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 clinical events
The events with the highest incidence ( ≥ 1%) in patients,
regardless of relationship to drug, were headache (3.6%), nausea (3.5%), photosensitivity
(2.3%) [see WARNINGS], dizziness (2.1%), diarrhea (1.4%), and abdominal
Additional clinical events reported in < 1% of patients
treated with Maxaquin, regardless of relationship to drug, are listed below:
Autonomic: increased sweating, dry mouth, flushing,
Body as a whole: fatigue, back pain, malaise,
asthenia, chest pain, face edema, hot flashes, influenza-like symptoms, edema,
chills, allergic reaction, anaphylactoid reaction, decreased heat tolerance.
Cardiovascular: tachycardia, hypertension,
hypotension, myocardial infarction, angina pectoris, cardiac failure,
bradycardia, arrhythmia, phlebitis, pulmonary embolism, extrasystoles,
cerebrovascular disorder, cyanosis, cardiomyopathy.
Central and peripheral nervous system: tremor,
vertigo, paresthesias, twitching, hypertonia, convulsions, hyperkinesia, coma.
Gastrointestinal: dyspepsia, vomiting, flatulence,
constipation, gastrointestinal bleeding, dysphagia, stomatitis, tongue
discoloration, gastrointestinal inflammation.
Hearing: earache, tinnitus.
Hematologic: purpura, lymphadenopathy,
thrombocythemia, anemia, thrombocytopenia, increased fibrinolysis.
Hepatic: abnormal liver function.
Metabolic: thirst, hyperglycemia, hypoglycemia, gout.
Musculoskeletal: arthralgia, myalgia, leg cramps.
Ophthalmologic: abnormal vision, conjunctivitis,
photophobia, eye pain, abnormal lacrimation.
Psychiatric: insomnia, nervousness, somnolence,
anorexia, depression, confusion, agitation, increased appetite,
depersonalization, paranoid reaction, anxiety, paroniria, abnormal thinking,
Reproductive system: Female: vaginal moniliasis,
vaginitis, leukorrhea, menstrual disorder, perineal pain, intermenstrual
bleeding. Male: epididymitis, orchitis.
Resistance mechanism: viral infection, moniliasis,
Respiratory: respiratory infection, rhinitis,
pharyngitis, dyspnea, cough, epistaxis, bronchospasm, respiratory disorder,
increased sputum, stridor, respiratory depression.
Skin/Allergic: pruritus, rash, urticaria, skin
exfoliation, bullous eruption, eczema, skin disorder, acne, skin discoloration,
skin ulceration, angioedema. (See also Body as a whole.)
Special senses: taste perversion.
Urinary: hematuria, micturition disorder, dysuria,
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,
Post-Marketing Adverse Events
Post-marketing adverse events
Adverse events reported from worldwide marketing experience
with lomefloxacin are: anaphylaxis, cardiopulmonary arrest, laryngeal or
pulmonary edema, ataxia, cerebral thrombosis, hallucinations, painful oral
mucosa, pseudomembranous colitis, hemolytic anemia, hepatitis, tendinitis,
diplopia, photophobia, phobia, exfoliative dermatitis, hyperpigmentation, Stevens-Johnson
syndrome, toxic epidermal necrolysis, dysgeusia, interstitial nephritis,
polyuria, renal failure, urinary retention, and vasculitis.
Quinolone-class adverse events
Additional quinolone-class adverse events include:
peripheral neuropathy, torsades de pointes, erythema nodosum, hepatic necrosis,
possible exacerbation of myasthenia gravis, dysphasia, nystagmus, intestinal
perforation, 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