Rivastigmine Tartrate Capsule USP 1.5mg Technical Specification:

Product Name:Rivastigmine Tartrate Capsule USP 1.5mg
Brand Name:Generics
Strength:(1.5mg), (3mg), (4.5mg), (6mg)
Dosage Form:Capsule (Hard gelatine)
Route of Administration:Via oral Route
Packing:30s, 60s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Alzheimer’s
Indication: Rivastigmine is used to treat mild to moderate dementia (memory loss and mental changes) associated with Alzheimer’s disease or Parkinson’s disease. Rivastigmine will not cure or stop Alzheimer’s disease or Parkinson’s disease from getting worse, however, rivastigmine can improve the thinking ability in some patients.
Storage:Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rivastigmine Tartrate Capsule USP 1.5mg
    Each Hard gelatin capsule contains
    Rivastigmine Tartrate USP
    Equivalent to rivastigmine………………1.5mg
    Excipients…………………………………q.s.
    Approved colors used in approved shell.
  • Rivastigmine Tartrate Capsule USP 3mg
    Each Hard gelatin capsule contains
    Rivastigmine Tartrate USP
    Equivalent to rivastigmine………………3mg
    Excipients…………………………………q.s.
    Approved colors used in approved shell.
  • Rivastigmine Tartrate Capsule USP 4.5mg
    Each Hard gelatin capsule contains
    Rivastigmine Tartrate USP
    Equivalent to rivastigmine………………4.5mg
    Excipients…………………………………q.s.
    Approved colors used in approved shell.
  • Rivastigmine Tartrate Capsule USP 6mg
    Each Hard gelatin capsule contains
    Rivastigmine Tartrate USP
    Equivalent to rivastigmine………………6mg
    Excipients…………………………………q.s.
    Approved colors used in approved shell.

THERAPEUTIC INDICATIONS:

Rivastigmine is used to treat mild to moderate dementia (memory loss and mental changes) associated with Alzheimer’s disease or Parkinson’s disease. Rivastigmine will not cure or stop Alzheimer’s disease or Parkinson’s disease from getting worse, however, rivastigmine can improve the thinking ability in some patients.

CAUTION & WARNING:

CAUTION:

Read enclosed leaflet before use.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Rivastigmine Tartrate Capsule USP 1.5mg
B. Rivastigmine Tartrate Capsule USP 3mg
C. Rivastigmine Tartrate Capsule USP 4.5mg
D. Rivastigmine Tartrate Capsule USP 6mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Rivastigmine Tartrate Capsule USP 1.5mg
Each Hard gelatin capsule contains
Rivastigmine Tartrate USP
Equivalent to rivastigmine………………1.5mg
Excipients…………………………………q.s.
Approved colors used in approved shell.


B) Rivastigmine Tartrate Capsule USP 3mg
Each Hard gelatin capsule contains
Rivastigmine Tartrate USP
Equivalent to rivastigmine………………3mg
Excipients…………………………………q.s.
Approved colors used in approved shell.

C) Rivastigmine Tartrate Capsule USP 4.5mg
Each Hard gelatin capsule contains
Rivastigmine Tartrate USP
Equivalent to rivastigmine………………4.5mg
Excipients…………………………………q.s.
Approved colors used in approved shell.

D) Rivastigmine Tartrate Capsule USP 6mg
Each Hard gelatin capsule contains
Rivastigmine Tartrate USP
Equivalent to rivastigmine………………6mg
Excipients…………………………………q.s.
Approved colors used in approved shell.

THERAPEUTIC INDICATIONS:

Rivastigmine is used to treat mild to moderate dementia (memory loss and mental changes) associated with Alzheimer's disease or Parkinson's disease. Rivastigmine will not cure or stop Alzheimer's disease or Parkinson's disease from getting worse, however, rivastigmine can improve the thinking ability in some patients.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.

KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

Dosage: As directed by the Physician.