Indications of Midolam 15 mg/3 ml
Midolam 15 mg/3 ml is indicated in-
Short-term treatment of insomnia.
Sedation in premedication before surgical or diagnostic procedures.
Theropeutic Class
Benzodiazepine hypnotics, Benzodiazepine sedatives
Pharmacology
Midolam 15 mg/3 ml binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites w/in the CNS, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to Cl ions, which results in hyperpolarisation (a less excitable state) and stabilisation. Benzodiazepine receptors and effects appear to be linked to the GABA-A receptors.
Dosage & Administration of Midolam 15 mg/3 ml
The duration of treatment with oral Midolam 15 mg/3 ml should not be more than of 2 weeks. In certain cases extension beyond the maximum treatment period may be necessary.Insomnia:
Adults: 7.5 mg to 15 mg daily (Oral)
Elderly: 7.5 mg daily (Oral)
Premedication: 7.5 mg to 15 mg, should be given 30-60 minutes before the procedure (Oral)
Endoscopic or Cardiovascular procedures:
Adult: initial dose is 2.5 mg (IV)
Elderly & debilitated patients: 1-1.5 mg (IV)
Induction of Anesthesia: Adult: 10-15 mg (IV) or 0.07-0.1 mg/Kg body weight, usually 5 mg (IM)
Children: 0.15-0.20 mg/Kg (IM)
Elderly & debilitated patients: 0.025-0.05 mg/Kg (IM)
Rectal administration in children: for preoperative sedation, rectal administration of the ampoule solution is 0.35-0.45 mg/Kg, 20-30 min before induction of general anesthesia
Dosage of Midolam 15 mg/3 ml
Oral dosage:
For adults: 7.5-15 mg daily.
In elderly and debilitated patients: The recommended dose is 7.5 mg.
In premedication: 15 mg of Midolam 15 mg/3 ml should be given 30-60 minutes before the procedure.
Intravenous administration:
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.
Intramuscular administration:
Adult: 0.07-0.1 mg/kg body weight. The usual dose is about 5 mg.
Children: 0.15-0.20 mg/kg
Elderly and debilitated patients: 0.025-0.05 mg/kg
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.
Interaction of Midolam 15 mg/3 ml
Midolam 15 mg/3 ml can enhance the central sedative effect of neuroleptics, tranquillizers, antidepressants, sleep-inducing drugs, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepileptic drugs and sedative antihistamines.
Contraindications
Midolam 15 mg/3 ml must not be given to patients with severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, sleep apnea syndrome and with known hypersensitivity to benzodiazepines or to any component of the product
Side Effects of Midolam 15 mg/3 ml
At the start of therapy, drowsiness during daytime, confusion, fatigue, headache and muscle weakness may occur which usually disappear with repeated administration. Following parenteral (IV or IM) administration of Midolam 15 mg/3 ml, fluctuations in vital signs have been noted including respiratory depression, apnea, variations in blood pressure and pulse rate.
Pregnancy & Lactation
Insufficient data are available on Midolam 15 mg/3 ml to assess its safety during pregnancy. But benzodiazepines adversely affect the human fetus. So their use should be avoided if there is safer alternative. Midolam 15 mg/3 ml is excreted through breast milk. Therefore, Midolam 15 mg/3 ml should not be used by the nursing mothers.
Precautions & Warnings
Midolam 15 mg/3 ml IV should be administered very slowly.
Overdose Effects of Midolam 15 mg/3 ml
Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnea. The effects of overdosage can be controlled with benzodiazepine antagonist flumazenil.
Storage Conditions
Protect from light and moisture, store in cool and dry place. Keep out of the reach of children.
Drug Classes
Benzodiazepine hypnotics, Benzodiazepine sedatives
Mode Of Action
The actions of benzodiazepines such as Midolam 15 mg/3 ml are mediated through the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), which is one of the major inhibitory neurotransmitters in the central nervous system. Benzodiazepines increase the activity of GABA, thereby producing a sedating effect, relaxing skeletal muscles, and inducing sleep, anesthesia, and amnesia. Benzodiazepines bind to the benzodiazepine site on GABA-A receptors, which potentiates the effects of GABA by increasing the frequency of chloride channel opening. These receptors have been identified in different body tissues including the heart and skeletal muscle, although mainly appear to be present in the central nervous system.
Pregnancy
Midolam 15 mg/3 ml should be avoided during pregnancy unless there is no safer alternative. Since Midolam 15 mg/3 ml passes into breast milk, it should not be administered to breast-feeding mothers.