Hikma Midazolam Injection
Midazolam
5mg/ml
Al Hikma Pharmaceuticals
| Pack size | 3ml Ampoule x 5 |
|---|---|
| Dispensing mode | CD |
| Source | JORDAN |
| Agent | AL HAYAT PHARMACEUTICALS |
| Retail Price | 33.00 AED |
Indications
Hikma Midazolam Injection is used for:
Short-term treatment of insomnia.
Sedation in premedication before surgical or diagnostic procedures.
Adult Dose
Adult
Oral
Short-term management of insomnia
Adult: 7.5-15 mg at bedtime.
Elderly: 7.5 mg at bedtime.
Hepatic impairment: Mild to moderate: Dosage reduction needed. Severe: Contraindicated.
Parenteral
Preoperative Sedation
IM
Adult: 0.07-0.1 mg/kg bodyweight i. m. Usual dose is about 5 mg.
Elderly and debilitated patients: 0.025-0.05 mg/kg
IV
Endoscopic or Cardiovascular Procedures
In healthy adults the initial dose is approximately 2.5 mg. In cases of severe illness and in elderly patients, the initial dose must be reduced to 1 to 1.5 mg.
Induction of Anesthesia
The dose is 10-15 mg I. V.
Child Dose
Oral
Seizures
Child: 3-6 mth Hospital setting: 2.5 mg;
>6 mth to <1 yr 2.5 mg;
1-<5 yr 5 mg;
5-<10 yr 7.5 mg;
10-<18 yr 10 mg.
Doses are given as single dose.
Sedation
500-750 mcg/kg PO once diluted by juice 20-30 minutes prior to procedure; not to exceed 20 mg
Rectal administration in children:
For preoperative sedation, rectal administration of the ampoule solution (0.35-0.45 mg/kg) 20-30 min before induction of general anesthesia.
Parenteral
Sedation
IM
100-150 mcg/kg IM; up to 500 mcg/kg used; not to exceed 10 mg
IV
<6 months: Initial, 50 mcg/kg IV over 2-3 minutes; titrate with small increments to clinical effect; monitor closely
6 months-6 years: Initial, 50-100 mcg/kg IV over 2-3 minutes; repeat q2-3min PRN; may require up to 600 mcg/kg total dose; not to exceed 6 mg total dose
6-12 years: Initial, 25-50 mcg/kg IV over 2-3 minutes; repeat q2-3min PRN; may require up to 400 mcg/kg; not to exceed 10 mg total dose
Anesthesia (Non-neonatal)
Loading dose: 50-150 mcg/kg IV over 2-3 minutes PRN to achieve desired effect
Continuous infusion: 1-2 mcg/kg/min IV infusion
Anesthesia (Neonatal)
IV loading dose should not be used in neonates
Continuous infusion: 0.5 mcg/kg/min IV infusion
Renal Dose
Administration
May be taken with or without food.
Midazolam IV should be administered very slowly.
Contra Indications
Severe resp failure or acute resp depression, acute narrow-angle glaucoma, myasthenia gravis, sleep apnoea syndrome; severe hepatic impairment (oral). Concomitant use w/ potent CYP3A4 inhibitors.
Precautions
Patients w/ heart failure, impaired gag reflex, resp disease, history of alcohol or drug abuse. Patient at risk of falls. Hepatic and renal impairment. Childn, elderly and debilitated patient. Pregnancy and lactation. Avoid abrupt withdrawal after prolonged use. Avoid rapid inj in neonates. Patient Counselling May impair ability to drive or operate machinery. Monitoring Parameters Monitor resp and CV status, BP.
Lactation: Distributed in breast milk, use caution
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies of midazolam intranasal in pregnant women
Available data suggest benzodiazepines are not associated with marked increases in risk for congenital anomalies
Clinical considerations
Exposure to benzodiazepines during the second and third trimesters of pregnancy or immediately prior to or during childbirth may increase risk for decreased fetal movement and/or fetal heart rate variability, floppy infant syndrome, dependence, and withdrawal
Clinical manifestations of withdrawal or neonatal abstinence syndrome may include hypertonia, hyperreflexia, hypoventilation, irritability, tremors, diarrhea, and vomiting
Animal studies
Administration of midazolam to rats and rabbits during the period of organogenesis or to rats during late pregnancy and throughout lactation at doses greater than those used clinically did not result in any apparent adverse effects on development
However, published data for benzodiazepines suggest potential of neuronal cell death and long-term effects on neurobehavioral and immunological function in animals following prenatal or early postnatal exposure at clinically relevant doses
Lactation
Midazolam is excreted in human milk
Studies assessing effects in the breastfed infant or on milk production/excretion have not been performed
Postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines may experience lethargy, somnolence, and poor sucking
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.
Adverse Effects
Side effects of Midazolam :
>10%
Decreased respiratory rate (23%), Apnea (15%)
1-10%
Drowsiness (1-5%), Seizure-like activity (1%), Nausea/vomiting (3%), Cough (1%), Pain at injection site (4-5%)
Frequency Not Defined
Headache, Sedation, Hiccoughs, Delirium, Euphoria
Pediatric
Desaturation, Hypotension, Seizurelike activity, Nystagmus, Paradoxical reactions, Hiccoughs, Apnea
Mechanism of Action
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.
Note
Hikma Midazolam 5mg/ml Injection manufactured by Al Hikma Pharmaceuticals. Its generic name is Midazolam. Hikma Midazolam is availble in United Arab Emirates.
Farmaco UAE drug index information on Hikma Midazolam Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.