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Active substance(s): LORAZEPAM / LORAZEPAM / LORAZEPAM
Stopping your medicine:
• After you have finished your prescribed treatment
with Ativan Injection, your doctor will decide whether
or not you need further treatment.
• Following a course of treatment your dose of Ativan
Injection may be reduced slowly. This allows your
body to get used to being without Ativan Injection,
and reduces the risk of unpleasant effects.
• On stopping Ativan Injection, you may experience
symptoms such as headaches, muscle or stomach
pains, anxiety, tension, depression, restlessness,
sweating, sleep problems, confusion or irritability.
If these symptoms do occur, they do not usually last
for long. If you suffer from any of these symptoms,
ask your doctor for advice.
• If you suffer from any of the following symptoms;
loss of the sense of reality, tinnitus (ringing sounds
in your ears), numbness or tingling of your arms or
legs, vomiting, twitching, hallucinations, convulsions,
or effects on sight, hearing or touch, ask your doctor
for advice immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ativan Injection can cause side
effects, although not everybody gets them.
It is very important that you immediately contact
your doctor if you develop any of the following
• Anaphylactic (severe allergic) reactions
• A serious allergic reaction which causes swelling of
your face or throat (angioedema)
• Develop signs of jaundice (yellowing of the skin or
the whites of the eyes)
• Difficulty breathing
• Thoughts of harming or killing yourself
• Changes in your mental state.
Tell your doctor or pharmacist if you develop any of
the following side effects:
Very common (affect more than 1 in 10 patients):
• Drowsiness, sedation
Common (affect more than 1 in 100 patients but less
than 1 in 10 patients):
• Confusion, depression, unmasking of depression
• Lack of muscle coordination, dizziness
• Muscle weakness
• Lack of energy.
Uncommon (affect more than 1 in 1000 patients but less
than 1 in 100 patients):
• Changes in sex drive, impotence, decreased orgasm.
The following side effects have also been reported
with this class of medicine:
• Blood disorders which can include lower levels
of red blood cells, white blood cells and platelets
(known as blood dyscrasias). Symptoms of this
include unexplained bruising, bleeding, pale skin,
weakness and/or breathlessness, mouth ulcers and/
or frequent infections
• Allergic reactions
• Abnormally concentrated urine
• Low levels of sodium in the blood
• Loss of inhibitions, euphoria, thoughts or attempts of
• Anxiety, agitation, excitation, hostility, aggression,
rage, sleep disturbances/insomnia, sexual arousal,
Involuntary trembling, vertigo, visual disturbances
(including double vision and blurred vision), slurred
speech, headache, vomiting, convulsions/seizures,
memory loss, coma
Low blood pressure
Reduced breathing rate, shortness of breath,
temporary cessation of breathing, including during
Worsening of chronic obstructive lung disease
Increase in specific liver enzymes (bilirubin, liver
transaminases and alkaline phosphatase)
Allergic skin reactions, hair loss
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
5. HOW TO STORE ATIVAN INJECTION
Ativan Injection should be stored and transported
refrigerated (2°C to 8°C).
Keep ampoule in the outer carton to protect from light.
Keep out of the reach and sight of children.
Do not use Ativan Injection after the expiry date, which
is stated on the carton. The expiry date refers to the last
day of that month.
6. FURTHER INFORMATION
What Ativan Injection contains
The active ingredient in Ativan Injection is lorazepam,
and there are 4 mg of lorazepam in each 1 ml of the
The other ingredients in Ativan Injection are polyethylene
glycol, benzyl alcohol and propylene glycol.
What Ativan Injection looks like and contents of the
Ativan Injection is supplied in small clear glass bottles
(called ampoules) and each ampoule contains 1 ml of
Ativan Injection is supplied in packs of 10 ampoules.
The Marketing Authorisation Holder is:
Kent, CT13 9NJ
The Manufacturer is:
Haupt Pharma Livron
1 rue Comte de Sinard
26 250 Livron Sur Drome
This leaflet was last revised in 05/2014
This leaflet can be made
available in large print, audio
or Braille on request.
