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MAXAQUIN (LOMEFLOXACIN HYDROCHLORIDE) TABLETS: ADVERSE REACTIONS

In clinical trials, most of the adverse events reported were mild to moderate in severity and transient in nature. During these clinical investigations, 5,623 patients received Maxaquin. In 2.2% of the patients, lomefloxacin was discontinued because of adverse events, primarily involving the gastrointestinal system (0.7%), skin (0.7%), or CNS (0.5%).

Adverse laboratory events

Changes in laboratory parameters, listed as adverse events, without regard to drug relationship include:

Hematologic: monocytosis (0.2%), eosinophilia (0.1%), leukopenia (0.1%), leukocytosis (0.1%).

Renal: elevated BUN (0.1%), decreased potassium (0.1%), increased creatinine (0.1%).

Hepatic: elevations of ALT (SGPT) (0.4%), AST (SGOT) (0.3%), bilirubin (0.1%), alkaline phosphatase (0.1%).

Additional laboratory changes occurring in < 0.1% in the clinical studies included: elevation of serum gamma glutamyl transferase, decrease in total protein or albumin, prolongation of prothrombin time, anemia, decrease in hemoglobin, thrombocythemia, thrombocytopenia, abnormalities of urine specific gravity or serum electrolytes, increased albumin, elevated ESR, albuminuria, macrocytosis.

Post-Marketing Adverse Events

Adverse events reported from worldwide marketing experience with Lomefloxacin Hydrochloride (Maxaquin) pills are: cardiopulmonary arrest, anaphylaxis, laryngeal or pulmonary edema, cerebral thrombosis, ataxia, hallucinations, pseudomembranous colitis, painful oral mucosa, hemolytic anemia, tendinitis, hepatitis, diplopia, phobia, photophobia, exfoliative dermatitis, Stevens-Johnson syndrome, hyperpigmentation, toxic epidermal necrolysis, interstitial nephritis, dysgeusia, polyuria, renal failure, urinary retention, and vasculitis.

Quinolone-class adverse events

Additional quinolone-class adverse events include: torsades de pointes, peripheral neuropathy, erythema nodosum, possible exacerbation of myasthenia gravis, hepatic necrosis, dysphasia, intestinal perforation, nystagmus, manic reaction, renal calculi, acidosis and hiccough.

Laboratory adverse events include: agranulocytosis, elevation of serum triglycerides, elevation of serum cholesterol, elevation of blood glucose, elevation of serum potassium, albuminuria, candiduria, and crystalluria.



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