Rivastigmine Tartrate description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Rivastigmine Tartrate

Sun Pharmaceutical Industries Limited

Rivastigmine Tartrate Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

RIVASTIGMINE TARTRATE DESCRIPTION


142222·466
Rivastigmine Tartrate

CLINICAL PHARMACOLOGY

Mechanism of Action




In vitroin vivo

Clinical Trial Data


Dementia of the Alzheimer’s type



Study Outcome Measures:





U.S. 26-Week Study




Effects on the ADAS-cog:

Rivastigmine Tartrate

Rivastigmine Tartrate
Effects on the CIBIC-Plus:



Rivastigmine Tartrate

Global 26-Week Study




Effects on the ADAS-cog: Rivastigmine Tartrate
Rivastigmine Tartrate
Effects on the CIBIC-Plus:



Rivastigmine Tartrate

U.S. Fixed Dose Study




Dementia Associated with Parkinson’s disease (PDD)

International Twenty-Four-Week Study




Study Outcome Measures:

Study Results:

Effects on the ADAS-cog: Rivastigmine Tartrate
Effects on the ADCS-CGIC:

Rivastigmine TartrateAge, Gender and Race:

Pharmacokinetics



 
Absorption: maxmax

Distribution: 1-12hr



Metabolism: in vitro Drug-Drug Interactions
 
Elimination: 14

Special Populations


Hepatic Disease:

Renal Disease:

Age:

Gender and Race:

Nicotine Use:

Drug-Drug Interactions


Effect of Rivastigmine Tartrate Capsules on the Metabolism of Other Drugs: in vitro



Effect of Other Drugs on the Metabolism of Rivastigmine Tartrate Capsules:

RIVASTIGMINE TARTRATE INDICATIONS AND USAGE






CLINICAL PHARMACOLOGY, Clinical Trial Data

RIVASTIGMINE TARTRATE CONTRAINDICATIONS


DESCRIPTION

WARNINGS

Gastrointestinal Side Effects


Rivastigmine Tartrate Capsules use is associated with significant gastrointestinal adverse reactions, including nausea and vomiting, anorexia, and weight loss. For this reason, patients should always be started at a dose of 1.5 mg BID and titrated to their maintenance dose. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose (see DOSAGE AND ADMINISTRATION) to reduce the possibility of severe vomiting and its potentially serious sequelae (e.g., there has been one postmarketing report of severe vomiting with esophageal rupture following inappropriate reinitiation of treatment with a 4.5 mg dose after 8 weeks of treatment interruption.)

Nausea and Vomiting: In the controlled clinical trials, 47% of the patients treated with Rivastigmine Tartrate Capsules dose in the therapeutic range of 6 to 12 mg/day (n=1189) developed nausea (compared with 12% in placebo). A total of 31% of Rivastigmine Tartrate Capsules -treated patients developed at least one episode of vomiting (compared with 6% for placebo). The rate of vomiting was higher during the titration phase (24% vs. 3% for placebo) than in the maintenance phase (14% vs. 3% for placebo). The rates were higher in women than men. Five percent of patients discontinued for vomiting, compared to less than 1% for patients on placebo. Vomiting was severe in 2% of Rivastigmine Tartrate Capsules -treated patients and was rated as mild or moderate each in 14% of patients. The rate of nausea was higher during the titration phase (43% vs. 9% for placebo) than in the maintenance phase (17% vs. 4% for placebo).

Weight Loss: In the controlled trials, approximately 26% of women on high doses of Rivastigmine Tartrate Capsules (greater than 9 mg/day) had weight loss equal to or greater than 7% of their baseline weight compared to 6% in the placebo-treated patients. About 18% of the males in the high dose group experienced a similar degree of weight loss compared to 4% in placebo-treated patients. It is not clear how much of the weight loss was associated with anorexia, nausea, vomiting, and the diarrhea associated with the drug.

