Rivastigmine Tartrate
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Rivastigmine tartrate capsules, USP are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
Rivastigmine tartrate capsules, USP are indicated for the treatment of mild to moderate dementia associated with Parkinson’s disease.
History
There is currently no drug history available for this drug.
Other Information
Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 • C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/ phosphate buffer solution pH 7 is 3.0.
Rivastigmine tartrate capsules, USP contain rivastigmine tartrate, equivalent to 1.5, 3, 4.5 and 6 mg of rivastigmine base for oral administration. Inactive ingredients are microcrystalline cellulose, starch and stearic acid. Each hard-gelatin capsule contains gelatin, iron oxides black, red and yellow and titanium dioxide.
Sources
Rivastigmine Tartrate Manufacturers
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Golden State Medical Supply, Inc.
![Rivastigmine Tartrate Capsule [Golden State Medical Supply, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rivastigmine Tartrate | Golden State Medical Supply, Inc.
2.1 Dosing in Alzheimer's DiseaseRivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
The recommended dosage of rivastigmine tartrate capsules in Alzheimer’s disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules.Dose Titration
2.2 Dosing in Parkinson's Disease Dementia
After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).Rivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
The dosage of rivastigmine tartrate capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules.Dose Titration
2.3 Interruption of Treatment
After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.
If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of rivastigmine tartrate capsules. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1)].
2.4 Dosing in Specific PopulationsDosing Modifications in Patients with Renal Impairment
Patients with moderate and severe renal impairment may be able to only tolerate lower doses.Dosing Modifications in Patients with Hepatic Impairment
Patients with mild (Child-Pugh score 5 to 6) and moderate (Child-Pugh score 7 to 9) hepatic impairment may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.Dosing Modifications in Patients with Low Body Weight
Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop. -
Alembic Pharmaceuticals Limited
Rivastigmine Tartrate | Alembic Pharmaceuticals Limited
2.1 Recommended DosingRivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
Alzheimer’s Disease
The dosage of Rivastigmine tartrate capsules shown to be effective in controlled clinical trials in Alzheimer’s disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
Initial Dose
Initiate treatment with the 1.5 mg twice a day with Rivastigmine tartrate capsules.
Dose Titration
After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).
Parkinson’s Disease Dementia
The dosage of Rivastigmine tartrate capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).
Initial Dose
Initiate treatment with the 1.5 mg twice a day with Rivastigmine tartrate capsules.
Dose Titration
After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).
Interruption of Treatment
If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.
If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of Rivastigmine tartrate capsules. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1)].
2.2 Dosing in Specific PopulationsDosing Modifications in Patients with Renal or Hepatic Impairment
Pharmacokinetic studies of oral rivastigmine in patients with moderate to severe renal impairment (glomerular filtration rate [GFR] <50 mL/min) and mild to moderate hepatic impairment (Child-Pugh score 5 to 9) showed reduced clearance of the drug [see Use in Specific Populations (8.6, 8.7), Clinical Pharmacology (12.3)]. Accordingly, such patients may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.
Dosing Modifications in Patients with Low Body Weight
Because rivastigmine blood levels vary with body weight [see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)], careful titration and monitoring should be performed in patients with low body weight. In patients with low body weight (less than 50 kg), monitor closely for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.
2.3 Important Administration InstructionsRivastigmine tartrate oral solution and Rivastigmine tartrate capsules may be interchanged at equal doses.
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Sun Pharmaceutical Industries Limited
Rivastigmine Tartrate | Sun Pharmaceutical Industries Limited
2.1 Dosing in Alzheimer's DiseaseRivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
The recommended dosage of rivastigmine tartrate capsules in Alzheimer’s disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules.
Dose Titration
After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).
2.2 Dosing in Parkinson's Disease DementiaRivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
The dosage of rivastigmine tartrate capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules.
Dose Titration
After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).
2.3 Interruption of TreatmentIf adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.
If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of rivastigmine tartrate capsules. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1)].
2.4 Dosing in Specific PopulationsDosing Modifications in Patients with Renal Impairment
2.5 Important Administration Instructions
Patients with moderate and severe renal impairment may be able to only tolerate lower doses.
