Details for: LORAZEPAM INJECTION USP
Company: PFIZER CANADA ULC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02388669 | LORAZEPAM INJECTION USP | LORAZEPAM | 4 MG / ML | SOLUTION | INTRAMUSCULAR |
02388669 | LORAZEPAM INJECTION USP | LORAZEPAM | 4 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Lorazepam Injection USP is useful for the short-term relief of manifestations of severe anxiety in people with anxiety neurosis.
It is also useful for the relief of excessive anxiety that might be present prior to surgical interventions.
Lorazepam Injection USP is not recommended for mild to moderate anxiety and tension associated with the stresses of everyday life
Lorazepam Injection USP is useful to help control severe seizures (status epilepticus).
What it does
Lorazepam Injection USP is a benzodiazepine with sedative properties which help in the treatment of anxiety.
When it should not be used
- If you are allergic to the group of medicines known as benzodiazepines (examples: diazepam, clonazepam, chlordiazepoxide, bromazepam, or flurazepam).
- If you are allergic to any of the ingredients it contains (see ‘What the nonmedicinal ingredients are’).
- If you have myasthenia gravis, a chronic disease characterized by weakness of the skeletal muscles.
- If you have acute narrow angle glaucoma (a disease of the eye which causes progressive vision loss).
What the medicinal ingredient is
Lorazepam
What the non-medicinal ingredients are
Benzyl alcohol (preservative), polyethylene glycol and propylene glycol.
What dosage form it comes in
Injection: 4 mg/mL
Warnings and precautions
Serious Warnings and Precautions
Taking Lorazepam Injection USP with opioid medicines can cause severe drowsiness, breathing problems, coma, and death.
- Severe anaphylactic/anaphylactoid allergic reactions have been reported with the use of benzodiazepines. Cases of angioedema (swelling inside the mouth and throat) 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 dyspnea (difficult respiration), 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 restart the drug
- Lorazepam Injection USP may affect your ability to be alert. Driving, operating machinery and other hazardous activities should therefore be avoided altogether or at least during the first few days of treatment. This effect of Lorazepam Injection USP may be made worse if you take alcoholic drinks. If your doctor has increased your dose or if you have changed the timings of when you take your medication this may also modify your reactions.
- You must not consume alcohol or other drugs that affect the central nervous system while taking Lorazepam Injection USP (see INTERACTIONS WITH THIS MEDICATION below).
- Benzodiazepines such as Lorazepam Injection USP have produced dependence (addiction) and withdrawal symptoms can occur when treatment is stopped suddenly. The risk of dependence (addiction) increases with higher doses and longer duration of treatment.
- Always contact your doctor before stopping or reducing your dosage of Lorazepam Injection USP, as suddenly stopping treatment or a large decrease in dose can cause withdrawal symptoms (See Withdrawal-related side effects in the section SIDE EFFECTS AND WHATTO DO ABOUT THEM below).
- An increased risk of falls and fractures has been reported in elderly people who take benzodiazepines such as Lorazepam Injection USP.
- Memory loss may occur when Lorazepam Injection USP is used at therapeutic doses.
- A variety of abnormal thinking and behaviour changes may occur when you use a benzodiazepine, including aggressiveness, extroversion, confusion, strange behaviour, restlessness, illusions, hallucinations, feeling like you are not yourself, worsening of insomnia or worsening of depression including suicidal thinking. It is rarely clear whether such symptoms are caused by the medication, by an illness that was present before the medication was used or are simply spontaneous happenings. If you develop any unusual or disturbing thoughts or behavior while using Lorazepam Injection USP, discuss the matter immediately with your doctor
- Lorazepam Injection USP is not recommended for use in depressive neurosis or in psychotic reactions.
- Certain benzodiazepines have been linked to birth defects when taken during the early months of pregnancy. In addition, benzodiazepines taken during the last weeks of pregnancy have been known to sedate the baby and may also cause withdrawal symptoms after birth. Do not take this medicine if you are pregnant, or might become pregnant, unless advised by your doctor. Contact your doctor if you think you may be pregnant, or are intending to become pregnant.
- Lorazepam Injection USP passes into breast milk. Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you.
