Drugs List

Therapeutic Indications

Uses

Bone and joint infection
Complicated urinary tract infections
Gastrointestinal tract infection
Genital-tract infections
Infections in neutropenic patients
Inhalation anthrax
Pseudomonal lower respiratory tract infection in cystic fibrosis
Respiratory tract infections - upper and lower
Severe systemic infections
Skin and soft tissue infections

Treatment of antibiotic sensitive infections in adults including:

Respiratory tract infections due to Gram-negative bacteria:
Chronic obstructive pulmonary disease exacerbation
Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
Pneumonia
Chronic suppurative otitis media
Acute exacerbation of chronic sinusitis
Malignant external otitis

Genital and Urinary tract infections: (Consider local prevalence of resistance)
Pyelonephritis
Prostatitis
Epididymo-orchitis
Pelvic inflammatory diseases

Gastrointestinal tract and intra-abdominal infections:
Infective diarrhoea
Intra-abdominal infections due to Gram-negative bacteria
Typhoid fever

Infection of the skin and soft tissue

Bone and joint infections

Infections of neutropenic patients

Inhalation anthrax:
Post-exposure prophylaxis and curative treatment

Prophylaxis in adults:
Prophylaxis of infections in neutropenic patients.

Children under 18 years:
Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
Complicated urinary tract infections and pyelonephritis
Inhalation anthrax (post exposure prophylaxis and curative treatment)

Treatment of severe infections in children under 18 years when necessary

Unlicensed Uses

Cutaneous anthrax
Gastrointestinal anthrax

Administration

For intravenous infusion.

The solution should be administered by intravenous infusion over a period 60 minutes in children. In adults, the 400mg/200ml should be administered over 60 minutes and the 200mg/100ml should be administered over 30 minutes.

Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.

Contraindications

History of tendon disorder secondary to quinolone use
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children under 18 years
Family history of long QT syndrome
Organ transplant recipients
Patients over 60 years
Predisposition to aortic aneurysm
Predisposition to aortic dissection
Restricted sodium intake
Aortic aneurysm
Aortic dissection
Breastfeeding
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
G6PD deficiency
History of seizures
History of torsade de pointes
Myasthenia gravis
Pregnancy
Renal impairment

Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Monitor for haemolysis in G6PD deficiency
Reduce dose in patients with creatinine clearance below 60ml/min
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Children under 18: Treatment to be initiated/supervised by a specialist
Consult national/regional policy on the use of anti-infectives
Ensure patient has adequate fluid intake
Perform ECG before and during treatment
Avoid excessive alkalinity of the urine
Discontinue at first sign of pain/inflammation of limb(possible tendonitis)
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for hypersensitivity reactions during infusion
Monitor for symptoms of peripheral neuropathy
Monitor serum electrolytes
Advise patient to report any blurred vision or any other eye symptoms
Advise patient to report any changes in vision, taste, smell or hearing
Advise patient to report signs of neuropathy
Advise patient to report signs of tendinitis
Advise patient to report tiredness, mood, memory or sleep disturbances
Advise patient to rest affected limb if tendonitis occurs
Advise patient to seek medical advice if joint aches or pain occur
Advise patients to report muscle pain/tenderness/weakness
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Consider pseudomembranous colitis if patient presents with diarrhoea
Crystalluria may occur
Discontinue if central nervous disturbances occur
May cause convulsions
Patients over 60 years are prone to tendon inflammation
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Prolonged use may result in superinfection with non-susceptible organisms
Refer immediately visual disturbances to a specialist
May produce false negative test for Mycobacterium tuberculosis
Discontinue at once if pseudomembranous colitis occurs
Discontinue if convulsions occur
Discontinue if hypersensitivity reactions occur
Discontinue if peripheral neuropathy occurs
Discontinue if photosensitivity occurs
Discontinue if symptoms of hepatic disease occur
Discontinue in patients showing suicidal behaviour
Avoid excessive exposure to sunlight
Avoid excessive exposure to UV light

Use of ciprofloxacin in children under 18 years should follow available official guidance. Ciprofloxacin treatment should be initiated by a physician experienced in management of cystic fibrosis and/or severe infections in children under 18 years. Ciprofloxacin, like other quinolones, has been shown to cause arthropathy in weight-bearing joints of immature animals. Drug related arthropathy has been reported in studies regarding the use of ciprofloxacin in children.

