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Versed
Midazolam
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FDA boxed warning
BOXED WARNING
WARNINGS
Personnel and Equipment for Monitoring and Resuscitation
Adults and Pediatrics:
Risks From Concomitant Use With Opioids
Individualization of Dosage
Neonates:
Midazolam should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl (see DOSAGE AND ADMINISTRATION for complete information).
About Versed
Overview
Versed is a prescription medicine containing midazolam, a benzodiazepine supplied in ampules for injection. It is used before surgery or during medical procedures, to help start general anesthesia, and to sedate patients who are intubated and mechanically ventilated. It produces sedation, reduces anxiety and helps limit memory of events around a procedure.
What it treats
- Sedation, anxiety relief and reduced memory of events before surgery. - Sedation, anxiety relief and reduced memory of events before or during diagnostic and treatment procedures, including endoscopy. - Starting general anesthesia and as part of balanced anesthesia. - Sedation of intubated, mechanically ventilated patients during anesthesia or critical care.
Safety information
Side effects
The most frequently observed effects include slower or shallower breathing and changes in blood pressure and pulse rate. Serious effects include pauses in breathing (apnea) and serious heart or breathing problems. Alert the treating clinician immediately if these occur. Most serious effects, especially those affecting breathing and oxygen levels, have been reported when midazolam is given with other medicines that depress the central nervous system. These events are more frequent during procedures involving the airway when no protective breathing tube is in place.
FDA boxed warning
BOXED WARNING
WARNINGS
Personnel and Equipment for Monitoring and Resuscitation
Adults and Pediatrics:
Risks From Concomitant Use With Opioids
Individualization of Dosage
Neonates:
Midazolam should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl (see DOSAGE AND ADMINISTRATION for complete information).
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Midazolam must not be used in people with a known allergy to midazolam, people with acute narrow-angle glaucoma, or premature infants, because this formulation contains benzyl alcohol. People with open-angle glaucoma may receive midazolam only if they are receiving appropriate treatment for their glaucoma. Because it contains benzyl alcohol, this injection is not intended for administration into the spinal fluid (intrathecal) or the epidural space around the spinal cord.
Using Versed
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light. Do not freeze, and use immediately once opened. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label MIDAZOLAM INJECTION [CIVICA, INC.] (DailyMed, retrieved 19 September 2026).
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