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|Midazolam hydrochloride Midazolam Hydrochloride |
Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home Midazolam hydrochloridePronouncation: (meh-DAZE-oh-lam HIGH-droe-KLOR-ide)Class: General anesthetic Trade Names: Mechanism of ActionPharmacologyDepresses all levels of CNS, including limbic and reticular formation, probably through increased action of GABA, which is major inhibitory neurotransmitter in brain. PharmacokineticsAbsorptionMidazolam is rapidly absorbed. The oral AUC ratio of metabolite to midazolam is higher than IV. Mean T max is 0.17 to 2.65 hr and the absolute bioavailability is 36%. DistributionMidazolam exhibits linear pharmacokinetics (dose 0.25 to 1 mg/kg). Approximately 97% is protein bound (mainly to albumin). The mean steady-state Vd is 1.24 to 2.02 L/kg in children 6 mo to less than 16 yr receiving 0.15 mg/kg IV. MetabolismMidazolam is subject to substantial intestinal and hepatic first-pass metabolism by cytochrome P450 3A4. Active metabolite is alpha-hydroxymidazolam. OnsetOnset is 10 to 20 min. Special PopulationsHepatic Function ImpairmentFollowing oral administration (15 mg), C max and bioavailability were 43% and 100% higher, respectively. The clearance was reduced 40% and t ½ increased 90%. Doses should be titrated. CHFFollowing oral administration (7.5 mg), t ½ increased 43%. Indications and UsagePreoperative sedative; conscious sedation prior to diagnostic, therapeutic or endoscopic procedures; induction of general anesthesia; supplement to nitrous oxide and oxygen for short surgical procedures; infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in critical care setting. Unlabeled UsesTreatment of epileptic seizures; alternative for the termination of refractory status epilepticus. ContraindicationsHypersensitivity to benzodiazepines; uncontrolled pain; existing CNS depression; shock; acute narrow-angle glaucoma; acute alcohol intoxication; coma. Dosage and AdministrationPreoperative SedativeAdults IM 0.07 to 0.08 mg/kg approximately 1 hr before surgery. Conscious SedationAdults IV 1 to 2.5 mg as 1 mg/mL dilution over 2 min. Increase by small increments to total dose of no more than 5 mg in at least 2 min intervals; use less if patient is premedicated with other CNS depressants. ChildrenIM 0.1 to 0.15mg/kg. Doses up to 0.5 mg/kg have been used for more anxious patients. Total dose usually does not exceed 10 mg. Children (younger than 6 mo)IV Titrate in small increments to clinical effect and monitor carefully. Children (6 mo to 5 yr)IV 0.05 to 0.1 mg/kg. Total dose up to 0.6 mg/kg may be necessary. Do not exceed 6 mg. Children (6 to 12 yr)IV 0.025 to 0.05 mg/kg. Total dose up to 0.4 mg/kg. Do not exceed 10 mg. Children (12 to 16 yr)IV Dose as adults. Induction of General AnesthesiaUnpremedicated Adults IV 0.3 to 0.35 mg/kg as 1 mg/mL dilution over 20 to 30 sec, allowing 2 min for effect; may use increments of approximately 25% of initial dose. Premedicated AdultsIV 0.15 to 0.35 mg/kg over 20 to 30 sec. Continuous InfusionAdults Loading dose 0.01 to 0.05 mg/kg given slowly over several minutes. May be repeated at 10- to 15-min intervals until adequate sedation is achieved. Maintenance0.02 to 0.1 mg/kg/hr (1 to 7 mg/hr). Pediatric (non-neonatal)IV 0.05 to 0.2 mg/kg over at least 2 to 3 min in patients whose trachea is intubated. Loading dose may be followed by continuous IV infusion at 0.06 to 0.12 mg/kg/hr (1 to 2 mcg/kg/min). Increase or decrease approximately 25% of the initial infusion rate or subsequent infusion rate. Intubated preterm and term newborns (younger than 32 wk)0.03 mg/kg/hr (0.5 mcg/kg/min). Intubated preterm and term newborns (younger than 32 wk)0.06 mg/kg/hr (1 mcg/kg/min). Maintenance Of AnesthesiaIV Increments of approximately 25% of induction dose in response to signs of lightening of anesthesia and repeat as necessary. Storage/StabilityStore at room temperature (59° to 86°F). Drug InteractionsAnesthetics, inhalationInhalation anesthetics may need to be reduced if midazolam is used as an induction agent. IV administration decreases minimum alveolar concentration of halothane required for general anesthesia. Azole antifungal agentsSerum concentration of certain benzodiazepines may be increased and prolonged, producing enhanced CNS depression and prolonged effects. Barbiturates, alcohol, other CNS depressantsMay prolong effect and increase risk of underventilation or apnea. CimetidineMay increase midazolam levels. Contraceptives, oralCoadministration may result in prolongation of benzodiazepine t 1/ 2 . Droperidol, narcotics, secobarbitalMay accentuate hypnotic effect of midazolam. EthanolIncreased CNS effects with acute ethanol ingestion. FluvoxamineReduced clearance, prolonged t 