RISPERIDONE 1mg/ml Syrup



Risperidone Syrup 1 mg/ml, each ml contains : Risperidone 1 mg.



Risperidone with Risperidone as active ingredient, available as 1 mg/ml syrup for oral administration. 



  • 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.



Adults :

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 patient will benefit from daily doses 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 should be used cautiously in these kinds of patients.

Renal and Liver Insufficiency :

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 should be used cautiously in these kinds of patients.



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 arrhythmias.



Hypersensitivity to Risperidone.



  • 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.
  • Drug with Dopamine receptors antagonistic properties have been associated with the induction of tardive dyskinesia characterized by rhythmical involuntary movements, predominantly of the tongue and/or  face.  It  has  been  reported  that  the  occurrence  of  extrapyramidal  symptoms is  a  risk  factor  for  the development  of  tardive   dyskinesia.  If  signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotic drug 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 benefits outweigh the risks.



  • Should be used with caution in combination with other centrally acting drugs. 
  • Effects of Levodopa and Dopamine agonists may be antagonized.
  • Carbamazepine has been shown to decrease the plasma levels of the active antipsychotic fraction of Risperidone.
  • Phenothiazines,   tricyclic  antidepressants   and   some β-Blockers   may   increase   the   plasma concentrations of Risperidone, but not those of the antipsychotic fraction.
  • Fluoxetine may increase the plasma concentration of Risperidone but less of the antipsychotic fraction.



  • Common :

Insomnia, agitation, anxiety, and headache. Sedation has been reported more frequently in children and adolescents than in adults. In general, sedation is mild and transient.

  • Less Common :

Somnolence, fatigue, dizziness, impaired concentration, constipation, dyspepsia,  nausea/vomiting, abdominal pain,  blurred  vision,  priapism,  erectile  dysfunction,  ejaculatory  dysfunction, orgasmic dysfunction, urinary incontinence, rhinitis, rash, and other allergic reactions.



Risperidone Syrup 1 mg/ml     Box, 1 bottle @ 30 ml Reg. No. GKL1402349137A1







Manufactured by :


Sidoarjo – Indonesia