Ibandronate 50 mg,150 mg Tab

Product Details
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Name Of Product(Genric Name) :

Ibandronate 50 mg,150 mg Tab

Product Description :

IBANDRONATE TABLETS

50 mg & 150 mg

1. COMPOSITION

Each tablet contains:

Ibandronic Acid 50 mg / 150 mg
Excipients: q.s.
Colour: As approved.

2. PHARMACEUTICAL FORM

Film-Coated Tablets

3. THERAPEUTIC CLASS

Bisphosphonate / Anti-resorptive Agent

4. INDICATIONS

Ibandronate is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fractures.

The 50 mg strength may be used in specific oncology indications, such as prevention of skeletal events in patients with breast cancer and bone metastases, according to the approved indication.

5. CONTRAINDICATIONS

  • Hypersensitivity to ibandronic acid or any component of the formulation.

  • Hypocalcaemia.

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

  • Inability to stand or sit upright for at least 60 minutes after taking the tablet.

  • Severe renal impairment: use is not recommended where renal function is significantly reduced.

6. DRUG INTERACTIONS

Ibandronate absorption may be reduced by:

  • Calcium supplements

  • Antacids containing calcium, magnesium or aluminium

  • Iron-containing preparations

  • Other medicines containing polyvalent cations

Food and beverages may also reduce absorption.

Take other oral medicines at a suitable interval from ibandronate as directed by the physician.

7. ADMINISTRATION

For oral use only.

150 mg Tablet

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

Take the tablet after an overnight fast and at least 60 minutes before the first food, beverage, or other oral medicine of the day.

Swallow 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 60 minutes after taking the tablet.

50 mg Tablet

The dosage and duration should be determined by the physician according to the approved indication.

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