Midamicum

Midazolam HCl

As IV sedative cover before & during minor medical, dental & surgical procedures eg, gastroscopy, endoscopy, cystoscopy, bronchoscopy & cardiac catheterisation. For sedation by continuous infusion in patients in intensive care. As IM premed for patients w/ physical status ASA I-IV who are to undergo surgical procedures. As an alternative IV agent for induction of anaesth in high risk & elderly patients, especially where CV stability is of particular importance.

IV sedation ≥1 IV administrations over a single operating session. Adult 0.4 mL (equiv to 2 mg) administered IV over 30 sec. If after 2 min, sedation is not adequate, incremental doses of 0.1-0.2 mL (0.5-1 mg) should be given. Usual dose range: 2.5-7.5 mg total dose (equiv to around 0.07 mg/kg). Maintenance dose: 0.03-0.2 mg/kg/hr, commencing at the lower end of the range. Combination therapy: IV bolus sedation Where analgesia is provided by narcotic analgesic the latter should be administered first, carefully titrate & low doses 1-2 mg (0.2-0.4 mL) may be adequate. Elderly 0.5-1 mg (0.1-0.2 mL) may be adequate. Sedation by continuous infusion in intensive care Where analgesia is provided by narcotic analgesics, titrate the rate of infusion carefully to the sedative needs of patient. IV induction of anaesth ≥1 bolus IV inj over a single anaesth session. Adult Titrate dose against individual response of patient. At least 0.3 mg/kg for young, fit unpremedicated patients, whereas 0.2 mg/kg for patients premedicated w/ opiate. Elderly 1-2 mg (0.2-0.4 mL) may be adequate. Do not exceed 1-1.5 mg (0.2-0.3 mL) for initial dose. Sedation by continuous infusion in intensive care Individualised dosage & titrated to desired state of sedation according to clinical need, physical status, age & concomitant medication. Adult & childn Loading dose: 0.03-0.3 mg/kg depending on the level of sedation required, administered over a 5-min period. Combination therapy: Elderly Induction may be adequate w/ 0.1 mg/kg in premedicated patients & 0.2 mg/kg in unpremedicated patients. Childn >7 yr 0.15 mg/kg. IM premed Adult 0.07-0.1 mg/kg single IM inj, administered 30-60 min pre-op. Usual dose: 5 mg. Elderly 2.5 mg may be adequate.

Hypersensitivity to benzodiazepines. Conscious sedation in patients w/ severe resp failure, or acute resp depression.

Severe cardioresp adverse events including resp depression, apnoea, resp &/or cardiac arrest are more likely to occur when inj is given too rapidly or when a high dosage is administered. Patients w/ impaired resp function. Chronically ill or debilitated patients eg, patients w/ chronic resp insufficiency; chronic renal failure, impaired hepatic or cardiac function. Patient w/ myasthenia gravis. Tolerance & physical dependence may develop when used as long-term sedation in ICU. Avoid abrupt discontinuation of treatment, decrease doses gradually. Amnesia. Paradoxical reactions may occur w/ high doses &/or when inj is given rapidly especially in childn & the elderly. Altered elimination in patients receiving compd that inhibit or induce CYP3A4; delayed elimination in patients w/ liver dysfunction, low cardiac output & in neonates. Avoid concomitant use w/ alcohol or/& CNS depressants; in patients w/ medical history of alcohol or drug abuse. May impair ability to drive & use machines. Pregnancy & lactation. Childn. Paed patients <6 mth; specially those w/ CV instability. Preterm infants & neonates. Avoid rapid inj in neonatal population. Elderly >60 yr.

Very rarely, generalised hypersensitivity reactions (skin reactions, CV reactions, bronchospasm), anaphylactic shock; confusional state, euphoric mood, hallucinations; paradoxical reactions eg, agitation, involuntary movements (including tonic/clonic movements & muscle tremor), hyperactivity, hostility, rage reaction, aggressiveness, paroxysmal excitement & assault; dependence, w/drawal symptoms including w/drawal convulsions; prolonged sedation, decreased alertness, somnolence, headache, dizziness, ataxia, post-op sedation, anterograde amnesia, convulsions (in premature infants & neonates); severe cardioresp adverse events including cardiac arrest, hypotension, bradycardia, vasodilating effects, resp depression, apnoea, resp arrest, dyspnoea, laryngospasm; hiccup; nausea, vomiting, constipation, dry mouth; skin rash, urticarial reaction, pruritus; fatigue, erythema & pain on inj site, thrombophlebitis, thrombosis; increased risk for falls & fractures in elderly.

Increased plasma conc of IV midazolam w/ ketoconazole, fluconazole & itraconazole, posaconazole; erythromycin; ritonavir-boosted lopinavir; diltiazem; atorvastatin. Increased exposure of IV midazolam w/ voriconazole. Increased plasma conc w/ clarithromycin, quinupristin/dalfopristin & telithromycin; therefore increasing risk of prolonged sedation w/ aprepitant. Large increase in conc w/ PIs. Decreased plasma conc of IV midazolam w/ rifampicin. Decrease in plasma conc of oral midazolam w/ carbamazepine/phenytoin. Increase in ratio of CYP3A4 generated metabolite w/ efavirenz. Decreased plasma conc w/ St John's wort. Enhanced sedation & resp depression w/ other sedative/hypnotic agents & CNS depressants, including alcohol; opiate derivatives (analgesics, antitussives or substitutive treatments), antipsychotics, other benzodiazepines used as anxiolytics or hypnotics, barbiturates, propofol, ketamine, etomidate; sedative antidepressants, non recent H1-antihistamines, Na oxybate, & centrally acting antihypertensive drugs. May markedly enhance sedative effect w/ alcohol. Increased sedative effect w/ baclofen & tizanidine. Decreases min alveolar conc of inhalational anaesth. Enhanced hypotensive effect w/ ACE-inhibitors, α-blockers, AIIA, Ca channel blockers, adrenergic neurone blockers, β-blockers, moxonidine, nitrates, hydralazine, minoxidil, Na nitroprusside & diuretics. Reduced plasma conc w/ carbamazepine. May alter ie, either increase or decrease plasma conc of phenytoin. May increase plasma conc w/ nilotinib & nabilone.

Hypnotics & Sedatives

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

DD, Rx