Dosing Modifications in Patients with Hepatic Impairment
Patients with mild (Child-Pugh score 5 to 6) and moderate (Child-Pugh score 7 to 9) hepatic impairment may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.
Dosing Modifications in Patients with Low Body Weight
Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.Rivastigmine tartrate oral solution and rivastigmine tartrate capsules may be interchanged at equal doses.
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Watson Laboratories, Inc.
Rivastigmine Tartrate | Watson Laboratories, Inc.
Dementia of the Alzheimer’s type
The dosage of Rivastigmine Tartrate Capsules shown to be effective in controlled clinical trials is 6-12 mg/day, given as twice-a-day dosing (daily doses of 3 to 6 mg BID). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
The starting dose of Rivastigmine Tartrate Capsules is 1.5 mg twice a day (BID). If this dose is well tolerated, after a minimum of two weeks of treatment, the dose may be increased to 3 mg BID. Subsequent increases to 4.5 mg BID and 6 mg BID should be attempted after a minimum of 2 weeks at the previous dose. If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above (see WARNINGS). The maximum dose is 6 mg BID (12 mg/day).
Dementia associated with Parkinson’s Disease
The dosage of Rivastigmine Tartrate Capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s Disease is 3 to 12 mg/day, given as twice-a-day dosing (daily doses of 1.5 to 6 mg BID). In that medical condition, the starting dose of Rivastigmine Tartrate Capsules is 1.5 mg BID; subsequently, the dose may be increased to 3 mg BID and further to 4.5 mg BID and 6 mg BID, based on tolerability, with a minimum of 4 weeks at each dose.
Rivastigmine Tartrate Capsules should be taken with meals in divided doses in the morning and evening.
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Dr.reddy’s Laboratories Limited
Rivastigmine Tartrate | Dr. Reddy's Laboratories Limited
2.1 Dosing in Alzheimer’s DiseaseRivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
The recommended dosage of rivastigmine tartrate capsules in Alzheimer’s disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules.
Dose Titration
After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).
2.2 Dosing in Parkinson’s Disease DementiaRivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
The dosage of rivastigmine tartrate capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules.
Dose Titration
After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).
2.3 Interruption of TreatmentIf adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.
If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of rivastigmine tartrate capsules. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1)].
2.4 Dosing in Specific PopulationsDosing Modifications in Patients with Renal Impairment
Patients with moderate and severe renal impairment may be able to only tolerate lower doses.
Dosing Modifications in Patients with Hepatic Impairment
Patients with mild (Child-Pugh score 5 to 6) and moderate (Child-Pugh score 7 to 9) hepatic impairment may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.
Dosing Modifications in Patients with Low Body Weight
Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.
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American Health Packaging
Rivastigmine Tartrate | American Health Packaging
Dementia of the Alzheimer's typeThe dosage of Rivastigmine Tartrate Capsules shown to be effective in controlled clinical trials in Alzheimer’s Disease is 6 to 12 mg/day, given as twice-a-day dosing (daily doses of 3 to 6 mg BID). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
The starting dose of Rivastigmine Tartrate Capsules is 1.5 mg twice a day (BID). If this dose is well tolerated, after a minimum of 2 weeks of treatment, the dose may be increased to 3 mg BID. Subsequent increases to 4.5 mg BID and 6 mg BID should be attempted after a minimum of 2 weeks at the previous dose. If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above (see WARNINGS) . The maximum dose is 6 mg BID (12 mg/day).
Dementia associated with Parkinson's DiseaseThe dosage of Rivastigmine Tartrate Capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s Disease is 3 to 12 mg/day, given as twice-a-day dosing (daily doses of 1.5 to 6 mg BID). In that medical condition, the starting dose of Rivastigmine Tartrate Capsules is 1.5 mg BID; subsequently, the dose may be increased to 3 mg BID and further to 4.5 mg BID and 6 mg BID, based on tolerability, with a minimum of 4 weeks at each dose.
Rivastigmine Tartrate Capsules should be taken with meals in divided doses in the morning and evening.
