Ativan ® – Lorazepam

Lorazepam (Ativan ®)

Usual Diluents

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

Alternatively: Glass bottle: 40 mg/250 ml (250ml D5W). Infusion Rate: As directed. (See comments).

Primary:
Dilution for 2 mg/ml - 10 ml vials.
== Final Concentration 1 mg/ml ==
20 mg/20 ml (10 ml diluent + 10ml of drug)
    Total volume =20ml.
40 mg/ 40 ml (20 ml diluent + 20ml of drug)
    Total volume =40ml.
80 mg/ 80 ml (40 ml diluent + 40ml of drug)
    Total volume =80ml.

Stability / Miscellaneous

EXP: 1 DAY (RT)
Label: Do not Refrigerate /An in-line 0.22u filter should be used.

Concentrations recommended by the manufacturer: 0.1 , 0.16, or 0.2 mg/ml.
May also dilute 4 mg/ml and 2 mg/ml vials 1:1 with D5W or NS.
Do not send if solution is yellow or contains a precipitate.
Maximum infusion rate: 2 mg/min.

Note: high dose infusions (>8-10 mg/hr) that are infused for extended periods (>24 hours) have been associated with  nephrotoxcity (reversible acute tubular necrosis) and/or osmolar gap metabolic acidosis due to the presence of the polyethylene glycol and propylene glycol solvents in solution.   The recommended IV infusion dose (continuous) for critically ill adults:  0.01 to 0.1 mg/kg/hr IV.  Patients should be monitored closely for possible acidosis.

Dosing: Status epilepticus: 4 mg IV push (range: 2 to 8 mg).
May repeat q5 to 15 minutes.
Monitor patient for acidosis.

DOSAGE AND ADMINISTRATION
ATIVAN must never be used without individualization of dosage particularly when used with other medications capable of producing central-nervous-system depression.

EQUIPMENT NECESSARY TO MAINTAIN A PATENT AIRWAY SHOULD BE IMMEDIATELY AVAILABLE PRIOR TO INTRAVENOUS ADMINISTRATION OF LORAZEPAM (see package insert for WARNINGS).

Status Epilepticus--------------------
Intravenous Injection
For the treatment of status epilepticus, the usual recommended dose of ATIVAN Injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional ATIVAN Injection is required. If seizures continue or recur after a 10- to 15-minute observation period, an additional 4 mg intravenous dose may be slowly administered. Experience with further doses of ATIVAN is very limited. The usual precautions in treating status epilepticus should be employed. An intravenous infusion should be started, vital signs should be monitored, an unobstructed airway should be maintained, and artificial ventilation equipment should be available.

Intramuscular Injection
IM ATIVAN is not preferred in the treatment of status epilepticus because therapeutic lorazepam levels may not be reached as quickly as with IV administration. However, when an intravenous port is not available, the IM route may prove useful.

Pediatric
The safety of ATIVAN in pediatric patients has not been established.

Preanesthetic------------------
Intramuscular Injection
For the designated indications as a premedicant, the usual recommended dose of lorazepam for intramuscular injection is 0.05 mg/kg up to a maximum of 4 mg. As with all premedicant drugs, the dose should be individualized. Doses of other central-nervous-system-depressant drugs ordinarily should be reduced. For optimum effect, measured as lack of recall, intramuscular lorazepam should be administered at least 2 hours before the anticipated operative procedure. Narcotic analgesics should be administered at their usual preoperative time.

There are insufficient data to support efficacy or make dosage recommendations for intramuscular lorazepam in patients less than 18 years of age; therefore, such use is not recommended.

Intravenous Injection
For the primary purpose of sedation and relief of anxiety, the usual recommended initial dose of lorazepam for intravenous injection is 2 mg total, or 0.02 mg/lb (0.044 mg/kg), whichever is smaller. This dose will suffice for sedating most adult patients and ordinarily should not be exceeded in patients over 50 years of age. In those patients in whom a greater likelihood of lack of recall for perioperative events would be beneficial, larger doses as high as 0.05 mg/kg up to a total of 4 mg may be administered. Doses of other injectable central-nervous-system-depressant drugs ordinarily should be reduced. For optimum effect, measured as lack of recall, intravenous lorazepam should be administered 15 to 20 minutes before the anticipated operative procedure.

There are insufficient data to support efficacy or make dosage recommendations for intravenous lorazepam in patients less than 18 years of age; therefore, such use is not recommended.

Dose Administration in Special Populations
Elderly Patients and Patients With Hepatic Disease
No dosage adjustments are needed in elderly patients and in patients with hepatic disease.

Patients With Renal Disease
For acute dose administration, adjustment is not needed for patients with renal disease. However, in patients with renal disease, caution should be exercised if frequent doses are given over relatively short periods of time.

Administration
When given intramuscularly, ATIVAN Injection, undiluted, should be injected deep in the muscle mass.

Injectable ATIVAN can be used with atropine sulfate, narcotic analgesics, other parenterally used analgesics, commonly used anesthetics, and muscle relaxants.

Immediately prior to intravenous use, ATIVAN Injection must be diluted with an equal volume of compatible solution. Contents should be mixed thoroughly by gently inverting the container repeatedly until a homogenous solution results. Do not shake vigorously, as this will result in air entrapment. When properly diluted, the drug may be injected directly into a vein or into the tubing of an existing intravenous infusion. The rate of injection should not exceed 2.0 mg per minute.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if solution is discolored or contains a precipitate.

ATIVAN Injection is compatible for dilution purposes with the following solutions: Sterile Water for Injection, USP; Sodium Chloride Injection, USP; 5% Dextrose Injection, USP.

HOW SUPPLIED
ATIVAN (lorazepam) Injection is available in the following dosage strengths in single-dose and multiple-dose vials:

2 mg per mL,NDC 60977-112-01, 25 x 1 mL vial
NDC 60977-112-02, 10 x 10 mL vial

4 mg per mL,NDC 60977-113-01, 25 x 1 mL vial
NDC 60977-113-02, 10 x 10 mL vial

For IM or IV injection.
Store in a refrigerator.
PROTECT FROM LIGHT.
Use carton to protect contents from light.

ATIVAN is a trademark of Biovail Laboratories, Ltd.
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)
MLT-01086/1.0

Source: [package insert]