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Lorazepam Injection

Pronunciation

Dosage Form: injection

Lorazepam Injection, USP

Rx Only

Lorazepam Injection Description

Lorazepam a benzodiazepine with antianxiety, sedative, and anticonvulsant effects, is intended
for the intramuscular or intravenous routes of administration. It has the chemical formula
7-Chloro-5(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. The molecular
weight is 321.16, and the C.A.S. No. is [846-49-1]. The molecular formula is C15H10CI2N2O2.
The structural formula is:

Lorazepam is a nearly white powder almost insoluble in water. Each mL of sterile injection
contains 2 mg of lorazepam, 0.18 mL polyethylene glycol 400 in propylene glycol with 2% benzyl
alcohol as preservative.

Lorazepam Injection - Clinical Pharmacology

Lorazepam interacts with the γ-aminobutyric acid (GABA)-benzodiazepine receptor complex,
which is widespread in the brain of humans as well as other species. This interaction is presumed
to be responsible for lorazepam’s mechanism of action. Lorazepam exhibits relatively high and
specific affinity for its recognition site but does not displace GABA. Attachment to the specific
binding site enhances the affinity of GABA for its receptor site on the same receptor complex. The
pharmacodynamic consequences of benzodiazepine agonist actions include antianxiety effects,
sedation, and reduction of seizure activity. The intensity of action is directly related to the degree
of benzodiazepine receptor occupancy.

Effects in Pre-Operative Patients

Intravenous or intramuscular administration of the recommended dose of 2 mg to 4 mg of
Lorazepam Injection to adult patients is followed by dose-related effects of sedation (sleepiness
or drowsiness), relief of preoperative anxiety, and lack of recall of events related to the day of
surgery in the majority of patients. The clinical sedation (sleepiness or drowsiness) thus noted
is such that the majority of patients are able to respond to simple instructions whether they give
the appearance of being awake or asleep. The lack of recall is relative rather than absolute, as
determined under conditions of careful patient questioning and testing, using props designed to
enhance recall. The majority of patients under these reinforced conditions had difficulty recalling
perioperative events or recognizing props from before surgery. The lack of recall and recognition
was optimum within 2 hours following intramuscular administration and 15 to 20 minutes after
intravenous injection.

The intended effects of the recommended adult dose of Lorazepam Injection usually last 6 to 8
hours. In rare instances, and where patients received greater than the recommended dose, excessive
sleepiness and prolonged lack of recall were noted. As with other benzodiazepines, unsteadiness,
enhanced sensitivity to CNS-depressant effects of ethyl alcohol and other drugs were noted
in isolated and rare cases for greater than 24 hours.

Physiologic Effects in Healthy Adults

Studies in healthy adult volunteers reveal that intravenous lorazepam in doses up to 3.5 mg/70
kg does not alter sensitivity to the respiratory stimulating effect of carbon dioxide and does not
enhance the respiratory depressant effects of doses of meperidine up to 100 mg/70 kg (also
determined by carbon dioxide challenge) as long as patients remain sufficiently awake to undergo
testing. Upper airway obstruction has been observed in rare instances where the patient received
greater than the recommended dose and was excessively sleepy and difficult to arouse. (See
WARNINGS and ADVERSE REACTIONS.)

Clinically employed doses of Lorazepam Injection do not greatly affect the circulatory system
in the supine position or employing a 70-degree tilt test. Doses of 8 mg to 10 mg of intravenous
lorazepam (2 to 2-1/2 times the maximum recommended dosage) will produce loss of lid reflexes
within 15 minutes.

Studies in 6 healthy young adults who received Lorazepam Injection and no other drugs revealed
that visual tracking (the ability to keep a moving line centered) was impaired for a mean of eight
(8) hours following administration of 4 mg of intramuscular lorazepam and four (4) hours following
administration of 2 mg intramuscularly with considerable subject variation. Similar findings
were noted with pentobarbital, 150 and 75 mg. Although this study showed that both lorazepam
and pentobarbital interfered with eye-hand coordination, the data are insufficient to predict when it
would be safe to operate a motor vehicle or engage in a hazardous occupation or sport.

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Pharmacokinetics and Metabolism

Absorption
Intravenous
A 4-mg dose provides an initial concentration of approximately 70 ng/mL.

Intramuscular
Following intramuscular administration, lorazepam is completely and rapidly absorbed reaching
peak concentrations within 3 hours. A 4-mg dose provides a Cmax of approximately 48 ng/mL.
Following administration of 1.5 to 5 mg of lorazepam IM, the amount of lorazepam delivered to the
circulation is proportional to the dose administered.

Distribution/Metabolism/Elimination
At clinically relevant concentrations, lorazepam is 91 ± 2% bound to plasma proteins; its volume of
distribution is approximately 1.3 L/kg. Unbound lorazepam penetrates the blood/brain barrier freely
by passive diffusion, a fact confirmed by CSF sampling. Following parenteral administration, the
terminal half-life and total clearance averaged 14 ± 5 hours and 1.1 ± 0.4 mL/min/kg, respectively.

Lorazepam is extensively conjugated to the 3-O-phenolic glucuronide in the liver and is known
to undergo enterohepatic recirculation. Lorazepam glucuronide is an inactive metabolite and is
eliminated mainly by the kidneys.

Following a single 2-mg oral dose of 14C-lorazepam to 8 healthy subjects, 88 ±4% of the
administered dose was recovered in urine and 7 ± 2% was recovered in feces. The percent of
administered dose recovered in urine as lorazepam glucuronide was 74 ± 4%. Only 0.3% of the
dose was recovered as unchanged lorazepam, and the remainder of the radioactivity represented
minor metabolites.

Special Populations

Effect of Age
Pediatrics

Neonates (Birth to 1 month)
Following a single 0.05 mg/kg (n=4) or 0.1 mg/kg (n=6) intravenous dose of lorazepam, mean
total clearance normalized to body weight was reduced by 80% compared to normal adults,
terminal half-life was prolonged 3-fold, and volume of distribution was decreased by 40% in neonates
with asphyxia neonatorum compared to normal adults. All neonates were of >37 weeks of
gestational age.

Infants (1 month up to 2 years)
There is no information on the pharmacokinetic profile of lorazepam in infants in the age range of 1
month to 2 years.

Children (2 years up to 12 years)
Total (bound and unbound) lorazepam had a 50% higher mean volume of distribution (normalized
to body-weight) and a 30% longer mean half-life in children with acute lymphocytic leukemia in
complete remission (2 to 12 years, n=37) compared to normal adults (n=10). Unbound lorazepam
clearance normalized to body-weight was comparable in children and adults.

Adolescents (12 years to 18 years)
Total (bound and unbound) lorazepam had a 50% higher mean volume of distribution (normalized
to body-weight) and a mean half-life that was two fold greater in adolescents with acute
lymphocytic leukemia in complete remission (12 to 18 years, n=13) compared to normal adults
(n=10). Unbound lorazepam clearance normalized to body-weight was comparable in adolescents
and adults.

Elderly
Following single intravenous doses of 1.5 to 3 mg of Lorazepam Injection, mean total body clearance
of lorazepam decreased by 20% in 15 elderly subjects of 60 to 84 years of age compared
to that in 15 younger subjects of 19 to 38 years of age. Consequently, no dosage adjustments
appears to be necessary in elderly subjects based solely on their age.

Effect of Gender
Gender has no effect on the pharmacokinetics of lorazepam.

Effect of Race
Young Americans (n=15) and Japanese subjects (n=7) had very comparable mean total clearance
value of 1 mL/min/kg. However, elderly Japanese subjects had a 20% lower mean total clearance
than elderly Americans, 0.59 mL/min/kg vs 0.77 mL/min/kg, respectively.

Patients with Renal Insufficiency
Because the kidney is the primary route of elimination of lorazepam-glucuronide, renal impairment
would be expected to compromise its clearance. This should have no direct effect on the glucuronidation
(and inactivation) of lorazepam. There is a possibility that the enterohepatic circulation of lorazepam-
glucuronide leads to a reduced efficiency of the net clearance of lorazepam in this population.
Six normal subjects, six patients with renal impairment (Clcr of 22+9 mL/min), and four patients on
chronic maintenance hemodialysis were given single 1.5 to 3 mg intravenous doses of lorazepam.
Mean volume of distribution and terminal half-life values of lorazepam were 40% and 25% higher,
respectively, in renally impaired patients than in normal subjects. Both parameters were 75%
higher in patients undergoing hemodialysis than in normal subjects. Overall, though, in this group
of subjects the mean total clearance of lorazepam did not change. About 8% of the administered
intravenous dose was removed as intact lorazepam during the 6-hour dialysis session.

The kinetics of lorazepam-glucuronide were markedly affected by renal dysfunction. The mean
terminal half-life was prolonged by 55% and 125% in renally impaired patients and patients
under hemodialysis, respectively, as compared to normal subjects. The mean metabolic clearance
decreased by 75% and 90% in renally impaired patients and patients under hemodialysis, respectively,
as compared with normal subjects. About 40% of the administered lorazepam intravenous
dose was removed as glucuronide conjugate during the 6-hour dialysis session.

Hepatic Disease
Because cytochrome oxidation is not involved with the metabolism of lorazepam, liver disease
would not be expected to have an effect on metabolic clearance. This prediction is supported by
the observation that following a single 2 mg intravenous dose of lorazepam, cirrhotic male patients
(n=13) and normal male subjects (n=11) exhibited no substantive difference in their ability to clear
lorazepam.

Effect of Smoking
Administration of a single 2 mg intravenous dose of lorazepam showed that there was no difference
in any of the pharmacokinetic parameters of lorazepam between cigarette smokers (n=10,
mean=31 cigarettes per day) and nonsmoking subjects (n=10) who were matched for age, weight
and gender.

Clinical Studies

The effectiveness of Lorazepam Injection in status epilepticus was established in two multi-center
controlled trials in 177 patients. With rare exceptions, patients were between 18 and 65 years of
age. More than half the patients in each study had tonic-clonic status epilepticus; patients with
simple partial and complex partial status epilepticus comprised the rest of the population studied,
along with a smaller number of patients who had absence status.

One study (n=58) was a double-blind active-control trial comparing lorazepam and diazepam.
Patients were randomized to receive lorazepam, 2 mg IV (with an additional 2 mg IV if needed)
or diazepam 5 mg IV (with an additional 5 mg IV if needed). The primary outcome measure was
a comparison of the proportion of responders in each treatment group, where a responder was
defined as a patient whose seizures stopped within 10 minutes after treatment and who continued
seizure-free for at least an additional 30 minutes. Twenty-four of the 30 (80%) patients were
deemed responders to lorazepam and 16/28 (57%) patients were deemed responders to diazepam
(p=0.04). Of the 24 lorazepam responders, 23 received both 2 mg infusions.

Non-responders to lorazepam 4 mg were given an additional 2 to 4 mg lorazepam; non-responders
to diazepam 10 mg were given an additional 5 to 10 mg diazepam. After this additional dose
administration, 28/30 (93%) of patients randomized to lorazepam and 24/28 (86%) of patients randomized
to diazepam were deemed responders, a difference that was not statistically significant.
Although this study provides support for the efficacy of lorazepam as the treatment for status
epilepticus, it cannot speak reliably or meaningfully to the comparative performance of either diazepam
or lorazepam under the conditions of actual use.