1/ 2 and increased serum concentrations of certain benzodiazepines may occur. Sedation or ataxia may be increased. IndinavirPossibly severe sedation and respiratory depression. PropofolPharmacologic effects of propofol may be increased. RifamycinsPharmacokinetic parameters of benzodiazepines may be altered. RitonavirPossibly severe sedation and respiratory depression. TheophyllinesSedative effects of benzodiazepines may be antagonized. ThiopentalModerate reduction in induction dosage requirements has been noted following use of IM midazolam for premedication. Valproic acidPharmacokinetic parameters of benzodiazepines may be increased. Liver metabolism may be decreased. VerapamilEffects of certain benzodiazepines may be increased, producing increased CNS depression and prolonged effects. IncompatibilityDimenhydrinate, pentobarbital, perphenazine, prochlorperazine, ranitidine. Laboratory Test InteractionsNone well documented. Adverse ReactionsCardiovascularBigeminy; hypotension; PVCs; tachycardia; cardiac arrest; vasovagal episode; bradycardia; nodal rhythm. CNSHeadache; oversedation; retrograde amnesia; euphoria or dysphoria; confusion; argumentativeness; anxiety; emergence delirium and dreaming; nightmares; tonic/clonic movements; tremor; athetoid movements; ataxia; dizziness; slurred speech; paresthesia; weakness; loss of balance; drowsiness; nervousness; agitation; restlessness; prolonged emergence from anesthesia; insomnia; dysphonia. DermatologicHives; hive-like elevation at injection site; swelling or feeling of burning; warmth or coldness at injection site; rash; pruritus. EENTVision disturbances; nystagmus; pinpoint pupils; cyclic eyelid movements; blocked ears; blurred vision; diplopia; difficulty focusing; loss of balance. GINausea; vomiting; acid taste; excessive salivation; retching. RespiratoryRespiratory depression or arrest; decreased tidal volume, decreased respiratory rate; apnea, coughing; laryngospasm; bronchospasm; dyspnea; hyperventilation; wheezing; shallow respirations; airway obstruction; tachypnea. MiscellaneousPain, tenderness and induration at injection site; yawning; chills; lethargy; weakness; toothache; faint feeling; hematoma; desaturation, apnea, hypotension, paradoxical reactions, hiccough, seizure-like activity, nystagmus (children). Precautions
PregnancyCategory D . LactationMidazolam is excreted in breast milk. Exercise caution when administering to a nursing mother. ChildrenAs a group, pediatric patients generally require higher dosages of midazolam (mg/kg) than do adults. Pediatric patients (younger than 6 yr) may require higher dosages (mg/kg) than older pediatric patients and may require closer monitoring. In obese pediatric patients, calculate the dose based on ideal body weight. ElderlyMay need to decrease dosage. Titration should be more gradual. Labor and DeliveryDrug not recommended because of transplacental transfer. Renal FunctionPatients with renal impairment may have longer t 1/ 2 for midazolam, which may result in slower recovery. Special Risk PatientsHigh-risk surgical patients require lower doses. Patients with COPD are unusually sensitive to respiratory depressant effects. In renal or heart failure patients, give less frequently. Exercise care when administering to patients with uncompensated acute illness (eg, severe fluid or electrolyte disturbances). Hazardous TasksNo patient should operate hazardous machinery or a motor vehicle until the side effects of the drug have subsided or until the day after anesthesia and surgery, whichever is longer. Abrupt withdrawalWithdrawal symptoms (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting, and sweating) may occur following abrupt discontinuation. Benzyl alcoholThe midazolam injection contains benzyl alcohol, which has been associated with a fatal “gasping syndrome” in premature infants. Debilitated patientsMay need to decrease dosage. Titration should be more gradual. Serious cardiorespiratory eventsHave occurred, including respiratory depression, airway obstruction, desaturation, permanent neurologic injury, apnea, respiratory arrest or cardiac arrest, sometimes resulting in death. Improper dosingReactions such as agitation, involuntary movements, hyperactivity and combativeness have been reported. OphthalmicModerate lowering of IOP following induction with midazolam. Intra-arterial injectionUnknown. Intracranial pressure/circulatory side effectsDoes not protect against the increase in intracranial pressure or circulatory effects associated with endotracheal intubation under light general anesthesia. OverdosageSymptomsSedation, impaired coordination and reflexes, hypotension, hypoventilation, somnolence, coma, confusion. Patient Information
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