Anorexia:
 
Peptic Ulcers/Gastrointestinal Bleeding:

Anesthesia


Cardiovascular Conditions


Genitourinary


Neurological Conditions


Seizures:

Pulmonary Conditions


PRECAUTIONS

Information for Patients and Caregivers




Drug-Drug Interactions


Effect of Rivastigmine Tartrate Capsules on the Metabolism of Other Drugs: in vitro



Effect of Other Drugs on the Metabolism of Rivastigmine Tartrate Capsules:


 
Use with Anticholinergics:

Use with Cholinomimetics and Other Cholinesterase Inhibitors:

Carcinogenesis, Mutagenesis, Impairment of Fertility


2

in vitro in vitro in vivo

2

Pregnancy


Pregnancy Category B: 2 22

Nursing Mothers


Pediatric Use


RIVASTIGMINE TARTRATE ADVERSE REACTIONS

Dementia of the Alzheimer's type


Adverse Events Leading to Discontinuation




Table 1. Most Frequent Adverse Events Leading to Withdrawal from Clinical Trials during Titration and Maintenance in Patients Receiving 6 to 12 mg/day Rivastigmine Tartrate Capsules Using a Forced Dose Titration
Study Phase Titration Maintenance Overall
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
Most Frequent Adverse Clinical Events Seen in Association with the Use of Rivastigmine Tartrate Capsules



Gastrointestinal Adverse Reactions


WARNINGS

Adverse Events Reported in Controlled Trials






Table 2. Adverse Events Reported in Controlled Clinical Trials in at Least 2% of Patients Receiving Rivastigmine Tartrate Capsules (6 to 12 mg/day) and at a Higher Frequency than Placebo-treated Patients
Body System/Adverse Event Placebo
(n=868)
Rivastigmine Tartrate Capsules
(6 to 12 mg/day)
(n=1189)
Percent of Patients with any Adverse Event 79
92
Autonomic Nervous System
Sweating increased
Syncope
 
1
2
 
4
3
Body as a Whole
Accidental Trauma
Fatigue
Asthenia
Malaise
Influenza-like Symptoms
Weight Decrease
 
9
5
2
2
2
<1
 
10
9
6
5
3
3
Cardiovascular Disorders, General
Hypertension
 
2
 
3
Central and Peripheral Nervous System
Dizziness
Headache
Somnolence
Tremor
 
11
12
3
1
 
21
17
5
4
Gastrointestinal System
Nausea
Vomiting
Diarrhea
Anorexia
Abdominal Pain
Dyspepsia
Constipation
Flatulence
Eructation
 
12
6
11
3
6
4
4
2
1
 
47
31
19
17
13
9
5
4
2
Psychiatric Disorders
Insomnia
Confusion
Depression
Anxiety
Hallucination
Aggressive Reaction
 
7
7
4
3
3
2
 
9
8
6
5
4
3
Resistance Mechanism Disorders
Urinary Tract Infection
 
6
 
7
Respiratory System
Rhinitis
 
3
 
4

Dementia Associated with Parkinson's disease


Adverse Events leading to discontinuation



Most Frequent Adverse Clinical Events Seen in Association with the Use of Rivastigmine Tartrate Capsules



Adverse Events Reported in Controlled Trials




Table 3. Adverse Events Reported in the Single Controlled Clinical Trial in at Least 2% of Patients Receiving Rivastigmine Tartrate Capsules (3 to 12 mg/day) and at a Higher Frequency than Placebo-treated Patients
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


Dementia of the Alzheimer's Type





Autonomic Nervous System: Infrequent:
 
Body as a Whole: Frequent: Infrequent
 
Cardiovascular System: Frequent:
 
Central and Peripheral Nervous System: Frequent: Infrequent:
 
Endocrine System: Infrequent:

Gastrointestinal System: Frequent: Infrequent:
 
Hearing and Vestibular DisordersFrequent:
 
Heart Rate and Rhythm Disorders: Frequent: Infrequent:
 
Liver and Biliary System Disorders: Infrequent:

Metabolic and Nutritional Disorders: Frequent: Infrequent:
 
Musculoskeletal Disorders: Frequent: Infrequent:
 
Myo-, Endo-, Pericardial and Valve Disorders: Frequent:
 
Platelet, Bleeding, and Clotting Disorders: Frequent: Infrequent:
 
Psychiatric Disorders: Frequent: Infrequent:

Red Blood Cell Disorders: Frequent: Infrequent:
 
