Dormicum

FC tab: Short-term treatment of insomnia (only if severe, disabling or subjecting the individual to extreme distress). Sedation in premed before surgical or diagnostic procedures. Soln for inj: Conscious sedation before & during diagnostic or therapeutic procedures w/ or w/o local anesth in adults & childn. Anesth in adults (premed before anesth induction, anesth induction, & as sedative component in combined anesth) & childn (premed before anesth induction). Sedation in ICU in adults & childn.

FC tab 7.5-15 mg. Duration: As short as possible, varying from a few days to max: 2 wk. Premed Give 30-60 min prior to procedure. Elderly &/or debilitated patient, & patient w/ resp or CV impairment 7.5 mg. Hepatic (mild-moderate) & renal impairment Consider lowest dose possible, not exceeding 7.5 mg. Soln for inj Conscious sedation IV Adult <60 yr Give at rate of approx 1 mg in 30 sec. Initial dose: 2-2.5 mg given 5-10 min prior to beginning of procedure. Titration doses: 1 mg. Total dose: 3.5-7.5 mg. Adult ≥60 yr/critically ill, high-risk patient Initial dose: 0.5-1 mg given 5-10 min prior to beginning of procedure. Titration doses: 0.5-1 mg. Total dose: <3.5 mg. Childn 13-16 yr Adult dose, 6-12 yr Initial dose: 0.025-0.05 mg/kg. Total dose: <10 mg, 6 mth-5 yr Initial dose: 0.05-0.1 mg/kg. Total dose: <6 mg. Rectal Childn >6 mth 0.3-0.5 mg/kg administered at once. IM Childn 1-15 yr 0.05-0.15 mg/kg given 5-10 min prior to beginning of procedure. Anesth premed IV Adult <60 yr 1-2 mg repeated as needed. Adult ≥60 yr/critically ill, high-risk patient Initial dose: 0.5 mg, & slowly uptitrated as needed (allow 2-3 min to fully evaluate effect between doses). IM Adult <60 yr 0.07-0.1 mg/kg given 20-60 min prior to anesth induction. Adult ≥60 yr/critically ill, high-risk patient 0.025-0.05 mg/kg given 20-60 min prior to anesth induction. Rectal Childn >6 mth 0.3-0.5 mg/kg given 20-30 min before anesth induction. IM Childn 1-15 yr 0.08-0.2 mg/kg given 30-60 min prior to anesth induction. Anesth induction IV Adult <60 yr 0.2 mg/kg over 20-30 sec & allow 2 min for effect (0.3-0.35 mg/kg w/o premed). Adult ≥60 yr/critically ill, high-risk patient 0.05-0.15 mg/kg over 20-30 sec & allow 2 min for effect (0.15-0.2 mg/kg w/o premed). Sedative component in combined anesth IV Adult <60 yr Can be given by either intermittent doses of 0.03-0.1 mg/kg or continuous infusion of 0.03-0.1 mg/kg/hr. Adult ≥60 yr/critically ill, high-risk patient Lower doses than adult <60 yr. Sedation in ICU IV Adult <60 yr & adult ≥60 yr/critically ill, high-risk patient Loading dose: 0.03-0.3 mg/kg given slowly in increments of 1-2.5 mg inj over 20-30 sec allowing 2 min between successive increments. Maintenance dose: 0.03-0.2 mg/kg/hr. Childn >6 mth Loading dose: 0.05-0.2 mg/kg given slowly over at least 2-3 min. Maintenance dose: 0.06-0.12 mg/kg/hr, >32 wk of gestational age-6 mth Starting dose: 0.06 mg/kg/hr, ≤32 wk of gestational age Starting dose: 0.03 mg/kg/hr.

May be taken with or without food: FC tab: Take immediately prior to sleep & swallow whole w/ fluid. Can be taken at any time of the day provided at least 7-8 hr of undisturbed sleep is assured.

Hypersensitivity to benzodiazepines. FC tab: Not be used in patients w/ severe resp insufficiency, severe hepatic impairment, sleep apnea syndrome, myasthenia gravis. Not to be given to patients receiving concomitant therapy w/ very strong CYP3A inducers or inhibitors (eg, ketoconazole, itraconazole, voriconazole, HIV PIs including ritonavir-boosted formulations) & HCV PIs boceprevir & telaprevir. Not to be given to childn ≤12 yr.

