What is Cipro used for?
Ciprofloxacin is indicated for the treatment of the following infections (see Warnings and precautions for use and pharmacodynamic properties).
Special attention should be paid to the information.
Available in bacterial resistance to ciprofloxacin before
to start treatment.
Official recommendations on the proper use of antibacterials should be taken into account.
In adults
· Lower respiratory tract infections caused by Gram negative bacteria;
o exacerbations of chronic obstructive pulmonary disease;
bronchopulmonary infections in cystic fibrosis or bronchiectasis;
or pneumonia;
· Chronic purulent otitis media;
· Acute exacerbations of chronic sinusitis, particularly due to gram-negative bacteria;
Urinary tract infections;
Reproductive system infections;
or gonococcal urethritis and cervicitis due to sensitive strains of Neisseria gonorrhoeae;
or orchid-epididymitis, including infections caused by susceptible strains of Neisseria gonorrhoeae;
o superior gynecological infections, including infections due to sensitive strains of Neisseria gonorrhoeae;
Gastrointestinal infections (eg, Traveler's Diarrhea)
Intra-abdominal infections;
Skin and soft tissue infections caused by Gram negative bacteria;
· Malignant external otitis;
Osteoarticular infections;
· Prophylaxis of invasive Neisseria meningitidis infections;
Anthrax (post-exposure prophylaxis and curative treatment).
The
Ciprofloxacin can be used to treat patients
Febrile neutropenics of suspected bacterial origin.
In children and adolescents
Bronchopulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa;
· Complicated urinary tract infections and pyelonephritis;
Anthrax (post-exposure prophylaxis and curative treatment).
The
Ciprofloxacin can also be used to treat infections
severe child and adolescent, if necessary.
The
treatment should only be started by doctors
with experience in the treatment of cystic fibrosis and / or
serious infections in children and adolescents (see sections 4.4 and 4.4).
Conditions for which this medicine may be prescribed
- Exacerbation of chronic obstructive pulmonary disease.
- Bronchopulmonary infection in cystic fibrosis caused by Gram-bacteria
- Bronchopulmonary infection in case of bronchiectasis due to Gram-bacteria
- Pneumonia
- Chronic otitis media
- Acute exacerbation of chronic sinusitis
- Urinary infection
- Gonococcal urethritis
- Gonococcal cervicitis
- Orchi-epididymitis
- High gynecological infection
- Gastrointestinal infection
- Intra-abdominal infection
- Gram-negative skin and soft tissue infection
- Malignant external otitis
- Osteoarticular infection
- Prophylaxis of invasive Neisseria meningitidis infection
- Anthrax
- Bacterial infection in adult neutropenic patients.
- Bronchopulmonary infection in cystic fibrosis caused by Pseudomonas aeruginosa
- Complicated urinary tract infection
- Pyelonephritis
- Severe infection
Method of administration and dosage of the drug Cipro
Dose
The dose depends on the indication, the severity and site of the infection, the sensitivity of the germs in question to ciprofloxacin, the patient's kidney function, and the weight of the child and adolescent. .
The duration of treatment depends on the severity of the disease and the clinical and bacteriological course.
Treatment of infections caused by certain germs (eg, Pseudomonas aeruginosa, Acinetobacter, or Staphylococci) may require higher doses of ciprofloxacin, as well as concomitant administration of other suitable antibacterial agents.
Treatment of certain infections (eg, upper gynecological infections, intra-abdominal infections, infections in neutropenic patients, and osteoarticular infections) may require the concomitant administration of other antibacterial agents appropriate for the germ involved.