Reproductive Disorders (Female & Male): Infrequent:

Resistance Mechanism Disorders: Infrequent:
 
Respiratory System: Infrequent:
 
Skin and Appendages: Frequent: Infrequent:
 
Special Senses: Infrequent:

Urinary System Disorders: Frequent: Infrequent:

Vascular (extracardiac) Disorders: Infrequent:

Vision Disorders: Frequent: Infrequent:

White Cell and Resistance Disorders: Infrequent:

Dementia Associated with Parkinson's Disease






Cardiovascular System: Frequent:Infrequent:

Central and Peripheral Nervous System: Frequent:Infrequent:

Endocrine System: Infrequent:

Gastrointestinal System: Frequent: Infrequent:

Hearing and Vestibular Disorders: Frequent: Infrequent:

Heart Rate and Rhythm Disorders: Infrequent:

Liver and Biliary System Disorders: Infrequent:

Musculoskeletal Disorders: Frequent:   Infrequent:

Psychiatric Disorders: Frequent: Infrequent:

Reproductive Disorders (Female & Male): Infrequent:

Respiratory System: Frequent: Infrequent:

Urinary System Disorders: Infrequent:

Vascular (extracardiac) Disorders: Infrequent:

Vision Disorders:
Infrequent:

Post-Introduction Reports




Skin and Appendages:

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.

RIVASTIGMINE TARTRATE DOSAGE AND ADMINISTRATION

Dementia of the Alzheimer's type




WARNINGS

Dementia associated with Parkinson's Disease




HOW SUPPLIED
































Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-Bottle Label-1.5 mg


NDC 62756-145-86
Rivastigmine Tartrate Capsules
equivalent to 1.5 mg base
Rx only
60 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
Rivastigmine Tartrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-Carton-3 mg


NDC 62756-146-61
Rivastigmine Tartrate Capsules
equivalent to 3 mg base
Rx only
100 (10 x 10) Unit Dose Capsules
SUN PHARMACEUTICAL INDUSTRIES LTD.
Rivastigmine Tartrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-Bottle Label-4.5 mg


NDC 62756-147-86
Rivastigmine Tartrate Capsules
equivalent to 4.5 mg base
Rx only
60 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.
Rivastigmine Tartrate

Rivastigmine Tartrate

Rivastigmine Tartrate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-145
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
rivastigmine tartrate RIVASTIGMINE 1.5 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
GELATIN
titanium dioxide
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
YELLOW (yellow opaque) 18 mm 145;145 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-145-86 60 in 1 BOTTLE
2 NDC:62756-145-13 500 in 1 BOTTLE
3 10 in 1 BLISTER PACK
4 NDC:62756-145-61 10 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077131 2010-07-01


Rivastigmine Tartrate

Rivastigmine Tartrate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-146
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
rivastigmine tartrate RIVASTIGMINE 3 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
GELATIN
titanium dioxide
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
ORANGE (orange opaque) 18 mm 146;146 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-146-86 60 in 1 BOTTLE
2 NDC:62756-146-13 500 in 1 BOTTLE
3 10 in 1 BLISTER PACK
4 NDC:62756-146-61 10 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077131 2010-07-01


Rivastigmine Tartrate

Rivastigmine Tartrate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-147
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
rivastigmine tartrate RIVASTIGMINE 4.5 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
GELATIN
titanium dioxide
ferric oxide red
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
ORANGE (orange opaque) 18 mm 147;147 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-147-86 60 in 1 BOTTLE
2 NDC:62756-147-13 500 in 1 BOTTLE
3 10 in 1 BLISTER PACK
4 NDC:62756-147-61 10 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077131 2010-07-01


Rivastigmine Tartrate

Rivastigmine Tartrate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62756-148
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
rivastigmine tartrate RIVASTIGMINE 6 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
GELATIN
titanium dioxide
FD&C YELLOW NO. 6
FD&C RED NO. 40
ferric oxide red
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
ORANGE (orange opaque) 18 mm 148;148 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-148-86 60 in 1 BOTTLE
2 NDC:62756-148-13 500 in 1 BOTTLE
3 10 in 1 BLISTER PACK
4 NDC:62756-148-61 10 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077131 2010-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.