Lorazepam Injection USP 2mg/1ml Taj Pharma

1. Name of the medicinal product

Lorazepam Injection USP 2mg/1ml Taj Pharma
Lorazepam Injection USP 20mg/10ml Taj Pharma
Lorazepam Injection USP 40mg/10ml Taj Pharma

2. Qualitative and quantitative composition

a) Lorazepam Injection USP 2mg/1ml
Each ml contains:
Lorazepam                                     2mg
Polyethylene glycol                      0.18ml
Benzyl alcohol   

b) Lorazepam Injection USP 20mg/10ml
Each ml contains:
Lorazepam                                     2mg
Polyethylene glycol                      0.18ml
Benzyl alcohol

c) Lorazepam Injection USP 40mg/10ml
Each ml contains:
Lorazepam                                     4mg
Polyethylene glycol                      0.18ml
Benzyl alcohol

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection

Clear, colourless solution supplied in clear glass ampoules.

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

Posology

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Treatment in all patients should be withdrawn gradually to minimise possible withdrawal symptoms (See section 4.4).

Method 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 of lorazepam.

Ativan should not be used for long-term chronic treatment.

Preparation of the injection

Ativan Injection is slightly viscid when cool.

Intramuscular administration:

A 1:1 dilution of Ativan Injection with normal saline or Sterile Water for Injection BP is recommended in order to facilitate intramuscular administration.

Intravenous administration:

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 1ml solution in a 2ml ampoule to facilitate dilution.

Ativan Injection should not be mixed with other drugs in the same syringe.

Dosage:

1. Premedication:

Paediatric population: Ativan Injection is not recommended in children under 12.

2. Acute Anxiety

Paediatric population: Ativan Injection is not recommended in children under 12.

3. Status epilepticus

Paediatric population: 2mg intravenously

Patients with Renal or Hepatic impairment:

Lower doses may be sufficient in these patients (See section 4.4). Use in patients with severe hepatic insufficiency is contraindicated.

Elderly and debilitated patients

For elderly and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated (see section 4.4 Special warnings and precautions for use)

4.3 Contraindications

• Acute pulmonary insufficiency
• Hypersensitivity to benzodiazepines, including lorazepam or to any of the excipients listed in section 6.1.
• Sleep apnoea syndrome
• Myasthenia gravis
• Severe hepatic insufficiency

Ativan Injection is not recommended for out-patient use unless the patient is accompanied.

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 section 4.2). 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 psychological dependence.

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 Ativan Injection.

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 (e.g. 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.

Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma, and death.

Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Ativan with opioids should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Ativan concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of these symptoms (see section 4.5).

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 prescribed.

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 they occur.

Withdrawal symptoms (e.g. 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 treatment.

Caution should be used in the treatment of patients with acute narrow-angle 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 section 4.8). 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.

Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse event, and death in paediatric patients including neonates characterized by central nervous system depression, metabolic acidosis, gasping respirations, cardio-vascular failure and haematological anomalies (“gasping syndrome”). Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Use only if it is necessary and if there are no alternatives possible. If given in high volumes, should be used with caution and preferably for short term treatment in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis)

Premature and low-birth weight infants may be more likely to develop toxicity.

Benzyl Alcohol containing products should not be used in pre-term or full-term neonates unless strictly necessary.

Elderly patients

Lorazepam should be used with caution in elderly due to the risk of sedation and/or musculoskeletal weakness that can increase the risk of falls, with serious consequences in this population. Elderly patients should be given a reduced dose (see section 4.2 Posology).

4.5 Interaction with other medicinal products and other forms of interaction

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.

The benzodiazepines, including Ativan Injection, produce additive CNS depressant effects including respiratory depression, when co-administered with other medications which themselves produce CNS depression, e.g. opioids, barbiturates, antipsychotics, sedatives/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants and anaesthetics (see section 4.4).

Opioids:

The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Ativan with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see section 4.4).

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 Fertility, pregnancy and lactation

Pregnancy

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.

Benzyl alcohol can cross the placenta, see section 4.4..

Breast-feeding

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

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:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and

o It was not affecting your ability to drive safely

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 section 4.5).

4.8 Undesirable effects

± Benzodiazepine effects on the CNS are dose-dependent, with more severe CNS depression occurring with high doses.

β The extent of respiratory depression with benzodiazepines is dose_–dependent, with more severe depression occurring with high doses.

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 section 4.4).

Paediatric population

Paradoxical reactions may be more likely to occur in children and the elderly (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

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).

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 dialysable.

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

Pharmacotherapeutic group: Benzodiazepine derivatives.

Ativan is a benzodiazepine with anxiolytic, sedative, hypnotic, anticonvulsant and muscle relaxant properties.

5.2 Pharmacokinetic properties

Absorption

Ativan Injection is readily absorbed when given intramuscularly. Peak plasma concentrations occur approximately 60-90 minutes following intramuscular administration.

