Pharmaniaga Midazolam

Midazolam

Conscious sedation prior & during diagnostic or therapeutic procedures w/ or w/o local anaesth. Premed prior to anaesth induction; sedation in ICU.

Conscious sedation Adult ≥60 yr, critically ill, high-risk patient Initially 0.5-1 mg given 5-10 min prior to procedure, may be given further doses of 0.5-1 mg. Total dose: <3.5 mg, <60 yr Initially 2-2.5 mg given 5-10 min prior to procedure, may be given further doses of 1 mg. Total dose: 3.5-7.5 mg. IV Paed 13-16 yr Adult dose, 6-12 yr Initially 0.025-0.05 mg/kg over 2-3 min. Total dose: Up to 0.4 mg/kg to max: 10 mg, 6 mth-5 yr Initially 0.05-1 mg/kg over 2-3 min. Total dose: <6 mg. IM Paed 1-15 yr 0.05-0.15 mg/kg given 5-10 min prior to procedure. Total dose: <10 mg. Rectal Paed >6 mth 0.3-0.5 mg/kg. Premed anaesth Adult ≥60 yr, critically ill, high-risk patient Initially 0.5 mg IV inj or 0.025-0.05 mg/kg IM inj, <60 yr 1-2 mg IV inj repeated or 0.07-0.1 mg/kg IM inj. Paed 1-15 yr 0.08-0.2 mg/kg IM inj 30-60 min prior to anaesth induction. Rectal Paed >6 mth 0.3-0.5 mg/kg 20-30 min prior to anaesth induction. Anaesth induction Adult ≥60 yr, critically ill, high-risk patient 0.05-0.15 mg/kg IV inj over 20-30 sec, patient w/o premed Initially 0.15-0.2 mg/kg, <60 yr 0.15-0.2 mg/kg IV inj over 20-30 sec, patient w/o premed 0.3-0.35 mg/kg IV inj over 20-30 sec. Sedative component in combined anaesth Adult ≥60 yr, critically ill, high-risk patient Lower doses than recommended for adult <60 yr, <60 yr Intermittent dose: 0.03-0.1 mg/kg IV inj or 0.03-0.1 mg/kg/hr as continuous infusion. Sedation in ICU Adult Loading dose: 0.03-0.3 mg/kg IV in increments of 1-2.5 mg over 20-30 sec. Maintenance: 0.03-0.2 mg/kg/hr IV inj. Paed >6 mth Loading dose: 0.05-0.2 mg/kg IV inj over at least 2-3 min. Maintenance: 0.06-0.12 mg/kg/hr as continuous infusion. Neonate >32 wk, gestational age up to 6 mth Initially 0.06 mg/kg/hr as continuous infusion, <32 wk gestational age Initially 0.03 mg/kg/hr as continuous infusion.

Hypersensitivity to midazolam or other benzodiazepines. Myasthenia gravis; acute narrow-angle glaucoma. Acute alcohol intoxication, hypnotics, neuroleptics, antidepressants or lithium.

Anaphylaxis & angioedema. Avoid intraarterial inj. Severe resp depression & arrest. Complex sleep-related behaviors; poor general condition, obese, obstructive airways diseases, sleep apnoea syndrome, cardiac decompensation; schizophrenia or endogene depression; cerebral hypoxia or paradoxical reactions; epilepsy. Dependence & tolerance. Avoid abrupt w/drawal. Long-term use. Not to be taken w/ alcohol prior to & at least 12 hr after inj. Concomitant use w/ CYP3A4 inhibitors eg, azole antifungals, macrolides. May affect ability to drive or use machines. Chronic renal or hepatic failure. Not to be used during last 6 mth of pregnancy. Lactation. Paed patients w/ CV instability; childn & adolescents <18 yr (IV). Paed <6 mth; neonates & infants up to 4-6 mth. Elderly >60 yr or debilitated patients.

Vital function changes; resp depression & arrest, apnoea, cardiac arrest; BP, heart rate or CV parameter changes. Hiccoughs, nausea, vomiting, dry cough, marked sedation, headache, dizziness, sensitivity, erythema, inj site induration.

Increased plasma conc w/ CYP3A4 inhibitors eg, azole antifungals, macrolides. Potentiated anaesth or sedative effect of other centrally-acting drugs eg, neuroleptics, tranquilisers, antidepressants, anticonvulsants, hypnotics, analgesics, anaesth, sedative antihistamines. Risk of resp depression w/ narcotic analgesics. Increased response w/ Na valproate. Mutual potentiation w/ alcohol. Deeper & longer lasting anaesth w/ cimetidine, erythromycin, clarithromycin, roxithromycin, diltiazem, verapamil, ketoconazole, itraconazole, fluoxetine, nefazodone. Potentiated hypotensive effect of antihypertensives & vasodilators. White precipitate w/ albumin, amoxicillin Na, ampicillin Na, bumetamide, dexamethasone Na phosphate, dimenhydrinate, floxacillin Na, furosemide, hydrocortisone Na succinate, pentobarbital Na, perphenazine, prochlorperazine edisylate, ranitidine, thiopental Na, trimethoprim-sulfamethoxazole; nafcillin Na; ceftazidine. Yellow precipitate w/ MTX Na. Orange discoloration w/ clonidine HCl. Brown discoloration w/ omeprazole Na. Gas formation w/ foscarnet Na. Not to be mixed w/ aciclovir, alteplase, acetazolam disodium, diazepam, enoximone, flecainide acetate, fluorouracil, imipenem, mezlocillin Na, phenobarb Na, phenytoin Na, K canrenoate, sulbactam Na, theophylline, trometamol, urokinase.

Hypnotics & Sedatives

N05CD08 - midazolam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.

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