A second study (n=119) was a double-blind dose-comparison trial with 3 doses of Lorazepam
Injection: 1 mg, 2 mg, and 4 mg. Patients were randomized to receive one of the three doses of
lorazepam. The primary outcome and definition of responder were as in the first study. Twenty-five
of 41 patients (61%) responded to 1 mg lorazepam; 21/37 patients (57%) responded to 2 mg
lorazepam; and 31/41 (76%) responded to 4 mg lorazepam. The p-value for a statistical test of
the difference between the lorazepam, 4 mg dose group and the lorazepam, 1-mg dose group was
0.08 (two-sided). Data from all randomized patients were used in this test.

Although analyses failed to detect an effect of age, sex, or race on the effectiveness of lorazepam
in status epilepticus, the numbers of patients evaluated were too few to allow a definitive conclusion
about the role these factors may play.

Indications and Usage for Lorazepam Injection

Status Epilepticus
Lorazepam Injection, is indicated for the treatment of the status epilepticus. Preanesthetic
Lorazepam Injection, is indicated in adult patients for preanesthetic medication, producing sedation
(sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related
to the day of surgery. It is most useful in those patients who are anxious about their surgical
procedure and who would prefer to have diminished recall of the events of the day of surgery (see
PRECAUTIONS: Information for Patients).

Contraindications

Lorazepam Injection is contraindicated in patients with a known sensitivity to benzodiazepines
or its vehicle (polyethylene glycol, propylene glycol and benzyl alcohol), in patients with acute
narrow-angle glaucoma, or in patients with sleep apnea syndrome. It is also contraindicated in
patients with severe respiratory insufficiency, except in those patients requiring relief of anxiety
and/or diminished recall of events while being mechanically ventilated. The use of lorazepam
injection intra-arterially is contraindicated because, as with other injectable benzodiazepines, inadvertent
intra-arterial injection may produce arteriospasm resulting in gangrene which may require
amputation (see WARNINGS).

Warnings

Use in Status Epilepticus

Management of Status Epilepticus
Status epilepticus is a potentially life-threatening condition associated with a high risk of permanent
neurological impairment, if inadequately treated. The treatment of status, however,
requires far more than the administration of an anticonvulsant agent. It involves observation and
management of all parameters critical to maintaining vital function and the capacity to provide
support of those functions as required. Ventilatory support must be readily available. The use of
benzodiazepines, like Lorazepam Injection, is ordinarily only one step of a complex and sustained
intervention which may require additional interventions (e.g., concomitant intravenous administration
of phenytoin). Because status epilepticus may result from a correctable acute cause such as
hypoglycemia, hyponatremia, or other metabolic or toxic derangement, such an abnormality must
be immediately sought and corrected. Furthermore, patients who are susceptible to further seizure
episodes should receive adequate maintenance antiepileptic therapy.

Any health care professional who intends to treat a patient with status epilepticus should be
familiar with this package insert and the pertinent medical literature concerning current concepts
for the treatment of status epilepticus. A comprehensive review of the considerations critical to
the informed and prudent management of status epilepticus cannot be provided in drug product
labeling. The archival medical literature contains many informative references on the management
of status epilepticus, among them the report of the working group on status epilepticus of
the Epilepsy Foundation of America “Treatment of Convulsive Status Epilepticus” (JAMA 1993;
270: 854-859). As noted in the report just cited, it may be useful to consult with a neurologist if a
patient fails to respond (e.g., fails to regain consciousness).

For the treatment of status epilepticus, the usual recommended dose of Lorazepam Injection
is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional
Lorazepam 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 Lorazepam Injection 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.

Respiratory Depression
The most important risk associated with the use of Lorazepam Injection in status epilepticus is
respiratory depression. Accordingly, airway patency must be assured and respiration monitored
closely. Ventilatory support should be given as required.

Excessive Sedation
Because of its prolonged duration of action, the prescriber should be alert to the possibility, especially
when multiple doses have been given, that the sedative effects of lorazepam may add to the
impairment of consciousness seen in the post-ictal state.

Preanesthetic Use

AIRWAY OBSTRUCTION MAY OCCUR IN HEAVILY SEDATED PATIENTS, INTRAVENOUS
LORAZEPAM AT ANY DOSE, WHEN GIVEN EITHER ALONE OR IN COMBINATION WITH OTHER
DRUGS ADMINISTERED DURING ANESTHESIA, MAY PRODUCE HEAVY SEDATION; THEREFORE,
EQUIPMENT NECESSARY TO MAINTAIN A PATENT AIRWAY AND TO SUPPORT RESPIRATION/
VENTILATION SHOULD BE AVAILABLE.

As is true of similar CNS-acting drugs, the decision as to when patients who have received
injectable lorazepam, particularly on an outpatient basis, may again operate machinery, drive a
motor vehicle, or engage in hazardous or other activities requiring attention and coordination must
be individualized. It is recommended that no patient engage in such activities for a period of 24 to
48 hours or until the effects of the drug, such as drowsiness, have subsided, whichever is longer.
Impairment of performance may persist for greater intervals because of extremes of age, concomitant
use of other drugs, stress of surgery, or the general condition of the patient.

Clinical trials have shown that patients over the age of 50 years may have a more profound and prolonged
sedation with intravenous lorazepam (see also DOSAGE AND ADMINISTRATION: Preanesthetic).

As with all central-nervous-system-depressant drugs, care should be exercised in patients given
injectable lorazepam as premature ambulation may result in injury from falling.

There is no added beneficial effect from the addition of scopolamine to injectable lorazepam,
and their combined effect may result in an increased incidence of sedation, hallucination and
irrational behavior.

