Midazolam injection

• Versed^® Injection

Yes

• 14 Ways to Avoid Epilepsy Injuries
• 9 Questions to Ask Before Having Surgery
• What It's Really Like to Have ADHD

• 13 Best Quit-Smoking Tips Ever
• What Stress Does to Your Mouth
• Healthy Home: To Buy or Not to Buy Organic?

• Frequent Constipation?
• Greater Food Accessibility

Midazolam Injection (midazolam) is indicated -

• intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
• intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;
• intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
• continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.

Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours. (see CLINICAL PHARMACOLOGY.)

Usual Adult Dose for Light Sedation:

Patients younger than 60 years:
IM:
-Usual dose: 0.07 to 0.08 mg/kg IM once, up to 1 hour before surgery

IV:
-Usual dose: 1 to 2.5 mg slow IV every 2 minutes as necessary for sedation
-Maintenance dose: After thorough clinical evaluation, additional doses may be given in increments of 25% of the initial dose used to reach sedation.
-Maximum dose: 2.5 mg/dose

Comments:
-Some patients respond to IV doses of 1 mg.
-A total IV dose over 5 mg is usually not necessary.
-The need for continued sedation with maintenance doses should be carefully considered.

Uses:
-Preoperative sedation/anxiolysis/amnesia
-Agent for sedation/anxiolysis/amnesia prior to/during diagnostic, therapeutic/endoscopic procedures (e.g., bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures alone/in combination of with other central nervous system depressants)

Usual Adult Dose for Light Anesthesia:

Patients younger than 55 years:
Premedicated patients:
-Usual dose: 0.25 mg/kg IV once, administered over 20 to 30 seconds. Healthcare providers should allow 2 minutes for effect.

Unpremedicated patients:
-Initial dose: 0.3 to 0.35 mg/kg IV once, administered over 20 to 30 seconds. Healthcare providers should allow 2 minutes to for effect. If induction is not complete after 2 minutes, inhalation anesthetics and/or further doses of this drug in increments of 25% of the initial dose may be given.
-Maximum dose: 0.6 mg/kg

Comments:
-When used concomitantly with other drugs used to induce anesthesia, initial doses may be reduced by to up to 25%.
-Total doses of 0.6 mg/kg may be used in unpremedicated, resistant patients, but the dose could prolong recovery.
-Doses between 0.15 and 0.35 mg/kg have been used in premedicated patients.
-Fentanyl, used as premedication, should be administered 5 minutes before induction. Other narcotics used for premedication should be administered approximately 1 hour prior to induction.

Uses:
-Induction of general anesthesia before administration of other anesthetic agents
-Component of IV supplementation of nitrous oxide and oxygen (balanced anesthesia)

Usual Geriatric Dose for Light Sedation:

60 years and older:
IM:
-Usual dose: 0.02 to 0.05 mg/kg IM once up to 1 hour before surgery

IV:
-Usual dose: 1 mg slow IV every 2 minutes as needed for sedation
-Maintenance dose: 25% of the dose used to reach desired sedation level

Comments:
-Some patients may achieve sufficient sedation with an IM dose of 1 mg if the intensity and duration of sedation is less critical.
-IM dosing is intended for patients who are not receiving concomitant narcotic or central nervous system depressants; lower doses should be considered in patients older than 60 years who are receiving narcotic or CNS depressants.
-A total IV dose greater than 3.5 mg is usually not necessary.
-The need for continued sedation with maintenance dosing should be carefully considered.

Uses:
-Preoperative sedation/anxiolysis/amnesia
-Agent for sedation/anxiolysis/amnesia prior to/during diagnostic, therapeutic/endoscopic procedures (e.g., bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures alone/in combination of with other central nervous system depressants)

Usual Geriatric Dose for Light Anesthesia:

Over 55 years:
Premedicated patients:
-Usual dose: 0.2 mg/kg IV once, administered over 20 to 30 seconds

Unpremedicated patients:
-Usual dose: 0.2 to 0.3 mg/kg IV once, administered over 20 to 30 seconds

Comments:
-Initial doses of 0.15 mg/kg have been sufficient in inducing anesthesia in patients, especially in those with severe systemic disease or debilitation.
-Fentanyl, used as premedication, should be administered 5 minutes before induction. Other narcotics used for premedication should be administered approximately 1 hour prior to induction.

