DIAZEPAM

Dosage form Tablets, 5 mg; Ampoules, 5 mg/mI -2 mI

Uses Diazepam is a benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties; it has a long duration of action. Its actions are mediated by enhancement of the activity of aminobutyric acid (GABA), a major inhibitory neurotransmitter in the brain. It is used in the treatment of severe anxiety disorders, as a hypnotic in the short-term management of insomnia, as a sedative and premedicant, as an anticonvulsant particularly in the management of status epilepticus and febrile convulsions, in the control of muscle spasm as in tetanus, and in the management of alcohol withdrawal symptoms. In view of the risk of dependence Diazepam should always be given in the lowest dose which can control symptoms and in short courses; treatment should not normally continue beyond 4 weeks and should always be withdrawn gradually. Intermittent treatment regimens may decrease the risk of dependence.

Administration
Treatment of anxiety states: Adults: Start with 4-5 mg orally.
To achieve relief of anxiety, e.g. before surgical or other medical interventions, one single dose of 5 mg 1-2 hours before will usually be sufficient.
Children: Dosage should be determined according to body weight: Start with 0.1 mg/kg orally 3 times daily. Dosage should then be adjusted according to clinical improvement.
Diazepam injection can be used to control acute psychosis-like states; give approximately 0.1 mg/kg body weight by i.m. or slow i. v. injection (maximum 1-2 mg Diazepam).
Thereafter antipsychotic treatment, e.g. with chlorpromazine should be considered.
Treatment in order to achieve muscular relaxation: Adults: Start with 5 mg orally 3 times daily. Tablets can be taken with meals.
Treatment of convulsions: Adults: Give 5-10 mg by slow i.v. injection. Repeat after 10 minutes if convulsions are not sufficiently controlled. Repeat as necessary thereafter (maximum: 30 mg). ,
Children over 5 years: Give approximately 1 mg by slow i. v. injection. Repeat after 2-5 minutes until maximal 10 mg.
Repeat after 2-4 hours if convulsions are not sufficiently controlled. Repeat as necessary thereafter.
Treatment of tetanus: Neonates: Start with 2.5 mg (0.5 mI) 4 times daily by slow i. v. injection.
Children and adults: Start with approximately 0.4-0.5 mg/kg body weight 4 times daily by slow i.v. injection.
Adjust dosage according to clinical effects on convulsions. Daily doses exceeding 5 mg/kg may become necessary.
Usually phenothiazines and/or barbiturates are given concomitantly.

Observe
Adverse Effects: Drowsiness, sedation, and ataxia are the most frequent adverse effects of Diazepam use. They generally decrease on continued administration and are a consequence of CNS depression. Less frequent effects
include vertigo, headache, confusion, mental depression, slurred speech or dysarthria, changes in libido, tremor, visual disturbances, urinary retention or incontinence, gastro-intestinal disturbances, changes in salivation, amnesia, and paradoxical excitation and disinhibition. Jaundice, blood disorders, and hypersensitivity reaction~ have been reported rarely. Respiratory depression and hypotension occasionally occur with high dosage and parenteral admini- stration. Rebound anxiety and insomnia may be a result of tolerance to the effects of Diazepam or part of a withdrawal syndrome.
Pain and thrombophlebitis may occur with some intravenous formulations of Diazepam.
Overdosage can produce CNS depression and coma although fatalities are rare when taken alone. High doses of intravenous Diazepam have been abused for their euphoriant effects.

Storage Store in a cool and dry place, away from light. Keep out of reach of children.