In adults
Indications | Daily dose in mg | Total duration of treatment (possibly including an initial phase of parenterally administered ciprofloxacin treatment) | |
Lower respiratory tract infections | 500 mg twice a day to 750 mg twice a day | 7-14 days | |
Upper respiratory tract infections | Acute exacerbations of chronic sinusitis | 500 mg twice a day to 750 mg twice a day | 7-14 days |
Chronic purulent otitis media | 500 mg twice a day to 750 mg twice a day | 7-14 days | |
Malignant external otitis | 750 mg twice a day | 28 days and up to 3 months | |
Urinary tract infections (see section 4.4) | Uncomplicated cystitis | 250 mg twice a day to 500 mg twice a day | 3 days |
In premenopausal women, a single dose of 500 mg can be used. | |||
Complicated cystitis, uncomplicated pyelonephritis | 500 mg twice a day | 7 days | |
Complicated pyelonephritis | 500 mg twice a day to 750 mg twice a day | At least 10 days; can continue for more than 21 days in certain specific situations (such as the presence of abscesses) | |
Prostats | 500 mg twice a day to 750 mg twice a day | 2-4 weeks (acute) 4-6 weeks (chronic) | |
Genital tract infections | Gonococcal urethritis and cervicitis | Single dose of 500 mg | 1 day (single dose) |
Orchi-epididymitis and upper gynecological infections | 500 mg twice a day to 750 mg twice a day | at least 14 days | |
Gastrointestinal and intra-abdominal infections. | Diarrhea caused by bacteria like Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment for severe traveler's diarrhea | 500 mg twice a day | 1 day |
Shigella dysenteriae type 1 diarrhea | 500 mg twice a day | 5 days | |
Vibrio cholerae diarrhea | 500 mg twice a day | 3 days | |
Typhoid fever | 500 mg twice a day | 7 days | |
Intra-abdominal infections caused by gram-negative bacteria | 500 mg twice a day to 750 mg twice a day | 5 to 14 days | |
Skin and soft tissue. | 500 mg twice a day to 750 mg twice a day | 7-14 days | |
Osteoarticular infections | 500 mg twice a day to 750 mg twice a day | Max. 3 months | |
Treatment of febrile neutropenic patients whose bacterial origin is suspected. Ciprofloxacin should be administered in combination with an appropriate antibiotic according to official recommendations. | 500 mg twice a day to 750 mg twice a day | Treatment should be continued for the duration of neutropenia. | |
Prophylaxis of invasive Neisseria meningitidis infections | Single dose of 500 mg | 1 day (single dose) | |
Anthrax: post-exposure prophylaxis and curative treatment in people who can receive oral treatment if the clinical context warrants it. Treatment should be started early as soon as exposure is suspected or confirmed. | 500 mg twice a day | 60 days from confirmation of exposure to Bacillus anthracis |
Pediatric population
Indications | Daily dose in mg | Total duration of treatment (possibly including an initial phase of parenterally administered ciprofloxacin treatment) |
Cystic fibrosis | 20 mg / kg 2 times / day with a maximum of 750 mg per dose | 10-14 days |
Complicated urinary tract infections and pyelonephritis | 10 mg / kg twice daily to 20 mg / kg twice daily with a maximum of 750 mg per dose | 10 to 21 days |
Anthrax: post-exposure prophylaxis and curative treatment in people who can receive oral treatment if the clinical context warrants it. Treatment should be started early as soon as exposure is suspected or confirmed. | 10 mg / kg twice daily to 15 mg / kg twice daily with a maximum of 500 mg per dose | 60 days from confirmation of exposure to Bacillus anthracis |
Other severe infections | 20 mg / kg 2 times / day with a maximum of 750 mg per dose | According to the type of infections. |
Elderly patients
In elderly patients, the dose administered will depend on the severity of the infection and creatinine clearance.
Patients with kidney and liver failure.
Initial and recommended maintenance dose for people with kidney disease:
Creatinine removal [ml / min / 1.73 m2] | Serum creatinine [micromol / l] | Oral dose [mg] |
more than 60 | minus 124 | See usual dose |
30-60 | 124 to 168 | 250-500 mg every 12 h |
minus 30 | more 169 | 250-500 mg every 24 h |
Hemodialysis patients | more 169 | 250-500 mg every 24 h (after dialysis) |
Peritoneal dialysis patients. | more 169 | 250-500 mg every 24 h |
No dosage adjustment is necessary in patients with hepatic impairment.
Dosage has not been studied in children with renal and / or hepatic impairment.
Administration form
The tablets should be swallowed with a drink, without chewing them. They can be taken regardless of meals. If ingested on an empty stomach, the active substance is absorbed more quickly. Ciprofloxacin tablets should not be taken with dairy products (eg, milk, yogurt) or mineral-fortified fruit juices (eg, calcium-fortified orange juice) (see section Interactions with other medicinal products and other forms interaction).
In case of severe involvement or if the patient is unable to swallow the tablets (eg, tube-fed patients), it is recommended to start treatment with intravenous administration of ciprofloxacin until oral relief is possible.
Possible side effects of the drug Ciprofloxacin
- Secondary fungal infection
- Eosinophilia
- Leukopenia
- Anemia
- Neutropenia
- Hyperleukocytosis
- Thrombocytopenia
- Thrombocythemia
- Hemolytic anemia
- Agranulocytosis
- Pancytopenia
- Medullary aplasia
- Allergic reaction
- Allergic edema
- Angioedema
- Anaphylactic reaction
- Anaphylactic shock
- Serum sickness
- Decreased appetite
- Hyperglycemia
- Hypoglycemia
- Psychomotor hyperactivity
- Agitation
- Confusion
- Disorientation
- Anxiety reaction
- Abnormal dreams
- Depression
- Suicidal idea
- Suicide attempt
- Suicide
- Hallucinations
- Psychotic reaction
- Mania
- Hypomania
- Headache
- Dizziness
- Sleep disorders
- Dysgeusia
- Paresthesia
- Dysesthesia
- Hypoesthesia
- Shaking
- Seizure crisis
- Epilepticus status
- Vertigo
- Migraine
- Coordination disorder
- Gait disorder
- Disorder of smell
- Intracranial hypertension
- Pseudotumor cerebri
- Peripheral neuropathy
- Polyneuropathy
- Impaired vision
- Diplopia
- Impaired color vision.
