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PRO-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: PRO-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.
1 Dosing Considerations PRO-CLONAZEPAM (clonazepam) should always be prescribed at the lowest effective dose for the shortest duration possible.
Individualize dose:
Dosage of PRO-CLONAZEPAM is essentially individual and depends above all on the age of the patient. • Dosage must be determined in each patient according to clinical response and tolerance. 4 Drug-Drug Interactions regarding pharmacokinetic and pharmacodynamic interactions with PRO-CLONAZEPAM.
PRO-CLONAZEPAM (clonazepam) page 6 of 40 o Avoid the concomitant use of opioids and PRO-CLONAZEPAM. See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. o The concomitant use of PRO-CLONAZEPAM with other anticonvulsants may increase depressant adverse effects.
The dosage of each drug may need to be adjusted. • Geriatrics: Elderly patients in particular may be more sensitive to benzodiazepines. Geriatrics. o Start with the lowest dose possible and observe closely. o Avoid long-term use of PRO-CLONAZEPAM.
o Enhanced monitoring is recommended. • Hepatic / Renal Impairment: PRO-CLONAZEPAM is contraindicated in patients with severe hepatic impairment. Patients with mild to moderate hepatic impairment should be given the lowest does possible.
Proceed cautiously in cases of renal impairment. See Recommended Dose and Dosage Adjustment, Special Populations.
Potential loss of efficacy over time:
Up to nearly one-third of the patients in some studies have shown a loss of anticonvulsant activity, often within the first three months of administration of clonazepam. In some cases, dosage adjustment may re-establish efficacy.
Reduce dose/Discontinue gradually:
PRO-CLONAZEPAM can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
• Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring. • Tapering should be tailored to the specific patient.
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.
PRO-CLONAZEPAM (clonazepam) page 18 of 40 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 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).
, Dependence/Tolerance) Risks from Concomitant Use with Opioids Concomitant use of PRO-CLONAZEPAM and opioids may result in profound sedation, respiratory depression, coma and death (see 7 WARNINGS AND PRECAUTIONS, General, Concomitant use with opioids).
• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation.
1 Dosing Considerations PRO-CLONAZEPAM (clonazepam) should always be prescribed at the lowest effective dose for the shortest duration possible.
Individualize dose:
Dosage of PRO-CLONAZEPAM is essentially individual and depends above all on the age of the patient. • Dosage must be determined in each patient according to clinical response and tolerance. 4 Drug-Drug Interactions regarding pharmacokinetic and pharmacodynamic interactions with PRO-CLONAZEPAM.
PRO-CLONAZEPAM (clonazepam) page 6 of 40 o Avoid the concomitant use of opioids and PRO-CLONAZEPAM. See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. o The concomitant use of PRO-CLONAZEPAM with other anticonvulsants may increase depressant adverse effects.
The dosage of each drug may need to be adjusted. • Geriatrics: Elderly patients in particular may be more sensitive to benzodiazepines. Geriatrics. o Start with the lowest dose possible and observe closely. o Avoid long-term use of PRO-CLONAZEPAM.
o Enhanced monitoring is recommended. • Hepatic / Renal Impairment: PRO-CLONAZEPAM is contraindicated in patients with severe hepatic impairment. Patients with mild to moderate hepatic impairment should be given the lowest does possible.
Proceed cautiously in cases of renal impairment. See Recommended Dose and Dosage Adjustment, Special Populations.
• PRO-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.
• PRO-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 o Narrow angle glaucoma PRO-CLONAZEPAM (clonazepam) page 5 of 40
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Special attention should be given to patients with a history of seizure. • If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper.
5 mg/day divided into three doses. 5 to 1 mg every three days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response.
A recommended maintenance dose for adults is 8 to 10 mg/day in three divided doses. Dosages in excess of 20 mg/day should be administered with caution. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the larger dose should be given before retiring.
05 mg/kg/day given in two or three divided doses. 2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. 3 Pharmacokinetics, Special Populations, Pediatrics.
Geriatrics (>65 years of age):
In general elderly patients should be started on lowest possible dose of PRO-CLONAZEPAM and observed closely. 4 Geriatrics.
Special Populations:
Renal Impairment: The safety and efficacy of clonazepam in patients with renal impairment has not been studied. Clonazepam metabolites are excreted by the kidneys; to avoid excessive accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.
3 Pharmacokinetics, Special Populations and Conditions.
Hepatic Impairment:
Patients with severe hepatic impairment should not be treated with clonazepam (see 2 CONTRAINDICATIONS). Patients with mild to moderate hepatic impairment should be given the lowest dose possible. See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic.
3 Administration For oral use. The tablets should be administered with water and swallowed without chewing. 4 Missed Dose A missed dose should be taken as soon as possible, when noticed. But, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule should be followed.
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).
PRO-CLONAZEPAM (clonazepam) page 19 of 40 Eye Disorders Particularly in long-term or high-dose treatment, reversible disorders of vision (diplopia) may occur. System Organ Class Adverse Reaction(s) Gastrointestinal Disorders Increased salivation, nausea, vomiting, anorexia, constipation, diarrhoea, encopresis, dry mouth, increased appetite, abdominal pain, sore gums, 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. PRO-CLONAZEPAM (clonazepam) page 20 of 40 System Organ Class Adverse Reaction(s) 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 withdrawal following discontinuation of therapy has been observed with benzodiazepines such as PRO-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.
Potential loss of efficacy over time:
Up to nearly one-third of the patients in some studies have shown a loss of anticonvulsant activity, often within the first three months of administration of clonazepam. In some cases, dosage adjustment may re-establish efficacy.
Reduce dose/Discontinue gradually:
PRO-CLONAZEPAM can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
• Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring. • Tapering should be tailored to the specific patient.
Special attention should be given to patients with a history of seizure. • If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper.
5 mg/day divided into three doses. 5 to 1 mg every three days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response.
A recommended maintenance dose for adults is 8 to 10 mg/day in three divided doses. Dosages in excess of 20 mg/day should be administered with caution. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the larger dose should be given before retiring.
05 mg/kg/day given in two or three divided doses. 2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. 3 Pharmacokinetics, Special Populations, Pediatrics.
Geriatrics (>65 years of age):
In general elderly patients should be started on lowest possible dose of PRO-CLONAZEPAM and observed closely. 4 Geriatrics.
Special Populations:
Renal Impairment: The safety and efficacy of clonazepam in patients with renal impairment has not been studied. Clonazepam metabolites are excreted by the kidneys; to avoid excessive accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.
3 Pharmacokinetics, Special Populations and Conditions.
Hepatic Impairment:
Patients with severe hepatic impairment should not be treated with clonazepam (see 2 CONTRAINDICATIONS). Patients with mild to moderate hepatic impairment should be given the lowest dose possible. See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic.
3 Administration For oral use. The tablets should be administered with water and swallowed without chewing. 4 Missed Dose A missed dose should be taken as soon as possible, when noticed. But, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule should be followed.
5 OVERDOSAGE Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of PRO-CLONAZEPAM (clonazepam) is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnea, hypotension, cardiorespiratory depression and coma.
Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations (see 10 CLINICAL PHARMACOLOGY, Absorption).
Benzodiazepine respiratory depressant effects are […]