Xolnic

Xolnic Adverse Reactions

zoledronic acid

Manufacturer:

Khandelwal Lab

Distributor:

Ni Lay Naing
Full Prescribing Info
Adverse Reactions
Hypercalcaemia of malignancy: Adverse reactions to Zoledronic acid injection are usually mild and transient and similar to those reported for other bisphosphonates. Intravenous administration has been most commonly associated with fever. Occasionally, patients experience a flulike syndrome consisting of fever, chills and bone pain and / or arthralgias, and myalgias. Gastrointestinal reactions such as nausea and vomiting have been reported following intravenous infusion of Zoledronic acid. Local reactions at the infusion site, such as redness or swelling, were observed infrequently. In most cases, no specific treatment is required and the symptoms subside after 24-48 hours.
Rare cases of rash, pruritus, and chest pain have been reported following treatment with Zoledronic acid.
As with other bisphosphonates, cases of conjunctivitis and hypomagnesaemia have been reported following treatment with Zoledronic acid.
Body as a Whole: Asthenia, chest pain, leg edema, mucositis, metastases.
Digestive System: dysphagia.
Hemic and Lymphatic System: Granulocytopenia, thrombocytopenia, pancytopenia.
Infection: non-specific infection.
Laboratory Abnormalities: Hypocalcemia.
Metabolic and Nutritional: Dehydration.
Musculoskeletal: Arthralgias.
Nervous System: Headache, somnolence.
Respiratory System: Pleural effusion.
Adverse events are listed regardless of presumed causality to study drug. Among the less frequently occurring adverse events (< 15% of patients), rigors, hypokalemia, influenza like illness, and hypocalcaemia showed a trend for more events with bisphosphonate administration compared to placebo group.
Less common adverse events reported more often with Zoledronic Acid 4mg than pamidronate included decreased weight, which was reported in 16.0% of patients in the Zoledronic acid 4mg compared with 9% in the pamidronate group. The incidence of deceased weight, however, was similar for the placebo group (12.5%) and Zoledronic acid. Decreased appetite was reported in slightly more patients in the Zoledronic acid 4mg. (13%) compared with the pamidronate (9%) and placebo 10%) groups, but the clinical significance of these small differences are not clear.
Single doses of Zoledronic acid should not exceed 4mg and the duration of the intravenous infusion should be not less than 15 minutes.
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