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Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Rivastigmine Tartrate | Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Dementia of the Alzheimer’s type
The dosage of Rivastigmine Tartrate Capsules shown to be effective in controlled clinical trials is 6-12 mg/day, given as twice-a-day dosing (daily doses of 3 to 6 mg BID). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
The starting dose of Rivastigmine Tartrate Capsules is 1.5 mg twice a day (BID). If this dose is well tolerated, after a minimum of two weeks of treatment, the dose may be increased to 3 mg BID. Subsequent increases to 4.5 mg BID and 6 mg BID should be attempted after a minimum of 2 weeks at the previous dose. If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above (see WARNINGS). The maximum dose is 6 mg BID (12 mg/day).
Dementia associated with Parkinson’s Disease
The dosage of Rivastigmine Tartrate Capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s Disease is 3 to 12 mg/day, given as twice-a-day dosing (daily doses of 1.5 to 6 mg BID). In that medical condition, the starting dose of Rivastigmine Tartrate Capsules is 1.5 mg BID; subsequently, the dose may be increased to 3 mg BID and further to 4.5 mg BID and 6 mg BID, based on tolerability, with a minimum of 4 weeks at each dose.
Rivastigmine Tartrate Capsules should be taken with meals in divided doses in the morning and evening.
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Apotex Corp.
Rivastigmine Tartrate | Apotex Corp.
2.1 Dosing in Alzheimer's DiseaseRivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
The recommended dosage of rivastigmine tartrate capsules in Alzheimer’s disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules.Dose Titration
2.2 Dosing in Parkinson's Disease Dementia
After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).Rivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening.
The dosage of rivastigmine tartrate capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules.Dose Titration
2.3 Interruption of Treatment
After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.
If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of rivastigmine tartrate capsules. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1)].
2.4 Dosing in Specific PopulationsDosing Modifications in Patients with Renal Impairment
Patients with moderate and severe renal impairment may be able to only tolerate lower doses.Dosing Modifications in Patients with Hepatic Impairment
Patients with mild (Child-Pugh score 5 to 6) and moderate (Child-Pugh score 7 to 9) hepatic impairment may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.Dosing Modifications in Patients with Low Body Weight
Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop. -
Breckenridge Pharmaceutical, Inc
Rivastigmine Tartrate | Boehringer Ingelheim Pharmaceuticals, Inc.
2.1 Patient SelectionSelect patients for the first-line treatment of metastatic NSCLC with GILOTRIF based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor specimens [see Indications and Usage (1) and Clinical Studies (14)]. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.
2.2 Recommended DoseThe recommended dose of GILOTRIF is 40 mg orally once daily until disease progression or no longer tolerated by the patient. Take GILOTRIF at least 1 hour before or 2 hours after a meal.
Do not take a missed dose within 12 hours of the next dose.
2.3 Dose ModificationWithhold GILOTRIF for any drug-related adverse reactions of:
NCI CTCAE* Grade 3 or higher Diarrhea of Grade 2 or higher persisting for 2 or more consecutive days while taking anti-diarrheal medication [see Warnings and Precautions (5.1)] Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable [see Warnings and Precautions (5.2)] Renal dysfunction of Grade 2 or higher*National Cancer Institute Common Terminology Criteria for Adverse Events, v 3.0
Resume treatment when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute GILOTRIF at a reduced dose, i.e., 10 mg per day less than the dose at which the adverse reaction occurred.
Permanently discontinue GILOTRIF for:
Life-threatening bullous, blistering, or exfoliative skin lesions [see Warnings and Precautions (5.2)] Confirmed interstitial lung disease (ILD) [see Warnings and Precautions (5.3)] Severe drug-induced hepatic impairment [see Warnings and Precautions (5.4)] Persistent ulcerative keratitis [see Warnings and Precautions (5.5)] Symptomatic left ventricular dysfunction Severe or intolerable adverse reaction occurring at a dose of 20 mg per dayP-gp Inhibitors
For patients who require therapy with a P-glycoprotein (P-gp) inhibitor, reduce GILOTRIF daily dose by 10 mg if not tolerated. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated [see Drug Interactions (7) and Clinical Pharmacology (12.3)].P-gp Inducers
For patients who require chronic therapy with a P-gp inducer, increase GILOTRIF daily dose by 10 mg as tolerated. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer [see Drug Interactions (7) and Clinical Pharmacology (12.3)]. -
Sandoz Inc
Rivastigmine Tartrate | Sandoz Inc
2.1 Recommended DosingRivastigmine tartrate should be taken with meals in divided doses in the morning and evening.
Alzheimer’s Disease
The dosage of rivastigmine tartrate shown to be effective in controlled clinical trials in Alzheimer’s disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate.
