Midazolam

(mid' ay zoe lam)

PCI / LCI  : Contraindicated in pregnancy and lactation

 

Molecule Info

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WARNING

Adult and Pediatric: Intravenous midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Intravenous midazolam should be used only in hospital or ambulatory care settings, including physicians’ and dental offices, that provide for continuous monitoring of respiratory and cardiac function, ie, pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured. For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedures.

The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and in patients receiving concomitant narcotics or other central nervous system (CNS) depressants. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect. The use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5 mg/mL formulation is recommended to facilitate slower injection. Doses of sedative medications in pediatric patients must be calculated on a mg/kg basis, and initial doses and all subsequent doses should always be titrated slowly. The initial pediatric dose of midazolam for sedation/anxiolysis/amnesia is age, procedure, and route dependent.

Neonates: Midazolam should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl.

Indication(s) & Dosage

Oral route
Short-term management of insomnia
Adult: 7.5-15 mg given at night.

Sedation for dental and minor surgical procedures
Child: ≥6 mth: Single dose of 250-500 mcg/kg, up to a max of 20 mg. Younger patients (6 mth-<6 yr) may require up to 1 mg/kg.

Premedication in surgery
Child: ≥6 mth: Single dose of 250-500 mcg/kg, up to a max of 20 mg. Younger patients (6 mth-<6 yr) may require up to 1 mg/kg.

Intramuscular route
Premedication in surgery
Adult: 70-100 mcg/kg (usual dose: 5 mg) given 20-60 minutes before surgery by deep IM inj.
Child: ≥1 yr: 80-200 mcg/kg given 20-60 minutes before surgery by deep IM inj. 
Elderly: 20-50 mcg/kg given 20-60 minutes before surgery by deep IM inj.

Parenteral
Sedation for dental and minor surgical procedures
Adult: IV admin: Initially, up to 2.5 mg given over at least 2-5 minutes, 5-10 minutes before procedure. Repeat after at least 2 minutes if necessary. Usual total: 3.5-5 mg. Max total: 7.5 mg. 
Child: IV admin: 6 mth-5 yr: Initial: 50-100 mcg/kg given over 2 minutes, increase slowly at 2-minute intervals up to a total of 600 mcg/kg, max total dose: 6 mg. 6-12 yr: 25-50 mcg/kg given over 2 minutes and increase slowly at 2-minute intervals up to a total of 400 mcg/kg; max total dose: 10 mg. IM admin (used only in exceptional cases): 1-15 yr: 50-150 mcg/kg; max: 10 mg.
Elderly: Initially 1-1.5 mg given over 2 min, increased by increments of 0.5-1 mg at 2 min intervals as needed.

Induction of anaesthesia
Adult: 150-200 mcg/kg by slow inj in premedicated patients and at least 300 mcg/kg for those who have not received a premedicant. Additional doses may be required to complete induction, up to 600 mcg/kg in resistant cases. 
Child: >7 yr: 150 mcg/kg. Max total: 500 mcg/kg (not >25 mg). 
Elderly: 100-200 mcg/kg in divided doses at 2-minute intervals. 

Sedation in critical care
Adult: Loading dose: 30-300 mcg/kg given as infusion over 5 minutes to induce sedation. Maintenance dose: 20-200 mcg/kg/hr. For patients with hypothermia, hypovolaemia or vasoconstriction: Reduce or omit loading dose, and reduce maintenance dose.
Child: Neonates with gestational age <32 wk: 30 mcg/kg/hr by continuous IV infusion. Neonates with gestational age >32 wk and who are <6 mth: 60 mcg/kg/hr. ≥6 mth: Initial loading dose of 50-200 mcg/kg given by slow IV inj; maintenance dose of 60-120 mcg/kg/hr given as IV infusion. In obese paediatric patients, calculate dose based on ideal wt.
Elderly: Dosage may need to be reduced.

Rectal route

Sedation for dental and minor surgical procedures
Child: >6 mth: 300-500 mcg/kg as a single dose. May dilute with water for inj up to a total volume of 10 mL if the volume is too small. 

