Hypnofast
Generic Name
Midazolam 15 mg Injection
Manufacturer
MediFast Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| hypnofast 15 mg injection | ৳ 150.00 | N/A |
Description
Overview of the medicine
Midazolam 15 mg Injection is a short-acting benzodiazepine used for sedation, anxiolysis, and amnesia before diagnostic or therapeutic procedures, and as an anesthetic adjunct.
Uses & Indications
Dosage
Adults
Premedication: 0.07-0.08 mg/kg IM 30-60 minutes prior to surgery. Procedural Sedation: Initial IV dose 0.5-2.5 mg slowly, titrated to effect. Anesthesia Induction: 0.15-0.35 mg/kg IV.
Elderly
Lower doses are recommended due to increased sensitivity and slower elimination. Initial IV dose 0.5-1 mg, titrated cautiously.
Renal_impairment
No specific dose adjustment for single doses; however, caution is advised for continuous infusions due to accumulation of active metabolites. Consider lower doses.
How to Take
Hypnofast 15 mg Injection is administered intravenously (IV) or intramuscularly (IM) by a healthcare professional. IV administration should be slow and titrated to effect. Not for intra-arterial administration.
Mechanism of Action
Midazolam binds to benzodiazepine receptors on GABA-A receptor complexes in the central nervous system, enhancing the inhibitory effects of GABA. This leads to increased chloride ion influx, hyperpolarization of the neuron, and decreased neuronal excitability.
Pharmacokinetics
Onset
IV: 1.5-5 minutes; IM: 5-15 minutes.
Excretion
Primarily excreted renally as conjugated metabolites, with a small amount in feces.
Half life
1.5-3.5 hours (terminal elimination half-life).
Absorption
Rapid and complete absorption after intramuscular (IM) administration. Bioavailability: IM ~90%, IV 100%.
Metabolism
Extensively metabolized in the liver by cytochrome P450 3A4 (CYP3A4) to its active metabolite, 1-hydroxymidazolam.
Side Effects
Contraindications
- Hypersensitivity to midazolam or any benzodiazepine.
- Acute narrow-angle glaucoma (unless adequately treated).
- Severe respiratory depression or acute respiratory insufficiency (without ventilatory support).
Drug Interactions
Protease inhibitors (e.g., ritonavir)
Potent CYP3A4 inhibitors, leading to marked increase in midazolam levels.
Opioids, alcohol, other CNS depressants
Increased risk of profound sedation, respiratory depression, hypotension, and death.
CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)
Can decrease midazolam plasma concentrations, reducing its effectiveness.
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, grapefruit juice)
Can significantly increase midazolam plasma concentrations, prolonging its effects.
Storage
Store below 30°C. Do not freeze. Protect from light. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, impaired coordination, diminished reflexes, coma, and cardiorespiratory depression. Management includes supportive care, maintaining a patent airway, and if clinically indicated, administration of flumazenil, a benzodiazepine receptor antagonist.
Pregnancy & Lactation
Pregnancy Category D. Can cause fetal harm. Avoid during pregnancy, especially in the first trimester. Midazolam is excreted in breast milk; therefore, caution is advised for nursing mothers. It may cause sedation in the infant.
Side Effects
Contraindications
- Hypersensitivity to midazolam or any benzodiazepine.
- Acute narrow-angle glaucoma (unless adequately treated).
- Severe respiratory depression or acute respiratory insufficiency (without ventilatory support).
Drug Interactions
Protease inhibitors (e.g., ritonavir)
Potent CYP3A4 inhibitors, leading to marked increase in midazolam levels.
Opioids, alcohol, other CNS depressants
Increased risk of profound sedation, respiratory depression, hypotension, and death.
CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)
Can decrease midazolam plasma concentrations, reducing its effectiveness.
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, grapefruit juice)
Can significantly increase midazolam plasma concentrations, prolonging its effects.
Storage
Store below 30°C. Do not freeze. Protect from light. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, impaired coordination, diminished reflexes, coma, and cardiorespiratory depression. Management includes supportive care, maintaining a patent airway, and if clinically indicated, administration of flumazenil, a benzodiazepine receptor antagonist.
Pregnancy & Lactation
Pregnancy Category D. Can cause fetal harm. Avoid during pregnancy, especially in the first trimester. Midazolam is excreted in breast milk; therefore, caution is advised for nursing mothers. It may cause sedation in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, check specific packaging.
Availability
Hospitals, clinics, specialized pharmacies
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Midazolam has undergone extensive clinical trials demonstrating its efficacy and safety for various indications, particularly in procedural sedation and anesthesia. Post-marketing surveillance continues to monitor its long-term safety profile.
Lab Monitoring
- Vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation) should be continuously monitored during and after administration.
- Assessment of consciousness level and sedation depth.
Doctor Notes
- Ensure resuscitation equipment and personnel are readily available when administering midazolam.
- Titrate dose slowly to individual patient response; avoid rapid bolus injections.
- Concomitant use with opioids requires extreme caution and careful patient monitoring.
Patient Guidelines
- This medication is administered by trained healthcare professionals in a controlled environment.
- Patients should be monitored closely for respiratory and cardiovascular effects.
- Avoid alcohol and other CNS depressants for at least 24 hours after administration.
Missed Dose Advice
As this medication is typically administered in a clinical setting for a specific procedure or continuous sedation, a missed dose is generally not applicable in the patient's self-administration context. Dosing is managed by healthcare professionals.
Driving Precautions
Hypnofast significantly impairs the ability to drive or operate machinery. Patients should be advised not to drive or engage in hazardous activities for at least 24 hours after administration.
Lifestyle Advice
- Avoid driving or operating heavy machinery for at least 24 hours after receiving the injection.
- Avoid making important decisions or signing legal documents for a day after administration.
- Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements.
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