- Tinnitus
- Deafness
- Hearing impairment
- Tachycardia
- Ventricular arrhythmia
- Torsades de pointes
- QT prolongation interval
- Vasodilation
- Hypotension
- Syncope
- Vasculitis
- Dyspnoea
- Asthmatic condition
- Sickness
- Diarrhea
- Vomiting
- Gastrointestinal pain
- Abdominal pain
- Dyspepsia
- Flatulence
- Antibiotic colitis
- Pseudomembranous colitis
- Pancreatitis
- Elevated transaminases
- Bilirubin elevation
- Liver failure
- Cholestatic jaundice
- Hepatitis
- Liver necrosis
- Acne
- Skin itching
- Hives
- Photosensitivity reaction
- Petechiae
- Polymorphic erythema
- Erythema nodosum
- Stevens-Johnson syndrome
- Lyell syndrome
- Generalized acute exanthematous pustulosis
- Dress syndrome
- Musculoskeletal pain
- Pain in the extremities
- Back pain
- Chest pain
- Arthralgia
- Myalgia
- Arthritis
- Increased muscle tone.
- Muscle cramp
- Muscular weakness
- Tendinitis
- Broken tendons
- Achilles tendon rupture
- Exacerbation of myasthenia gravis symptoms
- Renal dysfunction
- Renal insufficiency
- Hematuria
- Crystalluria
- Tubulointerstitial nephritis
- Asthenia
- Fever
- Edema
- Sweating
- Elevation of alkaline phosphatases.
- Elevation of amylasemia.
- INR increase
- Arthropathy in children.
- Aneurysm
- Aortic dissection
- Joint swelling
- Central Nervous System
- Insomnia
- Tired
- Memory impairment
- Hearing impairment
Show more The most commonly reported treatment-related adverse reactions are nausea and diarrhea.
Side effects reported in clinical trials and after market entry of ciprofloxacin (oral, intravenous and sequential treatment) are listed below by frequency: frequency analysis takes into account both oral and intravenous ciprofloxacin administration data
Organ systems class | Common ≥ 1/100 to less than 1/10 | Uncommon ≥ 1/1000 to at least 1/100 | Rare ≥ 1 / 10,000 to at least 1/1000 | Very rare minus 1 / 10,000 | Frequency not known (cannot be estimated from the available data) |
Infections and infestations. | Secondary fungal infections | ||||
Blood and lymphatic system disorders. | Eosinophilia | Leukopenia Anemia Neutropenia Hyperleukocytosis Thrombocytopenia Thrombocythemia | Aplemia-hemolytic agranulocytosis Pancytopenia (life-threatening) Aplastic anemia (life-threatening) | ||
Immune system disorders. | Allergic reaction Allergic edema / angioedema | Anaphylactic reaction Anaphylactic shock (life-threatening) (see section 4.4) Serum sickness-like reaction | |||
Metabolism and nutrition disorders. | Decreased appetite | Hyperglycemia Hypoglycemia (see section 4.4) | |||
Psychiatric disorders | Psychomotor hyperactivity / restlessness | Confusion and disorientation Anxiety reactions Abnormal dreams Depression (can lead to suicidal thoughts / thoughts or suicide or suicide attempts) (see section 4.4) Hallucinations | Psychotic reactions (which can lead to suicidal thoughts / thoughts or suicide attempts or suicide) (see section 4.4) | Mania, including hypomania | |
Nervous system disorders | Headache Dizziness Sleep disorders Dysgeusia | Paresthesia and dysesthesia Hypoaesthesia Tremor Convulsive seizures (including epilepticus states) (see Warnings and precautions for use) Dizziness | Migraine Coordination disorder Gait disorder Smell disorders Intracranial hypertension and pseudo brain tumor | Peripheral neuropathy and polyneuropathy (see section Warnings and precautions for use) | |
Eye conditions | Vision problems (for example, diplopia) | Color vision distortion. | |||
Ear and labyrinth disorders. | Tinnitus Deafness / hearing impairment | ||||
Heart conditions | Tachycardia | Ventricular arrhythmia and torsades de pointes (reported primarily in patients with risk factors for QT interval prolongation) Extension of the QT interval observed during ECG recording (see sections 4.4 and 4.4) | |||
Vascular disorders | Vasodilation Hypotension Syncope | Vasculitis | |||
Respiratory, thoracic and mediastinal disorders. | Dyspnea (including asthmatic condition) | ||||
Gastrointestinal disorders. | Nausea diarrhea | Vomiting Gastrointestinal and abdominal pain Dyspepsia Flatulence | Antibiotic-associated colitis (life-threatening in very rare cases) (see Warnings and precautions for use section) | Pancreatitis | |