Contact 0800 198 5000
to request this, quoting
the following number:
Page 4 of 4
HEALTH PROFESSIONAL’S USER LEAFLET
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ativan Injection contains the active ingredient lorazepam at a concentration
of 4 mg/ml.
Lorazepam (INN, BAN) is chemically defined as 7-chloro-5(o-chlorphenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one.
3. PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution supplied in clear glass ampoules containing 4 mg
lorazepam in 1 ml of solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Pre‑operative medication or premedication for uncomfortable or prolonged
investigations, e.g. bronchoscopy, arteriography, endoscopy.
The treatment of acute anxiety states, acute excitement or acute mania.
The control of status epilepticus.
4.2 Posology and method of administration
Dosage and duration of therapy should be individualised. The lowest
effective dose should be prescribed for the shortest time possible.
Treatment in all patients should be withdrawn gradually to minimise possible
withdrawal symptoms (See special warnings and precautions for use).
Route of administration
Ativan Injection can be given intravenously or intramuscularly. However, the
intravenous route is to be preferred. Care should be taken to avoid injection
into small veins and intra‑arterial injection.
Absorption from the injection site is considerably slower if the intramuscular
route is used and as rapid an effect may be obtained by oral administration
Ativan should not be used for long-term chronic treatment.
Preparation of the injection
Ativan Injection is slightly viscid when cool.
A 1:1 dilution of Ativan Injection with normal saline or Sterile Water
for Injection BP is recommended in order to facilitate intramuscular
For intravenous administration, Ativan Injection should always be diluted with
saline or Sterile Water for Injection BP as a 1:1 dilution.
Ativan Injection is presented as a 1 ml solution in a 2 ml ampoule to facilitate
Ativan Injection should not be mixed with other drugs in the same syringe.
Adults: 0.05 mg/kg (3.5 mg for an average 70 kg man).
By the intravenous route the injection should be given
30‑45 minutes before surgery when sedation will be evident
after 5-10 minutes and maximal loss of recall will occur after
By the intramuscular route the injection should be given
1-11/2 hours before surgery when sedation will be evident
after 30-45 minutes and maximal loss of recall will occur after
Children: Ativan Injection is not recommended in children under 12.
2. Acute Anxiety
Adults: 0.025‑0.03 mg/kg (1.75‑2.1 mg for an average 70 kg man).
Repeat 6 hourly.
Children: Ativan Injection is not recommended in children under 12.
3. Status epilepticus
Adults: 4 mg intravenously
Children: 2 mg intravenously
Elderly: The elderly may respond to lower doses and half the normal adult
dose may be sufficient.
Patients with Renal or Hepatic impairment:
Lower doses may be sufficient in these patients (See special warnings and
precautions for use). Use in patients with severe hepatic insufficiency is
• Acute pulmonary insufficiency
• Hypersensitivity to benzodiazepines, including Ativan Injection or any of
the vehicle constituents (polyethylene glycol, propylene glycol, benzyl
• Sleep apnoea syndrome
• Myasthenia gravis
• Severe hepatic insufficiency
• Ativan Injection contains benzyl alcohol and is contraindicated in infants
or young children, up to 3 years old.
Ativan Injection is not recommended for out‑patient use unless the patient
4.4 Special warnings and precautions for use
Prior to use, Ativan Injection may be diluted for IM administration and should
always be diluted for IV administration with equal amounts of compatible
diluent (see Posology and method of administration). Intravenous injection
should be administered slowly except in the control of status epilepticus
where rapid injection is required.
The possibility that respiratory arrest may occur or that the patient may
have partial airway obstruction should be considered. Therefore, equipment
necessary to maintain a patent airway and to support respiration/ventilation
should be available and used where necessary.
