Prazotec Injection Adverse Reactions

Main adverse reactions included abnormal changes in laboratory data such as increase ALT (GPT) (6.2%), AST (GOT) (5.7%), LDH (2.0%), and -GTP (1.5%).
Since the following adverse reactions were observed with use of the oral formulations of lansoprazole, caution should be exercised when the intravenous formulation of this drug is administered.
Clinically significant adverse reactions: Anaphylactic reactions (generalized rash, facial edema, dyspnea, etc.) may occur (<0.1%), and shock has consequently occurred in certain cases (<0.1%). Therefore, close observation should be made, and if any abnormality is observed, Prazotec Injection 30 mg should be discontinued and appropriate measures taken.
Pancytopenia, agranulocytosis or hemolytic anemia may occur (<0.1%). Granulocytopenia, thrombocytopenia or anemia may occur (0.1%-<5%). Therefore, close observation should be made, and if any abnormality is observed, such appropriate measures as discontinuation of Prazotec Injection 30 mg should be taken.
Severe hepatic dysfunction with jaundice, increased AST (GOT), ALT (GPT), etc., may occur (0.1%). Therefore, close observation should be made. If any abnormality is observed, Prazotec Injection 30 mg should be discontinued and appropriate measures taken.
Toxic epidermal necrolysis (Lyell syndrome) and oculomucocutaneous syndrome (Stevens-Johnson syndrome) (<0.1%) may occur. Therefore, close observation should be made, if any abnormality is observed, Prazotec Injection 30 mg should be discontinued and appropriate measures taken.
Interstitial pneumonia (<0.1%) may occur. Therefore, if fever, coughing, dyspnea, abnormal lung sound (crepitation), etc., are observed, such examinations as chest X-ray should immediately be performed, and Prazotec Injection 30 mg should be discontinued. Appropriate measures, such as treatment with a corticosteroid preparation, should be taken.
Interstitial nephritis (frequency unknown) may occur, resulting in acute renal failure in some cases. Therefore, pay attention to renal function test values (increases in BUN, creatinine, etc), and if any abnormality is observed, Prazotec Injection 30 mg should be discontinued and appropriate measures taken.
Other adverse reactions: If any of the following adverse reactions is observed, appropriate measures such as discontinuation of Prazotec Injection 30 mg should be taken. (See Table 3.)


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