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APO-CLONAZEPAM is a brand name for Clonazepam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-CLONAZEPAM (clonazepam) is indicated for use: • alone or as an adjunct in the management of myoclonic and akinetic seizures and petit mal variant (Lennox-Gastaut syndrome). • in patients with absence spells (petit mal) who have failed to respond to succinimides. Up to nearly one-third of the patients in some…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 09/2023 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 (<18 years of age) .........................................................................................
2 Geriatrics (>65 years of age) ......................................................................................... 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 ..................................................................................................................
7 5 OVERDOSAGE ............................................................................................................. 8
1 Adverse Reaction Overview Most Frequent Adverse Reactions: The most frequently occurring adverse reactions of clonazepam are referable to CNS depression. Experience to date has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%.
In some cases, these may diminish with time. Behaviour problems have been noted in approximately 25% of patients. Somnolence, slowed reaction, muscular hypotonia, muscle weakness, dizziness, ataxia occur relatively frequently and are usually transient and generally disappear spontaneously in the course of the treatment or on reduction of the dosage.
They can be partially prevented by increasing the dose slowly at the start of treatment.
Serious and Important Adverse Reactions:
There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly. Allergic reactions and a very few cases of anaphylaxis have been reported to occur with benzodiazepines.
Release of hostility and other paradoxical effects such as irritability, restlessness, agitation, aggressiveness, delusion, anger, hysteria, rages, nightmares, abnormal dreams, hallucinations, psychoses, hyperactivity, inappropriate behaviour and other adverse behavioural effects are known to occur with the use of benzodiazepines.
If these occur, use of the drug should be APO-CLONAZEPAM (Clonazepam Tablets) Page 18 of 41 discontinued. Paradoxical reactions are more likely to occur in children and in the elderly. Anterograde amnesia may occur with therapeutic doses of benzodiazepines, the risk increasing with higher doses.
Effects of anterograde amnesia may be associated with inappropriate behaviour. Chronic use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
4 Geriatrics 09/2023 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 (<18 years of age) .........................................................................................
2 Geriatrics (>65 years of age) ......................................................................................... 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 ..................................................................................................................
7 5 OVERDOSAGE ............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS ..................................................................................
• APO-CLONAZEPAM is contraindicated in patients who are hypersensitive to other benzodiazepines, to this drug or to any other ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• APO-CLONAZEPAM is contraindicated in patients with: o Severe respiratory insufficiency o Severe hepatic impairment as benzodiazepines may precipitate hepatic encephalopathy o Sleep apnea syndrome o Myasthenia gravis APO-CLONAZEPAM (Clonazepam Tablets) Page 5 of 41 o Narrow angle glaucoma
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clonazepam 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.
2 Clinical Trial Adverse Reactions This information is not available for this product. 3 Less Common Clinical Trial Adverse Reactions This information is not available for this product. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data This information is not available for this product.
5 Post-Market Adverse Reactions Other adverse reactions listed by system organ class in alphabetical order, are: System Organ Class Adverse Reaction(s) Blood and Lymphatic System Disorders Anaemia, leukopenia (WBC below 4000/cu mm), decreased platelet count (thrombocytopenia), eosinophilia and lymphadenopathy.
Cardiac Disorders Palpitations, cardiac failure including cardiac arrest. Endocrine Disorders Gynecomastia, isolated cases of reversible development of premature secondary sexual characteristics in children (incomplete precocious puberty).
Eye Disorders Particularly in long-term or high-dose treatment, reversible disorders of vision (diplopia) may occur. Gastrointestinal Disorders Increased salivation, nausea, vomiting, anorexia, constipation, diarrhoea, encopresis, dry mouth, increased appetite, abdominal pain, sore gums, APO-CLONAZEPAM (Clonazepam Tablets) Page 19 of 41 System Organ Class Adverse Reaction(s) gastritis, epigastric symptoms and coated tongue.
General Disorders and Administration Site Conditions Fever, general deterioration. Hepatobiliary Disorders Hepatomegaly. 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. Investigations Transient elevations of serum transaminase and alkaline phosphatase. Metabolism and Nutrition Disorders Weight gain or loss, dehydration.
Musculoskeletal and Connective Tissue Disorders Pains such as low back pain. Nervous System Disorders Abnormal eye movements, nystagmus, dysarthria, vertigo, insomnia, tiredness, lassitude, dysdiadokinesis, aphonia, withdrawal and coma.
Isolated reports of akinesia, hemiparesis, slurred speech, tremor, “glassy-eyed” appearance, headache and choreiform movements have been received. Minor changes in EEG patterns, specifically low- voltage fast activity. With certain forms of epilepsy, an increase in the frequency of seizures during long-term treatment is possible.
Impaired concentration. Psychiatric Disorders Restlessness, confusional state, disorientation, depression, paradoxical reactions (excitability, irritability, aggression, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and vivid dreams), increased libido, loss of libido.
Dependence/Withdrawal:
Development of physical dependence and APO-CLONAZEPAM (Clonazepam Tablets) Page 20 of 41 System Organ Class Adverse Reaction(s) withdrawal following discontinuation of therapy has been observed with benzodiazepines such as clonazepam.
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) Renal and Urinary Disorders Rare instances of dysuria, nocturia, urinary incontinence, urinary retention and enuresis.
Respiratory, Thoracic and Mediastinal Disorders Chest congestion, hypersecretion in the upper respiratory passages, rhinorrhea, shortness of breath, dyspnea and respiratory depression. Skin and Subcutaneous Tissue Disorders Nonspecific erythematous, papular and maculopapular skin rashes, swelling of the ankle, face and eyelids (ankle and facial edema), urticaria, pigmentation changes and pruritus.
Hirsutism and transient hair loss have also been reported, but drug relationship has not been established.
1 Special Populations ..................................................................................................... 1 Pregnant Women ...............................................................................................
2 Breast-feeding .................................................................................................... 3 Pediatrics ............................................................................................................
4 Geriatrics ............................................................................................................ 17 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview ........................................................................................ 2 Clinical Trial Adverse Reactions ..................................................................................
3 Less Common Clinical Trial Adverse Reactions ........................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data...........................................................................................................
5 Post-Market Adverse Reactions.................................................................................. 18 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.............................................................................. 23 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ..........................................................................................
2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................ 23 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
25 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 25 PART II: SCIENTIFIC INFORMATION ......................................................................................
26 13 PHARMACEUTICAL INFORMATION ............................................................................ 26 14 CLINICAL TRIALS .......................................................................................................
2 Comparative Bioavailability Studies .................................................................... 27 15 MICROBIOLOGY ........................................................................................................ 29 […]