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Alendronate Sodium Tablets USP 70mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Alendronate Sodium Tablets USP 5mg
B) Alendronate Sodium Tablets USP 10mg
C) Alendronate Sodium Tablets USP 35mg
D) Alendronate Sodium Tablets USP 70mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Alendronate Sodium Tablets USP 5mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………5mg
Excipients……………………………………..q.s.

B) Alendronate Sodium Tablets USP 10mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………5mg
Excipients……………………………………..q.s.

C) Alendronate Sodium Tablets USP 35mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………35mg
Excipients……………………………………..q.s.

D) Alendronate Sodium Tablets USP 70mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………70mg
Excipients……………………………………..q.s.

THERAPEUTIC INDICATIONS:

Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily.

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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Alendronate Sodium Tablets USP 70mg Technical Specification:

Product Name:Alendronate Sodium Tablets USP
Brand Name:Generic
Strength:5mg, 10mg, 35mg, 70mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiosteoporotic
Indication: Alendronate is also used to treat osteoporosis in men and women who are taking corticosteroids.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • A) Alendronate Sodium Tablets USP 5mg
  • B) Alendronate Sodium Tablets USP 10mg
  • C) Alendronate Sodium Tablets USP 35mg
  • D) Alendronate Sodium Tablets USP 70mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • A) Alendronate Sodium Tablets USP 5mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………5mg
    Excipients……………………………………..q.s.
  • B) Alendronate Sodium Tablets USP 10mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………5mg
    Excipients……………………………………..q.s.
  • C) Alendronate Sodium Tablets USP 35mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………35mg
    Excipients……………………………………..q.s.
  • D) Alendronate Sodium Tablets USP 70mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………70mg
    Excipients……………………………………..q.s.

THERAPEUTIC INDICATIONS:

Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily.

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

Dosage: As directed by the Physician
Attach dispensing label as per end country.