Uses:
-Induction of general anesthesia before administration of other anesthetic agents
-Component of IV supplementation of nitrous oxide and oxygen (balanced anesthesia)

Usual Pediatric Dose for Light Sedation:

Oral:
6 months to 16 years:
-Usual dose: 0.25 to 1 mg/kg orally once before the procedure
-Maximum dose: 20 mg

Parenteral:
IM ADMINISTRATION:
-Usual dose: 0.1 to 0.15 mg/kg IM once, with some patients requiring doses of 0.5 mg/kg
-Maximum total dose: 10 mg

IV ADMINISTRATION:
6 months to 5 years:
-Initial dose: 0.05 to 0.1 mg/kg IV injection, with evaluation for sedation. If an optimal sedation levels is not reached after 2 to 3 minutes, doses may be readministered every 2 to 3 minutes, up to a maximum dose of 0.6 mg/kg.
-Maximum total dose: 6 mg

6 years to 12 years:
-Initial dose: 0.025 to 0.05 mg/kg IV injection, with evaluation for sedation. If an optimal sedation level is not reached, doses may be readministered every 2 to 3 minutes, up to a maximum dose of 0.4 mg/kg.
-Maximum total dose: 10 mg

12 years and older:
-Usual dose: 1 to 2.5 mg slow IV every 2 minutes as necessary for sedation
-Maintenance dose: After thorough clinical evaluation, additional doses may be given in increments of 25% of the initial dose used to reach sedation.
-Maximum total dose: 10 mg

Comments:
-Less cooperative and/or younger (e.g., less than 6 years) patients may require oral doses up to 1 mg/kg. -Oral doses of 0.25 mg/kg usually suffice for cooperative and/or patients 6 to 16 years, especially when sedation duration and intensity are less critical.
-IV injection doses should be administered over 2 to 3 minutes. Maximum IV doses typically do not exceed 6 mg (patients 6 months to 5 years) or 10 mg (patients 6 years and older), and maximum IM doses typically do not exceed 10 mg.
-Lower doses should be considered in patients with cardiac/respiratory compromise, high-risk surgical patients, and/or those who have received narcotics/CNS depressants.

Uses:
-Sedation, anxiolysis, and amnesia prior to diagnostic, therapeutic, or endoscopic procedures or before induction of anesthesia
-Preoperative sedation/anxiolysis/amnesia
-Agent for sedation/anxiolysis/amnesia prior to/during diagnostic, therapeutic/endoscopic procedures (e.g., bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures alone/in combination of with other central nervous system depressants)

Usual Pediatric Dose for ICU Agitation:

Parenteral:
CONTINUOUS INFUSION:
Preterm and term neonates:
Less than 32 weeks with tracheal intubation:
-Initial dose: 0.03 mg/kg/hr (0.5 mcg/kg/min) IV

Over 32 weeks with tracheal intubation:
-Initial dose: 0.06 mg/kg/hr (1 mcg/kg/min) IV

Non-neonates and children:
Unpremedicated patients with tracheal intubation:
-Loading dose: 0.05 to 0.2 mg/kg IV once, administered over 2 to 3 minutes
-Initial dose: 0.06 to 0.12 mg/kg/hr (1 to 2 mcg/kg/min)

Premedicated patients with tracheal intubation:
-Initial dose: 0.06 to 0.12 mg/kg/hr (1 to 2 mcg/kg/min)

Hemodynamically compromised patients:
-Loading dose: The usual loading dosed should be increased in small increments.

Comments:
-To establish therapeutic plasma levels in neonates, the infusion should be run more rapidly for the first several hours.
-Infusion rates should be reassessed to ensure that the lowest effective dose is used, especially after the first 24 hours.
-Extreme caution should be used in current/former preterm patients who do not have tracheal intubation.
-The rate of continuous infusion may be increased or decreased (e.g., usually by 25% of the initial/subsequent rate) as necessary in premedicated non-neonates. Supplemental IV doses may be given to increase/maintain the desired effect.
-Patients should be monitored closely for hemodynamic instability, respiratory rate, and oxygen saturation, especially when this drug is used in those with hemodynamic instability.

Use: Sedation of intubated and mechanically ventilated patients during treatment in a critical care setting

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Shakiness.
• Twitching.
• Very bad dizziness or passing out.
• Feeling agitated.
• Trouble controlling body movements.
• Seizures.

See WARNINGS concerning serious cardiorespiratory events and possible paradoxical reactions. Fluctuations in vital signs were the most frequently seen findings following parenteral administration of midazolam in adults and included decreased tidal volume and/or respiratory rate decrease (23.3% of patients following IV and 10.8% of patients following IM administration) and apnea (15.4% of patients following IV administration), as well as variations in blood pressure and pulse rate. The majority of serious adverse effects, particularly those associated with oxygenation and ventilation, have been reported when midazolam is administered with other medications capable of depressing the central nervous system. The incidence of such events is higher in patients undergoing procedures involving the airway without the protective effect of an endotracheal tube, (e.g., upper endoscopy and dental procedures).

