Alendronate Sodium Tablets USP 70mg
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Alendronate Sodium Tablets USP 70mg Technical Specification:

Product Name:Alendronate Sodium Tablets USP 70mg
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:Antiosteoporosis
Indication: 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.
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:

  • Alendronate Sodium Tablets USP 5mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………5mg
    Excipients……………………………………..q.s.
  • Alendronate Sodium Tablets USP 10mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………10mg
    Excipients……………………………………..q.s.
  • Alendronate Sodium Tablets USP 35mg
    Each uncoated tablet contains:
    Sodium Alendronate USP
    Equivalent to Alendronic Acid………35mg
    Excipients……………………………………..q.s.
  • 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. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time. This medication works by slowing bone loss. This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Alendronate belongs to a class of drugs called bisphosphonates.

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, light-resistant container.

Dosage: As directed by the Physician.

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………10mg
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. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time. This medication works by slowing bone loss. This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Alendronate belongs to a class of drugs called bisphosphonates.

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, light-resistant container.
Dosage: As directed by the Physician.