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SANDOZ RIVASTIGMINE is a brand name for Rivastigmine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) is indicated for: • The symptomatic treatment of patients with mild to moderate dementia of the Alzheimer's type. • SANDOZ RIVASTIGMINE is indicated for the symptomatic treatment of patients with idiopathic Parkinson’s disease, and mild to moderate dementia, with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Dose escalation for patients with serious comorbid diseases should be undertaken with particular caution. 5 mg once a day) and to escalate dosage at a slower rate than for adults (see 7 WARNINGS AND PRECAUTIONS).
• Low Body Weight: Patients with body weight below 50 kg may experience more adverse events and may be more likely to discontinue due to adverse events. Particular caution should be exercised when titrating these patients to the maintenance dose.
5 mg once a day) and that dose escalation be slower than that recommended for adults. 3 Pharmacokinetics, Special Populations and Conditions). • In a population of cognitively-impaired individuals, safe use of this and all other medications may require supervision (see 7 WARNINGS AND PRECAUTIONS, Patient and Caregiver Counselling Information).
g. hypertension and hallucinations in patients with Alzheimer’s dementia, and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson’s disease) have been observed shortly after dose increase.
They may respond to a dose reduction. In other cases, rivastigmine has been discontinued. 2 Recommended Dose and Dosage Adjustment SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) capsules should only be prescribed by (or following consultation with) clinicians who are experienced in the diagnosis and management of dementia.
SANDOZ RIVASTIGMINE should be taken with food in divided doses in the morning and evening. Adults The usual maintenance dose range for rivastigmine is 6-12 mg/day. The following dosage escalation recommendations, derived from clinical trial data, are provided as a guide only, as individual tolerance to dose increases will vary.
The incidence of cholinergic adverse events associated with rivastigmine increase with dose and are more prevalent in females (see 8 ADVERSE REACTIONS). 5 mg BID (3 mg/day). If this initial dose is well tolerated, after a minimum of 2 weeks the dose may be increased to 3 mg BID (6 mg/day).
Dose increases above 6 mg/day should proceed cautiously. 5 mg BID (9 mg/day) and then 6 mg BID (12 mg/day) should also be based on good tolerability of the current dose and should only SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) Page 6 of 58 be considered after a minimum of two weeks treatment at that dose level.
). 5 mg BID (3 mg/day). If this initial dose is well tolerated, after a minimum of 2 weeks the dose may be increased to 3 mg BID (6 mg/day). Dose increases above 6 mg/day should proceed cautiously. 5 mg BID (9 mg/day) and then 6 mg BID (12 mg/day) should also be based on good tolerability of the current dose and should only SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) Page 6 of 58 be considered after a minimum of two weeks treatment at that dose level.
The maximum dose should not exceed 6 mg BID (12 mg/day). 5 mg BID; and 6 mg BID; based on tolerability, with a minimum of 4 weeks at each dose. 5 Missed Dose The missed dose should be taken at the next scheduled dose. Doses should not be doubled.
Following initiation of therapy or any dosage increase, patients should be closely monitored for adverse effects. g. nausea, vomiting, abdominal pain, loss of appetite) are observed during treatment, the patient should be instructed to stop treatment for several doses and then restart at the same dose level, or lower, as clinically indicated.
e. 5 mg OD, as clinically indicated) and be re- titrated to their maintenance dose as described above (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). If side effects persist, the drug should be discontinued. 5 OVERDOSAGE Symptoms: Manifestations include nausea, vomiting, diarrhea, abdominal pain, dizziness, tremor, headache, somnolence, bradycardia, confusional state, hyperhidrosis, hypertension, hallucinations and malaise.
Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterised by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.
Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur.
, Cardiovascular 03/2024 TABLE OF CONTENTS 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 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................... 5 Missed Dose.............................................................................................................
6 5 OVERDOSAGE ............................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 7 7 WARNINGS AND PRECAUTIONS....................................................................................
1 Special Populations ................................................................................................ 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
03/2024 7 WARNINGS AND PRECAUTIONS, Cardiovascular 03/2024 TABLE OF CONTENTS 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 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................... 5 Missed Dose.............................................................................................................
6 5 OVERDOSAGE ............................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 7 7 WARNINGS AND PRECAUTIONS....................................................................................
1 Special Populations ................................................................................................ 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rivastigmine 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.
The maximum dose should not exceed 6 mg BID (12 mg/day). 5 mg BID; and 6 mg BID; based on tolerability, with a minimum of 4 weeks at each dose. 5 Missed Dose The missed dose should be taken at the next scheduled dose. Doses should not be doubled.
