Cipro Side Effects, and Drug Interactions - Ciprofloxacin

Cipro Side Effects, and Drug Interactions - Ciprofloxacin

SIDE EFFECTS

The most frequently reported events, without regard to drug relationship, among patients treated with intravenous ciprofloxacin were nausea, diarrhea, central nervous system disturbance, local I.V. site reactions, abnormalities of liver associated enzymes (hepatic enzymes), and eosinophilia. Headache, restlessness, and rash were also noted in greater than 1% of patients treated with the most common doses of ciprofloxacin.

Local I.V. site reactions have been reported with the intravenous administration of ciprofloxacin. These reactions are more frequent if the infusion time is 30 minutes or less. These may appear as local skin reactions which resolve rapidly upon completion of the infusion. Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.

Additional events, without regard to drug relationship or route of administration, that occurred in 1% or less of ciprofloxacin patients are listed below:

CARDIOVASCULAR:  cardiovascular collapse, cardiopulmonary arrest, myocardial infarction, arrhythmia, tachycardia, palpitation, cerebral thrombosis, syncope, cardiac murmur, hypertension, hypotension, angina pectoris

CENTRAL NERVOUS SYSTEM:  convulsive seizures, paranoia, toxic psychosis, depression, dysphasia, phobia, depersonalization, manic reaction, unresponsiveness, ataxia, confusion, hallucinations, dizziness, lightheadedness, paresthesia, anxiety, tremor, insomnia, nightmares, weakness, drowsiness, irritability, malaise, lethargy

GASTROINTESTINAL:  ileus, jaundice, gastrointestinal bleeding, C. difficile associated diarrhea, pseudomembranous colitis, pancreatitis, hepatic necrosis, intestinal perforation, dyspepsia, epigastric or abdominal pain, vomiting, constipation, oral ulceration, oral candidiasis, mouth dryness, anorexia, dysphagia, flatulence

I.V. INFUSION SITE:  thrombophlebitis, burning, pain, pruritus, paresthesia, erythema, swelling

MUSCULOSKELETAL:  arthralgia, jaw, arm or back pain, joint stiffness, neck and chest pain, achiness, flare up of gout

RENAL/UROGENITAL:  renal failure, interstitial nephritis, hemorrhagic cystitis, renal calculi, frequent urination, acidosis, urethral bleeding, polyuria, urinary retention, gynecomastia, candiduria, vaginitis. Crystalluria, cylindruria, hematuria, and albuminuria have also been reported.

RESPIRATORY:  respiratory arrest, pulmonary embolism, dyspnea, pulmonary edema, respiratory distress, pleural effusion, hemoptysis, epistaxis, hiccough

SKIN/HYPERSENSITIVITY:  anaphylactic reactions, erythema multiforme/Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, vasculitis, angioedema, edema of the lips, face, neck, conjunctivae, hands or lower extremities, purpura, fever, chills, flushing, pruritus, urticaria, cutaneous candidiasis, vesicles, increased perspiration, hyperpigmentation, erythema nodosum, photosensitivity (See WARNINGS.)

SPECIAL SENSES:  decreased visual acuity, blurred vision, disturbed vision (flashing lights, change in color perception, overbrightness of lights, diplopia), eye pain, anosmia, hearing loss, tinnitus, nystagmus, a bad taste

Also reported were agranulocytosis, prolongation of prothrombin time, and possible exacerbation of myasthenia gravis.

Many of these events were described as only mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment.

In several instances, nausea, vomiting, tremor, irritability, or palpitation were judged by investigators to be related to elevated serum levels of theophylline possibly as a result of drug interaction with ciprofloxacin.

In randomized, double-blind controlled clinical trials comparing ciprofloxacin (I.V. and I.V. P.O sequential) with intravenous beta-lactam control antibiotics, the CNS adverse event profile of ciprofloxacin was comparable to that of the control drugs.

Post-Marketing Adverse Events:   Additional adverse events, regardless of relationship to drug, reported from worldwide marketing experience with quinolones, including ciprofloxacin, are:

BODY AS A WHOLE: change in serum phenytoin

CARDIOVASCULAR: postural hypotension, vasculitis

CENTRAL NERVOUS SYSTEM: agitation, delirium, myoclonus, toxic psychosis

HEMIC/LYMPHATIC: hemolytic anemia, methemoglobinemia

METABOLIC/NUTRITIONAL: elevation of serum triglycerides, cholesterol, blood glucose, serum potassium

MUSCULOSKELTAL: myalgia, tendinitis/tendon rupture

RENAL/UROGENITAL: vaginal candidiasis

(See PRECAUTIONS .)

Adverse Laboratory Changes:   The most frequently reported changes in laboratory parameters with intravenous ciprofloxacin therapy, without regard to drug relationship are listed below:

Other changes occurring infrequently were: decreased leukocyte count, elevated atypical lymphocyte count, immature WBCs, elevated serum calcium, elevation of serum gamma-glutamyl transpeptidase ((gamma) GT), decreased BUN, decreased uric acid, decreased total serum protein, decreased serum albumin, decreased serum potassium, elevated serum potassium, elevated serum cholesterol.

Other changes occurring rarely during administration of ciprofloxacin were: elevation of serum amylase, decrease of blood glucose, pancytopenia, leukocytosis, elevated sedimentation rate, change in serum phenytoin, decreased prothrombin time, hemolytic anemia, and bleeding diathesis.

As with some other quinolones, concurrent administration of ciprofloxacin with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline-related adverse reactions. (See WARNINGS.) If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.

Some quinolones, including ciprofloxacin, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and prolongation of its serum half-life.

Some quinolones, including ciprofloxacin, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin.

The concomitant administration of ciprofloxacin with the sulfonylurea has, in some patients, resulted in severe hypoglycemia. Fatalities have been reported.

Quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. When these products are administered concomitantly, prothrombin time or other suitable coagulation tests should be closely monitored.

Probenecid interferes with renal tubular secretion of ciprofloxacin and produces an increase in the level of ciprofloxacin in the serum. This should be considered if patients are receiving both drugs concomitantly.

As with other broad-spectrum antimicrobial agents, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition and microbial susceptibility testing are essential. If superinfection occurs during therapy, appropriate measures should be taken.