General (All Uses)

PRIOR TO INTRAVENOUS USE, Lorazepam Injection MUST BE DILUTED WITH AN EQUAL
AMOUNT OF COMPATIBLE DILUENT (SEE DOSAGE AND ADMINISTRATION). INTRAVENOUS
INJECTION SHOULD BE MADE SLOWLY AND WITH REPEATED ASPIRATION. CARE SHOULD
BE TAKEN TO DETERMINE THAT ANY INJECTION WILL NOT BE INTRA-ARTERIAL AND THAT
PERIVASCULAR EXTRAVASATION WILL NOT TAKE PLACE. IN THE EVENT THAT A PATIENT
COMPLAINS OF PAIN DURING INTENDED INTRAVENOUS INJECTION OF Lorazepam Injection
THE INJECTION SHOULD BE STOPPED IMMEDIATELY TO DETERMINE IF INTRA-ARTERIAL
INJECTION OR PERIVASCULAR EXTRAVASATION HAS TAKEN PLACE.

Since the liver is the most likely site of conjugation of lorazepam and since excretion of conjugated
lorazepam (glucuronide) is a renal function, this drug is not recommended for use in
patients with hepatic and/or renal failure. Lorazepam should be used with caution in patients
with mild-to-moderate hepatic or renal disease (see DOSAGE AND ADMINISTRATION).

Pregnancy

Lorazepam Injection MAY CAUSE FETAL DAMAGE WHEN ADMINISTERED TO PREGNANT
WOMEN. Ordinarily, Lorazepam Injection should not be used during pregnancy except in serious
or life-threatening conditions where safer drugs cannot be used or are ineffective. Status
epilepticus may represent such a serious and life-threatening condition.

An increased risk of congenital malformation associated with the use of minor tranquilizers
(chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been
suggested in several studies. In humans, blood levels obtained from umbilical cord blood indicate
placental transfer of lorazepam and lorazepam glucuronide.

Reproductive studies in animals were performed in mice, rats, and two strains of rabbits.
Occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis,
malformed skull, and microphthalmia) were seen in drug-treated rabbits without relationship to
dosage. Although all of these anomalies were not present in the concurrent control group, they
have been reported to occur randomly in historical controls. At doses of 40 mg/kg orally or 4
mg/kg intravenously and higher, there was evidence of fetal resorption and increased fetal loss
in rabbits which was not seen at lower doses.

The possibility that a woman of childbearing potential may be pregnant at the time of therapy should
be considered.

There are insufficient data regarding obstetrical safety of parenteral lorazepam, including use
in cesarean section. Such use, therefore, is not recommended.

Endoscopic Procedures

There are insufficient data to support the use of Lorazepam Injection for outpatient endoscopic
procedures. Inpatient endoscopic procedures require adequate recovery room observation time.

When Lorazepam Injection is used for peroral endoscopic procedures; adequate topical or
regional anesthesia is recommended to minimize reflex activity associated with such procedures.

Precautions

General

The additive central-nervous-system effects of other drugs, such as phenothiazines, narcotic
analgesics, barbiturates, antidepressants, scopolamine, and monoamine-oxidase inhibitors,
should be borne in mind when these other drugs are used concomitantly with or during the period
of recovery from Lorazepam Injection. (See CLINICAL PHARMACOLOGY and WARNINGS).

Extreme caution must be used when administering lorazepam to elderly patients, very ill
patients, or to patients with limited pulmonary reserve because of the possibility that hypoventilation
and/or hypoxic cardiac arrest may occur. Resuscitative equipment for ventilatory support
should be readily available (see WARNINGS and DOSAGE AND ADMINISTRATION).

When Lorazepam Injection is used IV as the premedicant prior to regional or local anesthesia,
the possibility of excessive sleepiness or drowsiness may interfere with patient cooperation in
determining levels of anesthesia. This is most likely to occur when greater than 0.05 mg/kg is
given and when narcotic analgesics are used concomitantly with the recommended dose. (See
ADVERSE REACTIONS).

As with all benzodiazepines, paradoxical reactions may occur in rare instances and in an
unpredictable fashion (see ADVERSE REACTIONS). In these instances, further use of the drug in
these patients should be considered with caution.

There have been reports of possible propylene glycol toxicity (e.g., lactic acidosis, hyperosmolarity,
hypotension) and possible polyethylene glycol toxicity (e.g., acute tubular necrosis) during administration
of Lorazepam Injection at higher than recommended doses. Symptoms may be more
likely to develop in patients with renal impairment.

Information for Patients

Patients should be informed of the pharmacological effects of the drug, including sedation, relief
of anxiety, and lack of recall, the duration of these effects (about 8 hours), and be apprised of the
risks as well as the benefits of therapy.

Patients who receive lorazepam as a premedicant should be cautioned that driving a motor
vehicle, operating machinery, or engaging in hazardous or other activities requiring attention and
coordination, should be delayed for 24 to 48 hours following the injection or until the effects of
the drug, such as drowsiness, have subsided, whichever is longer. Sedatives, tranquilizers and
narcotic analgesics may produce a more prolonged and profound effect when administered along
with injectable lorazepam. This effect may take the form of excessive sleepiness or drowsiness
and, on rare occasions, interfere with recall and recognition of events of the day of surgery and
the day after.

Patients should be advised that getting out of bed unassisted may result in falling and injury if
undertaken within 8 hours of receiving Lorazepam Injection. Since tolerance for CNS depressants will
be diminished in the presence of Lorazepam Injection, these substances should either be avoided or
taken in reduced dosage. Alcoholic beverages should not be consumed for at least 24 to 48 hours
after receiving lorazepam injectable due to the additive effects on central-nervous-system depression
seen with benzodiazepines in general. Elderly patients should be told that lorazepam may make them
very sleepy for a period longer than six (6) to eight (8) hours following surgery.

Laboratory Tests

In clinical trials no laboratory test abnormalities were identified with either single or multiple
doses of lorazepam. These tests included: CBC, urinalysis, SGOT, SGPT, bilirubin, alkaline phosphatase,
LDH, cholesterol, uric acid, BUN, glucose, calcium, phosphorus, and total proteins.