The use of benzodiazepines, including lorazepam, may lead to physical and
Severe anaphylactic/anaphylactoid reactions have been reported with the
use of benzodiazepines. Cases of angioedema involving the tongue, glottis
or larynx have been reported in patients after taking the first or subsequent
doses of benzodiazepines. Some patients taking benzodiazepines have
had additional symptoms such as dyspnoea, throat closing, or nausea and
vomiting. Some patients have required medical therapy in the emergency
department. If angioedema involves the tongue, glottis or larynx, airway
obstruction may occur and be fatal. Patients who develop angioedema after
treatment with a benzodiazepine should not be rechallenged with the drug.
It is recommended that patients receiving Ativan Injection should remain
under observation for at least eight hours and preferably overnight. When
Ativan Injection is used for short procedures on an outpatient basis, the
patient should be accompanied when discharged.
Patients should be advised that their tolerance for alcohol and other CNS
depressants will be diminished in the presence of Ativan Injection. Alcoholic
beverages should not be consumed for at least 24 to 48 hours after receiving
Use of benzodiazepines, including lorazepam, may lead to potentially fatal
respiratory depression. Extreme care must be taken in administering Ativan
Injection to elderly or very ill patients and to those with limited pulmonary
reserve or compromised respiratory function (eg, chronic obstructive
pulmonary disease [COPD]), because of the possibility that apnoea and/or
cardiac arrest may occur. Care should also be exercised when administering
Ativan Injection to a patient with status epilepticus, especially when the
patient has received other central nervous system depressants.
There is no evidence to support the use of Ativan Injection in coma or shock.
Ativan is not intended for the primary treatment of psychotic illness or
depressive disorders, and should not be used alone to treat depressed
patients. The use of benzodiazepines may have a disinhibiting effect and
may release suicidal tendencies in depressed patients.
Pre-existing depression may emerge during benzodiazepine use.
There are no clinical data available for Ativan Injection with regard
to abuse or dependence. However, based upon experience with oral
benzodiazepines, doctors should be aware that repeated doses of
Ativan Injection over a prolonged period of time may lead to physical and
psychological dependence. The risk of dependence on Ativan is low when
used at the recommended dose and duration, but increases with higher
doses and longer term use. The risk of dependence is further increased
in patients with a history of alcoholism or drug abuse, or in patients with
significant personality disorders. Therefore, use in individuals with a history
of alcoholism or drug abuse should be avoided.
Dependence may lead to withdrawal symptoms, especially if treatment is
discontinued abruptly. Therefore, the drug should always be discontinued
gradually - using the oral preparation if necessary.
Symptoms reported following discontinuation of oral benzodiazepines
include headaches, muscle pain, anxiety, tension, depression, insomnia,
restlessness, confusion, irritability, sweating, and the occurrence of
"rebound" phenomena whereby the symptoms that led to treatment with
benzodiazepines recur in an enhanced form. These symptoms may be
difficult to distinguish from the original symptoms for which the drug was
In severe cases the following symptoms may occur: derealisation;
depersonalisation; hyperacusis; tinnitus; numbness and tingling of the
extremities; hypersensitivity to light, noise, and physical contact; involuntary
movements; vomiting; hallucinations; convulsions. Convulsions may be more
common in patients with pre-existing seizure disorders or who are taking
other drugs that lower the convulsive threshold, such as antidepressants.
It may be useful to inform the patient that treatment will be of limited duration
and that it will be discontinued gradually. The patient should also be made
aware of the possibility of "rebound" phenomena to minimise anxiety should
Withdrawal symptoms (eg, rebound insomnia) can appear following
cessation of recommended doses after as little as one week of therapy.
There are indications that, in the case of benzodiazepines with a short
duration of action, withdrawal phenomena can become manifest within the
dosage interval, especially when the dosage is high.
When benzodiazepines with a long duration of action are being used,
it is important to warn against changing to a benzodiazepine with a short
duration of action, as withdrawal symptoms may develop.
Abuse of benzodiazepines has been reported.
Anxiety or insomnia may be a symptom of several other disorders. The
possibility should be considered that the complaint may be related to an
underlying physical or psychiatric disorder for which there is more specific
Caution should be used in the treatment of patients with acute narrowangle glaucoma.
