Ciprofloxacin (Page 6 of 15)

5.17 Interference with Timely Diagnosis of Syphilis

Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Perform a serologic test for syphilis in all patients with gonorrhea at the time of diagnosis. Perform follow-up serologic test for syphilis three months after ciprofloxacin treatment.

5.18 Crystalluria

Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline [see Nonclinical Toxicology ( 13.2)]. Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Avoid alkalinity of the urine in patients receiving ciprofloxacin. Hydrate patients well to prevent the formation of highly concentrated urine [see Dosage and Administration ( 2.4)] .

5.19 Blood Glucose Disturbances

Fluoroquinolones, including ciprofloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported. If a hypoglycemic reaction occurs in a patient being treated with ciprofloxacin, discontinue ciprofloxacin and initiate appropriate therapy immediately [see Adverse Reactions ( 6.1), Drug Interactions ( 7)].

6 ADVERSE REACTIONS

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

  • Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions ( 5.1)]
  • Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2)]
  • Peripheral Neuropathy [see Warnings and Precautions ( 5.3)]
  • Central Nervous System Effects [see Warnings and Precautions ( 5.4)] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5)]
  • Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions ( 5.6)]
  • Hypersensitivity Reactions [see Warnings and Precautions ( 5.7)]
  • Hepatotoxicity [see Warnings and Precautions ( 5.8)]
  • Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9)]
  • Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions ( 5.10)]
  • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ( 5.11)]
  • Prolongation of the QT Interval [see Warnings and Precautions ( 5.12)]
  • Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.13)]
  • Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.14)]
  • Development of Drug Resistant Bacteria [see Warnings and Precautions ( 5.15)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult Patients

During clinical investigations with oral and parenteral ciprofloxacin, 49,038 patients received courses of the drug.

The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).

Table 5: Medically Important Adverse Reactions That Occurred In less than 1% of Ciprofloxacin Patients
System Organ Class Adverse Reactions

Body as a Whole

Headache

Abdominal Pain/Discomfort

Pain

Cardiovascular

Syncope

Angina Pectoris

Myocardial Infarction

Cardiopulmonary Arrest

Tachycardia

Hypotension

Central Nervous System

Restlessness

Dizziness

Insomnia

Nightmares

Hallucinations

Paranoia

Psychosis (toxic)

Manic Reaction

Irritability

Tremor

Ataxia

Seizures (including Status Epilepticus)

Malaise

Anorexia

Phobia

Depersonalization

Depression (potentially culminating in self-injurious behavior

(such as suicidal ideations/thoughts and attempted or completed suicide)

Paresthesia

Abnormal Gait

Migraine

Gastrointestinal

Intestinal Perforation

Gastrointestinal Bleeding

Cholestatic Jaundice

Hepatitis

Pancreatitis

Hemic/Lymphatic

Petechia

Metabolic/Nutritional

Hyperglycemia

Hypoglycemia

Musculoskeletal

Arthralgia

Joint Stiffness

Muscle Weakness

Renal/Urogenital

Interstitial Nephritis

Renal Failure

Respiratory

Dyspnea

Laryngeal Edema

Hemoptysis

Bronchospasm

Skin/Hypersensitivity

Anaphylactic Reactions including life-threatening anaphylactic shock

Erythema Multiforme/Stevens-Johnson Syndrome

Exfoliative Dermatitis

Toxic Epidermal Necrolysis

Pruritus

Urticaria

Photosensitivity/Phototoxicity reaction

Flushing

Fever

Angioedema

Erythema Nodosum

Sweating

Special Senses

Blurred Vision

Disturbed Vision (chromatopsia and photopsia)

Decreased Visual Acuity

Diplopia

Tinnitus

Hearing Loss

Bad Taste

In randomized, double-blind controlled clinical trials comparing ciprofloxacin tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg–500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, ciprofloxacin demonstrated a CNS adverse reaction profile comparable to the control drugs.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.