Clinical Pharmacology Details


MIDAZOLAM


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Indications & Dose:

> To induce preoperative sedation or amnesia, to control preoperative anxiety


I.V. INJECTION


Adults age 60 and over. 1.5 mg over 2 min immediately before procedure. After 2-min waiting period, dosage adjusted to desired level in 25% increments, as ordered. Maximum: 1 mg in 2 min.


Adults under age 60 and adolescents. Up to 2.5 mg over 2 min immediately before procedure. After 2-min waiting period, dosage adjusted to desired level in 25% increments, as ordered. Maximum: 5 mg. Children ages 6 to 12. Initial: 0.025 to 0.05 mg/kg, up to 0.4 mg/kg, if needed. Maximum: 10 mg.


Children ages 6 months to 5 years. Initial: 0.05 to 0.1 mg/kg, up to 0.6 mg/kg, if need-ed. Maximum: 6 mg. I.M. INJECTION


Adults age 60 and over. 0.02 to 0.05 mg/kg as a single dose 30 to 60 min before surgery.


Adults under age 60 and adolescents. 0.07 to 0.08 mg/kg as a single dose 30 to 60 min before surgery.


Children ages 6 months to 12 years. 0.1 to 0.15 mg/kg, up to 0.5 mg/kg for more anxious patients. Maximum: 10 mg. >• To relieve agitation and anxiety in mechanically ventilated patients I.V.


INFUSION


Adults. Initial: 0.01 to 0.05 mg/kg infused over


several min, repeated at 10- to 15-min intervals until adequate sedation occurs. Maintenance: 0.02 to 0.1 mg/kg/hr initially, adjusted to desired level in 25% to 50% increments, as ordered. After achieving desired level of sedation, infusion rate decreased by 10% to 25% every few hr, as ordered, until minimum effective infusion rate is determined.


Children. Initial: 50 to 200 meg/kg over 2 to 3 min followed by 1 to 2 mcg/kg/min by continuous infusion. Maintenance: 0.4 to 6 mcg/kg/min.


Infants over age 32 weeks. 1 mcg/kg/min by continuous infusion. Infants under age 32 weeks. 0.5 meg/kg/ min by continuous infusion.


Route          Onset             Peak         Duration


I.V.*        1.5-5 min            Rapid              2-6 hr


I.M.*         5-15 min     15-60 min              2-6 hr


I.M.f        30-60 min       Unknown          Unknown

Contraindications:

 Acute angle-closure glaucoma; alcohol intoxication; coma; hypersensitivity to midazolam, other benzodiazepines, or their components; shock

Side Effects:

Cautions:

Precautions:

Interaction:

DRUGS


antihypertensives: Increased risk of hypotension cimetidine, diltiazem, erythromycin, flucon-azole, indinavir, itraconazole, ketoconazole, ranitidine, ritonavir, saquinavir, verapamil:


Intense and prolonged sedation caused by reduced midazolam metabolism


CNS depressants: Possibly increased CNS and respiratory depression and hypotension rifampin: Decreased blood midazolam level

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

 CNS: Agitation, delirium, or dreaming during emergence from anesthesia; anxiety; ataxia; chills; combativeness; confusion; dizziness; drowsiness; euphoria; excessive sedation; headache; insomnia; lethargy; nervousness; nightmares; paresthesia; prolonged emergence


* For sedation. For amnesia.


from anesthesia; restlessness; retrograde amnesia; sleep disturbance; slurred speech; weakness; yawning


CV: Cardiac arrest, hypotension, nodal rhythm,


PVCs, tachycardia, vasovagal episodes


EENT: Blurred vision, diplopia, or other vision changes; increased salivation; laryn-gospasm; miosis; nystagmus; toothache


GI: Hiccups, nausea, retching, vomiting


RESP: Airway obstruction, bradypnea, bronchospasm, coughing, decreased tidal volume, dyspnea, hyperventilation, respiratory arrest, shallow breathing, tachypnea, wheezing


SKIN: Pruritus, rash, urticaria


Other: Injection-site burning, edema, induration, pain, redness, and tenderness

Patient And Carer Advice: