Regpara Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

The following adverse reactions may occur. Patients must therefore be carefully monitored. If any abnormalities are observed, appropriate measures should be taken, including discontinuing administration.
Clinically Significant Adverse Reactions: Hypocalcemia/decreased serum calcium (13.7%): If symptoms considered attributable to hypocalcemia (prolonged QT interval, numbness, cramping, feeling unwell, arrhythmia, decreased blood pressure, seizure, etc.) occur, the serum calcium level should be confirmed, and administration of calcium or vitamin D preparations considered. (See "Precautions related to dosage and administration" under Dosage & Administration, "Important Precautions" under Precautions, "Precautions Concerning Patients with Specific Backgrounds" under Precautions, and Overdosage and see as follows.)
Prolonged QT interval (5.3%): (See as previously mentioned).
Gastrointestinal hemorrhage, gastrointestinal ulcer (incidence unknown): (See "Precautions Concerning Patients with Specific Backgrounds" under Precautions).
Decreased level of consciousness (0.2%), temporary loss of consciousness (0.2%).
Sudden death (0.3%): Unexplained sudden death has been reported in patientstreated with Regpara.
Other adverse reactions: (See Table 5.)

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View ADR Monitoring Form

Manufacturer:

Kyowa Kirin Asia Pacific

Distributor:

Steward Cross