Risedronate Sodium Tablets USP 30mg
Categories: , , ,
Date:

Risedronate Sodium Tablets USP 30mg Technical Specification:

Product Name: Risedronate Sodium Tablets USP 30mg
Brand Name: Generic
Strength: (5mg), (30mg), (35mg), (150mg)
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Antiosteoporotic
Indication: Risedronate is for use when you have a high risk of bone fracture due to osteoporosis.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Risedronate Sodium Tablets USP 5mg
    Each film-coated tablet contains:
    Risedronate Sodium Hemi-Pentahydrate USP
    Equivalent to Risedronate Sodium…………5mg
    Excipients ……………………………………………….q.s.
    Colour: Caramel
  • Risedronate Sodium Tablets USP 30mg
    Each film-coated tablet contains:
    Risedronate Sodium Hemi-Pentahydrate USP
    Equivalent to Risedronate Sodium…………30mg
    Excipients……………………………………………….q.s.
    Colour: Ponceau 4 R
  • Risedronate Sodium Tablets USP 35mg
    Each film-coated tablet contains:
    Risedronate Sodium Hemi-Pentahydrate USP
    Equivalent to Risedronate Sodium…………35mg
    Excipients ……………………………………………….q.s.
    Colour: Titanium dioxide
  • Risedronate Sodium Tablets USP 150mg
    Each film-coated tablet contains:
    Risedronate Sodium Hemi-Pentahydrate USP
    Equivalent to Risedronate Sodium…………150mg
    Excipients ……………………………………………….q.s.
    Colour: Tartrazine yellow

THERAPEUTIC INDICATIONS:

Risedronate is used by adults to treat a disease that weakens bones (Paget’s disease). This medication helps to reduce bone pain and may prevent long-term complications from this disease. Risedronate works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). It belongs to a class of medications called bisphosphonates.

CAUTION & SCHEDULE:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

WARNING:  NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A Endocrinologist/Rheumatologist/Gynecologist/Orthopedics.

STORAGE & DOSAGE:

Storage:  Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dosage:  One tablet same day every week.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Risedronate Sodium Tablets USP 5mg
B) Risedronate Sodium Tablets USP 30mg
C) Risedronate Sodium Tablets USP 35mg
D) Risedronate Sodium Tablets USP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Risedronate Sodium Tablets USP 5mg
Each film coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate USP
Equivalent to Risedronate Sodium…………5mg
Excipients ……………………………………………….q.s.
Colour: Caramel

B) Risedronate Sodium Tablets USP 30mg
Each film coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate USP
Equivalent to Risedronate Sodium…………30mg
Excipients……………………………………………….q.s.
Colour: Ponceau 4 R

C) Risedronate Sodium Tablets USP 35mg
Each film coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate USP
Equivalent to Risedronate Sodium…………35mg
Excipients ……………………………………………….q.s.
Colour: Titanium dioxide

D) Risedronate Sodium Tablets USP 150mg
Each film coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate USP
Equivalent to Risedronate Sodium…………150mg
Excipients ……………………………………………….q.s.
Colour: Tartrazine yellow

THERAPEUTIC INDICATIONS:

Risedronate is used by adults to treat a disease that weakens bones (Paget's disease). This medication helps to reduce bone pain and may prevent long-term complications from this disease. Risedronate works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). It belongs to a class of medications called bisphosphonates.

CAUTION & SCHEDULE:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A ENDOCRINOLOGIST/RHEUMATOLOGIST/GYNECOLOGISTS/ORTHOPEDICS.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: One tablet same day every week.