COMPOSITION :
Respirex® Syrup 1 mg/ml, each ml contains : Risperidone 1 mg.
DESCRIPTIONS :
Respirex® with Risperidone as active ingredient, available as 1 mg/ml syrup for oral administration.
INDICATIONS :
- Treatment broad range of patients with schizophrenia, including first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted affect, emotional and social withdrawal, poverty of speech) are prominent.
- Alleviates affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia.
DOSAGE AND ADMINISTRATIONS :
Adult :
A starting dose : 2 mg/day. The dosage may be increased on the second day to 4 mg and then on the third day increased to 6 mg/day. Risperidone may be given once daily or twice daily. From then on the dosage can be maintained unchanged, or further individualized, if needed.
Most patients will benefit from daily dose between 4 and 6 mg.
Doses above 10 mg/day have not been shown to be superior in efficacy to lower doses and may cause extrapyramidal symptoms.
Since the safety of doses above 16 mg/day has not been evaluated, doses above this level should not be used.
A Benzodiazepine may be added to Risperidone when additional sedation is required.
Children :
Experience in schizophrenia is lacking in children aged less than 15 years.
Geriatrics (elderly) :
Initial dose recommended is 0.5 mg, 2 times daily. This dose can be adjusted according to each patient’s needs with addition of 0.5 mg, 2 times daily, until 1 – 2 mg, 2 times daily. Risperidone is well tolerated by elderly patients.
Renal and liver insufficiency :
Patients with renal insufficiency will experience deficiency in the ability of eliminating active fraction of antipsychotic compared to normal patients. Patients with liver insufficiency will experience increases in the plasma concentration of Risperidone free fractions. Regardless of the indication, initial dose and maintenance dose in the patients should be half of normal dose and dose titration should be more slowly in patients with renal and liver insufficiency. Risperidone should be used cautiously in these kinds of patients.
OVERDOSAGE :
Symptoms of Overdosage :
- In general, reported signs and symptoms have been those resulting from an exaggeration of the drug’s known pharmacological effects. These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms.
- Overdosages of up to 360 mg have been reported.
- In overdose, rare case of QT-prolongation have been reported.
- In case of acute overdosage, the possibility of multiple drug involvement should be considered.
Treatment of Overdosage :
- Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
- Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered.
- Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrythmias.
CONTRAINDICATION :
Hypersensitivity to Risperidone.
WARNINGS AND PRECAUTIONS :
- Risperidone is not recommended for use in children aged < 15 years old.
- Due to the α-blocking activity of Risperidone, orthostatic hypotension can occur, especially during the initial dose-titration period. Risperidone should be used with caution in the patient with known cardiovascular disease. A dose reduction should be considered if hypotension occurs.
- Doses above 5 mg, twice daily have not been shown to be superior in efficacy to lower doses and may cause extrapyramidal symptoms. If additional sedation is required, administration of drugs such as Benzodiazepine is better than increase the dose of Risperidone.
- Drug with dopamine receptors antagonistic properties have been associated with the induction of tardive dyskinesia characterized by rhythmical involuntary movement, predominantly of the tongue and/or face. It has been reported that the occurrence of extrapyramidal is a risk factor for the development of tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotic drugs should be considered.
- Caution is also due when prescribing Risperidone to patients with Parkinson’s disease since, theoretically, it might cause a deterioration of the disease.
- Caution is recommended when treating patients with epilepsy.
- Patient may be advised to refrain from excessive eating in view of the possibility of weight gain.
- Risperidone may interfere with activities requiring mental alertness. Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
- Risperidone should only be used during pregnancy and lactation if the benefit outweighed the risks.
PRESENTATION :
Respirex® Syrup 1 mg/ml Box, 1 bottle @ 30 ml Reg. No. DKL1402349037A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia