Urbanol is not recommended for the primary treatment of psychotic illness. Urbanol should not be used alone to treat depression r anxiety with depression (suicide may be precipitated in such patients). Urbanol should be used with extreme caution in patients with a history of alcohol or drug abuse.
The side-effects most frequently encountered with Urbanol are drowsiness and oversedation, dizziness, dry mouth and constipation. Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses. Less common are depression of mood and affect, disorientation or confusion, lethargy, ataxia, tremor, increased motor activity, decreased motor activity and nausea/vomiting.
Paradoxical reactions such as acute hyperexcitable states with rage may occur - if these occur, Urbanol should be discontinued.
Blood dyscrasias and hepatic dysfunction have been reported.
Particular caution should be exercised with the elderly and debilitated - who are at particular risk of oversedation, respiratory depression and ataxia. (The initial oral dosage should be reduced in these patients).
Caution should also be observed in -
- patients suffering from impairment of renal or hepatic function.
- patients with pulmonary disease and limited pulmonary reserve.
- patients suffering from anxiety accompanied by underlying depressive disorders.
- patients receiving barbiturates, antihistamines, narcotics or other central nervous system depressants. There is an additive risk of central nervous system depression when these medicines are taken together. Large doses may produce syncope.
- patients should be cautioned regarding the additive effects of alcohol.
- Urbanol should be used judiciously during pregnancy and preferably avoided. Given during labour it crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypotonia, hypothermia, poor sucking and an increase in foetal heart rate. It should not be administered to lactating mothers.
- patients should be advised particularly at the initiation of therapy, not to drive a motor-vehicle, climb dangerous heights, or operate dangerous machinery. In these situations, impaired decision making could lead to accidents.
Dependence: There is a potential for abuse and the development of physical and psychic dependence, especially with prolonged use and high doses. The risk of dependence is also greater in patients with a history alcohol and drug abuse. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations of epileptic seizures.