- Risperidone is a selective monoaminergic antagonist with unique properties. It has a high
affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors. Risperidone binds also
to alpha1-adrenergic receptors, and with lower affinity to H1-histaminergic and
alpha 2-adrenergic receptors. Risperidone has no affinity for cholinergic receptors.
Although risperidone is a potent D2 antagonist, which is considered to improve the positive
symptoms of schizophrenia, it causes less depression of motor activity and induction of
catalepsy than classical neuroleptics. Balanced central serotonin and dopamine antagonism
may reduce extrapyramidal side effect liability and extend the therapeutic activity to the
negative and effective symptoms of schizophrenia.
- Risperidone is completely absorbed after oral administration, reaching peak plasma
concentrations within 1 to 2 hours. The absorption is not affected by food and thus
risperidone can be given with or without meals. Risperidone is metabolized by cytochrome
P-450 IID6 to 9-hydroxy-risperidone which has a similar pharmacological activity as
risperidone. After oral administration to psychotic patients, risperidone is eliminated with
a half-life of about 3 hours. The elimination half-life of 9-hydroxy-risperidone and of the
active antipsychotic fraction is 24 hours. Risperidone is rapidly distributed. The volume of
distribution is 1- 2 L/kg. The plasma protein binding of risperidone is 88%, that of
9-hydroxy-risperidone is 77% one week after administration, 70% of the dose is excreted
in the urine and 14% in the faeces. In urine, risperidone plus 9-hydroxy-risperidone
represent 35 - 45% of the dose. The reminder are inactive metabolites.
- Risperidone is a selective monoaminergic antagonist with unique properties. It has a high
Rispen® is used to treat the following:
- Schizophrenia, where you may see, hear or feel things that are not there, believe things
that are not true or feel unusually suspicious or confused.
- Mania, where you may feel very excited, elated, agitated, enthusiastic or
hyperactive. Mania occurs in an illness called "bipolar disorder".
- Short-term treatment (up to 6 weeks) of long-term aggression in people with
Alzheimer’s dementia, who harm themselves or others. Alternative (non-drug)
treatments should have been used previously
Dosage & Administration
For the treatment of schizophrenia
The usual starting dose is 2 mg per day; this may be increased to 4 mg per day on the
second day, the dose may then be adjusted by the doctor depending on how the patient
responds to the treatment, most people feel better with daily doses of 4 to 6 mg. This total
daily dose can be divided into either one or two doses a day. The doctor will tell the
patient which is the best for him/her.
- Children and adolescents
Children and adolescents under 18 years old should not be treated with Rispen® for
For the treatment of mania
- Adults: The starting dose will usually be 2 mg once a day. The dose may then be
gradually adjusted by the doctor depending on how the patient responds to the treatment.
- Most people feel better with doses of 1 to 6 mg once a day.
- Children and adolescents: Children and adolescents under 18 years old should not be
treated with Rispen® for mania.
- Elderly people: (Either Schizophrenia or Mania ) : the starting dose will usually be 0.5
mg twice a day.
The dose may then be gradually adjusted by the doctor to 1 mg to 2 mg twice a day
depending on how much the patient respond to the treatment.
For the treatment of long-standing aggression in people with Alzheimer's dementia
- Adults (including elderly people)
The starting dose will normally be 0.25 mg twice a day. The dose may then be gradually
adjusted by the doctor depending on how the patient responds to the treatment. Most people
feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day. Treatment
duration in patients with Alzheimer’s dementia should not be more than 6 weeks.
- People with kidney or liver problems:
Regardless of the disease to be treated, all starting doses and following doses of Rispen®
should be halved. Dose increases should be slower in these patients. Rispen® should be used
with caution in this patient group.
- Do not stop using this medicine suddenly without asking your doctor.
- Each Film Coated tablet of Rispen® contains:
Risperidone 1 mg
Risperidone 2 mg
Risperidone 3 mg
Risperidone 4 mg
This product is contraindicated in patients with a known hypersensitivity to Risperidone.
- The patient should talk to doctor or pharmacist if he or she is taking any of the Following:
- Drugs that work on the brain such as benzodiazepines or opiates, some antihistamines,
Rispen® may increase the sedative effect of all of these.
- Medicine that may change the electrical activity of the heart, such as medicines for malaria,
heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants
or other medicines for mental problems.