Premedication in surgery
Child: >6 mth: 300-500 mcg/kg as a single dose. May dilute with water for inj up to a total volume of 10 mL if the volume is too small.

Special Populations: If premedicated with opioids, debilitation and neonates, the dose should be adjusted appropriately.
Reconstitution: Midazolam solution for injection may be administered rectally. The inj solution may be diluted with Water for Injections up to a total volume of 10 ml if the volume is too small.

Administration May be taken with or without food.
Overdosage Symptoms of overdose include sedation, confusion, impaired coordination, muscle relaxation or paradoxical excitation. More serious symptoms would be areflexia, hypotension, cardiorespiratory depression, apnoea and coma. Treatment is generally supportive and symptomatic. The benzodiazepine antagonist flumazenil is indicated in cases of severe intoxication accompanied with coma or respiratory depression. Caution should be observed in the use of flumazenil in case of mixed drug overdosage and in patients with epilepsy already treated with benzodiazepines.
Contraindications Acute narrow-angle glaucoma; coma or patients in shock; acute alcohol intoxication; intrathecal and epidural admin. Acute pulmonary insufficiency or marked neuromuscular respiratory weakness including unstable myasthenia gravis; severe respiratory depression.
Special Precautions Paediatric patients with cardiovascular instability; chronic renal failure; open-angle glaucoma; cardiac disease; respiratory disease; myasthenia gravis; neonates; history of drug or alcohol abuse; elderly and debilitated (reduce dose); avoid prolonged use or abrupt withdrawal; hepatic impairment; severe fluid or electrolyte disturbances. May impair ability to drive or operate machinery; titrate dose carefully; monitor for early signs of hypoventilation, airway obstruction, or apnea. Pregnancy, lactation
Adverse Drug Reaction(s) Physical and psychological dependence with withdrawal symptoms; decreased tidal volume and respiration rate; apnoea; headache; hiccup; nausea, increased appetite, vomiting; cough; oversedation; seizure-like activity (paediatrics); paradoxical reactions; kernicterus; nystagmus; skin rash, pruritus; reduced alertness, confusion, euphoria, hallucinations, fatigue, dizziness, ataxia, post-operative sedation, anterograde amnesia; jaundice; cardiac arrest, heart rate changes, thrombosis; anaphylaxis; laryngospasm, bronchospasm.
Potentially Fatal: Respiratory depression, respiratory arrest; hypotension.
Drug Interactions Increased CNS depression with alcohol, opioids, barbiturates, other sedatives and anaesthetics. Increased respiratory depression with opiates, phenobarbital, other benzodiazepines. Plasma concentrations increased by CYP3A4 inhibitors such as cimetidine, erythromycin, clarithromycin, diltiazem, verapamil, ketoconazole and itraconazole, antiretroviral agents, quinupristin with dalfopristin. Midazolam concentration decreased by phenytoin, carbamazepine, phenobarbital, rifampicin. Halothane, thiopental requirements may be reduced during concurrent use.
Food Interaction Bioavailability of oral midazolam increased by grapefuit juice. Avoid concomittant use.
Pregnancy Category (FDA) Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Storage Intramuscular: Store at 20-25°C. At a final concentration of 0.5 mg/ml, midazolam is stable for up to 24 hr when diluted with 0.9% sodium chloride or 5% dextrose in water. Intravenous: Store at 20-25°C. At a final concentration of 0.5 mg/ml, midazolam is stable for up to 24 hr when diluted with 0.9% sodium chloride or 5% dextrose in water. Parenteral: Store at 20-25°C. At a final concentration of 0.5 mg/ml, midazolam is stable for up to 24 hr when diluted with 0.9% sodium chloride or 5% dextrose in water. Rectal: Store at 20-25°C.
Pharmacology Midazolam is a short-acting benzodiazepine. It exerts sedative and hypnotic, muscle relaxant, anxiolytic and anticonvulsant actions. While the probable anxiolytic action might be as a result of the drug's ability to increase glycine inhibitory neurotransmitter level, the hypnotic/anaesthetic action may be due to the occupation of the benzodiazepine and GABA receptors leading to membrane hyperpolarisation and neuronal inhibition, and further interfering with the re-uptake of GABA at the synapses.
Absorption: Rapidly absorbed (any route); peak plasma concentrations after 20-60 min (depending on route).
Distribution: Crosses the placenta; enters breast milk. Protein-binding: 96%
Metabolism: Extensively hepatic via CYP3A4 isoenzyme; converted to hydroxymethylmidazolam.
Excretion: Urine (as glucuronide conjugates); 2 hr (elimination half-life), prolonged in neonates, elderly and hepatic impairment.
ATC Classification N05CD08 - midazolam; Belongs to the class of benzodiazepine derivatives used as hypnotics and sedatives.