Discontinue use if paradoxical reactions occur. Not recommended for primary treatment of psychotic illness. Avoid use in patients w/ medical history of alcohol or drug abuse. Tolerance. Anterograde amnesia. May lead to development of physical & psychological dependence. Avoid concomitant use w/ alcohol &/or CNS depressants. Concomitant use w/ drugs that alter CYP3A activity. Gradually decrease dose when discontinuing treatment. Do not drive a vehicle or operate machinery prior to treatment. Hepatic & severe renal impairment. Avoid use during pregnancy. Not to be administered to breastfeeding mothers. FC tab: Not to be used alone to treat depression or anxiety associated w/ depression. Rebound insomnia. No observed residual effect provided dose is not >15 mg daily & at least 7-8 hr of undisturbed sleep is assured. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Elderly &/or debilitated patients, & patients w/ resp or CV impairment. Soln for inj: May depress myocardial contractility & cause apnea. Rare occurrences of severe cardioresp adverse events. Elimination may be delayed in patients w/ liver dysfunction, low cardiac output & in newborns. High-risk patients eg, adult >60 yr, critically ill, patients w/ organ, resp, kidney, hepatic & cardiac function impairment. Patients w/ sleep apnea syndrome; myasthenia gravis. Adequate observation of patient after administration is mandatory when used for premed. Exercise extreme caution & avoid rapid inj in preterm infants <36 wk of gestational age whose trachea is not intubated. Not indicated in anesth induction & as sedative component in combined anesth in childn. Childn <6 mth.

Hypersensitivity reactions, angioedema; confusional state, disorientation, emotional & mood disturbances, changes in libido, depression, paradoxical reactions, physical & psychological dependence, abuse; drowsiness during the day, headache, dizziness, decreased alertness, ataxia, post-op sedation (when used as premed), anterograde amnesia; GI disturbances; skin reactions; falls & fractures; resp depression; cardiac failure including cardiac arrest. FC tab: Diplopia; muscle weakness; fatigue. Soln for inj: Anaphylactic shock; convulsions (in premature infants & neonates); erythema & pain on inj site, thrombophlebitis, thrombosis.

Potentially increased & decreased plasma conc & subsequently pharmacodynamic effects w/ CYP3A inhibitors & inducers. Clinical effects of midazolam may be stronger & also longer lasting w/ a CYP3A inhibitor, & conversely may be weaker & last shorter w/ a CYP3A inducer. Pharmacokinetics may be affected which may persist for several days up to several wk after administration of CYP3A inhibitors including antibacterials (eg, clarithromycin, erythromycin, INH), anti-retrovirals (eg, HIV PIs eg, ritonavir, including ritonavir-boosted PIs; delavirdine), Ca channel blockers (eg, verapamil, diltiazem), tyrosine kinase inhibitors (eg, imatinib, lapatinib, idelalisib) or the estrogen receptor modulator raloxifene, & several herbal constitutents (eg, bergamottin) (for soln for inj only). Increased AUC w/ very strong (eg, ketoconazole, itraconazole, voriconazole, HIV PIs including ritonavir-boosted PIs), strong [eg, high dose clarithromycin, tyrosine kinase inhibitors (eg, idelalisib) & HCV PIs boceprevir & telaprevir], moderate [eg, fluconazole, telithromycin, erythromycin, diltiazem, verapamil, nefazodone, NK1 receptor antagonists (eg, aprepitant, netupitant, casopitant), tabimoreline, posaconazole], & weak [eg, fentanyl, roxithromycin, cimetidine, ranitidine, fluvoxamine, bicalutamide, propiverine, everolimus, cyclosporine, simeprevir, grapefruit juice, Echinacea purpurea, berberine (as also contained in goldenseal)] inhibitors of CYP3A. Decreased AUC w/ strong (eg, rifampin, carbamazepine, phenytoin, enzalutamide & mitotane), moderate (eg, St. John’s wort) & weak (eg, efavirenz, clobazam, ticagrelor, vemurafenib, quercetin & Panax ginseng) inducers of CYP3A. Increased sedative/hypnotic effects w/ other sedative/hypnotic agents including alcohol, opiates/opioids (used as analgesics, antitussives or substitutive treatments), antipsychotics, other benzodiazepines used as anxiolytics or hypnotics, barbiturates, propofol, ketamine, etomidate; sedative antidepressants, antihistamines & centrally acting antihypertensive drugs. Decreased min alveolar conc of inhalational anesth. Enhanced side effects (eg, sedation & cardio-resp depression) may occur w/ any centrally acting depressants including alcohol. Reversed hypnotic effects w/ drugs increasing alertness/memory eg, AchE inhibitor physostigmine. Partly reversed sedative effect w/ 250 mg caffeine. Soln for inj: Increased plasma conc w/ atorvastatin. Decreased ratio of metabolite to midazolam w/ chlorzoxazone. Increased conc of free midazolam due to displacement from plasma protein binding sites by valproic acid. Increased sedative effect w/ spinal anesth.

Hypnotics & Sedatives

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

FC tab: EDD, Rx; Soln for inj: DD, Rx