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Sedatives

Risperstad 2

 

Pack size:                          

Box of 6 blisters x 10 tablets.

 

Composition:

Each film-coated tablet contains risperidone 2 mg.

 

Shelf-life:  

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place.

Protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of schizophrenia and other psychoses.
  • Short-term treatment of acute manic or mixed episodes associated with bipolar disorder.
  • Treatment of irritability associated with autistic disorder in children.
     
  • Administrated orally without regarding to meals; either in once-daily dose or in 2 equally divide doses daily.
     
  • Schizophrenia:
    The usual initial oral dose of risperidone is 2 mg daily; this may be increased to 4 mg daily on the second day, and subsequently adjusted as required in steps of 1 or 2 mg according to tolerance, at intervals of not less than 24 hours. Most patients benefit from doses of 4 to 6 mg daily. Risperidone may be given once daily or in 2 divided doses. The maximum recommended dose is 16 mg daily.
  • Mania in bipolar disorder:
    A recommended initial oral dose is 2 to 3 mg once daily. Dosage adjustments of 1 mg daily may be made at intervals of not less than 24 hours up to a total of 6 mg daily.
  • Administration in children:
    Treatment of schizophrenia in adolescents aged 13-17 years, for the short-term treatment of acute manic or mixed episodes associated with bipolar disorder in children and adolescents aged 10 to 17 years, and for the treatment of irritability associated with autistic disorder in those aged 5 to 16 years.
    For schizophrenia or mania: An initial oral dose of 0.5 mg is given once daily in the morning or in the evening. This may be increased in steps of 0.5 or 1 mg according to tolerance, at intervals of not less than 24 hours, to a dose of 3 mg daily for schizophrenia or 2.5 mg daily for mania. The maximum recommended dose for both indications is 6 mg daily. The total daily dose may be given in 2 divided doses to those who experience persistent somnolence.
    For the treatment of irritability associated with autistic disorder: The following oral doses are given once daily or in 2 divided doses according to body-weight:
    Under 20 kg: the usual initial daily dose is 0.25 mg; this may be increased to 0.5 mg daily after at least 4 days and subsequently adjusted as required in steps of 0.25 mg, generally at intervals of no less than 2 weeks. The maximum recommended dose is 1 mg daily. Caution should be exercised with dosage for children who weigh less than 15 kg.
    20 kg and over: The usual initial daily dose is 0.5 mg; this may be increased to 1 mg daily after at least 4 days and subsequently adjusted as required in steps of 0.5 mg, generally at intervals of no less than 2 weeks. The maximum recommended dose is 2.5 mg daily in those weighing over 20 kg and 3 mg daily in those over 45 kg.
    For those who experience persistent somnolence, the total daily dose may be given as a single dose at bedtime, or in 2 divided doses, or in a reduced dose.
  • Elderly or debilitated patients: An initial oral dose of 0.5 mg twice daily slowly increased in steps of 0.5 mg twice daily, if necessary, to a dose of 1 to 2 mg twice daily. Above doses of 1.5 mg twice daily, increases should be made at intervals of at least 1 week.
  • Hepatic or renal impairment: The recommended initial oral dose of risperidone in patients with renal or hepatic impairment is 0.5 mg twice daily; this may be slowly increased in steps of 0.5 mg twice daily, if necessary, to a dose of 1 to 2 mg twice daily. Above doses of 1.5 mg twice daily, increases should be made at intervals of at least 1 week.
     

Or as prescribed by physicians.

 

  • Hypersensitivity to risperidone or to any ingrdient of the drug.

     

  • Risperidone is reported to be less likely to cause sedation or extrapyramidal effects but agitation may occur more frequently.
  • Other common adverse effects: include insomnia, anxiety, and headache.
  • Less common: Dyspepsia, nausea and vomiting, abdominal pain, constipation, blurred vision, sexual dysfunction including priapism, urinary incontinence, rash and other allergic reactions, drowsiness, concentration difficulties, dizziness, fatigue, and rhinitis.
  • In addition to orthostatic hypotension, hypertension has been reported infrequently.
  • Other adverse effects with risperidone include cerebrovascular accidents, tachycardia, weight gain, oedema, increased liver enzyme values, and decreases in neutrophil or thrombocyte counts. Risperidone may cause dose-dependent increases in prolactin levels.
  • In rare cases, hyperglycaemia and exacerbation of pre-existing diabetes mellitus have also been reported. Clinical monitoring for hyperglycaemia has been recommended, especially in patients with or at risk of developing diabetes.
  • Other rare effects include seizures, body temperature dysregulation, hyponatraemia, neuroleptic malignant syndrome, and tardive dyskinesia.

     

  • Serious adverse effects, including an increased risk of death, have been reported in geriatric patients receiving risperidone or other atypical antipsychotic agents in clinical trials in patients with dementia-related psychosis. Risperidone is not approved for the treatment of dementia-related psychosis.
  • Because of the possibility of orthostatic hypotension, caution should be observed in patient with known cardiovascular disease (e.g. history of myocardial infarction or ischemia, heart failure, conduction abnormalities), cerebrovascular disease, conditions that would predispose patients to hypotension (e.g. dehydration, hypovolemia) and patients receiving antihypertensive agents.
  • Because severe hyperglycemia, sometimes associated with ketoacidosis, hyperosmolar come, or death, has been report in patients receiving certain atypical antipsychotic agents, including risperidone, patients with preexisting diabetes mellitus in whom therapy with atypical antipsychotic is initiated should be closely monitored for worsening of glucose control; those with risk factors for diabetes (e.g. obesity, family history of diabetes) should undergo fasting blood glucose testing upon therapy initiation and periodically throughout treatment.
  • Patients with parkinsonian syndrome or dementia with Lewy bodies who receives antipsychotics, including risperidone, reportedly have an increased sensitivity to antipsychotic agents. Clinical manifestations of this increased sensitivity have been reported to include confusion, obtundation, postural instability with more frequent falling, extrapyramidal adverse effects, and clinical features consistent with neuroleptic malignant syndrome.
  • Risperidone should be used with caution in patients with cardiovascular disease, including conditions associated with QT prolongation, or conditions predisposing to hypotension. Caution is also recommended in patients with a history of or at risk of developing cerebrovascular disease, in patients with Parkinson's disease or epilepsy, and in patients with hepatic or renal impairment.
  • Gradual withdrawal of risperidone is recommended because of the risk of withdrawal symptoms, including sweating, nausea and vomiting, and rebound psychosis, with abrupt cessation.
  • The film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine.
  • Pregnancy: Placental transfer of risperidone occurs in rat pups. There are no adequate and well-controlled studies in pregnant women. Risperidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Lactation: In animal studies, risperidone and 9 – hydroxyrisperidone are excreted in milk. Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving risperidone should not breast – feed.
  • Effects on ability to drive and use machines: Because risperidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including driving automobiles, until they are reasonably certain that risperidone therapy does not adversely affect them.

     

Contact us

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