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PRO-OXAZEPAM is a brand name for Oxazepam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.2 Geriatrics 02/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 02/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 02/2023 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 02/2023 4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose 02/2023 7 WARNINGS AND PRECAUTIONS 02/2023 7 WARNINGS AND PRECAUTIONS, 7.1.2…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 02/2023 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 ......................................................................................................... 5 Missed Dose .............................................................................................................
6 5 OVERDOSAGE............................................................................................................ 6
1 Adverse Reaction Overview As with other benzodiazepines, adverse reactions most observed include drowsiness, dizziness, fatigue and ataxia. Other adverse reactions reported are headache, vertigo, diplopia, blurred vision, weakness, hypotension, impairment of memory, slurred speech, sluggish response, hypoactivity, dysarthria, depression, euphoria, anorexia, nausea, constipation, incontinence or urinary retention, changes in libido, urticaria, skin rashes, generalized exfoliative dermatitis, tremors, edema and changes in the EEG pattern (increased fast activity).
Drug dependence after withdrawal, abstinence symptoms such as anxiety, muscle twitches, convulsions or delirium with psychotic manifestations may occur (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance). Release of hostility and other paradoxical reactions such as irritability, excitability, rage, hallucination, increased muscle spasticity and sleep disturbances may occur with PRO-OXAZEPAM .
Leukopenia, jaundice, hypersensitivity reactions and abnormal kidney and liver function tests have been reported with this class of drugs (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic; Renal). 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 Fractures). Dependence/Withdrawal Development of physical dependence and withdrawal following discontinuation of therapy has been observed with benzodiazepines such as PRO-OXAZEPAM .
Severe and life-threatening symptoms have been reported (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Addiction, Abuse and Misuse; 7 WARNINGS AND PRECAUTIONS, Dependance/Tolerance). PRO-OXAZEPAM (oxazepam) Page 12 of 25
4 Geriatrics 02/2023 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 ......................................................................................................... 5 Missed Dose .............................................................................................................
6 5 OVERDOSAGE............................................................................................................ 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7 WARNINGS AND PRECAUTIONS .................................................................................
). No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experiences suggests that use in the geriatric population is associated with differences in safety or effectiveness.
Long-term use of PRO- OXAZEPAM should be avoided in elderly patients. 1 Dosing considerations, 7 WARNING AND PRECAUTIONS, Falls and Fractures). 2 CONTRAINDICATIONS PRO-OXAZEPAM is contraindicated in: • patients with previous history of hypersensitivity reactions to oxazepam, to other benzodiazepines or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGHTS, COMPOSITION AND PACKAGING. • infants • patients with a history of glaucoma • patients with myasthenia gravis PRO-OXAZEPAM (oxazepam) Page 5 of 25
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Oxazepam 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.
1 Special Populations ................................................................................................ 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
10 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................... 5 Post-Market Adverse Reactions.............................................................................
11 9 DRUG INTERACTIONS .............................................................................................. 1 Serious Drug Interactions ......................................................................................
2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions ............................................................................... 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions.........................................................................
13 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ..........................................................................................
3 Pharmacokinetics ............................................................................................. 13 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 14 12 SPECIAL HANDLING INSTRUCTIONS..........................................................................
14 PART II: SCIENTIFIC INFORMATION ..................................................................................... 15 13 PHARMACEUTICAL INFORMATION .......................................................................... 15 14 CLINICAL TRIALS ......................................................................................................
16 15 MICROBIOLOGY ...................................................................................................... 16 16 NON-CLINICAL TOXICOLOGY ....................................................................................
16 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 16 PATIENT MEDICATION INFORMATION ................................................................................ 17 PRO-OXAZEPAM (oxazepam) Page 4 of 25 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PRO-OXAZEPAM (oxazepam tablets) is indicated for the short-term symptomatic relief of excessive anxiety and tension in patients with anxiety neurosis.
Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. PRO-OXAZEPAM also is indicated for relieving the symptoms of acute alcoholic […]