- Drugs that cause a slow heart beat. Drugs that cause low blood potassium (e.g. certain
- Drugs to treat elevated blood pressure. Rispen® Tablets can lower blood pressure.
- Drugs for Parkinson's disease (such as levodopa), Water tablets (diuretics) used for heart
problems or swelling of parts of the body due to a build up of too much fluid (such as
furosemide or chlorothiazide).
- Rispen® Tablets taken by itself or with furosemide, may have an increased risk of stroke or
death in elderly people with dementia.
- The following drugs may reduce the effect of Risperidone: Rifampicin, Carbamazepine,
- The following drugs may increase the effect of Risperidone: Quinidine, Antidepressants,
beta blockers, Phenothiazines, Cimetidine, ranitidine.
- If the patient start or stop taking such medicines he/she may need a different dose of
- Symptoms resulting from an exaggeration of the drug :drowsiness and sedation, tachycardia
and hypotension, and extrapyramidal symptoms. Rare cases of QT-prolongation. The
alpha-blocking properties of bretylium might be additive to those of risperidone, resulting in
problematic hypotension. In case of acute overdosage, the possibility of multiple drug
involvement should be considered.
- 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.
- There is no specific antidote to Rispen® . Therefore appropriate supportive measures should
- Non-teratogenic Effects: Neonates exposed to antipsychotic drugs during the third trimester
of pregnancy are at risk for extra pyramidal and/or withdrawal symptoms following
delivery, there have been reports of agitation, hypertonia, tremor, somnolence, respiratory
distress and feeding disorder in these neonates.
• Antipsychotics should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
- Risperidone and 9-hydroxy-risperidone are also excreted in human breast milk. Therefore,
women receiving Risperidone should not breast feed.
- Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness,
drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no
expression on the face.
- Muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal
arm movements when walking, persistent blinking in response to tapping of the forehead (an
- Headache, difficulty falling or staying a sleep.
- Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, dizziness,
poor attention, feeling exhausted, sleep disorder.
- Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore
throat, dry mouth.
- Weight increased, increase in body temperature, decreased appetite
- Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages,
blurred vision, nose congestion, nose bleeding, cough.
- Urinary tract infection, bed wetting.
- Muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain, swelling
of arms and legs, pain in arms and legs.
- Rash, skin redness.
- Fast beating heart, chest pain.
- Blood prolactin hormone level increased.
Special warnings and special precautions for use:
- Due to alpha-blocking activity of Rispen®, (orthostatic) hypotension can occur, especially
during the initial dose-titration period. Rispen® should be used with caution in patients with
known cardiovascular disease and the dosage should be gradually titrated as recommended. A
dose reduction should be considered if hypotension occurs.
- Patients with diabetes mellitus who are started on atypical antipsychotic should be monitored
regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus who
are starting treatment with atypical antipsychotic should undergo fasting blood glucose testing
at the beginning of treatment and periodically during treatment. Patients who develop symptoms
of hyperglycemia during treatment with atypical antipsychotic should undergo fasting blood
glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was
discontinued; however, some patients required continuation of anti-diabetic treatment.
- Dopamine antagonistic drugs have been associated with the induction of tardive dyskinesia
characterized by rhythmical involuntary movements. Because Rispen® has a lower potential to
induce extrapyramidal symptoms than classical neuroleptics, it should have a reduced risk of
inducing as compared to classical neuroletics. If signs and symptoms of tardive dyskinesia
appear, the discontinuation of all antipsychotic drugs should be considered.
- As for all antipsychotic drugs, including Rispen® should be discontinued if signs and
symptoms of the Neuroleptic Malignant Syndrome appear.
- It is recommended to halve both the starting dose and the subsequent dose increments in
geriatric patients and in patients with renal or liver insufficiency.
- Caution is also due when prescribing Rispen® to patients with Parkinson's disease since,
theoretically, it might cause a deterioration of the disease.
- Classical neuroleptics are known to lower the seizure threshold. Caution is recommended when
treating patients with epilepsy.
- Patients may be advised to refrain from excessive eating in view of the possibility of weight
- Patients should be advised to avoid alcohol while taking Rispen®.
- Make sure your doctor knows if you are pregnant.
Rispen® : Blister of 10 tablets, pack of 2 blisters.
- Store in a dry place below 30ºC.