Midazolam Film-Coated Tablets (7.5 mg / 15 mg)
Healthy Inc is a specialized global supplier and exporter of advanced anesthesiology-support, psychiatric, and highly restricted central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically optimized Midazolam (as Maleate) Film-Coated Tablets (7.5 mg / 15 mg), manufactured in WHO–GMP certified, highly secure, rapid-release oral solid dosage facilities. This “Ultra-Short-Acting Benzodiazepine” is an ultra-high-value, strictly regulated export to anesthesiology centers, maxillofacial surgical clinics, sleep institutes, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for pre-procedural sedation, conscious sedation, and the short-term management of severe, intractable insomnia.
Product Overview
This highly advanced formulation takes one of the most potent, fastest-acting sedatives on earth and engineers it for immediate oral absorption. It fundamentally alters the brain’s electrical activity, acting as a massive “off-switch” to instantly induce sleep, calm extreme anxiety, and temporarily disable memory encoding.
The “Rapid-Onset Hypnotic & Amnesic” Specialist:
- Mechanism 1 (The GABA-A Hyper-Activation): Midazolam aggressively binds to the benzodiazepine site on the GABA-A receptor in the central nervous system. This violently amplifies the effects of GABA (the brain’s primary inhibitory neurotransmitter), forcing chloride channels to open wider and longer. The resulting flood of negative ions hyperpolarizes the neurons, instantly shutting down the excitatory electrical signals that cause anxiety and wakefulness.
- Mechanism 2 (Profound Anterograde Amnesia – CRITICAL): Unlike standard sleep aids, Midazolam possesses a highly specific, profound amnesic property. It physically prevents the brain from encoding new memories while the drug is active. For painful or terrifying diagnostic procedures (like endoscopies or heavy dental surgeries), the patient remains conscious and cooperative, but will have absolutely zero memory of the event once the drug wears off, preventing psychological trauma.
- Mechanism 3 (The Ultra-Short Half-Life): Older sedatives (like Diazepam/Valium) remain in the bloodstream for days, causing severe “hangover” effects and motor impairment the next morning. Midazolam is specifically chosen for its incredibly short half-life (roughly 2 hours). It hits the brain like a sledgehammer to induce sleep, and then rapidly clears the system, allowing the patient to wake up clear-headed and fully functional.
Product Composition & Strength
We supply this product as a Precision-Blended, Rapid-Burst Immediate-Release Tablet, packed exclusively in highly secure, tamper-evident Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the highly soluble maleate salt.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Midazolam (as Maleate) Ph.Eur./USP | 7.5 mg | Initiation / Geriatric Standard: Base therapeutic unit for pre-surgical anxiety reduction and sleep induction in elderly or debilitated patients. |
| Midazolam (as Maleate) Ph.Eur./USP | 15 mg | Global Anesthesiology Standard: High-efficacy adult dose for profound pre-procedural conscious sedation and the treatment of severe, treatment-refractory insomnia. |
| Excipients | Microcrystalline Cellulose / Lactose Anhydrous / Croscarmellose Sodium / Magnesium Stearate / Premium Opadry Film | Diluent / Fast-Dissolving Carrier / Superdisintegrant / Lubricant (Engineered specifically to shatter upon contact with gastric fluid, ensuring peak plasma concentration is reached within 20 to 30 minutes) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for strict, highly monitored hospital and short-term dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Anesthesiology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Psychotropics/Sedatives) |
| CAS Number | 59467-96-8 (Midazolam Maleate) |
| Dosage Form | Film-Coated Tablet (Rapid Immediate Release) |
| Packaging | Tamper-Evident High-Density PVC/PVDC or Alu-Alu Blisters. Strict barrier packaging guarantees stability and meets international psychotropic transport security protocols. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Light. (Must be stored in a highly secured, strictly audited locked pharmacy vault). |
| Export Compliance Note (CRITICAL) | Schedule IV Psychotropic Control: Midazolam is an internationally controlled substance closely monitored by the International Narcotics Control Board (INCB). Export requires explicit Import Certificates from the destination country and matched Export Authorizations from the relevant national narcotics bureau. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Rapid-Burst Disintegration & Vault Security (CRITICAL COMPLIANCE): For a pre-surgical sedative, a slow-dissolving tablet is a clinical failure. If the patient is not asleep when the surgeon arrives, the operating room timeline collapses. Our facilities utilize elite high-shear dry blending with high-performance superdisintegrants to guarantee a violent, complete gastric dissolution in under 10 minutes. Furthermore, every milligram of Midazolam API is tracked under continuous CCTV surveillance in reinforced concrete vaults, ensuring absolute regulatory compliance and zero diversion risk.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of the central nervous system:
- Pre-procedural Sedation (Premedication): To induce sleepiness, relieve anxiety, and cause anterograde amnesia prior to surgical or diagnostic procedures (e.g., endoscopy, bronchoscopy, dental surgery).
- Severe Insomnia: Short-term treatment of insomnia characterized by severe difficulty falling asleep, only when the disorder is severe, disabling, or subjecting the individual to extreme distress.
Dosage & Administration
Recommended Dosage (Strictly as per Anesthesiologist/Psychiatrist Guidelines):
- Premedication: 7.5 mg to 15 mg taken orally 30 to 60 minutes before the surgical or diagnostic procedure.
- Insomnia: 7.5 mg to 15 mg. The “Bedside Rule”: Because of its incredibly rapid onset, the tablet MUST be taken immediately before going to bed, literally while sitting on the edge of the mattress. Taking it while walking around can result in sudden collapse and traumatic injury.
- Duration Limitation: For insomnia, therapy should not exceed 2 weeks to prevent severe physical dependence and tolerance.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Fatal Respiratory Depression with Opioids): Concomitant use of benzodiazepines (Midazolam) with opioids (like Fentanyl or Morphine) may result in profound sedation, severe respiratory depression, coma, and death. Dosages must be drastically reduced if used together.
- Paradoxical Reactions (Agitation): In rare cases, particularly in pediatric and elderly patients, Midazolam can cause the exact opposite of sedation—triggering violent agitation, involuntary movements, hyperactivity, and combativeness.
- Anterograde Amnesia & “Sleep-Driving”: Patients may perform complex tasks (like driving, cooking, or making phone calls) while under the influence of the drug and have absolutely no memory of doing so the next morning.
- Addiction, Abuse, and Withdrawal: As a potent benzodiazepine, abrupt discontinuation after prolonged use can trigger severe, life-threatening withdrawal seizures.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Anesthesiology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced CNS, Sedative, and Controlled Psychotropic Formulations. Whether you are looking for a reliable Government Tender Supplier for surgical wards in the CIS or a B2B Pharma Marketplace partner for Latin America, our dedicated regulatory and logistics teams ensure the timely, fully licensed, and hyper-secure delivery of WHO-GMP certified products.