Ciprofloxacin IV
Name: Ciprofloxacin IV
- Ciprofloxacin IV injection
- Ciprofloxacin IV dosage
- Ciprofloxacin IV drug
- Ciprofloxacin IV 125mg
- Ciprofloxacin IV when to take
- Ciprofloxacin IV side effects
- Ciprofloxacin IV serious side effects
- Ciprofloxacin IV tablet
- Ciprofloxacin IV effects of
Description
CIPRO IV (ciprofloxacin) is a synthetic antimicrobial agent for intravenous (IV) administration. Ciprofloxacin, a fluoroquinolone, is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1piperazinyl)-3quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its chemical structure is:
Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 331.4. It is soluble in dilute (0.1N) hydrochloric acid and is practically insoluble in water and ethanol. CIPRO IV solutions are available as sterile 0.2% ready-for-use infusion solutions in 5% Dextrose Injection. CIPRO IV contains lactic acid as a solubilizing agent and hydrochloric acid for pH adjustment. The pH range for the 0.2% ready-for-use infusion solutions is 3.5 to 4.6.
The plastic container is not made with natural rubber latex.. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, for example, di(2-ethylhexyl) phthalate (DEHP), up to 5 parts per million. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
The glucose content for the 200 mL flexible container is 10 g.
Side effects
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Tendon Effects [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Myasthenia Gravis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Other Serious and Sometimes Fatal Reactions [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Serious Adverse Reactions with Concomitant Theophylline [see WARNINGS AND PRECAUTIONS]
- Central Nervous System Effects [see WARNINGS AND PRECAUTIONS]
- Clostridium Difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
- Prolongation of the QT Interval [see WARNINGS AND PRECAUTIONS]
- Musculoskeletal Disorders in Pediatric Patients [see WARNINGS AND PRECAUTIONS]
- Photosensitivity/Phototoxicity [see WARNINGS AND PRECAUTIONS]
- Development of Drug Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
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 CIPRO IV, 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%).
In clinical trials the following adverse reactions were reported in greater than 1% of patients treated with intravenous CIPRO IV: nausea, diarrhea, central nervous system disturbance, local intravenous site reactions, liver function tests abnormal, eosinophilia, headache, restlessness, and rash. Local intravenous site reactions are more frequent if the infusion time is 30 minutes or less. These may appear as local skin reactions that resolve rapidly upon completion of the infusion. Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.
Table 5: Medically Important Adverse Reactions That Occurred in less than 1% Ciprofloxacin Patients
| System Organ Class | Adverse Reactions |
| Body as a Whole | Abdominal Pain/Discomfort Pain |
| Cardiovascular | Cardiopulmonary Arrest Myocardial Infarction Tachycardia Syncope Hypertension Angina Pectoris Vasodilation |
| Central Nervous System | Restlessness Seizures (including Status Epilepticus) Paranoia Psychosis (toxic) Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide) Phobia Depersonalization Manic Reaction Unresponsiveness Ataxia Hallucinations Dizziness Paresthesia Tremor Insomnia Nightmares Irritability Malaise Abnormal Gait Migraine |
| Gastrointestinal | Ileus Gastrointestinal Bleeding Pancreatitis Hepatic Necrosis Intestinal Perforation Dyspepsia Constipation Oral Ulceration Mouth Dryness Anorexia Flatulence Hepatitis |
| Hemic/Lymphatic | Agranulocytosis Prolongation of Prothrombin Time Petechia |
| Metabolic/Nutritional | Hyperglycemia Hypoglycemia |
| Musculoskeletal | Arthralgia Joint Stiffness Muscle Weakness |
| Ren al/U rogenital | Renal Failure Interstitial Nephritis Hemorrhagic Cystitis Renal Calculi Frequent Urination Gynecomastia Crystalluria Cylindruria Hematuria Albuminuria |
| Respiratory | Respiratory Arrest Dyspnea Laryngeal Edema Hemoptysis Bronchospasm |
| Skin/Hypersensitivity | Allergic Reactions Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson Syndrome Exfoliative Dermatitis Toxic Epidermal Necrolysis Vasculitis Angioedema |
| extremities Purpura Fever Pruritus Urticaria Increased Perspiration Erythema Nodosum Thrombophlebitis Burning Photosensitivity/Phototoxicity Reaction | |
| Special Senses | Decreased Visual Acuity Blurred Vision Disturbed Vision (diplopia, chromatopsia, and photopsia) Anosmia Hearing Loss Tinnitus Nystagmus Bad Taste |
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 CIPRO (Intravenous and Intravenous/Oral. sequential) with intravenous beta-lactam control antibiotics, the CNS adverse reaction profile of CIPRO was comparable to that of the control drugs.
