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DIASTAT is a brand name for Diazepam, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.2 Geriatrics 05/2021 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 05/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Dosing Considerations 05/2021 7 WARNINGS AND PRECAUTIONS, Concomitant use with Opioids 05/2021 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance 05/2021 7 WARNINGS AND PRECAUTIONS, Falls and Fractures 05/2021 7…
Verbatim from this product's HC label. Tap a section to expand.
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..................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................
1 Dosing Considerations....................................................................................... 2 Recommended Dose and Dosage Adjustment ................................................... 4 Administration....................................................................................................
7 5 OVERDOSAGE .......................................................................................................... 7
1 Adverse Reaction Overview The most frequent adverse event (AE) reported to be related to DIASTAT (diazepam gel) in the 2 double-blind, placebo-controlled studies was somnolence (23%). Less frequent AEs were dizziness, headache, pain, diarrhea, euphoria, incoordination and nervousness, which occurred in approximately 2-5% of patients.
In addition, ataxia (8%), asthenia (4%), hiccup (2%) and vertigo (2%) were reported in open-label studies. There were no differences in the pattern of AEs in children and adults. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug . Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
DIASTAT AE data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of AEs were mild to moderate in severity and transient in nature.
T/CDIASTAT ® Diazepam Gel Product Monograph Page 14 of 32 Table 5 :
Number and Percent of Patients with Adverse Events for Combined Data from the Controlled Studies (AN094-001, AN094-003) (Adverse events with a frequency of 1%) Intent-to-Treat Population DIASTAT n= 101 All Related* n (%) n (%) Placebo n= 104 All Related* n (%) n (%) General Abdominal Pain Fever Headache Pain+ 12 (12) 7 (7) 2 (2) 1 (<1) 0 (0) 0 (0) 5 (5) 2 (2) 3 (3) 3 (3) 14 (13) 9 (9) 2 (2) 1 (<1) 4 (4) 2 (2) 4 (4) 3 (3) 4 (4) 3 (3) Cardiovascular Vasodilatation 2 (2) 2 (2) 2 (2) 2 (2) 1 (<1) 1 (<1) 0 (0) 0 (0) Digestive Anorexia Diarrhea Vomiting 6 (6) 4 (4) 1 (<1) 1 (<1) 4 (4) 2 (2) 1 (<1) 1 (<1) 8 (8) 6 (6) 2 (2) 2 (2) 1 (<1) 0 (0) 2 (2) 2 (2) Hemic and Lymphatic† 2 (2) 0 (0) 3 (3) 1 (<1) Metabolic and Nutritional† 0 (0) 0 (0) 3 (3) 1 (<1) Nervous Ataxia Convulsion Dizziness Euphoria Incoordination Nervousness Somnolence 32 (32) 29 (29) 3 (3) 1 (<1) 1 (<1) 1 (<1) 3 (3) 3 (3) 3 (3) 3 (3) 3 (3) 3 (3) 2 (2) 2 (2) 23 (23) 23 (23) 16 (15) 13 (13) 1 (<1) 1 (<1) 3 (3) 0 (0) 2 (2) 2 (2) 0 (0) 0 (0) 0 (0) 0 (0) 2 (2) 2 (2) 8 (8) 8 (8) Other Body System Other 1 (<1) 1 (<1) 1 (<1) 1 (<1) 2 (2) 2 (2) 2 (2) 2 (2) Respiratory Asthma Rhinitis 4 (4) 0 (0) 2 (2) 0 (0) 2 (2) 0 (0) 3 (3) 2 (2) 0 (0) 0 (0) 2 (2) 2 (2) Skin and Appendages Rash 5 (5) 3 (3) 3 (3) 2 (2) 1 (<1) 0 (0) 0 (0) 0 (0) Special Senses Otitis Media 1 (<1) 1 (<1) 0 (0) 0 (0) 2 (2) 0 (0) 2 (2) 0 (0) T/CDIASTAT ® Diazepam Gel Product Monograph Page 15 of 32 Table 5 : Number and Percent of Patients with Adverse Events for Combined Data from the Controlled Studies (AN094-001, AN094-003) (Adverse events with a frequency of 1%) Intent-to-Treat Population DIASTAT n= 101 All Related* n (%) n (%) Placebo n= 104 All Related* n (%) n (%) Urogenital† 1 (<1) 0 (0) 2 (2) 0 (0) *Related means the adverse event was definitely, probably, or possibly related to the study drug.
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..................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................
1 Dosing Considerations....................................................................................... 2 Recommended Dose and Dosage Adjustment ................................................... 4 Administration....................................................................................................
7 5 OVERDOSAGE .......................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................... 8 7 WARNINGS AND PRECAUTIONS .............................................................................