BEFORE you use talk to your doctor or pharmacist if:
- You have lung disease or breathing problems (e.g. chronic obstructive pulmonary disease (COPD), sleep apnea syndrome)
- You have a history of depression, suicide attempts or psychosis
- You regularly drink alcohol or use recreational drugs or have a history of dependence /addiction to alcohol or drugs.
- You have liver disease
- You have kidney disease
- You are pregnant or plan on becoming pregnant
- You are breastfeeding
Interactions with this medication
Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription and herbal products.
Drugs that may interact with Lorazepam Injection USP include:
- barbiturates
- antipsychotics
- sedative/hypnotics (sleeping pills)
- anxiolytics
- antidepressants
- antipsychotics (including Haloperidol, Clozapine)
- narcotic analgesics (pain relievers) (opioids) (see Serious Warnings and Precautions box)
- sedative antihistamines (allergy medications)
- anticonvulsants (including valproate)
- anesthetics
- probenecid (to reduce uric acid levels)
- theophylline or aminophylline (respiratory treatments)
- alcohol
Do not take Lorazepam Injection USP if you drink alcohol Do not use Lorazepam Injection USP along with other medications without first discussing this with your doctor.
Proper use of this medication
Usual Dose
Your doctor will prescribe a suitable dose for you. The dose your doctor prescribes will depend on your illness and how you respond to the medicine.
Lorazepam Injection USP will be given to you either intramuscularly (IM) by injection into a large muscle, such as your arm or buttock, or intravenously (IV) directly into a vein.
Because elderly patients can be more sensitive to the effects of Lorazepam Injection USP, lower doses may be prescribed.
Lorazepam Injection USP is not for use in children under 18 years of age.
Overdose
Side effects and what to do about them
The adverse reaction most frequently reported for Lorazepam Injection USP was drowsiness. Dizziness, weakness and unsteadiness were also common.
Release of hostility and other paradoxical effects such as irritability and excitability, are known to occur with the use of benzodiazepines. Please tell your doctor right away if you feel these effects when taking Lorazepam Injection USP. Paradoxical reactions may be more likely to occur in children or the elderly. In addition, hypotension (low blood pressure), mental confusion, slurred speech, over sedation and abnormal laboratory test results indicating changes in the liver, kidney and blood cells have been reported with these drugs.
If you develop symptoms of myasthenia gravis or the symptoms of your existing myasthenia gravis worsen, tell your doctor right away. These symptoms could include muscle weakness that gets worse with activity and gets better with rest, drooping eyelid, blurred or double vision, difficulty chewing and swallowing, or trouble breathing.
Withdrawal-related side effects:
- With sudden discontinuation of treatment with Lorazepam Injection USP symptoms of withdrawal may occur, including headache, muscle pain, convulsions, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases of withdrawal, symptoms may include numbness and tingling of the extremities, hallucinations, increased sensitivity to light, noise and physical contact and seizures.
Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
---|---|---|---|
Uncommon | |||
Unusual behavioural problems (aggression, rage), sudden anxiety or excitation; restlessness, agitation, irritability; hallucinations (see or hear things that are not there) or delusions; severe sleep disturbances, nightmares, inappropriate behavior | ✔ | ||
Anaphylactic /anaphylactoid reactions, severe allergic reactions (red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes) | ✔ | ||
Myasthenia gravis: muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing | ✔ | ||
Liver disorder: (symptoms include abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine) | ✔ | ||
Rare | |||
Depression: Symptoms may include: difficulty sleeping, changes in weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family gatherings and activities with friends, reduced libido (sex drive), and thoughts of death or suicide. | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking Lorazepam Injection USP, contact your doctor or pharmacist.
How to store
Refrigerate between 2°C and 8°C. Protect from light and freezing. Do not use if solution is discoloured or contains a precipitate. Discard within 28 days of initial use.
Keep out of the reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
Reminder: This medicine has been prescribed only for you. Do not give it to anybody else, even if you think they have the same symptoms that you have, as it may harm them. If you have any further questions, please ask your doctor or pharmacist.
If you want more information about Lorazepam Injection USP:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website at: www.pfizer.ca, under Prescription Products, or by contacting the sponsor, Pfizer Canada ULC at: 1-800-463-6001.
This leaflet was prepared by:
Pfizer Canada ULC
Kirkland, Québec
H9J 2M5
Last revised: August 22, 2019