Metabolism

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.

Elimination

The elimination half-life is about 12-16 hours when given intramuscularly or intravenously.

5.3 Preclinical safety data

Lorazepam glucuronide, the major metabolite of lorazepam, has no demonstrable CNS activity in animals.

Carcinogenicity

No evidence of carcinogenic potential emerged in rats and mice during an 18-month study with oral lorazepam.

Mutagenicity

A study of the mutagenic activity of lorazepam on Drosophila melanogaster indicated that this agent was mutationally inactive.

Impairment of fertility

A pre-implantation study in rats was performed with oral lorazepam at a 20 mg/kg dose that showed no impairment of fertility.

Effect of anesthetic and sedative drugs

Nonclinical research has shown that administration of anesthetic and sedation drugs that block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity can increase neuronal cell death in the brain and result in long term deficits in cognition and behavior of juvenile animals when administered during the period of peak brain development. Based on comparisons across nonclinical species, the window of vulnerability of the brain to these effects is believed to correlate with human exposures in the third trimester of pregnancy through the first year of life, but may extend to approximately 3 years of age. While there is limited information of this effect with lorazepam, since the mechanism of action includes potentiation of GABA activity, a similar effect may occur. The relevance of these nonclinical findings to human use is unknown.

6. Pharmaceutical particulars

6.1 List of excipients

Polyethylene glycol 400

Benzyl alcohol

Propylene glycol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

1 year.

6.4 Special precautions for storage

Store and transport refrigerated (2°C to 8°C).

Keep ampoule in the outer carton to protect from light.

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.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Lorazepam Injection USP 2mg/1ml Taj Pharma
Lorazepam Injection USP 20mg/10ml Taj Pharma
Lorazepam Injection USP 40mg/10ml Taj Pharma

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start using this medicine because it contains important information for you:

• Keep this leaflet. You may need to read it
• If you have further questions, ask your doctor, pharmacist or
• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section
• Lorazepam Injection 4 mg/ml Solution for Injection – this medicine will be referred to as Lorazepam Injection  Injection in the rest of this

What is in this leaflet

1. What Lorazepam Injection Injection is and what it is used
2. What you need to know before you use Lorazepam Injection
3. How to use Lorazepam Injection
4. Possible side
5. How to store Lorazepam Injection
6. Contents of the pack and other information.

1. What Lorazepam Injection  Injection is and what it is used for

Lorazepam Injection  Injection contains lorazepam, which is a member of a group of medicines called benzodiazepines. It helps to relieve anxiety and muscle tension.

Lorazepam Injection  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.

You must talk to a doctor if you do not feel better or if you feel worse.

Lorazepam Injection  Injection is not recommended for use in children under the age of 12 years except for status epilepticus.

2.  What you need to know before you use Lorazepam Injection  Injection

You should not be given Lorazepam Injection  Injection:

• If you have severe breathing or chest problems.
• If you are allergic to benzodiazepines, including lorazepam or any of the other of this medicine (listed in section 6).
• If you have myasthenia gravis (a disease causing weakened muscles and excessive tiredness).
• I you have serious liver
• If you suffer from sleep apnoea (breathing problems when you are asleep).

If you are an out-patient you should not be given Lorazepam Injection  Injection unless you have somebody to take you home.

Lorazepam Injection  Injection contains benzyl alcohol and should not be used in infants or young children up to 3 years old.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lorazepam Injection  Injection if:

• You are pregnant or trying to become
• You are breast-feeding, since the drug may pass into breast
• You abuse or have in the past abused drugs or
• You have a personality disorder. If so, you have a greater chance of becoming dependent on lorazepam.
• You have any kidney or liver
• 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 may
• You suffer from breathing
• You suffer from an eye problem called
• You enter hospital for

Other medicines and Lorazepam Injection  Injection

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, since they may affect the way Lorazepam Injection  Injection works. Lorazepam Injection  Injection may also affect the way other drugs work.

In particular, you should tell your doctor if you are taking any other sedative, anti-anxiety drugs, antidepressants, strong pain killers (e.g. opioids, 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 need to be reduced before you can take Lorazepam Injection  Injection. You should also tell your doctor if you are taking a drug called scopolamine, which may be used for gut problems or before an operation.

Use of Lorazepam Injection  at the same time as opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, use of Lorazepam Injection  at the same time as opioids should only be considered when other treatment options are not possible.

However if your doctor does prescribe Lorazepam Injection  together with opioids the dose and duration of  treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Lorazepam Injection  Injection with food, drink and alcohol

You should avoid alcohol for at least 24 to 48 hours after receiving Lorazepam Injection  Injection. Please refer to section 3.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.

Benzodiazepines, including Lorazepam Injection  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.

The drug may pass into breast milk.