Drug Interactions

Lorazepam Injection, like other injectable benzodiazepines, produces additive depression of the
central nervous system when administered with other CNS depressants such as ethyl alcohol,
phenothiazines, barbiturates, MAO inhibitors, and other antidepressants. When scopolamine is
used concomitantly with injectable lorazepam, an increased incidence of sedation, hallucinations
and irrational behavior have been observed.

There have been rare reports of significant respiratory depression, stupor and/or hypotension
with the concomitant use of loxapine and lorazepam.

Marked sedation, excessive salivation, ataxia, and, rarely, death have been reported with the
concomitant use of clozapine and lorazepam.

Apnea, coma, bradycardia, arrhythmias, heart arrest, and death have been reported with the
concomitant use of haloperidol and lorazepam.

The risk of using lorazepam in combination with scopolamine, loxapine, clozapine, haloperidol,
or other CNS-depressant drugs has not been systematically evaluated. Therefore, caution is
advised if the concomitant administration of lorazepam and these drugs is required.

Concurrent administration of any of the following drugs with lorazepam had no effect on
the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol,
metronidazole, and propoxyphene. No change in Lorazepam Injection dosage is necessary when
concomitantly given with any of these drugs.

Lorazepam-Valproate Interaction
Concurrent administration of lorazepam (2 mg intravenously) with valproate (250 mg twice
daily orally for 3 days) to 6 healthy male subjects resulted in decreased total clearance of lorazepam
by 40% and decreased formulation rate of lorazepam glucuronide by 55%, as compared
with lorazepam administered alone. Accordingly, lorazepam plasma concentrations were about
two-fold higher for at least 12 hours post-dose administration during valproate treatment.
Lorazepam dosage should be reduced to 50% of the normal adult dose when this drug combination
is prescribed in patients (see also DOSAGE AND ADMINISTRATION).

Lorazepam-Oral Contraceptive Steroids Interaction
Coadministration of lorazepam (2 mg intravenously) with oral contraceptive steroids (norethindrone
acetate, 1 mg, and ethinyl estradiol, 50 mcg, for at least 6 months) to healthy
females (n=7) was associated with a 55% decrease in half-life, a 50% increase in the volume
of distribution, thereby resulting in an almost 3.7-fold increase in total clearance of lorazepam
as compared with control healthy females (n=8). It may be necessary to increase the dose
of Lorazepam in female patients who are concomitantly taking oral contraceptives (see also
DOSAGE AND ADMINISTRATION).

Lorazepam-Probenecid Interaction
Concurrent administration of lorazepam (2 mg intravenously) with probenecid (500 mg orally every
6 hours) to 9 healthy volunteers resulted in a prolongation of lorazepam half-life by 130% and a
decrease in its total clearance by 45%. No change in volume of distribution was noted during
probenecid co-treatment. Lorazepam dosage needs to be reduced by 50% when coadministered
with probenecid (see also DOSAGE AND ADMINISTRATION).

Drug/Laboratory Test Interactions

No laboratory test abnormalities were identified when lorazepam was given alone or concomitantly
with another drug, such as narcotic analgesics, inhalation anesthetics, scopolamine, atropine,
and a variety of tranquilizing agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of carcinogenic potential emerged in rats and mice during an 18-month study with oral
lorazepam. No studies regarding mutagenesis have been performed. The results of a preimplantation
study in rats, in which the oral lorazepam dose was 20 mg/kg, showed no impairment of fertility.

Pregnancy

Teratogenic Effects--- Pregnancy Category D (See WARNINGS).

Labor and Delivery

There are insufficient data to support the use of Lorazepam Injection during labor and delivery,
including cesarean section; therefore, its use in this clinical circumstance is not recommended.

Nursing Mothers

Lorazepam has been detected in human breast milk. Therefore, lorazepam should not be
administered to nursing mothers because, like other benzodiazepines, the possibility exists
that lorazepam may sedate or otherwise adversely affect the infant.

Pediatric Use

Status Epilepticus
The safety of lorazepam in pediatric patients with status epilepticus has not been systematically
evaluated. Open-label studies described in the medical literature included 273 pediatric/
adolescent patients; the age range was from a few hours old to 18 years of age. Paradoxical
excitation was observed in 10% to 30% of the pediatric patients under 8 years of age and was
characterized by tremors, agitation, euphoria, logorrhea, and brief episodes of visual hallucinations.
Paradoxical excitation in pediatric patients also has been reported with other benzodiazepines
when used for status epilepticus, as an anesthesia, or for pre-chemotherapy treatment.

Pediatric patients (as well as adults) with atypical petit mal status epilepticus have developed
brief tonic-clonic seizures shortly after Lorazepam Injection was given. This “paradoxical” effect
was also reported for diazepam and clonazepam. Nevertheless, the development of seizures after
treatment with benzodiazepines is probably rare, based on the incidence in the uncontrolled treatment
of series reported (i.e., seizures were not observed for 112 pediatric patients and 18 adults
or during approximately 400 doses.).

Preanesthetic
There are insufficient data to support the efficacy of injectable lorazepam as a preanesthetic agent
in patients less that 18 years of age.

General
Seizure activity and myoclonus have been reported to occur following administration of Lorazepam
Injection, especially in very low birth weight neonates.

