Drugs List

Therapeutic Indications

Uses

Bone and joint infection
Gastrointestinal tract infection
Genital-tract infections
Gonorrhoea
Infections in neutropenic patients
Inhalation anthrax
Meningococcal meningitis - prophylaxis of
Pseudomonal lower respiratory tract infection in cystic fibrosis
Respiratory tract infections - upper and lower
Severe systemic infections
Skin and soft tissue infections
Urinary tract infection

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)
Cystitis
Pyelonephritis
Prostatitis

Urethritis, cervicitis, epididymo-orchitis and pelvic inflammatory disease due to susceptible Neisseria gonorrhoeae (only if ciprofloxacin resistant Neisseria gonorrhoeae can be excluded).

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

Infection of the skin and soft tissue caused by Gram-negative bacteria

Bone and joint infections

Infections of neutropenic patients

Inhalation anthrax:
Post exposure prophylaxis and curative treatment

Prophylaxis in adults:
Prophylaxis of invasive infections due to Neisseria meningitidis

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
Fistulating Crohn's disease
Gastrointestinal anthrax
Prophylaxis against infection during surgical procedures

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
Aortic aneurysm
Aortic dissection
Breastfeeding
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
G6PD deficiency
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
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
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Some formulations contain sucrose
Some products may contain soya or soya derivative
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 blood glucose closely in patients with diabetes mellitus
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
Discontinue if psychiatric disturbances develop
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
Advise avoid milk/antacid/mineral supplements 4 hrs before/2 hrs after dose
Dairy products may impair absorption
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

Ciprofloxacin is contraindicated 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.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ciprofloxacin is contraindicated 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.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute generalised exanthematous pustulosis
Agitation
Agranulocytosis
Allergic reaction
Anaemia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Anosmia
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
Interstitial nephritis
Intracranial hypertension
Jaundice
Leucocytosis
Leucopenia
Migraine
Musculoskeletal pain
Myalgia
Nausea
Neutropenia
Oedema
Pain
Pancreatitis
Pancytopenia
Paraesthesia
Parosmia
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
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
Weakness

Presentation

Oral formulations of ciprofloxacin.

Drugs List

Therapeutic Indications

Uses

Bone and joint infection
Gastrointestinal tract infection
Genital-tract infections
Gonorrhoea
Infections in neutropenic patients
Inhalation anthrax
Meningococcal meningitis - prophylaxis of
Pseudomonal lower respiratory tract infection in cystic fibrosis
Respiratory tract infections - upper and lower
Severe systemic infections
Skin and soft tissue infections
Urinary tract infection

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)
Cystitis
Pyelonephritis
Prostatitis

Urethritis, cervicitis, epididymo-orchitis and pelvic inflammatory disease due to susceptible Neisseria gonorrhoeae (only if ciprofloxacin resistant Neisseria gonorrhoeae can be excluded).

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

Infection of the skin and soft tissue caused by Gram-negative bacteria

Bone and joint infections

Infections of neutropenic patients

Inhalation anthrax:
Post exposure prophylaxis and curative treatment

Prophylaxis in adults:
Prophylaxis of invasive infections due to Neisseria meningitidis

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
Fistulating Crohn's disease
Gastrointestinal anthrax
Prophylaxis against infection during surgical procedures

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.

Adults

Children

Neonates

Patients with Renal Impairment

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
Aortic aneurysm
Aortic dissection
Breastfeeding
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
G6PD deficiency
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
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
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Some formulations contain sucrose
Some products may contain soya or soya derivative
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 blood glucose closely in patients with diabetes mellitus
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
Discontinue if psychiatric disturbances develop
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
Advise avoid milk/antacid/mineral supplements 4 hrs before/2 hrs after dose
Dairy products may impair absorption
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

Ciprofloxacin is contraindicated 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.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ciprofloxacin is contraindicated 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.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute generalised exanthematous pustulosis
Agitation
Agranulocytosis
Allergic reaction
Anaemia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Anosmia
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
Interstitial nephritis
Intracranial hypertension
Jaundice
Leucocytosis
Leucopenia
Migraine
Musculoskeletal pain
Myalgia
Nausea
Neutropenia
Oedema
Pain
Pancreatitis
Pancytopenia
Paraesthesia
Parosmia
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
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
Weakness

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 250mg film-coated tablets. Generics UK. Revised January 2016.
Summary of Product Characteristics: Ciproxin Tablets 500mg Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Ciproxin Tablets 750mg. Bayer Plc. Revised August 2017.
Summary of Product Characteristics: Ciproxin Suspension. Bayer Plc. Revised November 2018.

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: 09 January 2019

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