As with all benzodiazepines, the use of lorazepam may worsen hepatic
encephalopathy. Patients with impaired renal or hepatic function should
be monitored frequently and have their dosage adjusted carefully
according to patient response. Lower doses may be sufficient in these
patients. The same precautions apply to elderly or debilitated patients
and patients with chronic respiratory insufficiency.
As with all CNS-depressants, the use of benzodiazepines may precipitate
encephalopathy in patients with severe hepatic insufficiency. Therefore,
use in these patients is contraindicated.
Some patients taking benzodiazepines have developed a blood dyscrasia,
and some have had elevations in liver enzymes. Periodic haematologic
and liver-function assessments are recommended where repeated
courses of treatment are considered clinically necessary.
Transient anterograde amnesia or memory impairment has been reported
in association with the use of benzodiazepines. This effect may be
advantageous when Ativan is used as a premedicant.
Paradoxical reactions have been occasionally reported during
benzodiazepine use (see Undesirable effects). Such reactions may be
more likely to occur in children and the elderly. Should these occur, use of
the drug should be discontinued.
Although hypotension has occurred only rarely, benzodiazepines should
be administered with caution to patients in whom a drop in blood pressure
might lead to cardiovascular or cerebrovascular complications. This is
particularly important in elderly patients.
Ativan Injection contains the excipients polyethylene glycol and propylene
glycol. There have been reports of propylene glycol toxicity (e.g. lactic
acidosis, hyperosmolality, hypotension) and polyethylene glycol toxicity
(e.g. acute tubular necrosis) during administration of Ativan Injection,
including at higher than recommended doses. Central nervous system
toxicity, including seizures, as well as unresponsiveness, tachypnoea,
tachycardia and diaphoresis have also been associated with propylene
glycol toxicity. Those prone to propylene glycol accumulation and its
potential adverse effects include patients with impaired alcohol and
aldehyde dehydrogenase enzyme systems, those with renal or hepatic
disease; and paediatric patients.
4.5 Interaction with other medicinal products and other forms of
Not recommended: Concomitant intake with alcohol
The sedative effects may be enhanced when the product is used in
combination with alcohol. This affects the ability to drive or use machines.
• hold with one hand the bottom part of the ampoule
• put the other hand on the top of the ampoule
positioning the thumb above the coloured spot and
press back using thumb and hand. Please see
Page 1 of 4
Smallest Font Used
INFORMATION FOR THE USER
need to be reduced before you can take Ativan Injection. You
should also tell your doctor if you are taking a drug called
scopolamine, which may be used for gut problems or before
Taking Ativan Injection with food and drink
You should avoid alcohol for at least 24 to 48 hours after
receiving Ativan Injection.
Read all of this leaflet carefully before you start taking this
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or
• If any of the side effects gets serious, or you notice any
side effects not listed in this leaflet, please tell your doctor
IN THIS LEAFLET:
1. What Ativan Injection is and what it is used for.
2. Before you take Ativan Injection.
3. Receiving Ativan Injection.
4. Possible side effects.
5. How to store Ativan Injection.
6. Further information.
1. WHAT ATIVAN INJECTION IS AND WHAT IT IS
The name of your medicine is Ativan Injection. The active
ingredient in Ativan Injection is lorazepam, which is a member
of a group of medicines called benzodiazepines. It helps to
relieve anxiety and muscle tension.
Ativan Injection is usually prescribed as
pre-medication to help you to relax before an operation or
before uncomfortable or prolonged investigations. It may also
be used to relieve short periods of anxiety, excitement or
agitation, and in the control of convulsions.
2. BEFORE YOU TAKE ATIVAN INJECTION
You should not be given Ativan Injection if:
• You have severe breathing or chest problems.
• You are allergic to benzodiazepines or any of the
ingredients in Ativan Injection (see Section 6 for a full list of
• You have myasthenia gravis (a disease causing weakened
muscles and excessive tiredness).
• You have serious liver problems.
• You suffer from sleep apnoea (breathing problems when
you are asleep).
If you are an out-patient you should not be given Ativan
Injection unless you have somebody to take you home.
