VERSED (midazolam HCI)
Company: Roche
Approval Status: Approved March 1997
Treatment for: sedative for children undergoing painful surgeries
Areas: Neurology; Pediatrics/Neonatology
| General Information | Side Effects |
General Information
VERSED (midazolam HCI), can be used to calm and sedate children who must undergo procedures such as bone-marrow aspiration or spinal tap. Sedating a child also may spare parents the trauma of watching their child being physically restrained during procedures. Without sedation, such restraint is often necessary, and parents may even participate in restraining their child, which can be very distressing. VERSED also can be used to help calm children facing surgery, who might otherwise be terrified by the mask used to administer anesthesia, or by separation from their parents.
VERSED now is also available for use in infants and children of all ages in critical care settings. (This is the first time a sedative has been approved for use of any kind in newborns.) Without sedation, babies and children may have a difficult time tolerating a breathing tube or ventilator - and fighting a ventilator can be life-threatening.
After sedation with VERSED, a child usually has little or no memory of undergoing the procedure. This "amnestic" quality of VERSED is particularly advantageous because without it, children sometimes suffer from nightmares or other psychological traumas after undergoing medical procedures.
VERSED is an injectable sedative that has a variety of uses, depending on its dosage and administration. It can be used as a light sedative to help alleviate a child’s anxiety before a therapeutic or diagnostic procedure, as well as to allow the child to forget what happened during the period of sedation; as a mild to moderate sedative to cause a deeper state of sedation; and as a part of general anesthesia during surgery. Intravenous VERSED also can be administered by continuous infusion to children in critical care settings.
In seriously ill neonates, the half-life of midazolam is substantially prolonged and the clearance reduced compared to healthy adults or older groups of children. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity, particularly in neonates and preterm infants. The recommended dosage range of VERSED for preterm and term infants includes the amount of benzyl alcohol well below that associated with toxicity; however, the amount of benzyl alcohol at with toxicity may occur is not known. Intravenous bolus doses should not be used in neonates; if given as a loading dose, VERSED should be infused over ten minutes.
Side Effects
Hypotension may be observed in patients who are critically ill, and in preterm and term infants, particularly those receiving opioids and/or when VERSED is administered rapidly. When VERSED is given in conjunction with opioids or other sedatives, the potential for respiratory depression/airway obstruction is increased and the minimum effective dose of VERSED is generally reduced.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
