RIVASTIGMINE TARTRATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RIVASTIGMINE TARTRATE (UNII: 9IY2357JPE) (RIVASTIGMINE - UNII:PKI06M3IW0)

Available from:

American Health Packaging

INN (International Name):

RIVASTIGMINE TARTRATE

Composition:

RIVASTIGMINE 1.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the Alzheimer's type (AD). Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with Parkinson's disease (PD). Rivastigmine tartrate capsules are contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see Description ( 11)]. - a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see Warnings and Precautions ( 5.2)]. Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions ( 6.2)]. Risk Summary There are no adequate data on the developmental risks associated with the use of rivastigmine tartrate in pregnant women. In animals, no adverse effects on embryo-fetal development were obse

Product summary:

Rivastigmine Tartrate Capsules equivalent to 1.5 mg of rivastigmine base are available as follows: 1.5 mg Capsule – yellow, “145” is printed in black on the body and cap of the capsule. Unit dose packages of 100 (10 x 10) NDC 68084-550-01 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIVASTIGMINE TARTRATE- RIVASTIGMINE TARTRATE CAPSULE
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIVASTIGMINE TARTRATE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RIVASTIGMINE TARTRATE CAPSULES.
RIVASTIGMINE TARTRATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated
for treatment of:
Mild-to-moderate dementia of the Alzheimer’s type (AD) ( 1.1)
Mild-to-moderate dementia associated with Parkinson’s disease (PD) (
1.2)
DOSAGE AND ADMINISTRATION
Alzheimer’s Disease ( 2.1):
Initial Dose: Initiate treatment with 1.5 mg twice a day.
Dose Titration: After a minimum of 2 weeks, if tolerated, increase
dose to 3 mg twice a day and further to 4.5 mg twice a
day and 6 mg twice a day if tolerated with a minimum of 2 weeks at
each dose.
Parkinson’s Disease Dementia (PDD) ( 2.2):
Initial Dose: Initiate treatment with 1.5 mg twice a day.
Dose Titration: After a minimum of 4 weeks, if tolerated, increase
dose to 3 mg twice a day and further to 4.5 mg twice a
day and 6 mg twice a day if tolerated 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. ( 2.1, 2.2)
Rivastigmine tartrate oral solution and rivastigmine tartrate capsules
may be interchanged at equal doses ( 2.5)
DOSAGE FORMS AND STRENGTHS
Capsules: 1.5 mg, 3 mg, 4.5 mg, or 6 mg ( 3.1)
CONTRAINDICATIONS
Known hypersensitivity to rivastigmine, other carbamate derivatives or
other components of the formulation ( 4)
History of application site reaction with rivastigmine transdermal
patch suggestive of allergic contact dermatitis, in the
absence of negative allergy testing ( 4, 5.2)
WARNINGS AND PRECAUTIONS
Gastrointestinal adverse reactions may include significant nausea,
vomiting, diarrhea, anorexia/decreased appetite, and
weight loss, and may necessitate treatment in