Pediatric Patients
Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous ciprofloxacin was compared to a cephalosporin for treatment of cUTI or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years) in an international multicenter trial. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). A total of 335 ciprofloxacin-and 349 comparator-treated patients were enrolled.
An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse reactions including abnormal gait or abnormal joint exam (baseline or treatment-emergent). Within 6 weeks of treatment initiation, the rates of musculoskeletal adverse reactions were 9.3% (31/335) in the ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients. All musculoskeletal adverse reactions occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment. Radiological evaluations were not routinely used to confirm resolution of the adverse reactions. Ciprofloxacin-treated patients were more likely to report more than one adverse reaction and on more than one occasion compared to control patients. The rate of musculoskeletal adverse reactions was consistently higher in the ciprofloxacin group compared to the control group across all age subgroups. At the end of 1 year, the rate of these adverse reactions reported at any time during that period was 13.7% (46/335) in the ciprofloxacin-treated group versus 9.5% (33/349) in the comparator-treated patients (Table 6).
Table 6: Musculoskeletal Adverse Reactions1 as Assessed by the IPSC
| CIPRO | Comparator | |
| All Patients (within 6 weeks) | 31/335 (9.3%)
OverdoseIn the event of acute overdosage, reversible renal toxicity has been reported in some cases. Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria. Adequate hydration must be maintained. Only a small amount of ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis. In mice, rats, rabbits and dogs, significant toxicity including tonic/clonic convulsions was observed at intravenous doses of ciprofloxacin between 125mg/kg and 300 mg/kg. Patient informationCIPRO® CIPRO® CIPRO®XR CIPRO®IV Read this Medication Guide before you start taking CIPRO and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about CIPRO? CIPRO, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects could result in death. If you get any of the following serious side effects while you take CIPRO, get medical help right away. Talk with your healthcare provider about whether you should continue to take CIPRO. 1. Tendon rupture or swelling of the tendon (tendinitis).
2. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like CIPRO may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems. See “What are the possible side effects of CIPRO?” What is CIPRO? CIPRO is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
Who should not take CIPRO? Do not take CIPRO if you:
Ask your healthcare provider if you are not sure. What should I tell my healthcare provider before taking CIPRO? Before you take CIPRO, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CIPRO and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:
Ask your healthcare provider for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take CIPRO?
What should I avoid while taking CIPRO?
What are the possible side effects of CIPRO? CIPRO may cause serious side effects, including:
The most common side effects of CIPRO include:
Tell your healthcare provider about any side effect that bothers you, or that does not go away. These are not all the possible side effects of CIPRO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088. How should I store CIPRO? CIPRO Tablets
CIPRO Oral Suspension
CIPRO XR
Keep CIPRO and all medicines out of the reach of children. General Information about the safe and effective use of CIPRO. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIPRO for a condition for which it is not prescribed. Do not give CIPRO to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about CIPRO. If you would like more information about CIPRO, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIPRO that is written for healthcare professionals. For more information call 1-888-842-2937. What are the ingredients in CIPRO? CIPRO Tablets:
CIPRO Oral Suspension:
CIPRO XR:
CIPRO IV:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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