Adults: The following additional adverse reactions were reported after intramuscular administration:

Administration of IM midazolam to elderly and/or higher risk surgical patients has been associated with rare reports of death under circumstances compatible with cardiorespiratory depression. In most of these cases, the patients also received other central nervous system depressants capable of depressing respiration, especially narcotics (see DOSAGE AND ADMINISTRATION).

The following additional adverse reactions were reported subsequent to intravenous administration as a single sedative/anxiolytic/amnestic agent in adult patients:

Pediatric Patients: The following adverse events related to the use of IV midazolam in pediatric patients were reported in the medical literature: desaturation 4.6%, apnea 2.8%, hypotension 2.7%, paradoxical reactions 2.0%, hiccough 1.2%, seizure-like activity 1.1% and nystagmus 1.1%. The majority of airway-related events occurred in patients receiving other CNS depressing medications and in patients where midazolam was not used as a single sedating agent.

Neonates: For information concerning hypotensive episodes and seizures following the administration of midazolam to neonates, see Boxed WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS.

Other adverse experiences, observed mainly following IV injection as a single sedative/anxiolytic/amnesia agent and occurring at an incidence of <1.0% in adult and pediatric patients, are as follows:

Respiratory: Laryngospasm, bronchospasm, dyspnea, hyperventilation, wheezing, shallow respirations, airway obstruction, tachypnea

Cardiovascular: Bigeminy, premature ventricular contractions, vasovagal episode, bradycardia, tachycardia, nodal rhythm

Gastrointestinal: Acid taste, excessive salivation, retching

CNS/Neuromuscular: Retrograde amnesia, euphoria, hallucination, confusion, argumentativeness, nervousness, anxiety, grogginess, restlessness, emergence delirium or agitation, prolonged emergence from anesthesia, dreaming during emergence, sleep disturbance, insomnia, nightmares, athetoid movements, seizure-like activity, ataxia, dizziness, dysphoria, slurred speech, dysphonia, paresthesia

Special Senses: Blurred vision, diplopia, nystagmus, pinpoint pupils, cyclic movements of eyelids, visual disturbance, difficulty focusing eyes, ears blocked, loss of balance, light-headedness

Integumentary: Hive-like elevation at injection site, swelling or feeling of burning, warmth or coldness at injection site

Hypersensitivity: Allergic reactions including anaphylactoid reactions, hives, rash, pruritus

Miscellaneous: Yawning, lethargy, chills, weakness, toothache, faint feeling, hematoma

Symptoms

The manifestations of midazolam overdosage reported are similar to those observed with other benzodiazepines, including sedation, somnolence, confusion, impaired coordination, diminished reflexes, coma and untoward effects on vital signs. No evidence of specific organ toxicity from midazolam overdosage has been reported.

Treatment

Treatment of injectable midazolam overdosage is the same as that followed for overdosage with other benzodiazepines. Respiration, pulse rate and blood pressure should be monitored and general supportive measures should be employed. Attention should be given to the maintenance of a patent airway and support of ventilation, including administration of oxygen. An intravenous infusion should be started. Should hypotension develop, treatment may include intravenous fluid therapy, repositioning, judicious use of vasopressors appropriate to the clinical situation, if indicated, and other appropriate countermeasures. There is no information as to whether peritoneal dialysis, forced diuresis or hemodialysis are of any value in the treatment of midazolam overdosage.

Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. There are anecdotal reports of reversal of adverse hemodynamic responses associated with midazolam following administration of flumazenil to pediatric patients. Prior to the administration of flumazenil, necessary measures should be instituted to secure the airway, assure adequate ventilation, and establish adequate intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. Flumazenil will only reverse benzodiazepine-induced effects but will not reverse the effects of other concomitant medications. The reversal of benzodiazepine effects may be associated with the onset of seizures in certain high-risk patients. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, should be consulted prior to use.

Single-dose Vial
Preservative-Free

NDC 0409-2305-49
Rx only

Midazolam
Injection, USP
CIV

2 mg / 2 mL (1 mg / mL)
FOR I.M. or I.V. Use. Discard unused portion.
NOVAPLUS®
RL-3003
Mfg. by Hospira, Inc., Lake Forest, IL 60045 USA

Single-dose Fliptop Vial
Preservative-Free

NDC 0409-2305-50
Rx only

Midazolam Injection, USP
CIV

5 mg/5 mL (1 mg/mL)

FOR I.M. or I.V. Use. Discard unused portion.

NOVAPLUS®
RL-6897
Mfg. by Hospira, Inc., Lake Forest, IL 60045 USA