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Cipro IV

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Cipro I.V.




Cipro IV Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cipro I.V. (ciprofloxacin) is used to treat a variety of bacterial infections. It is a quinolone antibiotic. This medication is available in generic form. Common side effects include diarrhea, nausea, dizziness, or lightheadedness.

The dosage of Cipro I.V. is individualized and takes into consideration the severity and nature of the infection, among other factors. Cipro I.V. may interact with clozapine, corticosteroids, cyclosporine, duloxetine, glyburide, methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs), phenytoin, probenecid, ropinirole, theophylline, tizanidine, live bacterial vaccines, warfarin, amiodarone, dofetilide, quinidine, procainamide, sotalol, macrolide antibiotics, antipsychotic medications, isoniazid, phenothiazines, theophylline, or tricyclic antidepressants. Tell your doctor all medications and supplements you use. During pregnancy, Cipro I.V. should be used only when prescribed. Some antibiotics may decrease the effectiveness of hormonal birth control (i.e. pills, patch, or ring). Consult your doctor about birth control. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Cipro I.V. (ciprofloxacin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cipro IV Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Diarrhea, nausea, dizziness, or lightheadedness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: sunburn-like skin reaction (sun sensitivity), redness/swelling/pain at the injection site, unusual change in the amount of urine, easy or unusual bruising/bleeding, signs of a new infection (such as new/persistent fever, persistent sore throat), signs of liver problems (such as unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: severe/persistent headache, vision changes, shaking (tremors), seizures, severe dizziness, fainting, chest pain, fast/irregular heartbeat, mental/mood changes (such as anxiety, confusion, hallucinations, depression, rare thoughts of suicide).

Rarely, this medication may cause serious, possibly permanent, nerve problems (peripheral neuropathy). Stop taking ciprofloxacin and tell your doctor right away if you have any of the following symptoms: pain/numbness/burning/tingling/weakness in your arms, hands, legs, or feet, changes in how you sense touch/pain/temperature/vibration/body position.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cipro IV (Ciprofloxacin IV)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cipro IV FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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%) 21/349 (6%)
95% Confidence Interval2
(-0.8%, +7.2%)
Age Group
12 months to 24 months 1/36 (2.8%) 0/41
2 years to < 6 years 5/124 (4%) 3/118 (2.5%)
6 years to < 12 years 18/143 (12.6%) 12/153 (7.8%)
12 years to 17 years 7/32 (21.9%) 6/37 (16.2 %)
All Patients (within 1 year) 46/335 (13.7%) 33/349 (9.5%)
95% Confidence Interval2
(-0.6%, + 9.1%)
1Included: arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint (knee, elbow, ankle, hip, wrist, and shoulder)
2The study was designed to demonstrate that the arthropathy rate for the CIPRO group did not exceed that of the control group by more than + 6%. At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that the ciprofloxacin group had findings comparable to the control group.

The incidence rates of neurological adverse reactions within 6 weeks of treatment initiation were 3% (9/335) in the ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.

In this trial, the overall incidence rates of adverse reactions within 6 weeks of treatment initiation were 41% (138/335) in the ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent adverse reactions were gastrointestinal: 15% (50/335) of ciprofloxacin patients compared to 9% (31/349) of comparator patients. Serious adverse reactions were seen in 7.5% (25/335) of ciprofloxacintreated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse reaction was observed in 3% (10/335) of ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse events that occurred in at least 1% of ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.

Short-term safety data for ciprofloxacin was also collected in a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5-17 years). Sixty seven patients received CIPRO IV 10 mg/kg/dose every 8 hours for one week followed by CIPRO tablets 20 mg/kg/dose every 12 hours to complete 10-21 days treatment and 62 patients received the combination of ceftazidime intravenous 50 mg/kg/dose every 8 hours and tobramycin intravenous 3 mg/kg/dose every 8 hours for a total of 10-21 days. Periodic musculoskeletal assessments were conducted by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0- 93 days). Musculoskeletal adverse reactions were reported in 22% of the patients in the ciprofloxacin group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the ciprofloxacin group and 11% in the comparison group. Other adverse reactions were similar in nature and frequency between treatment arms. The efficacy of CIPRO for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established.

In addition to the adverse reactions reported in pediatric patients in clinical trials, it should be expected that adverse reactions reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.

Postmarketing Experience

The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO IV. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 7).

Table 7: Postmarketing Reports of Adverse Drug Reactions

System Organ Class Adverse Reactions
Cardiovascular QT prolongation
Torsade de Pointes
Vasculitis and ventricular arrhythmia
Central Nervous System Hypertonia
Myasthenia
Exacerbation of myasthenia gravis
Peripheral neuropathy
Polyneuropathy
Twitching
Eye Disorders Nystagmus
Gastrointestinal Pseudomembranous colitis
Hemic/Lymphatic Pancytopenia (life threatening or fatal outcome)
Methemoglobinemia
Hepatobiliary Hepatic failure (including fatal cases)
Infections and Infestations Candidiasis (oral, gastrointestinal, vaginal)
Investigations Prothrombin time prolongation or decrease
Cholesterol elevation (serum)
Potassium elevation (serum)
Musculoskeletal Myalgia
Myoclonus
Tendinitis
Tendon rupture
Psychiatric Disorders Agitation
Confusion
Delirium
Skin/Hypersensitivity Acute generalize exanthematous pustulosis (AGEP)
Fixed eruption Serum sickness-like reaction
Special Senses Anosmia
Hyperesthesia
Hypesthesia
Taste loss

Adverse Laboratory Changes

Changes in laboratory parameters while on CIPRO IV therapy are listed below:

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

Read the entire FDA prescribing information for Cipro IV (Ciprofloxacin IV)

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Cipro I.V. - User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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