Midazolam Hydrochloride Syrup
"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Midazolam Hydrochloride Syrup
MIDAZOLAM HCI SYRUP MUST BE USED AS SPECIFIED IN THE LABEL.
DOSAGE AND ADMINISTRATION
Midazolam HCI syrup is indicated for use as a single dose (0.25 to 1 mg/kg with a maximum dose of 20 mg) for preprocedural sedation and anxiolysis in pediatric patients.
Midazolam HCI syrup is not intended for chronic administration.
Monitoring: Midazolam HCI syrup should only be used in hospital or ambulatory care settings, including physicians' and dentists' offices, that can provide for continuous monitoring of respiratory and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured (see WARNINGS). For deeply sedated patients, a dedicated individual whose sole responsibility it is to observe the patient, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. Continuous monitoring of respiratory and cardiac function is required.
Midazolam HCI syrup must be given only to patients if they will be monitored by direct visual observation by a health care professional. Midazolam HCI syrup should only be administered by persons specifically trained in the use of anesthetic drugs and the management of respiratory effects of anesthetic drugs, including respiratory and cardiac resuscitation of patients in the age group being treated.
Patient response to sedative agents, and resultant respiratory status, is variable. Regardless of the intended level of sedation or route of administration, sedation is a continuum; a patient may move easily from light to deep sedation, with potential loss of protective reflexes, particularly when coadministered with anesthetic agents, other CNS depressants, and concomitant medications which may potentially cause a more intense and prolonged sedation (see PRECAUTIONS: DRUG INTERACTIONS). This is especially true in pediatric patients. The health care practitioner who uses this medication in pediatric patients should be aware of and follow accepted professional guidelines for pediatric sedation appropriate to their situation.
Sedation guidelines recommend a careful presedation history to determine how a patient's underlying medical conditions or concomitant medications might affect their response to sedation/analgesia as well as a physical examination including a focused examination of the airway for abnormalities. Further recommendations include appropriate prese-dation fasting.
Intravenous access is not thought to be necessary for all pediatric patients sedated for a diagnostic or therapeutic procedure because in some cases the difficulty of gaining IV access would defeat the purpose of sedating the child;rather, emphasis should be placed upon having the intravenous equipment available and a practitioner skilled in establishing vascular access in pediatric patients immediately available.
Midazolam HCI syrup must never be used without individualization of dosage, particularly when used with other medications capable of producing CNS depression. Younger (<6 years of age) pediatric patients may require higher dosages (mg/kg) than older pediatric patients, and may require close monitoring. The 2.5 mL size container is not a unit dose.
When midazolam HCI syrup is given in conjunction with opioids or other sedatives, the potential for respiratory depression, airway obstruction, or hypoventilation is increased. For appropriate patient monitoring, see WARNINGS and Monitoring subsection of DOSAGE AND ADMINISTRATION. The health care practitioner who uses this medication in pediatric patients should be aware of and follow accepted professional guidelines for pediatric sedation appropriate to their situation.
The recommended dose for pediatric patients is a single dose of 0.25 to 0.5 mg/kg, depending on the status of the patient and desired effect, up to a maximum dose of 20 mg. In general, it is recommended that the dose be individualized and modified based on patient age, level of anxiety, concomitant medications, and medical need (See WARNINGS and PRECAUTIONS). The younger (6 months to <6 years of age) and less cooperative patients may require a higher than usual dose up to 1 mg/kg. A dose of 0.25 mg/kg may suffice for older (6 to <16 years of age) or cooperative patients, especially if the anticipated intensity and duration of sedation is less critical. For all pediatric patients, a dose of 0.25 mg/kg should be considered when midazolam HCI syrup is administered to patients with cardiac or respiratory compromise, other higher risk surgical patients, and patients who have received concomitant narcotics or other CNS depressants. As with any potential respiratory depressant, these patients must be monitored for signs of car-diorespiratory depression after receiving midazolam HCI syrup. In obese pediatric patients, the dose should be calculated based on ideal body weight. Midazolam HCI syrup has not been studied, nor is it intended for chronic use.
INSERTION OF PRESS-IN BOTTLE ADAPTER (PIBA) (for 118 mL bottle only)
1. Remove the cap and push bottle adapter into neck of bottle.
2. Close the bottle tightly with cap. This will assure the proper seating of the bottle adapter in the bottle.
USE OF ORAL DISPENSERS AND PIBA*
1. Remove the cap.
2. Before inserting the tip of the oral dispenser into bottle adapter, push the plunger completely down toward the tip of the oral dispenser. *Insert tip firmly into opening of the bottle adapter.
3. Turn the entire unit (bottle and oral dispenser) upside down.
4. Pull the plunger out slowly until the desired amount of medication is withdrawn into the oral dispenser.
5. Turn the entire unit right side up and remove the oral dispenser slowly from the bottle.
6. The tip of the dispenser may be covered with a tip cap, until time of use.
7. Close the bottle with cap after each use.
8. Dispense directly into mouth. Do not mix with any liquid (such as grapefruit juice) prior to dispensing.
*For 2.5 mL container, insert tip of oral dispenser directly into opening of the bottle. Continue with steps 4, 6, 7, and 8.
DISPOSAL OF MIDAZOLAM HCI SYRUP
The disposal of Schedule IV controlled substances must be consistent with State and Federal Regulations.
Midazolam HCI syrup is supplied as a clear, red to purplish-red, mixed fruit flavored syrup containing midazolam hydrochloride equivalent to 2 mg of midazolam per mL;each amber glass bottle of 118 mL is supplied with 1 press-in bottle adapter, 4 single-use, graduated, oral dispensers and 4 tip caps;10 x bottle of 2.5 mL is supplied with 10 single-use, graduated, oral dispensers and 10 tip caps.
NDC 0574-0150-04 Bottle of 118 mL.
NDC 0574-0150-25 10 x Bottle of 2.5 mL.
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). [See USP Controlled Room Temperature]
Manufactured by: Paddock Laboratories Inc., Minneapolis, MN 55427. FDA revision date: 5/2/2005This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/25/2008
Additional Midazolam Hydrochloride Syrup Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.