There is an increased risk of aortic aneurysm and dissection following treatment with ciprofloxacin. Use ciprofloxacin only after careful benefit risk assessment in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and or aortic dissection, or in the presence of other risk factors or conditions predisposing for aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arthritis, Behcet's disease, hypertension, known atherosclerosis.)

Disabling, long-lasting and potentially irreversible adverse reactions mainly affecting musculoskeletal and nervous systems have been reported with quinolone and fluoroquinolone antibiotics. Treatment should be discontinued at the first signs of a serious adverse reaction such as tendinitis, pain or inflammation.

Pregnancy and Lactation

Pregnancy

Use ciprofloxacin with caution during pregnancy.

The manufacturer does not recommend using ciprofloxacin during pregnancy.

Based on limited amount of human data, the use of fluoroquinolones in the first trimester of pregnancy has not been associated with an increased risk of major malformations or other adverse effects on pregnancy outcome.

Ciprofloxacin has been shown to cause arthropathy in immature animals. Reproduction studies in rats and rabbits did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri- and post-natal development. Animal studies do not entirely exclude the risk of damage to the cartilage of joints in the growing subject.

Schaefer (2015) suggests quinolones should only be used in case of complicated infections resistant to the antibiotics of choice in pregnancy. Ciprofloxacin and norfloxacin have a relatively large amount of documented experience. Even the first trimester use of a quinolone antibiotic is not an indication for termination of pregnancy, but detailed foetal ultrasonography can be offered.

Lactation

Use ciprofloxacin with caution during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking ciprofloxacin.

Quinolones have been shown to cause arthropathy in animal studies.

Ciprofloxacin is excreted into breast milk. Avoiding breastfeeding for 3 to 4 hours after a dose should decrease the exposure of the infant to ciprofloxacin in breast milk.

Schaefer (2015) suggests as a rule, a standard antibiotic with a lower potential for risk can be substituted for the use of quinolones.

Side Effects

Acute generalised exanthematous pustulosis
Agitation
Agranulocytosis
Allergic reaction
Anaemia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Anxiety
Arrhythmias
Arthralgia
Arthritis
Arthropathy
Asthenia
Bone marrow depression
Confusion
Convulsions
Crystalluria
Decreased appetite
Depression
Diarrhoea
Disorientation
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dysaesthesia
Dyspnoea
Elevated amylase levels
Eosinophilia
Erythema multiforme
Erythema nodosum
Exacerbation of myasthenia gravis
Fever
Gait abnormality
Gastro-intestinal disturbances
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatic impairment
Hepatic necrosis
Hepatitis
Hot flushes
Hyperglycaemia
Hypoaesthesia
Hypoglycaemia
Hypotension
Increase in alkaline phosphatase
Increase in serum transaminases
Injection site reactions
Interstitial nephritis
Intracranial hypertension
Jaundice
Leucocytosis
Leucopenia
Migraine
Muscle weakness
Musculoskeletal pain
Myalgia
Nausea
Neutropenia
Oedema
Pain
Pancreatitis
Pancytopenia
Paraesthesia
Peripheral neuropathy
Petechiae
Photosensitivity
Prolongation of QT interval
Pruritus
Pseudomembranous colitis
Psychoses
Rash
Renal failure
Renal impairment
Serum bilirubin increased
Serum sickness-like reactions
Sleep disturbances
Smelling disturbances
Stevens-Johnson syndrome
Suicidal tendencies
Superinfections
Sweating
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon rupture
Thrombocythaemia
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Tremor
Urticaria
Vasculitis
Vasodilation
Vertigo
Visual disturbances

Presentation

Infusions of ciprofloxacin in sodium chloride.

