Diazepam

Diazepam has anticonvulsant, anxiolytic, sedative, muscle relaxant and amnesic properties.

It is indicated for:

Adults i) For the short-term relief (2-4 weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness; ii) As a sedative and premedicant; iii) As an anticonvulsant in the management of status epilepticus, febrile convulsions and poisoning; iv) In the control of muscle spasms as in tetanus; v) In the management of alcohol withdrawal symptoms; vi) In selected cases it may be useful in the management of cerebral spasticity; Children i) Night terrors and somnambulism; ii) Premedication; iii) In the control of muscle spasms as in tetanus; iv) In selected cases, it may be useful in controlling tension and irritability in cerebral spasticity; The use of diazepam to treat short term anxiety is inappropriate and unsuitable.

INDICATIONS

Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.

Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies.

4 Geriatrics 05/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ....................................................................................

2 TABLE OF CONTENTS ......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.............................................................. 4 1 INDICATIONS.............................................................................................................

1 Pediatrics .......................................................................................................... 2 Geriatrics...........................................................................................................

4 2 CONTRAINDICATIONS .............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX..................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................