Midazolam is a benzodiazepine sold in the U.S. under 4 brand and generic names, for anxiety disorders, psychomotor agitation and status epilepticus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Nayzilam (application NDA211321). Other midazolam products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer NAYZILAM by the nasal route only. ( 2.2 ) Initial Dose : Administer one spray (5 mg dose) into one nostril. ( 2.2 ) Second Dose : One additional spray (5 mg dose) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose. ( 2.2 ) Maximum Dosage and Treatment Frequency: Do not use more than 2 doses of NAYZILAM to treat a seizure cluster. It is recommended that NAYZILAM be used to treat no more than one episode every three days and treat no more than five episodes per month. ( 2.2 ) 2.1 Instructions Prior to Dosing NAYZILAM prescribers should consider the following prior to initiation of treatment: For patients at increased risk of respiratory depression from benzodiazepines, administration of NAYZILAM under healthcare professional supervision should be considered prior to treatment with NAYZILAM; this administration may be performed in the absence of a seizure episode [see Warnings and Precautions (5.4) ] . Prior to treatment, the healthcare professional should instruct the individual administering NAYZILAM on how to identify seizure clusters and use the product appropriately [see Patient Counseling Information: Administration Information (17) ] . Patients and caregivers should be counseled to read carefully the "Instructions for Use" for complete directions on how to properly administer NAYZILAM. 2.2 Dosage…
The following serious adverse reactions are discussed in more detail in other sections of the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1) ] Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2) ] Dependence and Withdrawal Reactions After Use of NAYZILAM More Frequently Than Recommended [see Warnings and Precautions (5.3) ] Risks of Cardiorespiratory Adverse Reactions [see Warnings and Precautions (5.4) ] CNS Depression from Concomitant Use with Other CNS Depressants or Moderate or Strong CYP3A4 Inhibitors [see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6) ] Impaired Cognitive Function [see Warnings and Precautions (5.7) ] Glaucoma [see Warnings and Precautions (5.8) ] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.9) ] Other Adverse Reactions [see Warnings and Precautions (5.10) ] The most common adverse reactions (≥5% in any NAYZILAM treatment group) were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Spray/Inhaler | Generic | $0 | View → | |
| 2 |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
NAYZILAM is contraindicated in patients with: Known hypersensitivity to midazolam. Acute narrow-angle glaucoma [see Warnings and Precautions (5.8) ]. Patients with hypersensitivity to midazolam ( 4 ) Patients with acute narrow-angle glaucoma ( 4 )
Table 3: Clinically Significant Drug Interactions With NAYZILAM 7.1 CYP3A4 Inhibitors Clinical Impact: Concomitant use of CYP3A4 inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam. Intervention: Avoid co-administration of NAYZILAM with moderate or strong CYP3A4 inhibitors. NAYZILAM should be used with caution when co-administered with mild CYP3A4 inhibitors. Examples: Moderate CYP3A4 inhibitors: erythromycin, diltiazem, verapamil Strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin 7.2 Opioids Clinical Impact: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required [see Warnings and Precautions (5.1) ]. Examples: Morphine, hydrocodone, oxymorphone, codeine, fentanyl 7.3 Other Central Nervous System (CNS) Depressants Clinical Impact: Concomitant use of barbiturates,…
| 54/100 |
| Prescription |
| Injectable |
| Generic |
| $0 |
| View → |
| 3 | Not yet rated | Prescription | Solution | Generic | $0 | View → |
| 4 | Not yet rated | Prescription | Injectable | Generic | $0 | View → |