Following initiation of therapy or any dosage increase, patients should be closely monitored for adverse effects. g. nausea, vomiting, abdominal pain, loss of appetite) are observed during treatment, the patient should be instructed to stop treatment for several doses and then restart at the same dose level, or lower, as clinically indicated.
e. 5 mg OD, as clinically indicated) and be re- titrated to their maintenance dose as described above (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). If side effects persist, the drug should be discontinued.
In a documented case of a 46 mg overdose with rivastigmine capsules, a 69 year old female patient experienced vomiting, incontinence, hypertension, psychomotor retardation and loss of consciousness. The patient was managed conservatively with only supportive measures and fully recovered within 24 hours.
5 mg/24hrs) per day was accidentally administered 6 patches per day on two consecutive days. The patient experienced vomiting, fall and hyperhidrosis and was hospitalized on the second day. At the time of hospitalization he presented with an elevated creatinine level (149 mcmol/L; normal range: 70-115 mcmol/L) and signs of urinary infection.
He was treated by SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) Page 7 of 58 removal of all patches and ciprofloxacin was initiated. Subsequently, the patient developed acute renal failure with anuria and died approximately 14 days after hospitalization.
The reporter suspected that overdose contributed to the patient's dehydration and renal failure. Autopsy results were not provided by the reporter. Dose-related signs of toxicity in animals included lacrimation, excessive salivation, vomiting, decreased locomotor activity, ataxia, twitches/flutters, tremors and clonic convulsions.
Treatment:
Rivastigmine hydrogen tartrate has a short plasma half-life (about 1- 2 hours) and a moderate duration of cholinesterase inhibition of 8-12 hours. It is recommended that in cases of asymptomatic overdoses, no further dose of rivastigmine should be administered for the next 24 hours and that patients be monitored.
As in any case of overdose, general supportive measures should be utilised. Tertiary anticholinergics such as atropine may be used as an antidote for rivastigmine overdosage. 0 mg IV with subsequent doses based upon clinical response.
Due to the short half-life of rivastigmine, dialysis (hemodialysis, peritoneal dialysis, or hemofiltration) would not be clinically indicated in the event of an overdose. In overdoses accompanied by severe nausea and vomiting, the use of antiemetics should be considered.
Symptomatic treatment for other adverse events should also be given as necessary. For management of a suspected drug overdose, contact your regional poison control centre. 5 mg, or 6 mg of rivastigmine base. 5 mg capsules are yellow. “RIV 1,5 MG” is printed in red on the body of the capsule.
Available in bottles of 100 and in cartons containing 4 blister strips of 14 capsules. The 3 mg capsules are orange. “RIV 3 MG” is […]
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
15 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 ............................................................................. 29 SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) Page 3 of 58 9 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 .........................................................................
32 10 CLINICAL PHARMACOLOGY......................................................................................... 1 Mechanism of Action ......................................................................................... 3 Pharmacokinetics ...............................................................................................
32 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 34 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 35 PART II: SCIENTIFIC INFORMATION ........................................................................................
36 13 PHARMACEUTICAL INFORMATION ............................................................................. 36 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication ................................................................................. 37 15 MICROBIOLOGY ..........................................................................................................
45 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 45 PATIENT MEDICATION INFORMATION ...................................................................................
50 SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) Page 4 of 58 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) is indicated for: • The symptomatic treatment of patients with mild to moderate dementia of the Alzheimer's type.
• SANDOZ RIVASTIGMINE is indicated for the symptomatic treatment of patients with idiopathic Parkinson’s disease, and mild to moderate dementia, with onset at least 2 years after the initial diagnosis of Parkinson’s disease, and in whom other causes of […]
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
15 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 ............................................................................. 29 SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) Page 3 of 58 9 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 .........................................................................
32 10 CLINICAL PHARMACOLOGY......................................................................................... 1 Mechanism of Action ......................................................................................... 3 Pharmacokinetics ...............................................................................................
32 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 34 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 35 PART II: SCIENTIFIC INFORMATION ........................................................................................
36 13 PHARMACEUTICAL INFORMATION ............................................................................. 36 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication ................................................................................. 37 15 MICROBIOLOGY ..........................................................................................................
45 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 45 PATIENT MEDICATION INFORMATION ...................................................................................
50 SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) Page 4 of 58 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SANDOZ RIVASTIGMINE (rivastigmine hydrogen tartrate) is indicated for: • The symptomatic treatment of patients with mild to moderate dementia of the Alzheimer's type.
• SANDOZ RIVASTIGMINE is indicated for the symptomatic treatment of patients with idiopathic Parkinson’s disease, and mild to moderate dementia, with onset at least 2 years after the initial diagnosis of Parkinson’s disease, […]