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:
- Rivastigmine Tartrate Capsule USP 1.5mg
- Rivastigmine Tartrate Capsule USP 3mg
- Rivastigmine Tartrate Capsule USP 4.5mg
- Rivastigmine Tartrate Capsule USP 6mg
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
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.
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.
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.
Dosage: As directed by the Physician.










