Alendronate 5,10,35,70 mg Tab

Product Details
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Name Of Product(Genric Name) :

Alendronate 5,10,35,70 mg Tab

Product Description :

RISEDRONATE TABLETS

35 mg & 150 mg

1. COMPOSITION

Each film-coated tablet contains:

Risedronate Sodium equivalent to Risedronic Acid 35 mg / 150 mg
Excipients: q.s.
Colour: As approved.

2. PHARMACEUTICAL FORM

Film-Coated Tablets

3. THERAPEUTIC CLASS

Bisphosphonate / Anti-resorptive Agent

4. INDICATIONS

Risedronate is indicated for the treatment and prevention of osteoporosis in:

  • Postmenopausal women at increased risk of fractures.

  • Men with osteoporosis at increased risk of fractures.

  • Osteoporosis associated with long-term systemic glucocorticoid therapy.

5. CONTRAINDICATIONS

  • Hypersensitivity to risedronate sodium or any component of the formulation.

  • Hypocalcaemia.

  • Severe renal impairment.

  • Abnormalities of the oesophagus that delay oesophageal emptying, such as stricture or achalasia.

  • Inability to remain upright for at least 30 minutes after taking the tablet.

6. DRUG INTERACTIONS

Risedronate absorption may be reduced by:

  • Calcium supplements

  • Antacids containing calcium, magnesium, or aluminium

  • Iron-containing preparations

  • Other medicines containing polyvalent cations

  • Food and beverages, particularly those containing calcium

These products should be taken at an appropriate interval from risedronate as directed by the physician.

7. ADMINISTRATION

For oral use only.

35 mg Tablet

Take one 35 mg tablet once weekly, preferably on the same day each week, or as directed by the physician.

150 mg Tablet

Take one 150 mg tablet once monthly, preferably on the same date each month, or as directed by the physician.

Take the tablet after an overnight fast and at least 30 minutes before the first food, beverage, or other oral medicine of the day.

Swallow the tablet whole with a full glass of plain water while sitting or standing upright. Do not chew, suck, or crush the tablet.

Remain upright for at least 30 minutes after taking the tablet.

Adequate calcium and vitamin D intake should be maintained unless contraindicated.

8. STORAGE

Store below 25°C, protected from moisture and excessive heat.

Keep the container tightly closed and out of reach of children.

Do not use after the expiry date stated on the package.


Market : international export

Private Label : Available

Registration Support : Available

Regulatory documents : Available on request



TABLETS