WARNINGS
Personnel and Equipment for Monitoring and Resuscitation
Adults and Pediatrics
Intravenous...
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midazolam injection, USP PRESERVATIVE FREE
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
midazolam injection, USP PRESERVATIVE FREE Quick Finder
Indications and Usage
INDICATIONS AND USAGE
Midazolam injection is indicated:
- intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
- intravenously as an agent for sedation/anxiolysis/amnesia...
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Dosage and Administration
DOSAGE AND ADMINISTRATION
Midazolam injection is a potent sedative agent that requires slow administration and individualization of dosage. Clinical experience has shown midazolam to be 3 to 4 times as...
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Contraindications
CONTRAINDICATIONS
Injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. Benzodiazepines may be used...
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Warnings and Precautions
WARNINGS
Personnel and Equipment for Monitoring and Resuscitation
Prior to the intravenous administration of midazolam in any dose, the immediate availability of...
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Adverse Reactions
ADVERSE REACTIONS
see The following additional adverse reactions were reported after intramuscular administration:Adults
...
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Drug Abuse and Dependence
DRUG ABUSE AND DEPENDENCE
Midazolam Injection contains midazolam a Schedule IV control substance.
Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of...
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Overdosage
OVERDOSAGE
Symptoms
The manifestations of midazolam overdosage reported are similar to those observed with other benzodiazepines, including sedation, somnolence,...
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Description
DESCRIPTION
Midazolam hydrochloride injection is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride...
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Clinical Pharmacology
CLINICAL PHARMACOLOGY
Midazolam is a short-acting benzodiazepine central nervous system (CNS) depressant.
Pharmacodynamics
The effects of midazolam...
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Nonclinical Toxicology
ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY
Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte...
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How Supplied/Storage and Handling
...
HOW SUPPLIED
Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam/mL:
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Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.