ALSAVAL (amp)
-
Chemical Name:
Diazepam -
Therapeutic Category:
Central nervous system drugs -
Pharmacologic Category:
Benzodiazepine -
Pharmaceutical Form:
Ampoule -
Composition:
Diazepam 10mg
ALSAVAL
Injection (Ampoule)
Diazepam
1- PHARMACOLOGY:
Diazepam is a long-acting benzodiazepine with an anticonvulsant, anxiolytic, sedative, muscle relaxant and hypnotic properties.
It's actions are mediated by enhancement of the activity of aminobutyric acid.
2- INDICATIONS:
- ALSAVAL is indicated for all clinical states characterized or complicated by mental tension, anxiety, excitation, neurasthenia, psychoneurosis, phobia, schizo-affective reactions, physical symptoms of emotional origin, autonomic dystonia, conversion hysteria, psychosomatic disturbances (cardiovascular complaints, duodenal ulcer, migraine, tension headache, intestinal spasm), the menopausal syndrome and sleep disturbance.
- ALSAVAL is indicated for acute alcohol withdrawal syndrome.
- ALSAVAL is indicated as an adjunct prior to endoscopic procedures.
- ALSAVAL is a useful adjunct in muscle spasm of central and peripheral origin.
- ALSAVAL is a useful adjunct in status epilepticus and severe recurrent convulsive seizures.
- ALSAVAL is a useful premedication (the IM route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures.
- ALSAVAL is indicated intravenously, prior to cardioversion for the relief of anxiety and tension.
3- CONTRAINDICATIONS:
- Hypersensitivity to Benzodiazepines.
- Diazepam is contraindicated in acute narrow angle glaucoma.
4- PRECAUTIONS:
- The solution should be injected slowly taking at least on minute for each 1 ml given; extreme care should be taken to avoid intra-arterial administration or extravasation.
- Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask.
- Extreme care must be used in administering injectable diazepam, to the elderly, to very ill patients and to those with limited pulmonary reserve.
- Injectable diazepam should not be administered to patients in shock, coma, or in acute alcoholic intoxication with depression of vital signs.
- Patients receiving diazepam should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.
- Tonic status epilepticus has been precipitated in patients treated with IV diazepam for petit mal status or petit mal variant status.
- Patients receiving diazepam should be cautioned against drinking alcohol.
- Although seizures may be brought under control promptly, however, diazepam is not recommended for maintenance, and once seizures are brought under control, consideration should be given to the administration of agents useful in longer term control of seizures.
- Since an increase in cough reflex and laryngospasm may occur with other per oral endoscopic procedures, the use of a topical anesthetic agent and the availability of necessary countermeasures are recommended.
- Injectable diazepam has produced hypotension or muscular weakness in some patients.
- Diazepam should be used with caution in case of hepatic or kidney impairment.
- Diazepam should be used with caution with other psychotropic agents or anticonvulsant drugs.
- Efficacy and safety of parenteral diazepam has not been established in the neonate (30 days or less of age).
- Usage in pregnancy: Avoid diazepam during the first trimester of pregnancy.
5- SIDE EFFECTS:
Most commonly reported side effects were drowsiness, fatigue, ataxia, phlebitis and local inflammation in the site of injection.
6- DRUG INTERACTIONS:
If Diazepam is combined with centrally acting drugs (neuroleptics, antidepressants, hypnotics, analgesics and anesthetics), it should be born in mind that their effect may be intensified.
7- DOSAGE & ADMINISTRATION:
Adults:
Moderate anxiety disorders and symptoms of anxiety: 2 mg to 5 mg , IM or IV. Repeat in 3 to 4 hours.
Severe anxiety disorders and symptoms of anxiety: 5 mg to 10 mg , IM or IV. Repeat in 3 to 4 hours.
Acute alcohol withdrawal: 10 mg, IM or IV initially, then 5 mg to 10 mg IM or IV in 3 to 4 hours, if necessary.
Endoscopic procedures: 10 mg IV. If IV cannot be used, 5 mg to 10 mg IM approximately 30 minutes prior to the procedure.
Muscle spasm associated with local pathology cerebral palsy and tetanus: 5 mg to 10 mg, IM or IV initially, in 3 to 4 hours, if necessary.
Status epilepticus and severe recurrent convulsive seizures: 5 mg to 10 mg (IV preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg.
Preoperative medication: 10 mg, IM (preferred route).
Cardioversion: 5 mg to 15 mg, IV, within 5 to 10 minutes prior to the procedure.
Children:
Muscle spasm:
Up to 5 years: 1 mg to 2 mg IM or IV, slowly, repeated every 3 to 4 hours.
In children 5 years or older: 5 mg to 10 mg repeated every 3 to 4 hours. Respiratory assistance should be available.
Status epilepticus and severe recurrent convulsive seizures:
Up to 5 years: 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg.
In children 5 years or older:1 mg every 2 to 5 minutes up to a maximum of 10 mg.
8- PACKAGING & COMPOSITION:
ALSAVAL 10 – Injection: A pack of 5 or 25 or 100 ampoules of 2 mL. Each ampoule (2mL) contains 10 mg Diazepam.
9- STORAGE CONDITIONS:
Store ALSAVAL – Injection at temperature between (15-30)°C. Protect from light
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