Description
Midazolam is used to produce sleepiness or drowsiness and to relieve anxiety before surgery or certain procedures. Midazolam is also given to produce amnesia (loss of memory) so that the patient will not remember any discomfort or undesirable effects that may occur after a surgery or procedure.
Midazolam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.
This medicine is given only by or under the immediate supervision of a doctor trained to use this medicine.
This product is available in the following dosage forms:
- Syrup
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of midazolam in children below 6 months of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of midazolam in the geriatric population. Safety and efficacy have not been established.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Amprenavir
- Atazanavir
- Boceprevir
- Cobicistat
- Darunavir
- Delavirdine
- Flumazenil
- Fosamprenavir
- Indinavir
- Isocarboxazid
- Itraconazole
- Ketoconazole
- Levoketoconazole
- Lonafarnib
- Lopinavir
- Nelfinavir
- Nirmatrelvir
- Ritonavir
- Saquinavir
- Telaprevir
- Tipranavir
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Alfentanil
- Alprazolam
- Amobarbital
- Anileridine
- Aprobarbital
- Aripiprazole
- Aripiprazole Lauroxil
- Avacopan
- Baclofen
- Benzhydrocodone
- Bromazepam
- Bromopride
- Buprenorphine
- Buspirone
- Butabarbital
- Butalbital
- Butorphanol
- Calcifediol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbidopa
- Carbinoxamine
- Carisoprodol
- Ceritinib
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
- Chlorpromazine
- Chlorzoxazone
- Ciprofloxacin
- Clarithromycin
- Clobazam
- Clonazepam
- Clorazepate
- Codeine
- Conivaptan
- Cyclobenzaprine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Apalutamide
- Aprepitant
- Armodafinil
- Cimetidine
- Crizotinib
- Cyclosporine
- Dalfopristin
- Diltiazem
- Echinacea
- Erythromycin
- Fluvoxamine
- Fosaprepitant
- Fosphenytoin
- Ginkgo Biloba
- Goldenseal
- Halothane
- Hydrastis
- Laropiprant
- Mavacamten
- Mitotane
- Phenytoin
- Quinupristin
- Rifapentine
- Roxithromycin
- St John's Wort
- Tecovirimat
- Telithromycin
- Theophylline
- Verapamil
- Voriconazole
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Apnea (temporary stopping of breathing) or
- Heart disease or
- Hypoventilation (slow breathing) or
- Infections or
- Lung disease, severe or
- Lung or airway blockage—Use with caution. May increase risks for more serious side effects.
- Congestive heart failure or
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Glaucoma, acute narrow-angle—Should not be used in patients with this condition.
Proper Use
Midazolam will be given to you or to your child in a hospital or clinic by a doctor trained to use this medicine. If you or your child will be receiving midazolam during surgery, your doctor or anesthesiologist will give you the medicine.
After you receive midazolam, you or your child will be watched closely to make sure this medicine is working. Your breathing, blood pressure, nervous system, and heart will also be watched closely to make sure the medicine is not causing unwanted side effects.
Precautions
If you will be receiving midazolam before surgery, your doctor will give you the medicine and closely follow your progress, to make sure this medicine is working properly and to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
For patients going home within 24 hours after receiving midazolam:
- Midazolam may cause some people to feel drowsy, tired, or weak for 1 or 2 days after it has been given. It may also cause problems with coordination and one's ability to think. Therefore, do not drive, use machines, or do anything else that could be dangerous if you are not alert until the effects of the medicine have disappeared or until the day after you receive midazolam, whichever period of time is longer.
- Do not drink alcoholic beverages or take other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) for about 24 hours after you have received midazolam, unless otherwise directed by your doctor. To do so may add to the effects of the medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; other sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures; and muscle relaxants.
Do not drink grapefruit juice or eat grapefruit while you are using this medicine. Also, do not take this medicine if you have allergies to cherries.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common
- Anxiety
- chest pain or discomfort
- choking
- confusion
- difficult or troubled breathing
- drowsiness
- dry mouth
- fast heartbeat
- hyperventilation
- irregular heartbeats
- irregular, fast or slow, or shallow breathing
- irritability
- lightheadedness, dizziness, or fainting
- nausea
- nervousness
- noisy breathing
- pale or blue lips, fingernails, or skin
- restlessness
- shaking
- shortness of breath
- slow or irregular heartbeat
- tightness in the chest
- trouble sleeping
- unable to speak
- unusual tiredness
- weakness
- wheezing
Rare
- Attack, assault, or force
- changes in patterns and rhythms of speech
- feeling of constant movement of self or surroundings
- headache
- lack or loss of self-control
- loss of balance
- mood swings
- noisy breathing
- not breathing
- restlessness
- seeing, hearing, or feeling things that are not there
- sensation of spinning
- shakiness and unsteady walk
- sleepiness
- slow to respond
- slurred speech
- trouble in speaking
- unconsciousness
- unsteadiness, trembling, or other problems with muscle control or coordination
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in consciousness
- difficulty with coordination
- loss of consciousness
- sleepiness or unusual drowsiness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Vomiting
Less common
- Rash
Rare
- Blurred vision
- double vision
- gagging
- hiccups
- seeing double
- watering of mouth and drooling
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
