Rivastigmine Tartrate Capsules
DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of Action
Clinical Trial Data
U.S. 26-Week Study
Global 26-Week Study
U.S. Fixed Dose Study
Pharmacokinetics
Special Populations
Drug-Drug Interactions
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
Gastrointestinal Adverse Reactions
Anesthesia
Cardiovascular Conditions
Genitourinary
Neurological Conditions
Pulmonary Conditions
PRECAUTIONS
Information for Patients and Caregivers
Drug-Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Nursing Mothers
Pediatric Use
ADVERSE REACTIONS
Dementia of the Alzheimer's type
| Event/% Discontinuing | Placebo(n=868) | Rivastigmine Tartrate Capsules≥6 to 12 mg/day(n=1189) | Placebo(n=788) | Rivastigmine Tartrate Capsules≥6 to 12 mg/day(n=987) | Placebo(n=868) | Rivastigmine Tartrate Capsules≥6 to 12 mg/day(n=1189) |
| Nausea | <1 | 8 | <1 | 1 | 1 | 8 |
| Vomiting | <1 | 4 | <1 | 1 | <1 | 5 |
| Anorexia | 0 | 2 | <1 | 1 | <1 | 3 |
| Dizziness | <1 | 2 | <1 | 1 | <1 | 2 |
| Percent of Patients with any Adverse Event | 79 | 92 |
| Autonomic Nervous SystemSweating increasedSyncope | 12 | 43 |
| Body as a WholeAccidental TraumaFatigueAstheniaMalaiseInfluenza-like SymptomsWeight Decrease | 95222<1 | 1096533 |
| Cardiovascular Disorders, GeneralHypertension | 2 | 3 |
| Central and Peripheral Nervous SystemDizzinessHeadacheSomnolenceTremor | 111231 | 211754 |
| Gastrointestinal SystemNauseaVomitingDiarrheaAnorexiaAbdominal PainDyspepsiaConstipationFlatulenceEructation | 12611364421 | 47311917139542 |
| Psychiatric DisordersInsomniaConfusionDepressionAnxietyHallucinationAggressive Reaction | 774332 | 986543 |
| Resistance Mechanism DisordersUrinary Tract Infection | 6 | 7 |
| Respiratory SystemRhinitis | 3 | 4 |
Dementia Associated with Parkinson's disease
| Body System/Adverse Event | Placebo | Rivastigmine Tartrate Capsules |
| (n=179) | (3 to 12 mg/day)(n=362) | |
| Percent of Patients with any Adverse Event | 71 | 84 |
| Gastrointestinal disorders | ||
| Nausea | 11 | 29 |
| Vomiting | 2 | 17 |
| Diarrhea | 4 | 7 |
| Upper abdominal pain | 1 | 4 |
| General Disorders and administrative site conditions | ||
| Fatigue | 3 | 4 |
| Asthenia | 1 | 2 |
| Metabolism and nutritional disorders | ||
| Anorexia | 3 | 6 |
| Dehydration | 1 | 2 |
| Nervous system Disorders | ||
| Tremor | 4 | 10 |
| Dizziness | 1 | 6 |
| Headache | 3 | 4 |
| Somnolence | 3 | 4 |
| Parkinson’s disease (worsening) | 1 | 3 |
| Parkinsonism | 1 | 2 |
| Psychiatric Disorders | ||
| Anxiety | 1 | 4 |
| Insomnia | 2 | 3 |
Other Adverse Events Observed During Clinical Trials
Post-Introduction Reports
OVERDOSAGE
Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.
As Rivastigmine Tartrate Capsule has a short plasma half-life of about one hour and a moderate duration of acetylcholinesterase inhibition of 8 to 10 hours, it is recommended that in cases of asymptomatic overdoses, no further dose of Rivastigmine Tartrate Capsules should be administered for the next 24 hours.
As in any case of overdose, general supportive measures should be utilized. Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized 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 drugs that increase cholinergic activity when co-administered with quaternary anticholinergics such as glycopyrrolate. Due to the short half-life of Rivastigmine Tartrate Capsules, 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. In a documented case of a 46 mg overdose with Rivastigmine Tartrate Capsules, the patient experienced vomiting, incontinence, hypertension, psychomotor retardation, and loss of consciousness. The patient fully recovered within 24 hours and conservative management was all that was required for treatment.
DOSAGE AND ADMINISTRATION
Dementia of the Alzheimer's type
Dementia associated with Parkinson's Disease
HOW SUPPLIED
| Bottles of 60's with Child Resistant Cap | NDC 54868-6145-0 |