Dose Titration
After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).
Parkinson’s Disease Dementia
The dosage of rivastigmine tartrate shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate.
Dose Titration
After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).
Interruption of Treatment
If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.
If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of rivastigmine tartrate. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1)].
2.2 Dosing in Specific PopulationsDosing Modifications in Patients with Renal or Hepatic Impairment
Pharmacokinetic studies of oral rivastigmine in patients with moderate to severe renal impairment (glomerular filtration rate [GFR] <50 mL/min) and mild to moderate hepatic impairment (Child-Pugh score 5 to 9) showed reduced clearance of the drug [see Use in Specific Populations (8.6, 8.7), Clinical Pharmacology (12.3)]. Accordingly, such patients may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.
Dosing Modifications in Patients with Low Body Weight
Because rivastigmine blood levels vary with body weight [see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)], careful titration and monitoring should be performed in patients with low body weight. In patients with low body weight (less than 50 kg), monitor closely for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.
2.3 Important Administration InstructionsRivastigmine tartrate oral solution and rivastigmine tartrate capsules may be interchanged at equal doses. Caregivers should direct questions about the administration of rivastigmine tartrate oral solution to either their physician or pharmacist [see Patient Counseling Information (17)].
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Carilion Materials Management
Rivastigmine Tartrate | Carilion Materials Management
Dementia of the Alzheimer's typeThe dosage of Rivastigmine Tartrate Capsules shown to be effective in controlled clinical trials in Alzheimer’s Disease is 6 to 12 mg/day, given as twice a day dosing (daily doses of 3 to 6 mg BID). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial. The starting dose of Rivastigmine Tartrate Capsules is 1.5 mg twice a day (BID). If this dose is well tolerated, after a minimum of 2 weeks of treatment, the dose may be increased to 3 mg BID. Subsequent increases to 4.5 mg BID and 6 mg BID should be attempted after a minimum of 2 weeks at the previous dose. If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above (see ). The maximum dose is 6 mg BID (12 mg/day).
WARNINGS Dementia associated with Parkinson's DiseaseThe dosage of Rivastigmine Tartrate Capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s Disease is 3 to 12 mg/day, given as twice-a-day dosing (daily doses of 1.5 to 6 mg BID). In that medical condition, the starting dose of Rivastigmine Tartrate Capsules is 1.5 mg BID; subsequently, the dose may be increased to 3 mg BID and further to 4.5 mg BID and 6 mg BID, based on tolerability, with a minimum of 4 weeks at each dose. Rivastigmine Tartrate Capsules should be taken with meals in divided doses in the morning and evening.
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Macleods Pharmaceuticals Limited
Rivastigmine Tartrate | Macleods Pharmaceuticals Limited
2.1 Recommended DosingRivastigmine tartrate should be taken with meals in divided doses in the morning and evening.
Alzheimer's Disease
The dosage of rivastigmine tartrate shown to be effective in controlled clinical trials in Alzheimer's disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.
Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate.
Dose Titration
After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).Parkinson's Disease Dementia
The dosage of rivastigmine tartrate shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson's disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).Initial Dose
Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate.
Dose Titration
After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).Interruption of Treatment
If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of rivastigmine tartrate. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1)].
2.2 Dosing in Specific Populations
Dosing Modifications in Patients with Renal or Hepatic Impairment
Pharmacokinetic studies of oral rivastigmine in patients with moderate to severe renal impairment (glomerular filtration rate [GFR] <50 mL/min) and mild to moderate hepatic impairment (Child-Pugh score 5 to 9) showed reduced clearance of the drug [see Use in Specific Populations (8.6, 8.7), Clinical Pharmacology (12.3)]. Accordingly, such patients may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.Dosing Modifications in Patients with Low Body Weight
Because rivastigmine blood levels vary with body weight [see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)], careful titration and monitoring should be performed in patients with low body weight. In patients with low body weight (less than 50 kg), monitor closely for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.
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