Pediatric patients may exhibit a sensitivity to benzyl alcohol, polyethylene glycol and propylene
glycol, components of Lorazepam Injection (see also CONTRAINDICATIONS). The “gasping
syndrome,” characterized by central nervous system depression, metabolic acidosis, gasping
respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine,
has been associated with the administration of intravenous solutions containing the preservative
benzyl alcohol in neonates. Additional symptoms may include gradual neurological deterioration,
seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal
failure, hypotension, bradycardia, and cardiovascular collapse. Central nervous system toxicity,
including seizures and intraventricular hemorrhage, as well as unresponsiveness, tachypnea,
tachycardia, and diaphoresis have been associated with propylene glycol toxicity. Although normal
therapeutic doses of Lorazepam Injection contain very small amounts of these compounds,
premature and low-birth-weight infants as well as pediatric patients receiving high dosages may
be more susceptible to their effects.

Geriatric Use

Clinical studies of lorazepam generally were not adequate to determine whether subjects aged 65
and over respond differently than younger subjects, however, age over 65 years may be associated
with a greater incidence of central nervous system depression and more respiratory depression (see
WARNINGS: Preanesthetic Use, PRECAUTIONS: General, and ADVERSE REACTIONS: Preanesthetic).

Age does not appear to have significant effect on lorazepam kinetics (see CLINICAL
PHARMACOLOGY).

Clinical circumstances, some of which may be more common in the elderly, such as hepatic or
renal impairment, should be considered. Greater sensitivity (e.g., sedation) of some older individuals
cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range (see DOSAGE AND ADMINISTRATION).

Adverse Reactions

Status Epilepticus
The most important adverse clinical event caused by the use of Lorazepam Injection is respiratory
depression (see WARNINGS).

The adverse clinical events most commonly observed with the use of Lorazepam Injection in
clinical trials evaluating its use in status epilepticus were hypotension, somnolence, and respiratory
failure.

Incidence in Controlled Clinical Trials
All adverse events were recorded during the trials by the clinical investigators using terminology
of their own choosing. Similar types of events were grouped into standardized categories using
modified COSTART dictionary terminology. These categories are used in the table and listings
below with the frequencies representing the proportion of individuals exposed to Lorazepam
Injection or to comparative therapy.

The prescriber should be aware that these figures cannot be used to predict the frequency of
adverse events in the course of usual medical practice where patient characteristics and other
factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies
cannot be directly compared with figures obtained from other clinical investigators involving different
treatment, uses, or investigators. An inspection of these frequencies, however, does provide
the prescribing physician with one basis to estimate the relative contribution of drug and nondrug
factors to the adverse event incidences in the population studied.

Commonly Observed Adverse Events in a Controlled Dose-Comparison Clinical Trial
Table 1 lists the treatment-emergent adverse events that occurred in the patients treated with
Lorazepam Injection

Commonly Observed Adverse Events in Active-Controlled Clinical Trials
In two studies, patients who completed the course of treatment for status epilepticus were permitted
to be reenrolled and to receive treatment for a second status episode, given that there was a
sufficient interval between the two episodes. Safety was determined from all treatment episodes
for all intent-to-treat patients, i.e., from all patient-episodes. Table 2 lists the treatment emergent
adverse events that occurred in at least 1% of the patient-episodes in which Lorazepam Injection
or diazepam was given. The table represents the pooling of results from the two controlled trials.

These trials were not designed or intended to demonstrate the comparative safety of the
two treatments.

The overall adverse experience profile for lorazepam was similar between women and men.
There are insufficient data to support a statement regarding the distribution of adverse events by
race. Generally, age greater than 65 years may be associated with a greater incidence of centralnervous-
system depression and more respiratory depression.

Other Events Observed During the Pre-marketing Evaluation of Lorazepam Injection for the
Treatment of Status Epilepticus
Lorazepam Injection, active comparators, and Lorazepam Injection in combination with a
comparator were administrated to 488 individuals during controlled and open-label clinical trials.
Because of reenrollments, these 488 patients participated in a total of 521 patient-episodes.
Lorazepam Injection alone was given in 69% of these patient-episodes (n=360). The safety
information below is based on data available from 326 of these patient-episodes in which
Lorazepam Injection was given alone.

All adverse events that were seen once are listed, except those already included in previous
listings (Table 1 and Table 2).

Study events were classified by body system in descending frequency by using the following
definitions: frequent adverse events were those that occurred in at least 1/100 individuals; infrequent
study events were those that occurred in 1/100 to 1/1000 individuals.

Frequent and Infrequent Study Events

BODY AS A WHOLE-- Infrequent: asthenia, chills, headache, infection.
DIGESTIVE SYSTEM-- Infrequent: abnormal liver function test, increased salivation, nausea, vomiting.
METABOLIC AND NUTRITIONAL-- Infrequent: acidosis, alkaline phosphatase increased.
NERVOUS SYSTEM -- Infrequent: agitation, ataxia, brain edema, coma, confusion,
convulsion, hallucinations, myoclonus, stupor, thinking
abnormal, tremor.
RESPIRATORY SYSTEM -- Frequent: apnea; Infrequent: hyperventilation, hypoventilation, respiratory disorder.
TERMS NOT CLASSIFIABLE -- Infrequent: injection site reaction.
UROGENITAL SYSTEM -- Infrequent: cystitis.

Preanesthetic
Central Nervous System
The most frequent adverse drug event reported with injectable lorazepam is central-nervous-system
depression. The incidence varied from one study to another, depending on the dosage, route
of administration, use of other central-nervous-system depressants, and the investigator’s opinion
concerning the degree and duration of desired sedation. Excessive sleepiness and drowsiness
were the most common consequences of CNS depression. This interfered with patient cooperation
in approximately 6% (25/446) of patients undergoing regional anesthesia, causing difficulty
in assessing levels of anesthesia. Patients over 50 years of age had a higher incidence of excessive
sleepiness or drowsiness when compared with those under 50 (21/106 versus 24/245) when
lorazepam was given intravenously (see DOSAGE AND ADMINISTRATION). On rare occasion
(3/1580) the patient was unable to give personal identification in the operating room on arrival,
and one patient fell when attempting premature ambulation in the postoperative period.
Symptoms such as restlessness, confusion, depression, crying, sobbing, and delirium
occurred in about 1.3% (20/1580). One patient injured himself by picking at his incision during
the immediate postoperative period.

