Dormax
Generic Name
Midazolam
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
dormax 15 mg injection | ৳ 150.00 | N/A |
Description
Overview of the medicine
Midazolam is a short-acting benzodiazepine central nervous system depressant. It is used for premedication, conscious sedation, induction of general anesthesia, and continuous sedation in critical care settings.
Uses & Indications
Dosage
Adults
Dosage is highly individualized. For premedication (IM): 0.07-0.08 mg/kg. For procedural sedation (IV): Initial 1-2.5 mg, titrated slowly to desired effect. For induction of anesthesia (IV): 0.15-0.35 mg/kg. For continuous sedation (IV infusion): 0.03-0.2 mg/kg/hr.
Elderly
Reduced doses (e.g., 25-50% lower) are typically required due to increased sensitivity and slower clearance. Initial dose for procedural sedation (IV): 0.5-1 mg, titrated slowly.
Renal_impairment
Dose adjustment is required, especially for prolonged infusions, due to accumulation of active metabolites. Lower doses and slower titration are recommended.
How to Take
Dormax 15 mg injection is administered intravenously (IV) or intramuscularly (IM). IV administration should be slow, over at least 2 minutes, and titrated to effect. Close monitoring of vital signs is essential.
Mechanism of Action
Midazolam enhances the activity of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the brain, by binding to GABA-A receptors. This leads to increased chloride ion influx, hyperpolarization of neurons, and reduced neuronal excitability, resulting in sedative, anxiolytic, hypnotic, anticonvulsant, and muscle relaxant effects.
Pharmacokinetics
Onset
IV: 1.5-5 minutes; IM: 15 minutes
Excretion
Primarily renal, with metabolites excreted in urine, mostly as glucuronide conjugates.
Half life
Elimination half-life: 1.8-6.4 hours (variable, influenced by age and disease states)
Absorption
Rapid and complete after IM administration; faster after IV. Bioavailability after IM is approximately 90%.
Metabolism
Extensively metabolized in the liver by cytochrome P450 3A4 (CYP3A4) to its primary active metabolite, 1-hydroxymidazolam.
Side Effects
Contraindications
- Hypersensitivity to midazolam or other benzodiazepines.
- Acute narrow-angle glaucoma.
- Severe respiratory depression or acute pulmonary insufficiency.
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) when oral midazolam is used.
Drug Interactions
CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin)
Can decrease midazolam plasma concentrations, potentially reducing its efficacy.
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, grapefruit juice)
Can significantly increase midazolam plasma concentrations, prolonging its effects and increasing risk of adverse reactions.
Opioids and other CNS depressants (e.g., alcohol, barbiturates, antidepressants, antihistamines)
Increased risk of profound sedation, respiratory depression, coma, and death.
Storage
Store below 25°C. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, coma, and respiratory depression. Management involves general supportive measures, maintaining a patent airway, monitoring vital signs, and intravenous fluids. Flumazenil, a benzodiazepine receptor antagonist, can be used to reverse the effects but should be used with caution, especially in patients on chronic benzodiazepine therapy or with seizure disorders.
Pregnancy & Lactation
Pregnancy Category D: There is positive evidence of human fetal 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). Midazolam is excreted in breast milk; therefore, caution should be exercised when administered to a nursing mother. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to midazolam or other benzodiazepines.
- Acute narrow-angle glaucoma.
- Severe respiratory depression or acute pulmonary insufficiency.
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) when oral midazolam is used.
Drug Interactions
CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin)
Can decrease midazolam plasma concentrations, potentially reducing its efficacy.
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, grapefruit juice)
Can significantly increase midazolam plasma concentrations, prolonging its effects and increasing risk of adverse reactions.
Opioids and other CNS depressants (e.g., alcohol, barbiturates, antidepressants, antihistamines)
Increased risk of profound sedation, respiratory depression, coma, and death.
Storage
Store below 25°C. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, coma, and respiratory depression. Management involves general supportive measures, maintaining a patent airway, monitoring vital signs, and intravenous fluids. Flumazenil, a benzodiazepine receptor antagonist, can be used to reverse the effects but should be used with caution, especially in patients on chronic benzodiazepine therapy or with seizure disorders.
Pregnancy & Lactation
Pregnancy Category D: There is positive evidence of human fetal 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). Midazolam is excreted in breast milk; therefore, caution should be exercised when administered to a nursing mother. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Refer to the manufacturer's specific instructions and expiry date on the packaging. Typically 2-3 years.
Availability
Hospitals, Clinics, Pharmacies (with prescription)
Approval Status
Approved (Widely)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Midazolam has been extensively studied in numerous clinical trials for its various indications, demonstrating its efficacy and safety profile. Further information is available in medical literature and regulatory submissions.
Lab Monitoring
- Respiratory rate and depth
- Oxygen saturation (pulse oximetry)
- Blood pressure
- Heart rate
- Level of consciousness
Doctor Notes
- Midazolam should be administered by or under the direct supervision of physicians experienced in the use of sedative drugs.
- Individualize the dose carefully, especially in elderly, debilitated, or renally impaired patients, and those receiving other CNS depressants.
- Always have resuscitation equipment and personnel immediately available when administering midazolam intravenously.
- Monitor vital signs continuously for respiratory depression and hypotension.
Patient Guidelines
- Inform your healthcare provider about all medications you are taking, including over-the-counter drugs and herbal supplements.
- Avoid alcohol and other CNS depressants for at least 24 hours after receiving the injection or as advised by your doctor.
- Do not drive or operate heavy machinery until the effects of the medication have completely worn off and you feel fully alert.
Missed Dose Advice
As Dormax injection is typically administered in a clinical setting for acute indications or planned procedures, a missed dose is generally not applicable. For continuous infusions, dose adjustments are made by healthcare professionals based on patient response.
Driving Precautions
Dormax injection causes significant sedation and can impair mental and physical abilities. Patients should not drive, operate machinery, or engage in potentially hazardous activities for at least 24 hours (or longer, depending on the individual's response and the dose received) after receiving the injection.
Lifestyle Advice
- Follow your doctor's post-procedure instructions carefully.
- Ensure someone can drive you home after the procedure if midazolam was administered.
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