Ativan Injection contains benzyl alcohol and should not be
used in infants or young children up to 3 years old.
Tell your doctor or pharmacist if:
• You are pregnant or trying to become pregnant.
• You are breast-feeding, since the drug may pass into
• You abuse or have in the past abused drugs or alcohol.
• You have a personality disorder. If so, you have a greater
chance of becoming dependent on lorazepam.
• You have any kidney or liver problems.
• You have suffered from depression in the past since it
could re-occur during treatment with lorazepam.
• You are currently suffering from depression, since
lorazepam may increase any suicidal feelings, which you
• You suffer from breathing problems.
• You suffer from an eye problem called glaucoma.
• You enter hospital for treatment.
Taking other medicines
You should tell your doctor or pharmacist if you are taking
any other medicines, including those which have not been
prescribed by a doctor, since they may affect the way Ativan
Injection works. Ativan Injection may also affect the way other
In particular, you should tell your doctor if you are taking any
other sedative, anti-anxiety drugs, antidepressants, strong pain
killers (e.g. methadone), drugs for epilepsy, antihistamines,
drugs for mood or mental disorders (e.g. chlorpromazine,
clozapine and haloperidol), drugs for respiratory diseases,
drugs for gout (probenecid). The dose of these drugs may
Pregnancy and breast-feeding
If you are pregnant or might become pregnant do not take this
medicine without consulting your doctor first. Benzodiazepines,
including Ativan Injection, may cause damage to the foetus if
taken during early pregnancy. If you take this medicine during
late pregnancy or during labour, your baby, when born, may be
less active than other babies, have a low body temperature,
be floppy or have breathing or feeding difficulties for a while.
Your baby’s response to the cold might be temporarily impaired
also. If this medicine is taken regularly in late pregnancy, your
baby may develop withdrawal symptoms after birth.
Talk to your doctor or pharmacist if you are breast-feeding,
since the drug may pass into breast milk.
Driving and using machines
Do not drive or use machinery within 24 to 48 hours of
receiving Ativan Injection. The medicine can affect your ability
to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how
it affects you.
• It is an offence to drive if this medicine affects your ability
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or
dental problem and
- You have taken it according to the instructions given by
the prescriber or in the information provided with the
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine.
Important information about some of the ingredients of
Toxic effects (including seizures) caused by the ingredients
contained in Ativan Injection (polyethylene glycol and propylene
glycol) have been reported following very high doses of Ativan
3. RECEIVING ATIVAN INJECTION
Your doctor will give you Ativan Injection, by injecting it into one
of your veins (intravenously) or into one of your muscles. Ativan
Injection may be diluted with water or saline just before it is
given to you. The amount of Ativan Injection you are given
will depend on how much you weigh and why it is being
given to you:
• Before an operation or investigation, you will usually be
given 0.05 mg of Ativan Injection for each kilogram that
you weigh (e.g. if you weigh 70 kilograms you will receive
3.5 mg of Ativan Injection).
• For anxiety or excitement, the usual dose is 0.025 to
0.03 mg for each kilogram that you weigh (e.g. if you
weigh 70 kilograms you will probably receive 1.75 to
2.1 mg of Ativan Injection).
• When Ativan Injection is used to control convulsions a
dose of 4 mg is usually given intravenously to adults.
A lower dose of 2 mg given intravenously is usually given
to control convulsions in children.
Your doctor may prescribe a different dose or length of
treatment, especially if you are elderly.
Page 3 of 4
Immune system disorders
Undetermined: Hypersensitivity reactions, anaphylactic/
oid reactions, angioedema.
Syndrome of Inappropriate Antidiuretic
Hormone secretion (SIADH).
Metabolism and nutrition disorders
Ativan Injection is usually only prescribed for one
or two doses, or for a short course of treatment.
This reduces the risk of becoming dependent on
Ativan Injection, or suffering unpleasant effects when
you stop taking it (See `Stopping your medicine',
Instructions for use:
Ativan ampoules are equipped with the OPC (One
Point Cut) opening system and must be opened using
the following instructions:
Blood and lymphatic system disorders
Undetermined: Thrombocytopenia, agranulocytosis, pancytopenia.
