Isn't that reg Cipro?
SIDE EFFECTS
Oral
During clinical investigation with the tablet, 2799 patients received 2868 courses of the drug. Adverse events that were considered likely to be drug related occurred in 7.3% of patients treated, possibly related in 9.2% (total of 16.5% thought to be possibly or probably related to drug therapy), and remotely related in 3.0%. Ciprofloxacin was discontinued because of an adverse event in 3.5% of patients treated, primarily involving the gastrointestinal system (1.5%), skin (0.6%) and central nervous system (0.4%).
The most frequently reported events, drug related or not, were nausea (5.2%), diarrhea (2.3%), vomiting (2.0%), abdominal pain/discomfort (1.7%), headache (1.2%), restlessness (1.1%) and rash (1.1%).
Additional Events That Occurred in Less Than 1% of Ciprofloxacin Patients:
Cardiovascular: Palpitation, atrial flutter, ventricular ectopy, syncope, hypertension, angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thromobosis
Central Nervous System: Dizziness, lightheadedness, insomnia, nightmares, hallucinations, manic reaction, irritability, tremor, ataxia, convulsive seizures, lethargy, drowsiness, weakness, malaise, anorexia, phobia, depersonalization, depression, paresthesia. (See above.) (See PRECAUTIONS.)
Gastrointestinal: Painful oral mucosa, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding. (See above.) Cholestatic jaundice has been reported.
Musculoskeletal: Arthralgia, jaw, arm or back pain, joint stiffness, neck and chest pain, achiness, flare up of gout
Renal/Urogenital: Interstitial nephritis, nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginitis, acidosis.
Respiratory: Dyspnea, epistaxis, laryngeal or pulmonary edema, hiccough, hemophysis, bronchospasm, pulmonary embolism.
Skin/Hypersensitivity: Pruritus, urticaria, photosensitivity, flushing, fever, chills, angioedema, edema of the face, neck, lips, conjunctivae or hands, cutaneous candidiasis, hyperpigmentation, erytherna nodosum. (See above.) Allergic reactions ranging from urticaria to anaphylactic reactions have been reported. (See WARNINGS.)
Special Senses: Blurred vision, disturbed vision (change in color perception, overbrightness of lights), decreased visual acuity, diplopia, eye pain, tinnitus, hearing loss, bad taste.
Most of the adverse events reported 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 domestic clinical trials involving 214 patients receiving a single 250-mg oral dose, approximately 5% of patients reported adverse experiences without reference to drug relationship. The most common adverse experiences were vaginitis (2%), headache (1%), and vaginal pruritus (1%). Additional reactions, occurring in 0.3%-1% of patients, were abdominal discomfort, lymphadenopathy, foot pain, dizziness, and breast pain. Less than 20% of these patients had laboratory values obtained, and these results were generally consistent with the pattern noted for multi-dose therapy.
In randomized, double-blind controlled clinical trials comparing ciprofloxacin HCl tablets (500 mg b.i.d.) to cefuroxime axetil (250 mg - 500 mg b.i.d.) and to clarithromycin (500 mg b.i.d.) in patients with respiratory tract infections, ciprofloxacin demonstrated a CNS adverse event profile comparable to the control drugs.
I.V.
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 eosinophila. 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. difficle 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, intarstitial nephritis, hemorrhagic cystitis, renal calcuti, frequent urination, acidosis, urethral bleeding, polyuria, urinary retention, gynecomastia, candiduria, vaginitis. Crystalluria, cylindruria, hematuria, and albuminutia 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, urtigaria, cutaneous candidiasis, vesicles, increased perspiration, hyperpigmentation, erythema nodosum, photosensitivity. Allergic reactions ranging from urticaria to anaphylactic reactions have been reported. (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.Q., 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
Oral and I.V.
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, confusion, delirium, dysphasia, myoclonus, nystagmus, toxic psychosis.
Gastrointestinal: Constipation, dyspepsia, flatulence, hepatic necrosis, jaundice, pancreatitis, pseudomembranous colitis. (The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.)
Hemic/Lymphatic: Agranulocytosis, hemolytic anemia, methemaglobinemia, prolongation of prothrombin time.
Metabolic/Nutritional: Elevation of serum triglycerides, cholesterol, blood glucose, serum potassium.
Musculoskeletal: Myalgia, possible exacerbation of myasthenia gravis, tendinitis/tendon rupture.
Renal/Urogenital: Albuminuria, candiduria, renal calculi, vaginal candidiasis.
Skin/Hypersensitivity: Anaphylactic reactions, erythema multiforme/Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis.
Special Senses: Anosmia, taste loss. (See PRECAUTIONS.)
Adverse Laboratory Changes
Oral
Changes in Laboratory Parameters Listed as Adverse Events Without Regard to Drug Relationship:
Hepatic: Elevations of ALT (SGPT) (1.9%), AST (SGOT) (1.7%), alkaline phosphatase (0.8%), LDH (0.4%), serum bilirubin (0.3%).
Hematologic: Eosinophilia (0.6%), leukopenia (0.4%), decreased blood platelets (0.1%), elevated blood platelets (0.1%), pancytopenia (0.1%).
Renal: Elevations of serum creatinine (1.1%), BUN (0.9%), CRYSTALLURIA, CYLINDRURIA, AND HEMATURIA HAVE BEEN REPORTED.
Other Changes Occurring in Less than 0.1% of Courses Were: Elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, leukocytosis.
I.V.
The most frequently reported changes in laboratory parameters with intravenous ciprofloxacin therapy, without regard to drug relationship are listed below:
Hepatic: Elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, LDH, and serum bilirubin.
Hematologic: Elevated eosinophil and platelet counts, decreased platelet counts, hemoglobin and/or hematocrit.
Renal: Elevations of serum creatinine, BUN, and uric acid.
Other: Elevations of serum creatinine, phosphokinase, serum theophylline (in patients receiving theophylline concomitantly), blood glucose, and triglycerides.
Other changes occurring infrequently were: decreased leukocyte count, elevated atypical lymphocyte count, immature WBCs, elevated serum calcium, elevation of serum gamma-glutamyl transpeptidose (g GI), 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.