DRUG INTERACTIONS :

- Concomitant use of Risperidone with Rifampicin, Carbamazepine, Phenytoin and Phenobarbital lead to a

decrease in the effect of Risperidone.

- Concomitant use of Risperidone with Quindine, antidepressant such as (Paroxetine, Fluoxetine,

tricyclic antidepressants), beta blockers, Phenothiazines, Cimetidine, Ranitidine, Itraconazole,

Ketoconazole, Ritonavir, verapamil, Sertraline or Fluvoxamine lead to an increase in the effect of

Risperidone.

- Concomitant use of Risperidone with benzodiazepines ,opiates , alcohol and some antihistamines may

increase the risk of sedation.

- Risperidone inhibits the effect of levodopa and other dopamine agonist.

ADVERSE EFFECTS :

Respirotab is generally well tolerated and may has some side effects that doesn’t occur to all patients.

Common effect: insomnia, agitation, anxiety and headache

Less common effect: Somnolence, fatigue, dizziness, impaired concentration, constipation, dyspepsia,

nausea, vomiting, abdominal pain, blurred vision, erectile and ejaculatory dysfunction, infections,

appetite change, hyperprolactinemia, menstrual disorder and weigh increase. Respirotab also has lower

propensity to induce extrapyramidal symptoms than typical antipsychotic and these symptoms are:

tremor, rigidity, dystonia and muscle spasms.

OVERDOSE :

Symptoms of overdose: drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms.

Overdose treatment: 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 only when drug intake was less than one hour

before. Cardiovascular monitoring should commence immediately and should include continuous

electrocardiographic monitoring to detect possible arrhythmias. There is no specific antidote to

Risperidone. Therefore, appropriate supportive measures should be instituted. In case of severe

extrapyramidal symptoms anticholinergic medication should be administrated and medical monitoring

should be continued till the patient is treated.

STORAGE INSTRUCTIONS :

Store below 30°C, in a dry place.

PRESENTATION :

Respirotab 2 mg tablet : blister pack of 20 tablets and hospital packs of different sizes.

Respirotab 3 mg tablet : blister pack of 20 tablets and hospital packs of different sizes.

Colour Information :

Reflex blue C

Black

COMPOSITION :

Each f/c tablet contains : Risperidone 2mg, 3mg.

DESCRIPTION :

Respirotab (Risperidone) is antipsychotic belong to second generation (atypical) agents that works by

changing the imbalance of some substances in the brain “increase in dopamine that has an effect on the

patient” rebalances them also it does not cause significant extrapyramidal symptoms (disorders in body's

movement) like other antipsychotic drugs.

The effect of Risperidone is by block dopamine (D2) receptors and serotonin (5-HT2) receptors, its affinity

for (5-HT2) receptors is more than (D2) receptors consequently it not causes significant extrapyramidal

symptoms in a comparison with first generation antipsychotics, also has an activity to block α1

adrenergic antagonist and H1 histamine antagonist.

INDICATION & DOSAGE :

Treatment of schizophrenia :

Adults: The starting dose is 2 mg per day, may be increased in the second day to 4 mg per day, slower

titration is appropriate in some patients.

The usual dose is 4-6mg per day and dose adjustment should be done according to patient’s

response.

Doses above 10mg per day not give superior efficacy to lower doses and may cause extrapyramidal symptoms and the safety of doses above 16mg per day has not been evaluated so it is not

recommended to be used.

Elderly: The starting dose is 0.5 mg twice a day then increased gradually by 0.5mg twice daily until reach

1-2mg twice daily by physician.

Treatment of mania in bipolar disorder :

Adults: The starting dose is 2 mg daily may be increased gradually by 1 mg daily if required.

The usual dose is 1 – 6 mg daily.

Elderly: The starting dose is 0.5 mg twice a day then increased gradually by 0.5mg twice daily until reach

1-2mg twice daily by physician.

Patients with kidney or liver problems:

Patient with kidney problem have less ability to eliminate the drug also patient with liver problems has

increases in plasma concentration of Risperidone so the starting and usual doses should be halved for

those patients and dose titration should be slower.

* Note :The total daily dose can be used at once time or divided into doses during the day and that is

determined by your doctor for what is best for patient.

RESTRICTIONS ON USE :

Contraindications

- Hypersensitivity to Risperidone.

Precautions

- If you have a heart problem, prone to low blood pressure or you are using medicines for your blood

pressure and if you had have stroke.

- If you have Neuroleptic Malignant Syndrome , Parkinson’s disease or dementia.

- If you have experienced low levels of white blood cells in the past.

- If you have diabetes, epilepsy or elevate level of prolactin hormone.

- If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are

taking Respirotab.

-If you or someone in your family has history of blood clot, as antipsychotics have been associated with

formation of blood clots.

- Respirotab should not be interrupt but should be decreased gradually over few days.

- Don’t take double doses (two doses at the same time) to make up for a forgotten dose.

Use in Pregnancy & Lactaion

Respirotab is used in pregnancy only if potential benefits outweighs the risks. While in breastfeeding it's

not known whether Risperidone is excreted in human milk, therefore women receiving Respirotab should

avoid breastfeeding.

Effects on ability to drive vehicles and use machines

Dizziness, tiredness, and vision problems may occur during treatment with Respirotab. Don’t drive or use

any tools or machines without talking to your doctor first.

012-06-184 04/19

Respirotab