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MED-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: Med-Rivastigmine (rivastigmine hydrogen tartrate) is indicated for: • The symptomatic treatment of patients with mild to moderate dementia of the Alzheimer's type. • Med-Rivastigmine is indicated for the symptomatic treatment of patients with idiopathic Parkinson's disease, and mild to moderate dementia, with onset at…
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. Caution should be used when titrating renal or hepatically impaired patients (see 10 CLINICAL PHARMACOLOGY). • 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 Counseling 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 hydrogen tartrate has been discontinued. 2 Recommended Dose and Dosage Adjustment Med-Rivastigmine capsules should only be prescribed by (or following consultation with) clinicians who are experienced in the diagnosis and management of dementia.
Med-Rivastigmine should be taken with food in divided doses in the morning and evening.
MED-RIVASTIGMINE (Rivastigmine hydrogen tartrate) Page 6 of 61 Adults:
The usual maintenance dose range for Med-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 hydrogen tartrate increase with dose and are more prevalent in females (see 8 ADVERSE REACTIONS). d. (3 mg/day). d. (6 mg/day). Dose increases above 6 mg/day should proceed cautiously.
d. d. (12 mg/day) should also be based on good tolerability of the current dose and should only be considered after a minimum of two weeks treatment at that dose level. d. (12 mg/day). ; based on tolerability, with a minimum of 4 weeks at each dose.
). d. (3 mg/day). d. (6 mg/day). Dose increases above 6 mg/day should proceed cautiously. d. d. (12 mg/day) should also be based on good tolerability of the current dose and should only be considered after a minimum of two weeks treatment at that dose level.
d. (12 mg/day). ; 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.
d. , 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. In a documented case of extreme MED-RIVASTIGMINE (Rivastigmine hydrogen tartrate) Page 7 of 61 overdose with transdermal rivastigmine additional symptoms have been observed including fall, elevated creatinine level, signs of urinary infection and acute renal failure with anuria.
, Cardiovascular 03/2024 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 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 ..........................................................................................
03/2024 7 WARNINGS AND PRECAUTIONS, Cardiovascular 03/2024 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 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 ..........................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. d. , 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.
Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/or syncope may also occur. In a documented case of a 46 mg overdose with rivastigmine hydrogen tartrate 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. 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 Med-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 Med-Rivastigmine overdosage. 0 mg IV with subsequent doses based upon clinical response.
Due to the short half-life of rivastigmine hydrogen tartrate, 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. 5 mg, 6 mg Hypromellose 5cP; magnesium stearate; microcrystalline cellulose; silica colloidal anhydrous; hard gelatin capsules contain: gelatin, titanium dioxide and red and/or yellow iron oxides.
5 mg, or 6 mg of rivastigmine base. For management of a suspected drug overdose, contact your regional poison control centre. 5mg” on the body with black ink. The 3 mg capsules are light orange/light orange, imprinted with “RIVA 3mg” on the body with black ink.
5mg” on the body with black ink. The 6 mg capsules are light orange/caramel, imprinted with “RIVA 6mg” on the body with black ink. All strengths are available in bottles of 100 capsules and blister packages of 56 capsules (14 capsules per blister strip and 4 strips per package).
7 WARNINGS AND PRECAUTIONS General In a population of cognitively-impaired individuals, safe use of this medication may require supervision. Patients and caregivers should be instructed in the proper use of Med-Rivastigmine (see 7 WARNINGS AND PRECAUTIONS, Patient and Caregiver Counseling Information).
Rivastigmine hydrogen tartrate has not been studied in patients […]
1 Special Populations ................................................................................................................ 1 Pregnant Women..........................................................................................................
2 Breast-feeding .............................................................................................................. 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 ............................................................................................. 28 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 .........................................................................................
31 10 CLINICAL PHARMACOLOGY ............................................................................................... 1 Mechanism of Action ........................................................................................................
3 Pharmacokinetics.............................................................................................................. 31 11 STORAGE, STABILITY, AND DISPOSAL ................................................................................
34 PART II: SCIENTIFIC INFORMATION .............................................................................................. 35 13 PHARMACEUTICAL INFORMATION ....................................................................................
35 14 CLINICAL TRIALS ................................................................................................................ 1 Trial Design and Study Demographics ...............................................................................
2 Study Results .................................................................................................................... 3 Comparative Bioavailability Studies ..................................................................................
45 15 MICROBIOLOGY ................................................................................................................ 46 16 NON-CLINICAL TOXICOLOGY […]
1 Special Populations ................................................................................................................ 1 Pregnant Women..........................................................................................................
2 Breast-feeding .............................................................................................................. 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 ............................................................................................. 28 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 .........................................................................................
31 10 CLINICAL PHARMACOLOGY ............................................................................................... 1 Mechanism of Action ........................................................................................................
3 Pharmacokinetics.............................................................................................................. 31 11 STORAGE, STABILITY, AND DISPOSAL ................................................................................
34 PART II: SCIENTIFIC INFORMATION .............................................................................................. 35 13 PHARMACEUTICAL INFORMATION ....................................................................................
35 14 CLINICAL TRIALS ................................................................................................................ 1 Trial Design and Study Demographics ...............................................................................
2 Study Results .................................................................................................................... 3 Comparative Bioavailability Studies ..................................................................................
45 15 MICROBIOLOGY ................................................................................................................ 46 16 NON-CLINICAL TOXICOLOGY […]