Product image of Ossica (Ibandronate Sodium Hydrate) supplied by GNH India

Ossica

Active Ingredient:
Ibandronate Sodium Hydrate
Origin:
EU

Ossica (Ibandronate Sodium Hydrate)

Ibandronate Sodium Hydrate, the active ingredient in Ossica, is a bisphosphonate presented as a oral tablet for osteoporosis treatment in postmenopausal women and men at risk of fracture. It works by inhibiting bone resorption and increasing bone mineral density.

GNH India supplies Ossica as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Ossica is a bisphosphonate that acts on bone metabolism to reduce fracture risk in several skeletal conditions.

  • Post‑menopausal osteoporosis: improves the bone mineral density and lowers the risk of vertebral fractures.
  • Male osteoporosis: helps the increase the bone mass and decreases fracture incidence.
  • Glucocorticoid‑induced osteoporosis: mitigates the bone‑loss caused by long‑term steroid use.
  • Paget’s disease of the bone (though only in some regions off label use but recognised in guidelines for bisphosphonates).

How It Works

  • Ibandronate binds to hydroxy‑apatite crystals in bone, where it is taken up by osteoclasts during resorption. The drug inhibits farnesyl pyrophosphate synthase in the mevalonate pathway, disrupting osteoclast function and inducing apoptosis, which reduces bone turnover and increases bone mineral density.

Side Effects

Adverse reactions to ibandronate are reported across a spectrum of frequency.

Common Side Effects

  • Gastrointestinal discomfort: nausea, abdominal pain, dyspepsia.
  • Musculoskeletal pain: transient bone, joint or muscle aches.
  • Flu‑like symptoms: mild fever, chills, fatigue.
  • Headache.

Serious or Rare Side Effects

  • Osteonecrosis of the jaw (ONJ).
  • Atypical femoral fractures.
  • Severe esophagitis or esophageal ulceration.
  • Acute renal impairment.
  • Hypocalcaemia.
  • Severe allergic reactions (anaphylaxis).

Precautions & Warnings

When prescribing ibandronate, clinicians should assess patient history and monitor for specific risks.

  • Renal function: evaluate baseline creatinine and adjust use if impairment present.
  • Calcium/Vitamin D status: ensure adequate supplementation to reduce hypocalcaemia risk.
  • Gastro‑intestinal health: advise patients to remain upright for at least 30 minutes after dosing.
  • Concomitant medications: review for drugs that may affect absorption or renal function.
  • Pregnancy and lactation: contraindicated; avoid use in women who are pregnant or breastfeeding.
  • Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and direct sunlight.

Avoid Interactions

Ibandronate may interact with several drug classes; careful review is recommended.

Major Interactions (Avoid)

  • Antacids or supplements containing calcium, magnesium, aluminium, or iron: reduce ibandronate absorption.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) combined with high‑dose ibandronate: increase risk of gastrointestinal ulceration.\nModerate ...

Frequently Asked Questions

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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