Some people feel sleepy after receiving Ativan
Injection. Therefore, you may need to stay in hospital
for at least 8 hours, or overnight, after receiving your
injection. If you are to leave hospital shortly after
receiving Ativan Injection you should have someone
The benzodiazepines, including Ativan Injection, produce additive CNS
depressant effects when co-administered with other medications which
themselves produce CNS depression, e.g. barbiturates, antipsychotics,
sedatives/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative
antihistamines, anticonvulsants and anaesthetics.
Concurrent administration of lorazepam with sodium valproate may result in
reduced clearance (20 to 40%) and increased concentrations of lorazepam.
Therefore clinical monitoring is advised and lorazepam dosage should be
reduced when appropriate.
Concurrent administration of lorazepam with probenecid may result in reduced
clearance, increased elimination half-life and increased concentrations of
lorazepam. Therefore clinical monitoring is advised and lorazepam dosage
should be reduced when appropriate.
An enhancement of the euphoria induced by narcotic analgesics may occur
with benzodiazepine use, leading to an increase in psychic dependence.
Compounds which inhibit certain hepatic enzymes (particularly cytochrome
P450) may enhance the activity of benzodiazepines. To a lesser degree this
also applies to benzodiazepines which are metabolised only by conjugation.
The addition of scopolamine to Ativan Injection is not recommended, since
their combination has been observed to cause an increased incidence of
sedation, hallucination and irrational behaviour.
Concomitant use of clozapine and lorazepam may produce marked sedation,
excessive salivation, and ataxia.
Administration of theophylline or aminophylline may reduce the sedative
effects of benzodiazepines, including lorazepam.
There have been reports of apnoea, coma, bradycardia, heart arrest and death
with the concomitant use of lorazepam injection solution and haloperidol.
4.6 Pregnancy and lactation
Ativan Injection should not be used during pregnancy, especially during
the first and last trimesters, unless in the judgement of the physician such
administration is clinically justifiable. Benzodiazepines may cause foetal
damage when administered to pregnant women.
If the drug is prescribed to a woman of childbearing potential, she should
be warned to contact her physician about stopping the drug if she intends to
become, or suspects that she is, pregnant.
Use of Ativan Injection during the late phase of pregnancy may require
ventilation of the infant at birth.
If, for compelling medical reasons, the product is administered during the late
phase of pregnancy, or during labour at high doses, effects on the neonate,
such as hypothermia, hypotonia and moderate respiratory depression, can be
expected, due to the pharmacological action of the compound.
Infants of mothers who ingested benzodiazepines for several weeks or more
preceding delivery have been reported to have withdrawal symptoms during
the postnatal period.
Symptoms such as hypotonia, hypothermia, respiratory depression, apnoea,
feeding problems, and impaired metabolic response to cold stress have been
reported in neonates born of mothers who have received benzodiazepines
during the late phase of pregnancy or at delivery.
There are insufficient data regarding obstetrical safety of parenteral Ativan,
including use in caesarean section. Such use, therefore, is not recommended.
Since benzodiazepines are found in breast milk, Ativan Injection should not
be given to breast feeding mothers unless the expected benefit to the woman
outweighs the potential risk to the infant.
4.7 Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration and impaired muscular function
may adversely affect the ability to drive or use machines. Therefore, patients
should not drive or operate machinery within 24‑48 hours of administration
of Ativan Injection and should be advised not to take alcohol (see also
This medicine can impair cognitive function and can affect a patient’s ability to
drive safely. This class of medicine is in the list of drugs included in regulations
under 5a of the Road Traffic Act 1988. When prescribing this medicine,
patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called ‘statutory defence’) if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber
and in the information provided with the medicine and
- It was not affecting your ability to drive safely
4.8 Undesirable effects
Adverse reactions are listed in the table in CIOMS frequency categories:
≥ 1% and < 10%
≥ 0.1% and < 1%
≥ 0.01% and < 0.1%
Undetermined: Insufficient data to calculate significant frequencies.