1 Special Populations ......................................................................................... 1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph. DIASTAT is contraindicated in patients with a known hypersensitivity to diazepam.
DIASTAT (diazepam gel) may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma. T/CDIASTAT ® Diazepam Gel Product Monograph Page 5 of 32
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Diazepam in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
+ Pain includes rectal symptoms such as rectal burning, discomfort, that code to “pain”. † Individual adverse events in these categories were less than 1% and therefore are not included in this table. 3 Less Common Clinical Trial Adverse Reactions General: Asthenia, infection.
Cardiovascular:
Palpitation.
Digestive:
Dyspepsia, dysphagia, fecal incontinence, nausea.
Hemic and Lymphatic:
Anemia, cyanosis, ecchymosis, lymphadenopathy, thromboplastin decreased.
Metabolic and Nutritional:
Acidosis, dehydration, peripheral edema.
Nervous:
Agitation, grand mal convulsion, hyperkinesia, increased salivation, stupor, tremor, twitching.
Respiratory:
Cough increased, pneumonia, sinusitis.
Skin and Appendages:
Pruritus, skin discoloration, sweating.
Special senses:
Mydriasis.
Urogenital:
Kidney failure, urinary incontinence, urinary tract infection. Other AEs occurring less frequently (< 2%) and reported to be related to DIASTAT in clinical studies General: Abdominal pain, accidental injury, accidental overdose, back pain, chills, fever, infection.
Cardiovascular:
Hypotension, pallor, postural hypotension, vasodilation.
T/CDIASTAT ® Diazepam Gel Product Monograph Page 16 of 32 Digestive:
Abnormal stools, anorexia, diarrhea, dysphagia, increased salivation, nausea, nausea and vomiting, rectal disorder, rectal hemorrhage, tenesmus, thirst, vomiting.
Hemic and Lymphatic:
Prothrombin time increased.
Musculoskeletal:
Myasthenia, back pain.
Nervous:
Agitation, amnesia, confusion, convulsion, dysarthria, emotional lability, euphoria, hyperkinesia, hypokinesia, hypotonia, incoordination, increased salivation, insomnia, movement disorder, nervousness, speech disorder, stupor, thinking abnormal, tremor, twitching.
Respiratory:
Cough increased, hypoventilation, hypoxia.
Skin and Appendages:
Pruritis, rash.
Special senses:
Abnormal vision, amblyopia, diplopia, mydriasis, taste perversion.
Urogenital:
Urinary incontinence. 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 (see 7 WARNINGS AND PRECAUTIONS, Falls and Fracture). Dependence/Withdrawal Development of physical dependence and withdrawal following discontinuation of therapy has been observed with benzodiazepines such as DIASTAT.
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). T/CDIASTAT ® Diazepam Gel Product Monograph Page 17 of 32
3 Pediatrics................................................................................................... 4 Geriatrics ................................................................................................... 13 T/CDIASTAT ® Diazepam Gel Product Monograph Page 3 of 32 8 ADVERSE REACTIONS ...........................................................................................
1 Adverse Reaction Overview............................................................................. 2 Clinical Trial Adverse Reactions ....................................................................... 3 Less Common Clinical Trial Adverse Reactions................................................
5 Post-Market Adverse Reactions ....................................................................... 16 9 DRUG INTERACTIONS ............................................................................................ 1 Serious Drug Interactions.................................................................................
2 Drug Interactions Overview.............................................................................. 3 Drug-Behavioral Interactions............................................................................ 4 Drug-Drug Interactions.....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions..................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
18 10 CLINICAL PHARMACOLOGY .................................................................................. 1 Mechanism of Action .................................................................................. 3 Pharmacokinetics.......................................................................................
19 11 STORAGE, STABILITY AND DISPOSAL ................................................................. 20 12 SPECIAL HANDLING INSTRUCTIONS .................................................................... 20 PART II: SCIENTIFIC INFORMATION .................................................................................
21 13 PHARMACEUTICAL INFORMATION ....................................................................... 21 14 CLINICAL TRIALS ................................................................................................... 1 Clinical Trials by Indication .........................................................................
22 The Management of Selected, Refractory Patients with Epilepsy ................ 22 15 MICROBIOLOGY...................................................................................................... 24 16 NON-CLINICAL TOXICOLOGY ................................................................................
24 PATIENT MEDICATION INFORMATION ............................................................................. 25 T/CDIASTAT ® Diazepam Gel Product Monograph Page 4 of 32 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS DIASTAT (diazepam gel) is indicated for the management of selected, refractory, patients with epilepsy, on stable regimens of anti-epileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity.
These bouts are defined as a form of severe seizures variously referred to as recurrent, serial, cluster or crescendo seizures. […]