MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) (midazolam hydrochloride) · RAFA LABS LTD
Midazolam Injection is indicated for the treatment of status epilepticus in adults.
Details
- Status
- Prescription
- First Approved
- 2022-08-08
- Routes
- INTRAMUSCULAR
- Dosage Forms
- SOLUTION
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) Approval History
What MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) Treats
2 indicationsMIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety
- Amnesia
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) Boxed Warning
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation [see Warnings and Precautions (5.1), Drug Interactions (7.1)]. The use of benzodiazepines, including midazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse ...
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation [see Warnings and Precautions (5.1), Drug Interactions (7.1)]. The use of benzodiazepines, including midazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with a n increased frequency of serious adverse outcomes. Before prescribing Midazolam Injection and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2)]. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although Midazolam Injection is indicated only for intermittent use [see Indications and Usage (1) and Dosage and Administration (2)], if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of Midazolam Injection may precipitate acute withdrawal reactions, which can be life-threatening. For patients using Midazolam Injection more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue Midazolam Injection [see Warnings and Precautions (5.3)]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation. (5.1, 7.1) The use of benzodiazepines, i
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07569198 KET-DBT | 25-5431 | Ph 2 | recruiting | Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT) |
| NCT06496750 KMD | STU-2023-1086 | Ph 2 | completed | Ketamine for Methamphetamine Use Disorder |
| NCT06867068 | 2014-3556 | Ph 1 | completed | Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery |
| NCT05004896 KET-BD | 21-5560 | Ph 2 | completed | Ketamine for Treatment-Resistant Bipolar Disorder |
| NCT06480500 Ket-CBT | 21-6000 | Ph 2 | active not recruiting | i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial |
| NCT04592809 TASK results posted | STU-2020-0973 R01MH125181 | Ph 3 | completed | Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents |
| NCT03556592 | LP0162-1342 2018-000534-35 | Ph 1 | completed | Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 |
| NCT06090422 KeDA | 2022/484848(REK) 2023-506052-24, U1111-1293-2654 | Ph 1, Ph 2 | recruiting | Ketamine for Combined Depression and Alcohol Use Disorder |
| NCT03330990 | RXDX-101-14 GO40785 | Ph 1 | completed | Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients |
| NCT03457597 | CORT125134-126 | Ph 1 | completed | Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s |
| NCT02473627 | DS1971-A-E105 | Ph 1 | completed | A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTS |
| NCT01218620 | NCI-2012-02916 NCI-2012-02916, CDR0000685426 | Ph 1 | completed | Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) FDA Label Details
Indications & Usage
FDA Label (PDF)Midazolam Injection is indicated for the treatment of status epilepticus in adults. Midazolam Injection is a benzodiazepine indicated for the treatment of status epilepticus in adults.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation [s...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.