Brand/Product Info


Total Products : 19                   
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ANQUIL General Pharmaceuticals Ltd Midazolam 7.5mg & 15mg Tablet 7.5mg x30's, 15mg x10's: 240.90 & 150.60 MRP
DORMAX Aristopharma Ltd. Midazolam 7.5mg Tablet 30's: 240.00 MRP
DORMAX Injection Aristopharma Ltd. Midazolam 15mg/3ml Injection 15mg/3ml: 150.00 MRP
DORMICUM Roche Bangladesh Limited Midazolam 7.5mg Tablet 30's: 420.00 MRP
DORMICUM Injection Roche Bangladesh Limited Midazolam 5mg/5ml & 15mg/3ml Injection 5mg x10's, 15mg x5's: 1700.00 & 1147.50 MRP
DORMITOL 15 Square Pharmaceuticals Ltd. Midazolam 15mg Tablet 2x10's: 401.20 MRP
DORMITOL 7.5 Square Pharmaceuticals Ltd. Midazolam 7.5mg Tablet 3x10's: 300.90 MRP
DORMITOL INJ Square Pharmaceuticals Ltd. Midazolam 15mg/3 ml IM/IV Injection 1x1's: 120.37 MRP
HYPNOCUM Healthcare Pharmacuticals Ltd. Midazolam BP 7.5 mg (as Midazolam Maleate) Tablet 30's MRP 300 Tk
Hypnofast 15 Incepta Pharmaceuticals Limited Midazolam BP 15 mg (as Midazolam Maleate) Tablet 10x1's:MRP 150 Tk
Hypnofast 1ml Incepta Pharmaceuticals Limited Midazolam BP 5mg/ml (as Midazolam Hydrochloride) Injection 1x1's:MRP 50 Tk
Hypnofast 3ml Incepta Pharmaceuticals Limited Midazolam BP 15mg/3ml (as Midazolam Hydrochloride) Injection 1x1's:MRP 150 Tk
Hypnofast 5ml Incepta Pharmaceuticals Limited Midazolam BP 5mg/5ml (as Midazolam Hydrochloride) Injection 1x1's:MRP 90 Tk
Hypnofast 7.5 Incepta Pharmaceuticals Limited Midazolam BP 7.5 mg (as Midazolam Maleate) Tablet 10x3's:MRP 240 Tk
MIDOLAM Opsonin Pharma Limited Midazolam 7.5mg,15mg Tablet 7.5mg x30's, 15mg x10's: 240.00 & 150.00 MRP
MIDOLAM Injection Opsonin Pharma Limited Midazolam 5mg/1ml & 5mg/5ml; 15mg/3ml Capsule 5mg/1ml & 5ml: 50.00 & 55.00; 15mg/3ml x1's & 5's: 75.00 & 375.00 MRP
MILAM Eskayef Bangladesh Ltd Midazolam BP 7.5mg & 15mg (as Midazolam Maleate) Tablet 7.5mg x40's & 15mg x10's MRP: 400.00 & 150.00
MILAM Injection Eskayef Bangladesh Ltd Midazolam BP 5mg/ml (as Midazolam Hydrochloride) Injection 15mg/3ml, MRP: 75.00
MIZOLAM The Acme Laboratories Ltd. Midazolam 7.5mg Tablet 30's: 240.00 MRP

Gen. MedInfo

IMPORTANT WARNING: 