Drugs List

Therapeutic Indications

Uses

Bone and joint infection
Complicated urinary tract infections
Gastrointestinal tract infection
Genital-tract infections
Infections in neutropenic patients
Inhalation anthrax
Pseudomonal lower respiratory tract infection in cystic fibrosis
Respiratory tract infections - upper and lower
Severe systemic infections
Skin and soft tissue infections

Treatment of antibiotic sensitive infections in adults including:

Respiratory tract infections due to Gram-negative bacteria:
Chronic obstructive pulmonary disease exacerbation
Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
Pneumonia
Chronic suppurative otitis media
Acute exacerbation of chronic sinusitis
Malignant external otitis

Genital and Urinary tract infections: (Consider local prevalence of resistance)
Pyelonephritis
Prostatitis
Epididymo-orchitis
Pelvic inflammatory diseases

Gastrointestinal tract and intra-abdominal infections:
Infective diarrhoea
Intra-abdominal infections due to Gram-negative bacteria
Typhoid fever

Infection of the skin and soft tissue

Bone and joint infections

Infections of neutropenic patients

Inhalation anthrax:
Post-exposure prophylaxis and curative treatment

Prophylaxis in adults:
Prophylaxis of infections in neutropenic patients.

Children under 18 years:
Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
Complicated urinary tract infections and pyelonephritis
Inhalation anthrax (post exposure prophylaxis and curative treatment)

Treatment of severe infections in children under 18 years when necessary

Unlicensed Uses

Cutaneous anthrax
Gastrointestinal anthrax

Dosage

The dose is determined by the severity and site of infection, the sensitivity of the causative organisms, the renal function of the patient, and in children and adolescents the body weight.

The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.

Treatment of some infections may require higher doses of ciprofloxacin and/or co-administration with other appropriate antibacterial agents.

After treatment has been initiated intravenously, the treatment can be switched to oral treatment with tablet or suspension if clinically indicated. Intravenous treatment should be followed by oral route as soon as possible.

Adults

Children

Neonates

Patients with Renal Impairment

Administration

For intravenous infusion.

The solution should be administered by intravenous infusion over a period 60 minutes in children. In adults, the 400mg/200ml should be administered over 60 minutes and the 200mg/100ml should be administered over 30 minutes.

Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.

Contraindications

History of tendon disorder secondary to quinolone use
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children under 18 years
Family history of long QT syndrome
Organ transplant recipients
Patients over 60 years
Predisposition to aortic aneurysm
Predisposition to aortic dissection
Restricted sodium intake
Aortic aneurysm
Aortic dissection
Breastfeeding
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
G6PD deficiency
History of seizures
History of torsade de pointes
Myasthenia gravis
Pregnancy
Renal impairment

Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Monitor for haemolysis in G6PD deficiency
Reduce dose in patients with creatinine clearance below 60ml/min
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Children under 18: Treatment to be initiated/supervised by a specialist
Consult national/regional policy on the use of anti-infectives
Ensure patient has adequate fluid intake
Perform ECG before and during treatment
Avoid excessive alkalinity of the urine
Discontinue at first sign of pain/inflammation of limb(possible tendonitis)
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for hypersensitivity reactions during infusion
Monitor for symptoms of peripheral neuropathy
Monitor serum electrolytes
Advise patient to report any blurred vision or any other eye symptoms
Advise patient to report any changes in vision, taste, smell or hearing
Advise patient to report signs of neuropathy
Advise patient to report signs of tendinitis
Advise patient to report tiredness, mood, memory or sleep disturbances
Advise patient to rest affected limb if tendonitis occurs
Advise patient to seek medical advice if joint aches or pain occur
Advise patients to report muscle pain/tenderness/weakness
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Consider pseudomembranous colitis if patient presents with diarrhoea
Crystalluria may occur
Discontinue if central nervous disturbances occur
May cause convulsions
Patients over 60 years are prone to tendon inflammation
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Prolonged use may result in superinfection with non-susceptible organisms
Refer immediately visual disturbances to a specialist
May produce false negative test for Mycobacterium tuberculosis
Discontinue at once if pseudomembranous colitis occurs
Discontinue if convulsions occur
Discontinue if hypersensitivity reactions occur
Discontinue if peripheral neuropathy occurs
Discontinue if photosensitivity occurs
Discontinue if symptoms of hepatic disease occur
Discontinue in patients showing suicidal behaviour
Avoid excessive exposure to sunlight
Avoid excessive exposure to UV light

Use of ciprofloxacin in children under 18 years should follow available official guidance. Ciprofloxacin treatment should be initiated by a physician experienced in management of cystic fibrosis and/or severe infections in children under 18 years. Ciprofloxacin, like other quinolones, has been shown to cause arthropathy in weight-bearing joints of immature animals. Drug related arthropathy has been reported in studies regarding the use of ciprofloxacin in children.