System Organ Class
Confusion, depression, unmasking of depression.
Disinhibition, euphoria, suicidal ideation/attempt.
Paradoxical reactions, including anxiety,
agitation, excitation, hostility, aggression, rage,
sleep disturbances/insomnia, sexual arousal,
Nervous system disorders*
Very common: Sedation, drowsiness.
Extrapyramidal symptoms, tremor, vertigo, visual
disturbances (including diplopia and blurred
vision), dysarthria/slurred speech, headache,
convulsions/seizures, amnesia, coma.
* Benzodiazepine effects on the CNS are dose dependent, with more
severe CNS depression occurring with higher doses.
Respiratory, thoracic and mediastinal disorders†
Undetermined: Respiratory depression, apnoea, worsening
Worsening of obstructive pulmonary disease.
The extent of respiratory depression with benzodiazepines is dose
dependent with more severe depression occurring with high doses.
Increase in bilirubin, increase in liver
transaminases, increase in alkaline phosphatase.
Skin and subcutaneous tissue disorders
Undetermined: Allergic skin reactions, alopecia.
Reproductive system and breast disorders
Change in libido, impotence, decreased
General disorders and administration site conditions
Very common: Fatigue.
Muscle weakness, asthenia.
Tolerance at the injection site is generally good although, rarely, pain and
redness have been reported after Ativan Injection.
Transient anterograde amnesia or memory impairment may occur using
therapeutic doses, the risk increasing at higher doses (see Special warnings
and precautions for use).
Paradoxical reactions may be more likely to occur in children and the elderly
(see Special warnings and precautions for use).
In the management of overdosage with any drug, it should be borne in mind
that multiple agents may have been taken.
Overdosage of benzodiazepines is usually manifested by degrees of central
nervous system depression ranging from drowsiness to coma. In mild cases,
symptoms include drowsiness, mental confusion and lethargy. In more serious
cases, and especially when other CNS-depressant drugs or alcohol are
ingested, symptoms may include ataxia, hypotension, hypotonia, respiratory
depression, cardiovascular depression, coma and, very rarely, death.
Propylene glycol toxicity and polyethylene glycol toxicity have been reported
following higher than recommended doses of Ativan Injection (see Section
4.4 Special warnings and precautions for use).
Treatment of overdosage is mainly supportive including monitoring of vital
signs and close observation of the patient. An adequate airway should
be maintained and assisted respiration used as needed. Hypotension,
though unlikely, may be controlled with noradrenaline. Lorazepam is poorly
The benzodiazepine antagonist, flumazenil, may be useful in hospitalised
patients for the management of benzodiazepine overdosage. Flumazenil
product information should be consulted prior to use. The physician should be
aware of a risk of seizure in association with flumazenil treatment, particularly
in long-term benzodiazepine users and in tricyclic antidepressant overdose.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ativan is a benzodiazepine with anxiolytic, sedative, hypnotic, anticonvulsant
and muscle relaxant properties.
5.2 Pharmacokinetic properties
Ativan Injection is readily absorbed when given intramuscularly. Peak
plasma concentrations occur approximately 60-90 minutes following
Ativan is metabolised by a simple one-step process to a pharmacologically
inactive glucuronide. There is minimal risk of accumulation after repeated
doses, giving a wide margin of safety.
There are no major active metabolites. The elimination half-life is about
12-16 hours when given intramuscularly or intravenously.
5.3 Preclinical safety data
Nothing of relevance to the prescriber.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polyethylene glycol 400
6.3 Shelf life
6.4 Special precautions for storage
Store and transport refrigerated (2°C to 8°C).
Keep ampoule in the outer carton.
6.5 Nature and contents of container
1ml solution in 2ml ampoules (Type I glass) with a one-point-cut opening,
position marked by red spot in pack sizes of 10.
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
Kent, CT13 9NJ
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
11 August 2011
10. DATE OF REVISION OF THE TEXT
Ref: AT 6_1
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Source: Medicines and Healthcare Products Regulatory Agency
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