aminotransferase, increased alkaline phosphatase, iron deficiency anemia. Increased creatinine, bilirubinemia, increased lactate dehydrogenase, obesity; Rare - hyperkalemia, gout, hypernatremia, cyanosis, hyperuricemia, hypoglycemic reaction. 7.7 Musculoskeletal System: Common - muscle cramps; Uncommon - arthralgia, bone pain, myasthenia, arthritis, arthropathy, muscular weakness, cramps, bursitis; Rare - rhabdomyolysis, tendinitis, tenosynovitis, rheumatoid arthritis, myopathy. 7.8 Nervous System: Common - depression, nervousness, increased salivation, hostility, suicidal thoughts, manic reaction, abnormal gait, confusion, cogwheel rigidity; Uncommon - dystonia, spasticity, impaired attention, paresthesia, vasodilation, dysesthesia, tremor in limbs, impotence, bradykinesia, decreased libido, panic attack, apathy, movement disorder, somnolence, vertigo, dysphonia, tardive dyskinesia, ataxia, memory impairment, coma, increased libido, amnesia, cerebrovascular accident, hyperactivity, depersonalization, hypokinesia, akathisia, myoclonus, restlessness, neuropathy, increased reflexes, slow thinking, hyperkinesia, hyperesthesia, hypotonia, oculomotor crisis; Rare - delirium, euphoria, bucco-lingual syndrome, akinesia, affective blunting, decreased consciousness, ataxia, cerebral ischemia, decreased reflexes, obsessive-compulsive thinking, intracranial hemorrhage. 7.9 Respiratory system: Common - dyspnea, pneumonia; Uncommon - asthma, epistaxis, hiccups, laryngitis; Rare - hemoptysis, aspiration pneumonia, sputum, dry nasal cavity, pulmonary edema, pulmonary embolism, hypoxia, respiratory failure, apnea.7.10 Skin and appendages: Common - dermatitis; Rare - maculopapular rash, exfoliative dermatitis, urticaria.7.11 Special sensory system: Common - conjunctivitis, earache; Uncommon - dry eyes, eye pain, tinnitus, otitis media, cataract, taste changes, blepharitis; Rare - increased tearing, frequent blinking, otitis externa, amblyopia, deafness, diplopia, eye hemorrhage, photophobia. Urogenital System: Common - interrupted urine flow; Uncommon - cystitis, frequent urination, increased leucorrhea, urinary retention, hematuria, dysuria, amenorrhea, abnormal ejaculation, vaginal bleeding, candidal vaginitis, renal failure, uterine bleeding, menorrhagia, proteinuria, kidney stones, excessive nocturia, polyuria, urgency; Rare - breast pain, cervicitis, female lactation, anorgasmia, urethral burning, diabetes, gynecomastia, urinary stones, priapism.

Patients with known hypersensitivity to this product are contraindicated.

Precautions for children: There is currently a lack of sufficient clinical experience in children. Precautions for pregnancy and lactation: It is not clear whether this product is safe for pregnant women to take. For pregnant women, the pros and cons should be weighed to decide whether to take this product. It can only be used when the potential benefits outweigh the risks, otherwise it should not be taken during pregnancy and lactation. Precautions for the elderly: Aripiprazole is well tolerated by the elderly at the recommended dose and no dose adjustment is required.

1. Use with caution when combined with other drugs that act on the central nervous system and alcohol. 2. Aripiprazole may enhance the effects of certain antihypertensive drugs. 3. CYP3A4 inducers (such as carbamazepine) will increase the clearance rate of aripiprazole and reduce its blood concentration. CYP3A4 inhibitors (such as ketoconazole) or CYP2D inhibitors (such as quinidine, fluoxetine, paroxetine) can inhibit the elimination of aripiprazole and increase its blood concentration.

Seal tightly and store in a cool, dry place.

5 mg

24 months

ZheJiang Otsuka Pharmaceutical Co., Ltd.

• Founded in:

  1991-10-12

• Address:

  No. 1 Shangguafan, Jinnan Street, Lin'an District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100609129453D

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  $54,333,333

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