Hallucinations were present in about 1% (14/1580) of patients and were visual and self-limiting.

An occasional patient complained of dizziness, diplopia and/or blurred vision. Depressed hearing
was infrequently reported during the peak-effect period.

An occasional patient had a prolonged recovery room stay, either because of excessive sleepiness
or because of some form of inappropriate behavior. The latter was seen most commonly
when scopolamine was given concomitantly as a premedicant.

Limited information derived from patients who were discharged the day after receiving injectable
lorazepam showed one patient complained of some unsteadiness of gait and a reduced ability
to perform complex mental functions. Enhanced sensitivity to alcoholic beverages has been
reported more than 24 hours after receiving injectable lorazepam, similar to experience with
other benzodiazepines.

Local Effects
Intramuscular injection of lorazepam has resulted in pain at the injection site, a sensation of
burning, or observed redness in the same area in a very variable incidence from one study to
another. The overall incidence of pain and burning in patients was about 17% (146/859) in
the immediate postinjection period and about 1.4% (12/859) at the 24-hour observation time.
Reactions at the injection site (redness) occurred in approximately 2% (17/859) in the immediate
postinjection period and were present 24 hours later in about 0.8% (7/859).

Intravenous administration of lorazepam resulted in painful responses in 13/771 patients or
approximately 1.6% in the immediate postinjection period, and 24 hours later 4/771 patients or about
0.5% still complained of pain. Redness did not occur immediately following intravenous injection
but was noted in 19/771 patients at the 24-hour observation period. This incidence is similar to that
observed with an intravenous infusion before lorazepam is given. Intra-arterial injection may produce
arteriospasm resulting in gangrene, which may require amputation (see CONTRAINDICATIONS).

Cardiovascular System
Hypertension (0.1%) and hypotension (0.1%) have occasionally been observed after patients
have received injectable lorazepam.

Respiratory System
Five patients (5/446) who underwent regional anesthesia were observed to have airway obstruction.
This was believed due to excessive sleepiness at the time of the procedure and resulted in
temporary hypoventilation. In this instance, appropriate airway management may become necessary
(see also CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS).

Other Adverse Experiences
Skin rash, nausea and vomiting have occasionally been noted in patients who have received
injectable lorazepam combined with other drugs during anesthesia and surgery.

Paradoxical Reactions
As with all benzodiazepines, paradoxical reactions such as stimulation, mania, irritability, restlessness,
agitation, aggression, psychosis, hostility, rage, or hallucinations may occur in rare
instances and in an upredictable fashion. In these instances, further use of the drug in these
patients should be considered with caution (see PRECAUTIONS: General).

Postmarketing Reports
Voluntary reports of other adverse events temporally associated with the use of Lorazepam
Injection that have been received since market introduction and that may have no causal relationship
with the use of Lorazepam Injection include the following: acute brain syndrome, aggravation
of pheochromocytoma, amnesia, apnea/respiratory arrest, arrhythmia, bradycardia, brain
edema, coagulation disorder, coma, convulsion, gastrointestinal hemorrhage, heart arrest/failure,
heart block, liver damage, lung edema, lung hemorrhage, nervousness, neuroleptic malignant
syndrome, paralysis, pericardial effusion, pneumothorax, pulmonary hypertension, tachycardia,
thrombocytopenia, urinary incontinence, ventricular arrhythmia.
Fatalities also have been reported, usually in patients on concomitant medications (e.g., respiratory
depressants) and/or with other medical conditions (e.g., obstructive sleep apnea).

Drug Abuse and Dependence

Controlled Substance Class
Lorazepam is a controlled substance in Schedule IV.

Abuse and Physical and Psychological Dependence
As with other benzodiazepines, Lorazepam Injection has a potential for abuse and may lead to
dependence. Physicians should be aware that repeated doses over a prolonged period of time
may result in physical and psychological dependence and withdrawal symptoms, following
abrupt discontinuance, similar in character to those noted with barbiturates and alcohol.

Overdosage

Symptoms
Overdosage of benzodiazepines is usually manifested by varying degrees of central-nervoussystem
depression, ranging from drowsiness to coma. In mild cases symptoms include drowsiness,
mental confusion and lethargy. In more serious examples, symptoms may include ataxia,
hypotonia, hypotension, hypnosis, stages one (1) to three (3) coma, and, very rarely, death.

Treatment
Treatment of overdosage is mainly supportive until the drug is eliminated from the body. Vital
signs and fluid balance should be carefully monitored in conjunction with close observation of
the patient. An adequate airway should be maintained and assisted respiration used as needed.
With normally functioning kidneys, forced diuresis with intravenous fluids and electrolytes may
accelerate elimination of benzodiazepines from the body. In addition, osmotic diuretics, such as
mannitol, may be effective as adjunctive measures. In more critical situations, renal dialysis and
exchange blood transfusions may be indicated. Lorazepam does not appear to be removed in
significant quantities by dialysis, although lorazepam glucuronide may be highly dialyzable. The
value of dialysis has not been adequately determined for lorazepam.

The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct
to, not as a substitute for, proper management of benzodiazepine overdose. The prescriber
should be aware of a risk of seizure in association with flumazenil treatment, particularly in
long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil
package insert including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS should be
consulted prior to use.

Lorazepam Injection Dosage and Administration

Lorazepam 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 WARNINGS).

