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Drug Details

Temazepam Tablets 10mg and 20mg

• Presentation
  Tablet
• Description
  Temazepam Tablets 10mg: Each tablet contains: 10mg temazepam BP Temazepam Tablets 20mg: Each tablet contains: 20mg temazepam BP
• Indications
  For the short-term treatment of insomnia in cases where it is severe, disabling or subjecting the individual to extreme distress. Temazepam is also indicated for pre-operative medication prior to minor surgery or other similar procedures
• Adult Dosage
  

  The recommended doses are as follows:

  
  Insomnia:

  Adults - 10-20mg. In extreme cases this may be increased to 30-40mg.

  Elderly - 10mg. In extreme cases this may be increased to 20mg.

  Tablets should be taken approximately 30 minutes before retiring to bed.

  
  Premedication:

  Adults - The normal dose is 20-40mg, half an hour to an hour before the procedure.

  Elderly - 10-20mg

  
  Children - temazepam tablets are not recommended for use in children.

  The lowest possible dose should be used. Treatment should not be continued beyond four weeks and treatment should be tapered off gradually. (See Special Warnings and Precautions).

  Oral administration.

   

• Contra Indications
  

  Temazepam is contra-indicated in the treatment of patients suffering from severe respiratory or hepatic insufficiency, myasthenia gravis or sleep apnoea syndrome. It is also contra-indicated for use in those who have previously experienced hypersensitivity to this or other benzodiazepines.

• Special Precautions
  

  The cause for insomnia should be determined prior to the use of temazepam, and it should not be used for first line treatment of psychotic illness. Temazepam should also not be used on its own to treat depression or anxiety accompanying depression.

  The duration of treatment should be as short as possible (less than 4 weeks) including the tapering off process. More long-term treatment is not advised without re-assessment of the condition. Treatment should be discontinued gradually to minimise the risk of withdrawal or rebound phenomena where the symptoms requiring the treatment recur in an enhanced form.

  Temazepam should also be used cautiously in patients with a history of alcohol or drug abuse, or severe hepatic or renal insufficiency.

  When used to treat insomnia patients should ensure that they will be able to have 7-8 hours of uninterrupted sleep in order to reduce the risk of anterograde amnesia occurring. If insufficient sleep does occur, this could lead to impaired alertness. Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines.

  When temazepam is used for pre-medication, patients should be accompanied home afterwards.

  There is a risk of drug dependency developing with the use of temazepam. This risk increases in severity with increasing dose and duration of treatment. There is also a greater risk in patients with a history of alcohol or drug abuse, or personality disorder.

  If dependence does develop, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.

  The use of benzodiazepines in patients also suffering from depression may unveil suicidal tendencies. Amnesia may occur and in cases of loss and bereavement, psychological adjustment may be inhibited by benzodiazepines.

• Interactions
  

  The concomitant use of temazepam and alcohol may enhance the sedative effect and is therefore not recommended.

  Concurrent use of antipsychotics, antidepressants, narcotic analgesics, hypnotics, anxiolytics/sedatives, sedative antihistamines, anaesthetics and antiepileptic drugs may further enhance the central depressive effect.

  Enhanced euphoria may also occur with combined use of temazepam and narcotic analgesics, therefore possibly increasing the risk of dependence.

• Adverse Drug Reactions
  

  At the start of treatment patients may suffer from drowsiness, reduced alertness, dizziness, confusion, fatigue, muscle weakness, numbed emotions, headache, ataxia or double vision. These will normally disappear with continued treatment.

  More rarely, vivid dreams/nightmares, restless sleep, palpitations, change in libido, skin reactions, sedation, impaired muscular function, dry mouth and gastrointestinal disturbances may occur.

  Pre-existing depression may be unmasked during treatment with temazepam.

  Blood dyscrasias, urinary retention, increased liver enzymes, jaundice and visual disturbances have also been reported to occur occasionally. If any of these effects do occur, treatment should be discontinued.

  Other effects, including delusions, psychoses, hallucinations, irritability and restlessness, aggressiveness and rages or other inappropriate behaviour have also been reported to occur, predominantly in elderly patients. If any of these effects occur, treatment should be discontinued.