DORALESE Film-coated tablets Ref.[9312] Active ingredients: Indoramin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Chemidex Pharma Ltd., T/A Essential Generics, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom

Therapeutic indications

Conditions for which alpha blockade is indicated.

Management of urinary outflow obstruction due to benign prostatic hyperplasia.

Posology and method of administration

Posology

Hyperplasia

Adults

20 mg twice daily.

Dosage may be increased in 20 mg increments at two-weekly intervals up to max. 100 mg per day if required.

Elderly

20 mg at night may be adequate.

Paediatric population

Not recommended.

Method of administration

For oral administration.

Overdose

Information available at present of the effects of acute overdosage in human beings with indoramin is limited. Effects seen have included deep sedation leading to coma, hypotension and fits. Results of animal work suggest that hypothermia may also occur.

Suggested therapy is along the following lines:

  1. Recent ingestion of large numbers of tablets would require gastric lavage or a dose of ipecacuanha to remove any of the product still in the stomach of the conscious patient.
  2. Ventilation should be monitored and assisted if necessary.
  3. Circulation support and control of hypotension should be maintained.
  4. If convulsions occur diazepam may be tried.

Temperature should be closely monitored. If hypothermia occurs, rewarming should be carried out very slowly to avoid possible convulsions.

Shelf life

3 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Blister packs – packs of 60.

Special precautions for disposal and other handling

No special requirements.

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