Posology : מינונים

4.2    Posology and method of administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

For intravenous administration, the drug shoud be injected slowly, maximum 5 mg (1 ml) per minute; small veins (e.g. dorsum of hand or wrist) should not be used. Extreme care should be taken to avoid intra-arterial administration or extravasation.
If it is not feasible to administer Assival Teva directly I.V., it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
When Assival Teva is administered intramuscularly, it should be injected deeply into the muscle.
Once the acute symptomatology has been controlled with injectable Assival Teva, the patient may be placed on oral therapy with Assival if further treatment is required.

Dosage should be individualized for maximum beneficial effect.
The usual recommended dose in older children and adults ranges from 2-20 mg I.M. or I.V. depending on the indication and its severity. In some conditions, larger doses may be required. In such cases doses should be increased cautiously to avoid adverse effects.

In acute conditions, the injection may be repeated within 1 hour although an interval of 3-4 hours is usually satisfactory.
Lower doses (usually 2-5 mg) with a slow increase in dosage, should be used for elderly or debilitated patients and when other sedative drugs are administered simultaneously.

Recommended doses as per specific indications are listed below:

Adults
Moderate Anxiety Disorders and Symptoms of Anxiety
2-5 mg I.M. or I.V. Repeat after 3- 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5-10 mg, I.M. or I.V. Repeat after 3 to 4 hours, if necessary.

Acute Alcohol Withdrawal
Initially, 10 mg I.M. or I.V., then 5-10 mg after 3 to 4 hours, if necessary.

Endoscopic Procedures
The I.V. dosage should be titrated to the desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg I.V. may be given, particularly when concomitant narcotics are omitted. If I.V. administration cannot be used, 5-10 mg should be given I.M.
approximately 30 minutes prior to the procedure.

Muscle Spasm
5-10 mg I.M. or I.V. initially, then 5-10 mg after 3-4 hours, if necessary. For tetanus, larger doses may be required.

Status Epilepticus and Severe Recurrent Convulsive Seizures
Initially 5-10 mg (I.V. preferred). If necessary, this injection may be repeated at 10- 15 minute intervals up to a maximum dose of 30 mg.
Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.

Preoperative Medication
10 mg I.M. (preferred route), before surgery.

Cardioversion
5-15 mg, I.V., within 5-10 minutes prior to the procedure.
Children
Note: Since Assival Teva Solution for Injection contains benzyl alcohol, this preparation should not be administered to neonates and premature infants.

To obtain maximum clinical effect with minimum amount of drug, and to reduce the risk of hazardous side effects such as apnea or prolonged periods of somnolence, the drug should be administered slowly over 3 minutes, not exceeding 0.25 mg/kg. After an interval of 15-30 minutes, the initial dose can be repeated. If relief of symptoms is not obtained after a third dose, appropriate adjunctive therapy is recommended. Facilities for respiratory assistance should be readily available.

Muscle Spasm
For tetanus in infants over 30 days of age, 1-2 mg I.M. or I.V., slowly, repeated every 3-         4 hours, as necessary. In children 5 years or older, 5-10 mg, repeated every 3 to 4 hours,
may be required to control tetanus spasms. Respiratory assistance should be available.

Status Epilepticus and Severe Recurrent Convulsive Seizures
Infants over 30 days of age and children under 5 years, 0.2-0.5 mg, slowly, every 2- 5 minutes, up to a maximum of 5 mg (I.V. preferred). Children 5 years or older, 1 mg every 2-5 minutes, up to a maximum of 10 mg (slow I.V. administration preferred).
Repeat after 2-4 hours if necessary.
EEG monitoring of the seizure may be helpful.

Special populations
Elderly or debilitated patients as well as patients with organic brain changes, circulatory or respiratory insufficiency or with impaired hepatic or renal function shall receive lower doses.
Dose increase, if necessary, should take place gradually and should be guided by the effect achieved.

This also applies for patients that take concomitantly other drugs acting on the central nervous system.