There is an increased risk of aortic aneurysm and dissection following treatment with ciprofloxacin. Use ciprofloxacin only after careful benefit risk assessment in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and or aortic dissection, or in the presence of other risk factors or conditions predisposing for aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arthritis, Behcet's disease, hypertension, known atherosclerosis.)

Disabling, long-lasting and potentially irreversible adverse reactions mainly affecting musculoskeletal and nervous systems have been reported with quinolone and fluoroquinolone antibiotics. Treatment should be discontinued at the first signs of a serious adverse reaction such as tendinitis, pain or inflammation.

Pregnancy and Lactation

Pregnancy

Use ciprofloxacin with caution during pregnancy.

The manufacturer does not recommend using ciprofloxacin during pregnancy.

Based on limited amount of human data, the use of fluoroquinolones in the first trimester of pregnancy has not been associated with an increased risk of major malformations or other adverse effects on pregnancy outcome.

Ciprofloxacin has been shown to cause arthropathy in immature animals. Reproduction studies in rats and rabbits did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri- and post-natal development. Animal studies do not entirely exclude the risk of damage to the cartilage of joints in the growing subject.

Schaefer (2015) suggests quinolones should only be used in case of complicated infections resistant to the antibiotics of choice in pregnancy. Ciprofloxacin and norfloxacin have a relatively large amount of documented experience. Even the first trimester use of a quinolone antibiotic is not an indication for termination of pregnancy, but detailed foetal ultrasonography can be offered.

Lactation

Use ciprofloxacin with caution during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking ciprofloxacin.

Quinolones have been shown to cause arthropathy in animal studies.

Ciprofloxacin is excreted into breast milk. Avoiding breastfeeding for 3 to 4 hours after a dose should decrease the exposure of the infant to ciprofloxacin in breast milk.

Schaefer (2015) suggests as a rule, a standard antibiotic with a lower potential for risk can be substituted for the use of quinolones.

Side Effects

Acute generalised exanthematous pustulosis
Agitation
Agranulocytosis
Allergic reaction
Anaemia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Anxiety
Arrhythmias
Arthralgia
Arthritis
Arthropathy
Asthenia
Bone marrow depression
Confusion
Convulsions
Crystalluria
Decreased appetite
Depression
Diarrhoea
Disorientation
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dysaesthesia
Dyspnoea
Elevated amylase levels
Eosinophilia
Erythema multiforme
Erythema nodosum
Exacerbation of myasthenia gravis
Fever
Gait abnormality
Gastro-intestinal disturbances
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatic impairment
Hepatic necrosis
Hepatitis
Hot flushes
Hyperglycaemia
Hypoaesthesia
Hypoglycaemia
Hypotension
Increase in alkaline phosphatase
Increase in serum transaminases
Injection site reactions
Interstitial nephritis
Intracranial hypertension
Jaundice
Leucocytosis
Leucopenia
Migraine
Muscle weakness
Musculoskeletal pain
Myalgia
Nausea
Neutropenia
Oedema
Pain
Pancreatitis
Pancytopenia
Paraesthesia
Peripheral neuropathy
Petechiae
Photosensitivity
Prolongation of QT interval
Pruritus
Pseudomembranous colitis
Psychoses
Rash
Renal failure
Renal impairment
Serum bilirubin increased
Serum sickness-like reactions
Sleep disturbances
Smelling disturbances
Stevens-Johnson syndrome
Suicidal tendencies
Superinfections
Sweating
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon rupture
Thrombocythaemia
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Tremor
Urticaria
Vasculitis
Vasodilation
Vertigo
Visual disturbances

Effects on Laboratory Tests

In vitro activity of ciprofloxacin against Mycobacterium tuberculosis may give false negative bacteriological test results in specimens from patients taking ciprofloxacin.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2019

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Ciprofloxacin 200mg/100ml solution for infusion. Fresenius Kabi Ltd. Revised January 2021.
Summary of Product Characteristics: Ciprofloxacin 400mg/200ml solution for infusion. Fresenius Kabi Ltd. Revised January 2021.
Summary of Product Characteristics: Ciproxin solution for infusion. Bayer Plc. Revised August 2017.

MHRA Drug Safety Update March 2019
Available at: https://www.mhra.gov.uk
Last accessed: 20 May 2019

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 May 2022

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ciprofloxacin Last revised: 31 October 2018
Last accessed: 09 January 2019