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Rispharm®
Risperidone
Pharmacological properties:
Rispharm® is a novel benzisoxazole-derivative antipsychotic agent. Rispharm®
has a balanced central serotonin and dopamine antagonist activity that improve
both negative, positive, and affective symptoms of schizophrenia with reduced
liability to extrapyramidal side effects compared to classical neuroleptics.
Indications:
Acute and chronic schizophrenic psychoses, and any other psychotic conditions
characterized by usual positive and/or negative symptoms. It also relieves the
affective symptoms associated with schizophrenia, such as anxiety, depression and
feeling of guilt.
Dosage and Administration:
Adults:
- Rispharm® may be given once or twice daily.
- The usual optimal dosage is 4-8mg/day. The dose is titrated to 6mg/day
gradually over 3 days starting with 2mg/day then dose is increased to 4mg
on the second day and 6mg on the third day.
- Doses above 10mg/day may cause extrapyramidal symptoms.
- Doses of 16mg/day should not be exceeded since the safety of such doses
has not been evaluated.
- As absorption is not affected by food, Rispharm® can be given regardless of
meals.
- When switching from other antipsychotics, gradual discontinuation of the
previous agent is recommended meanwhile Rispharm® is initiated. In case of
depot antipsychotics; Rispharm® is taken in place of the next injection.
- The need for any anti-parkinson medication should be re-evaluated
periodically.
Geriatrics: The recommended starting dose is 0.5mg BID titrated to 1-2mg BID
gradually by 0.5mg BID increments.
Pediatrics: Safety and effectiveness has not been established in children less
than 15 years of age.
Renal or hepatic impairment:
The recommended starting dose is 0.5mg BID (0.5 ml oral solution) titrated to
1-2mg BID gradually by 0.5mg BID increments.
Pregnancy and Lactation:
- Pregnancy category C: Risperidone should only be used if the potential
benefit justifies the potential risk to the fetus.
- Risperidone is excreted in human breast milk, therefore breast feeding
should be discontinued during course of treatment.
Side Effects:
Rispharm® is generally highly tolerated; some side effects cannot be easily
differentiated from the symptoms of the disease itself. Commonly insomnia,
agitation, anxiety, and headache are encountered. Less commonly somnolence,
fatigue, dizziness, impaired concentration, blurred vision, extrapyramidal
symptoms, rhinitis, rash and other allergic reactions, dyspepsia, nausea,
vomiting, abdominal pain, constipation, erectile dysfunction, priapism,
ejaculatory dysfunction, orgastic dysfunction, urinary incontinence, orthostatic
hypotension, reflex tachycardia, hypertension, a mild fall in neutrophil and/or
thrombocyte count, dose-induced increase in plasma prolactin (Which may
result in galactorrhea, gynecomastia, disturbances of the menstrual cycle and
amenorrhea), weight gain, edema, increased hepatic enzymes levels, water
intoxication, tardive dyskinesia, neuroleptic malignant syndrome, body
temperature disregulation and seizures.
Precautions:
- Risperidone should be given with caution to patients with known
cardiovascular disease because it may cause orthostatic hypotension
which can be minimized by following the recommended gradual
titration at the beginning of therapy and reducing the dose if it occurs.
- Risperidone has a low potential to cause tardive dyskinesia compared
to other neuroplastics, but if happened discontinuation of treatment is
recommended.
- As for all neuroleptics, discontinuation of therapy is recommended if
signs and symptoms of the neuroleptic malignant syndrome appear.
- Cerebrovascular adverse events including stroke were reported in
trials in elderly patients with dementia related psychosis.
- Hyperglycemia has been reported in patients treated with atypical
antipsychotics including risperidone. Diabetic patients should be
-
monitored regularly for worsening of glucose control. Patients with
risk factors for diabetes mellitus should undergo fasting blood glucose
testing at the beginning of treatment and periodically during
treatment. Any patient treated with atypical antipsychotics should be
monitored for symptoms of hyperglycemia.
Risperidone should be given with caution to patients suffering from
Parkinson as it might cause deterioration of the disease.
Both starting and maintenance doses should be halved for geriatrics
and patients with renal or liver impairment.
Neuroleptics are known to lower the seizers threshold, thus patients
with epilepsy should be treated cautiously.
It is advised to avoid excessive eating due to possibly of weight gain
during treatment with risperidone.
It is advised not to drive or operate machinery until individual
susceptibility to alteration in mental awareness is monitored.
Oral solution is incompatible with tea and cola.
Contraindications
Hypersensitivity to risperidone.
Drug interactions:
- Risperidone may antagonize the effects of levodopa and other
dopamine agonists.
- Plasma levels of the active metabolite of risperidone is reported to be
decreased by carbamazepine and other hepatic enzyme inducers.
Risperidone dose might be decreased if necessary upon
discontinuation of these agents.
- Phenothiazines, tricyclic anti depressants and some B-blockers may
increase the plasma concentrations of risperidone but not those of the
active metabolite. Fluoxetine also may increase plasma concentrations
of risperidone but less of the active metabolite.
Presentations:
Rispharm® 0.5mg tab: Risperidone 0.5mg/tablet.(Pack of 30 Tabs.).
Rispharm® 1mg tab: Risperidone 1mg/tablet.(Pack of 30 Tabs.).
Rispharm® 2mg tab: Risperidone 2mg/tablet.(Pack of 30 Tabs.).
Rispharm® 3mg tab: Risperidone 3mg/tablet.(Pack of 30 Tabs.).
Rispharm® 4mg tab: Risperidone 4mg/tablet.(Pack of 30 Tabs.).
Rispharm® 6mg tab: Risperidone 6mg/tablet.(Pack of 30 Tabs.).
Rispharm® Oral solution: Risperidone 1mg/ml.(Pack of 100ml.).