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EPIVAL

Composition
Each (2ml) ampoule contains:
Diazepam 10 mg

Properties and Mode of Action

EPIVAL is a benzodiazepine with anxiolytic, sedative, muscle relaxant and anticonvulsant properties. It appears to
potentiate the inhibitory neurotransmitter of gamma-aminobutyric acid (GABA).

Indications
EPIVALis useful as a tranquilizer and in anxiety.
In acute agitation due to alcohol withdrawal.
In psychoneurotic cases.
As adjuvant therapy in epileptic cases particularly in status epilepticus.
To relieve anxiety and tension in patients before and after surgical interactions.
Muscular spasm:
Given parenterally, EPIVAL rapidly relieves severe spasms of central, peripheral and rheumatic or tetanic origin.

Dosage and Administration

Adults:
Insomnia:
A single dose of 5 - 10 mg should be given according to the response of patients.
The evening before surgeries: 5 - 30 mg are given orally.
Immediately Before Surgical and Instrumental Interventions:
10 - 20 mg are to be injected I.M. or I.V..
For Treatment of Hospitalized Patients in Cases of Agitation, Excitement, Motor Restlessness and Hallucination
States: 10 - 20 mg 3 times daily I.M. in the acute states and orally for maintenance.
Epileptic States:
10 - 20 mg I.V. as initial dose followed in subsequent hours by 20 mg I.M. according to the need.
The same dose may be given also as drop infusion.
Muscular Spasticity:
Initially:10 mg once or twice daily I.M. followed by 10 - 30 mg a day orally.
Treatment of Tetanus:
10 mg for adults and 2 - 5 mg for children I.V. (or by drip) every 1 - 8 hours.
To Facilitate Labour in the Second Stage (2-3 finger-wide orifice of the uterus):
20 mg I.M..
In Cases of Threatening Premature Birth, Early Rupture of the Amnion, Imminent Abortion:
Initial dose: 20 mg I.V. or I.M., to be repeated, if necessary after 1 hour.
Maintenance dose: 10 - 20 mg daily 3 - 4 times I.M..
Upon improvement of symptoms, doses have to be reduced gradually.
Persons who display their daily activities should not take more a day than 5 mg at evening and 2 single doses of 2 mg
each during day-time.

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Infants and Children:

The usual recommended dose: 0.1 - 0.5 mg/kg/dose I.M.or I.V. (may be repeated at 3 - 5 minutes intervals).

Precautions
The established medical principle of not prescribing drugs of any kind in early pregnancy except when absolutely
necessary should also be borne in mind.
With EPIVAL, as with other psychoactive substances, patients should avoid taking alcohol while under the influence of the
treatment, since the individual response cannot be foreseen.Like all medications of this type, EPIVAL may modify the
patient's reactions (driving ability, behaviour in traffic,etc.) to a varying extent depending on dosage administration and
individual susceptibility.

Drug Interactions
If EPIVAL is combined with centrally-acting drugs such as neuroleptics, tranquilizers, anticonvulsants, hypnotics,
analgesics and anaesthetics, it should be borne in mind their sedative effect may be intensified by EPIVAL, especially
when the latter is given parenterally.
This reinforcement can sometimes be made use of therapeutically.

Contra_indications
Myasthenia gravis.

Side effects
EPIVAL is well-tolerated.
EPIVAL has no harmful effects on the liver or kidneys.
As for all psychopharmaceuticals, dosage of EPIVAL must be adapted to the widely varying limits of tolerance
encountered in patients with organic cerebral changes ( particularly arteriosclerosis ) or with cardiorespiratory
insufficiency. As a rule, parenteral administration should not be employed in these patients.

Presentation
Box of 3 ampoules of 2 ml each.

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