DIAZEPAM

4 Geriatrics 05/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................

2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................

4 1 INDICATIONS ............................................................................................................. 1 Pediatrics..................................................................................................................

2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................

4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 4 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .............................................................................................

2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 6 5 OVERDOSAGE............................................................................................................

7

1 Adverse Reaction Overview The most common adverse reactions reported for diazepam injectable are drowsiness and ataxia. Other reactions noted less frequently are fatigue, dizziness, nausea, blurred vision, diplopia, vertigo, headache, slurred speech, tremors, hypoactivity, dysarthria, euphoria, impairment of memory, confusion, depression, incontinence or urinary retention, constipation, skin rash, generalized exfoliative dermatitis, hypotension, tachycardia, flushing, hematuria, changes in libido, pain at the site of injection and phlebitis following intravenous administration.

The more serious adverse reactions occasionally reported are leucopenia, jaundice, hypersensitivity and paradoxical reactions. Circulatory and respiratory depression may follow rapid intravenous administration of diazepam injectable.

Paradoxical reactions such as hyperexcited states, anxiety, excitement, hallucinations, increased muscle spasticity, insomnia, rage, as well as sleep disturbances and stimulation have been reported, should these occur, the drug should be discontinued.

Minor changes in EEG patterns have been observed in patients on diazepam injectable therapy. These changes consist of low to moderate voltage fast activity, 20-30 cycles per second, and are of no known significance. 5 Post-Market Adverse Reactions Injury, Poisoning and Procedural Complications: There have been reports of falls and fractures in benzodiazepine users due to adverse reactions such as sedation, dizziness and ataxia.

The risk is increased in those taking concomitant sedatives (including alcoholic beverages), the elderly and debilitated patients.

Dependence/Withdrawal:

Development of physical dependence and withdrawal following discontinuation of therapy has been observed with benzodiazepines such as Diazepam Injection USP. Severe and life-threatening symptoms have been reported. (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Addiction, Abuse and Misuse; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance)

4 Geriatrics 05/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................

2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................

4 1 INDICATIONS ............................................................................................................. 1 Pediatrics..................................................................................................................

2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................

4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 4 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .............................................................................................

2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 6 5 OVERDOSAGE............................................................................................................

7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations ................................................................................................

Diazepam Injection USP is contraindicated in:  patients with known hypersensitivity to benzodiazepines, to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.

 myasthenia gravis,  acute narrow angle glaucoma,  infants