Midazolam may cause serious or life-threatening breathing problems such as shallow, slowed, or temporarily stopped breathing. Your child should only receive Midazolam in a hospital or doctor's office that has the equipment that is needed to monitor his or her heart and lungs and to provide life-saving medical treatment quickly if his or her breathing slows or stops. Your child's doctor or nurse will watch your child closely after he or she receives Midazolam to make sure that he or she is breathing properly. Tell your child's doctor if your child has a severe infection or if he or she has or has ever had any airway or breathing problems or heart or lung disease. Tell your child's doctor if your child is taking any of the following medications: antidepressants; barbiturates such as secobarbital; droperidol; medications for anxiety, mental illness, or seizures; narcotic medications for pain such as fentanyl (Fentanyl Hexal, Duragesic others), morphine, and meperidine; sedatives; sleeping pills; or tranquilizers.

Why is Midazolam prescribed?

Midazolam is given to children before medical procedures or before anesthesia for surgery to cause drowsiness, relieve anxiety, and prevent any memory of the event. Midazolam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow relaxation and sleep.

How should Midazolam be used?

Midazolam comes as a syrup to take by mouth. It is usually given as a single dose by a doctor or nurse before a medical procedure or surgery.

Other uses for Midazolam

Midazolam may be prescribed for other uses; ask your child's doctor for more information.

What special precautions to follow?

Before your child receives midazolam,

  • inform your child's doctor if he or she is allergic to midazolam, any other medications, or cherries.
  • inform your child's doctor if your child is taking certain medications for human immunodeficiency virus  including amprenavir, atazanavir, darunavir, delavirdine, efavirenz, fosamprenavir, indinavir,lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir . Your child's doctor may decide not to give midazolam to your child if he or she is taking one or more of these medications.
  • inform your child's doctor what other prescription and nonprescription medications, vitamins, and nutritional supplements your child is taking or plans to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone; aminophylline; antifungals such as fluconazole, itraconazole, and ketoconazole; certain calcium channel blockers such as diltiazem  and verapamil; cimetidine; clarithromycin; dalfopristin-quinupristin; erythromycin; fluvoxamine; certain medications for seizures such as carbamazepine, phenobarbital, and phenytoin; methylphenidate; nefazodone; ranitidine; rifabutin; and rifampin . Your child's doctor may need to change the doses of your child's medications or monitor your child carefully for side effects. Many other medications may also interact with midazolam, so be sure to inform your child's doctor about all the medications your child is taking, even those that do not appear on this list.
  • inform your child's doctor what herbal products your child is taking, especially St. John's wort.
  • inform your child's doctor if your child has glaucoma. Your child's doctor may decide not to give your child midazolam.
  • inform your child's doctor if your child has or has ever had kidney or liver disease.
  • inform your child's doctor if your child is or may be pregnant, or is breast-feeding.
  • you should know that midazolam may make your child very drowsy and may affect his or her memory, thinking, and movements. Do not allow your child to ride a bicycle, drive a car, or do other activities that require him or her to be fully alert for at least 24 hours after receiving midazolam and until the effects of the medication have worn off. Watch your child carefully to be sure that he or she does not fall while walking during this time.
  • you should know that alcohol can make the side effects of midazolam worse.

What special dietary instructions to follow?

Do not let your child eat grapefruit or drink grapefruit juice while taking Midazolam.

What side effects can Midazolam cause?

Midazolam may cause side effects. Tell your child's doctor if any of these symptoms are severe or do not go away:

  • nausea

  • vomiting

  • rash

Some side effects can be serious. If your child experiences any of these symptoms, call his or her doctor immediately:

  • agitation

  • restlessness

  • uncontrollable shaking of a part of the body

  • stiffening and jerking of the arms and legs

  • aggression

  • slow or irregular heartbeat

Midazolam may cause other side effects. Call your child's doctor if your child has any unusual problems while taking Midazolam.

In case of emergency/overdose

In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include:

  • drowsiness

  • confusion

  • problems with balance and movement

  • slowed breathing and heartbeat

  • loss of consciousness

Midazolam may cause other side effects.  Consult your doctor if you have any unusual problems while taking this.

What other information to know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Midazolam.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

 


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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