INDICATION
SedilĀ® is mainly used for the treatment of anxiety, which may be the result
of many factors e.g. transient situational problems, acute and chronic stress
of life, chronic medical problems, intractable pain exacerbated by
apprehension and depression etc. For skeletal muscle spasm due to reflex
spasm to local pathology, SedilĀ® is indicated as an adjunct to relieve the
symptoms.
In patients who are to undergo surgical measures, SedilĀ® is a useful
premedication (I.M. route recommended) for relief of anxiety and tension.
DOSAGE AND ADMINISTRATION
Adults :
Indication Route Dosage
Severe anxiety states Oral 15 to 30 mg daily in divided doses.
I.V. or I.M. 10 mg repeated after 4 hours.
Status epilepticus I.V. 5 to 10 mg as required. This may be
repeated at intervals of 10 to 15
minutes up to a maximal dose of 30
mg. If necessary, this regimen can be
repeated in 2 to 4 hours, but no more
than 100 mg should be administered
in 24 hours period.
Anaesthesia I.V. 0.6 mg/kg
Tetanus I.V. 2 to 20 mg at intervals of 2 to 8 hours.
Minor surgical I.M. 10 to 30 mg adjusted to patients
procedure and dentistry requirement.
Strychnine poisoning I.V. 10 mg. Smaller doses for children.
Mild anxiety states Oral 5 mg twice daily or 2 mg thrice daily.
Cerebral palsy Oral Up to 60 mg.
Muscle Spasm Oral 2 to 15 mg daily in divided doses. I.V. or I.M. 10 mg repeated after 4 hours.
Children :
Status epileptius, convulsions 0.2 to 0.3 mg/kg body weight IV
due to poisoning, febrile convulsions (or IM) or 1 mg per year of life
Tetanus As for adults dose
Pre-operative medication 0.2 mg/kg body weight
CONTRAINDICATION AND PRECAUTION
SedilĀ® is contraindicated in patients with known history of hypersensitivity to
it. Porphyria or a family history of porphyria contraindicates the use of
SedilĀ®. It is also contraindicated in patients with acute narrow angle
glaucoma and open angle glaucoma unless concomitant appropriate
therapy is given. Head injury also contraindicates the use of diazepam.
Caution should be observed when giving SedilĀ® to elderly or debilitated
patients who are liable to be sensitive to its side effects; to patients with real
or hepatic dysfunctions. Extreme care should be taken in administering
injectable SedilĀ® particularly by the I.V. route to the elderly patients to very
ill patients and to those with limited pulmonary reserve because of the
possibility of apnea and/or cardiac arrest. Barbiturates, alcohol and other
central nervous system depressants will increase the risk of apnea if given
concomitantly. Injectable SedilĀ® should be administered to patients in shock,
coma, or in acute alcohol intoxication.
SIDE EFFECT
The side effects of SedilĀ® are infrequent and mild. Drowsiness, light
headedness, slight ataxia, vertigo, dry mouth, inattentiveness may occur and
are dose dependent. Other effects that may be observed rarely include
hypotension, gastro-intestinal and visual disturbances. In case of long term
medication change in libido may occur.
DRUG INTERACTION
If diazepam is given concomitantly with centrally acting drugs such as
neuroleptics, tranquillisers, antidepressants, hypnotics, analgesics and
anaesthetics, the sedative effects are likely to be intensified.
Known inhibitors of hepatic enzymes e.g. cimetidine and omeprazole have
been shown to reduce the clearance of diazepam and may potentiate their
action and known inducers of hepatic enzyme, e.g. rifampicin may increase
the clearance of diazepam.
USE IN PREGNANCY AND LACTATION
The use of SedilĀ® during the first trimester of pregnancy should almost
always be avoided as it bears a risk of congenital malformation.
Diazepam has been detected in breast milk. If possible the use of diazepam
should be avoided during lactation.
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