Status Epilepticus
General Advice
Status epilepticus is a potentially life-threatening condition associated with a high risk of permanent
neurological impairment, if inadequately treated. The treatment of status, however, requires
far more that the administration of an anticonvulsant agent. It involves observation and management
of all parameters critical to maintaining vital function and the capacity to provide support
of those functions as required. Ventilatory support must be readily available. The use of benzodiazepines,
like Lorazepam Injection, is ordinarily only an initial step of a complex and sustained
intervention which may require additional interventions, (e.g., concomitant intravenous administration
of phenytoin). Because status epilepticus may result from a correctable acute cause such
as hypoglycemia, hyponatremia, or other metabolic or toxic derangement, such an abnormality
must be immediately sought and corrected. Furthermore, patients who are susceptible to further
seizure episodes should receive adequate maintenance antiepileptic therapy.
Any health care professional who intends to treat a patient with status epilepticus should be
familiar with this package insert and the pertinent medical literature concerning current concepts
for the treatment of status epilepticus. A comprehensive review of the considerations critical to
the informed and prudent management of status epilepticus cannot be provided in drug product
labeling. The archival medical literature contains many informative references on the management
of status epilepticus, among them the report of the working group on status epilepticus of
the Epilepsy Foundation of America “Treatment of Convulsive Status Epilepticus” (JAMA 1993;
270:854-859). As noted in the report just cited, it may be useful to consult with a neurologist if
a patient fails to respond (e.g., fails to regain consciousness).

Intravenous Injection
For the treatment of status epilepticus, the usual recommended dose of Lorazepam Injection is
4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional
Lorazepam 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 Lorazepam Injection 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 Lorazepam 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 (see CLINICAL PHARMACOLOGY:
Pharmacokinetics and Metabolism).

Pediatric
The safety of lorazepam 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 (see also CLINICAL PHARMACOLOGY, WARNINGS,
PRECAUTIONS, and ADVERSE REACTIONS). Doses of other central-nervous-system-depressant
drugs ordinarily should be reduced (see PRECAUTIONS). 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 (see also CLINICAL PHARMACOLOGY, WARNINGS,
PRECAUTIONS, and ADVERSE REACTIONS). Doses of other injectable central-nervous-systemdepressant
drugs ordinarily should be reduced (see PRECAUTIONS). 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 (see also CLINICAL PHARMACOLOGY).

Dose Adjustment Due to Drug Interactions
The dose of Lorazepam Injection should be reduced by 50% when coadministered with probenecid
or valproate (see PRECAUTIONS: Drug Interactions).

It may be necessary to increase the dose of lorazepam in female patients who are concomitantly
taking oral contraceptives.

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

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

Immediately prior to intravenous use, Lorazepam Injection must be diluted with an equal volume
of compatible solution. When properly diluted, the drug may be injected into a vein or into
the tubing of an existing intravenous infusion. The rate of injection should not exceed 2 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.

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

To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

How is Lorazepam Injection Supplied

Lorazepam Injection USP, is available in the following dosage strength in multiple-dose vials:

2 mg per mL      NDC 76329-8261-1      10 x 10 mL vials      Stock No. 8261

Directions for Dilution for IV use
For vial
Aspirate the desired amount of Lorazepam Injection into the syringe. Then proceed as follows:
To dilute, adhere to the following procedure:
1. Slowly aspirate the desired volume of diluent. Do not exceed the volume of the drug.
2. Do not add additional medication to the syringe.
3. Pull back slightly on the plunger to provide additional mixing space.
4. Immediately mix contents thoroughly by gently inverting syringe repeatedly until a homogenous
solution results. Do not shake vigorously, as this will result in air entrapment.

For IM or IV injection
Protect from light. Use carton to protect contents from light.
Store in a refrigerator 2˚ to 8˚C (36˚ to 46˚F).

International Medication Systems, Limited
So. El Monte, CA 91733
An Amphastar Pharmaceuticals Company
                                                                            9-13
© 2013

Lorazepam Injection, USP - Vial Label

LORAZEPAM INJECTION, USP

20 mg/10 mL

(2 mg/mL)

FOR IM OR IV USE.

MUST DILUTE BEFORE USE

SEE ENCLOSED DIRECTIONS.

10mL multiple-Dose Vial

Each mL contains: 2 mg lorazepam, 0.18 mL polyethylene glycol 400 in propylene glylocol with 2% benzyl alcohol as preservative.

Protect from light / Do not use if solution is discolored or contains precipitate.

Store in refrigerator 2° TO 8° C (36° to 46°F).

USUAL DOSAGE: See Insert.

7382610G

Rev: 8-12

Rx Only

IMS, Limited

So El Monte

CA 91733, USA

Lorazepam Injection, USP - Carton

NDC 76329-8261-0

Stock No. 8261

Lorazepam Injection, USP

20 mg/10 mL

(2 mg/mL) Rx Only

For IM or IV use.

MUST DILUTE BEFORE IV USE.

SEE ENCLOSED DIRECTIONS.

10 x 10 Ml 

Multiple-dose vials

10 mL

Each mL contains: 2 mg lorazepam

0.18 mL propylene glycol

400 in propylene glycol with 2%

benzyl alcohol as preservative.

USUAL DOSAGE: See Insert

Do not use if solution is discolored or contains precipitate.

Protect from light.

Use this carton to protect from light.

Retain in Carton until use.

Store in refrigerator 2° to 8°C (36° to 46°F).

LORAZEPAM 
Lorazepam Injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76329-8261
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lorazepam (Lorazepam) Lorazepam 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Polyethylene glycol 400 0.18 mL  in 1 mL
Benzyl Alcohol  
Packaging
# Item Code Package Description
1 NDC:76329-8261-1 10 VIAL in 1 CARTON
1 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076150 12/01/2012
Labeler - International Medication Systems, Limited (055750020)
Establishment
Name Address ID/FEI Operations
International Medication Systems, Limited 055750020 analysis(76329-8261), manufacture(76329-8261), label(76329-8261)
Revised: 05/2015
 
International Medication Systems, Limited
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