Driving and using machines

Do not drive or use machinery within 24 to 48 hours of receiving Lorazepam Injection  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
• It is an offence to drive if this medicine affects your ability to
• 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 medicine and
• 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.

Lorazepam Injection  Injection contains polyethylene glycol and propylene glycol

Toxic effects (including seizures) caused by the ingredients contained in Lorazepam Injection  Injection (polyethylene glycol and propylene glycol) have been reported following very high doses of Lorazepam Injection  Injection.

Lorazepam Injection  Injection contains 20.9mg/ml benzyl alcohol and must not be given to premature babies and babies less than one month old. This preservative may cause allergic and toxic reactions in young children up to three years old.

Propylene glycol may cause alcohol like symptoms.

3.  How to use Lorazepam Injection  Injection

Your doctor will give you Lorazepam Injection  Injection, by injecting it into one of your veins (intravenously) or into one of your muscles. Lorazepam Injection  Injection may be diluted with water or saline just before it is given to you. The amount of Lorazepam Injection  Injection you are given will depend on how much you weigh and why it is being given to you:

The recommended dose is:

• Before an operation or investigation, you will usually be given 0.05 mg of Lorazepam Injection Injection for each kilogram that you weigh (e.g. if you weigh 70 kilograms you will receive 3.5 mg of Lorazepam Injection  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 Lorazepam Injection Injection).
• When Lorazepam Injection 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

Your doctor may prescribe a different dose or length of treatment, especially if you are elderly.

Some people feel sleepy after receiving Lorazepam Injection  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 Lorazepam Injection  Injection you should have someone with you.

Lorazepam Injection  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 Lorazepam Injection  Injection, or suffering unpleasant effects when you stop taking it (See `If you stop using Lorazepam Injection  Injection’, below).

If you stop using Lorazepam Injection  Injection:

• After you have finished your prescribed treatment with Lorazepam Injection Injection, your doctor will decide whether or not you need further
• Following a course of treatment your dose of Lorazepam Injection Injection may be reduced slowly. This allows your body to get used to being without Lorazepam Injection  Injection, and reduces the risk of unpleasant effects.
• On stopping Lorazepam Injection 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
• 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.  Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Reasons for stopping Lorazepam Injection  Injection

It is very important that you immediately contact your doctor if you develop any of the following symptoms:

• Anaphylactic (severe allergic) reactions such as swelling of the face, tongue, lips or throat (angioedema), which may cause difficulty breathing; swelling of the extremities (hands or feet)
• 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

Other side effects that may occur are:

Very common: may affect more than 1 in 10 people

• Drowsiness, sedation

Common: may affect up to 1 in 10 people

• Confusion, depression, unmasking of depression
• Lack of muscle coordination, dizziness
• Muscle weakness
• Lack of

Uncommon: may affect up to 1 in 100 people

• Nausea
• Changes in sex drive, impotence, decreased

Not known: frequency cannot be estimated from available data Contact your doctor if you develop any of the following symptoms:

• 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
• Allergic (hypersensitivity) reactions
• Abnormally concentrated urine
• Low levels of sodium in the blood
• Loss of inhibitions, feelings of great happiness or well-being (euphoria), thoughts or attempts of suicide
• Anxiety, agitation, excitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations
• Extrapyramidal symptoms, involuntary trembling, vertigo, visual disturbances (including double vision and blurred vision), slurred speech, headache, vomiting, fits, memory loss, coma
• Low blood pressure
• Reduced breathing rate, shortness of breath, temporary cessation of breathing, including during sleep, worsening of sleep
• Worsening of chronic obstructive lung disease
• Constipation
• Increases in liver enzymes, which may affect the way your liver works (will be detected by blood tests)
• Allergic skin reactions, hair loss
• Hypothermia
• Pain or redness at the injection

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5.  How to store Lorazepam Injection  Injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton or bottle after ‘EXP’. The expiry date refers to the last day of that month.

Lorazepam Injection  Injection should be stored and transported refrigerated (2C to 8C). Keep ampoule in the outer carton to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.  Contents of the pack and other information What Lorazepam Injection  Injection contains

The active ingredient in Lorazepam Injection  Injection is lorazepam, and there are 4 mg of lorazepam in each 1 ml of the injection.

The other ingredients in Lorazepam Injection  Injection are polyethylene glycol, benzyl alcohol and propylene glycol (see section 2 “Lorazepam Injection  Injection contains polyethylene glycol and propylene glycol”).

What Lorazepam Injection  Injection looks like and contents of the pack

Lorazepam Injection  Injection is a clear, colourless solution supplied in small clear glass bottles (called ampoules) and each ampoule contains 1 ml of Lorazepam Injection  Injection.

Lorazepam Injection  Injection is supplied in packs of 10 ampoules. Not all pack sizes may be marketed.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com