📌 COMPOSITION

Each F/C tablet contains: Risperidone 2 mg, 3 mg.

📌 DESCRIPTION

Respirotab (Risperidone) is an antipsychotic belonging to the 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" and rebalances them. It also does not cause significant extrapyramidal symptoms (disorders in body movement) like other antipsychotic drugs. The effect of Risperidone is by blocking dopamine (D2) receptors and serotonin (5-HT2) receptors; its affinity for (5-HT2) receptors is more than (D2) receptors, consequently it does not cause significant extrapyramidal symptoms in comparison with first‑generation antipsychotics. It also has activity to block α1 adrenergic receptors and H1 histamine receptors.

📌 INDICATIONS & DOSAGE

Treatment of schizophrenia:

• Adults: The starting dose is 2 mg per day; may be increased on the second day to 4 mg per day. Slower titration is appropriate in some patients. The usual dose is 4-6 mg per day, and dose adjustment should be done according to the patient's response. Doses above 10 mg per day do not give superior efficacy to lower doses and may cause extrapyramidal symptoms. The safety of doses above 16 mg 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 0.5 mg twice daily until reaching 1-2 mg twice daily, as directed by a 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 0.5 mg twice daily until reaching 1-2 mg twice daily, as directed by a physician.

Patients with kidney or liver problems:

Patients with kidney problems have less ability to eliminate the drug; also, patients with liver problems have increases in plasma concentration of Risperidone. Therefore, the starting and usual doses should be halved for these patients, and dose titration should be slower.

* Note: The total daily dose can be used at one time or divided into doses during the day, and that is determined by your doctor for what is best for the patient.

📌 RESTRICTIONS ON USE

Contraindications

Hypersensitivity to Risperidone.

Precautions

Caution should be taken and a specialist physician consulted in the following cases:

• If you have a heart problem, are prone to low blood pressure, are using medicines for your blood pressure, or if you have had a 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 elevated levels 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 a history of blood clots, as antipsychotics have been associated with the formation of blood clots.
• Respirotab should not be interrupted abruptly but should be decreased gradually over a few days.
• Don't take double doses (two doses at the same time) to make up for a forgotten dose.

Use in Pregnancy and Lactation

Respirotab is used in pregnancy only if the potential benefits outweigh the risks. While in breastfeeding, it is 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.

📌 DRUG INTERACTIONS

• Concomitant use of Risperidone with rifampicin, carbamazepine, phenytoin and phenobarbital leads to a decrease in the effect of Risperidone.
• Concomitant use of Risperidone with quinidine, antidepressants such as (paroxetine, fluoxetine, tricyclic antidepressants), beta blockers, phenothiazines, cimetidine, ranitidine, itraconazole, ketoconazole, ritonavir, verapamil, sertraline or fluvoxamine leads 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 agonists.

📌 ADVERSE EFFECTS

Respirotab is generally well tolerated and may have some side effects that don't occur in all patients.

Common effects: Insomnia, agitation, anxiety and headache.

Less common effects: Somnolence, fatigue, dizziness, impaired concentration, constipation, dyspepsia, nausea, vomiting, abdominal pain, blurred vision, erectile and ejaculatory dysfunction, infections, appetite change, hyperprolactinaemia, menstrual disorder and weight increase. Respirotab also has a lower propensity to induce extrapyramidal symptoms than typical antipsychotics, and these symptoms are: tremor, rigidity, dystonia and muscle spasms.

📌 OVERDOSAGE

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. 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 administered, and medical monitoring should be continued until the patient is treated.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Respirotab 2 mg tablets: Blister pack of 20 tablets and hospital packs of different sizes.
• Respirotab 3 mg tablets: Blister pack of 20 tablets and hospital packs of different sizes.

012-06-184 04/19