Darflox Adverse Reactions

In a total of 2936 patients evaluated for the safety Darflox, 172 episodes of adverse reactions were observed in 131 patients (4.46%). The main adverse reactions were abdominal pain, diarrhea and nausea, etc. In a total of 2584 patients, 240 changes in laboratory values were observed in 148 patients (5.73%). The main changes were increased AST (GOT) and increased ALT (GPT) etc.
Clinically Significant Adverse Reactions: Shock or anaphylactoid reaction (incidence unknown) may occur. Patients should be carefully monitored and if any symptoms eg, dyspnea, decreased blood pressure, generalized redness, urticaria or face edema occur, administration should be discontinued and appropriate measures should be taken.
Rhabdomyolysis (<0.1%) which is characterized by myalgia, feelings of weakness, increased CK (CPK) and increased myoglobin in blood or urine and is accompanied by abrupt aggravation of renal function may occur. Patients should be carefully monitored and if any abnormality is observed, administration should be discontinued and appropriate measures should be taken.
Hypoglycemia (incidence unknown) may occur. (Hypoglycemia is more frequently observed in elderly patients, patients with renal disorder or diabetes mellitus.) Patients should be carefully monitored and if any symptoms eg, depressed level of consciousness, convulsion or general malaise occur, administration should be discontinued and appropriate measures should be taken.
Clinically Significant Adverse Reactions (Similar Drugs): The following clinically significant adverse reactions (<0.1%) have been reported in patients treated with other new quinolones. Patients should be carefully monitored and if any abnormality is observed, administration should be discontinued and appropriate measures should be taken. Muco-cutaneo-ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome); pancytopenia, agranulocytosis, hemolytic anemia, thrombocytopenia; serious renal disorder eg, acute renal failure; hepatic function disorder, jaundice; ventricular tachycardia (including Torsades de pointes), QT prolongation; tendon disorder eg, Achilles tendonitis or tendon rupture (symptoms: Pain in the periphery of tendons, edema); serious colitis with bloody stool eg, pseudomembranous colitis (symptoms: Abdominal pain, frequent diarrhea, etc); interstitial pneumonia (symptoms: Fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, etc) (treatment: Administration of adrenocortical hormones); convulsion; psychiatric symptoms eg, confusion, depression, etc; vasculitis.
Others: The following adverse reactions may occur. If any abnormalities are observed, appropriate measures eg, discontinuation of administration should be taken according to the symptoms.
Hypersensitivity: <5%, ≥0.1%: Rash. <0.1%: Eczema, itching, urticaria. Incidence Unknown: Edema, photosensitivity.
Renal: <5%, ≥0.1%: Increased BUN and creatinine, hematuria.
Hepatic: <5%, ≥0.1%: Increased AST (GOT), ALT (GPT), Al-P, LDH, γ-GTP, LAP and bilirubin.
Gastrointestinal: <5%, ≥0.1%: Abdominal pain, diarrhea, nausea, vomiting, anorexia, dyspepsia, stomatitis. <0.1%: Constipation, angular stomatitis.
Hematologic: <5%, ≥0.1%: Leucopenia, thrombocytopenia, eosinophilia.
Psychoneurologic: <5%, ≥0.1%: Headache, dizziness. <0.1%: Insomnia, sleepiness.
Others: <5%, ≥0.1%: Chest pain, feelings of weakness, increased CK (CPK). <0.1%: Fever, tinnitus, dyspnea, palpitation, myalgia, malaise, hot flush, conjunctival hyperaemia.