Hepatobiliary disorders. | High transaminases High bilirubin | Liver failure Cholestatic jaundice Hepatitis | Liver necrosis (which progresses in very rare cases to life-threatening liver failure) (see section Warnings and precautions for use) | ||
Skin and subcutaneous tissue disorders. | Itchy rash Urticaria | Photosensitivity reactions (see section 4.4) | Petechiae Polymorphic erythema Erythema nodosum Stevens-Johnson syndrome (can be fatal) Lyell syndrome (can be fatal) | Pharmacological hypersensitivity syndrome to generalized exanthematous acute pustulosis (PEAG) (DRESS syndrome) | |
Musculoskeletal and connective tissue disorders. | Musculoskeletal pain (for example, pain in the extremities, back pain, chest pain) Arthralgia | Myalgia Arthritis Increased muscle tone and cramps | Muscle weakness Tendinitis Tendon rupture (mainly Achilles tendon) (see section Warnings and precautions for use) Exacerbation of symptoms of myasthenia gravis (see section Warnings and precautions for use) | ||
Kidney and urinary tract disorders. | Renal dysfunction | Renal impairment Hematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis | |||
General disorders and administration site conditions. | Asthenia fever | Sweaty edema (hyperhidrosis) | |||
Research | Elevation of alkaline phosphatases. | Elevation of amylasemia. | Increased international normalized ratio (INR) (in patients treated with antivitamins K) |
Pediatric population
The incidence of arthropathies (arthralgia, arthritis) mentioned above refers to the data collected in studies in adults. In children, arthropathies are frequently reported (see section Warnings and precautions for use).
Incapacitating, long-lasting, and potentially irreversible side effects have been reported with antibiotics of the (fluoro) quinolone family, affecting the musculoskeletal system, including tendinitis, tendon rupture, muscle pain, muscle weakness, arthralgia, joint swelling. and gait disorders. In addition to the peripheral nervous system and the central nervous system, including peripheral neuropathy, insomnia, depression, fatigue, memory impairment, as well as vision, hearing, smell and taste disturbances.
Contraindications: when not to use this medicine?
- Ciprofloxacin hypersensitivity
- Quinolone hypersensitivity
- Child under 6
- Breastfeeding
- Sun exposure
- Exposure to UV rays
- G6PD deficiency
- Pregnancy
Hypersensitivity to the active substance, to other quinolones or to any of the excipients included in the Composition section;
Co-administration of ciprofloxacin and tizanidine (see section Interactions with other medicinal products and other forms of interaction).
Presentation of this medicine
12 tablets in blister (PVC / Aluminum).
Appearance and shape
Compressed film.
Cipro: its other forms
- Cipro 250 mg film-coated tablet, box of 12
Composition of the drug Cipro
Active principle | Compressed film |
Ciprofloxacin | 500 mg * |
* per unit dose Active ingredients: Ciprofloxacin Excipients: Core: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, film coating: hypromellose, Macrogol 400, titanium dioxide No excipient with known effect? not present in the composition of this medicine
Effects on ability to drive and use machines
Due to its neurological effects, ciprofloxacin can affect the reaction time. Therefore, the ability to drive or use machines may be affected.
Warnings and precautions for use
- Hypersensitivity reaction
- Elderly patient
- Tendinitis
- Myasthenia
- Predisposing factor for the appearance of seizures
- Seizure crisis
- Depression
- Psychosis
- Suicidal idea
- Neuropathy
- Reduced vision
- Eye problems
- Risk of QT interval prolongation
- Congenital long QT syndrome
- Cardiac pathology
- Family history of aneurysm.
- Aneurysm
- Aortic dissection
- Marfan syndrome
- Ehlers-Danlos vascular syndrome
- Takayasu's arteritis
- Horton's disease
- Behçet's disease
- Arterial hypertension
- Atherosclerosis
- Woman
- Diabetes
- Antibiotic colitis
- Alkaline urine
- Hepatic injury
- Bacteriological diagnosis of tuberculosis.
- Renal insufficiency
- Solid organ transplant
- Broken tendons
- Muscle pain
- Muscular weakness
- Joint pain
- Joint swelling
- Peripheral neuropathy
- Central Nervous System
Show more Serious and mixed infections with gram-positive and anaerobic bacteria
Laciprofloxacin monotherapy is not suitable for the treatment of serious infections and infections that may be due to gram-positive or anaerobic microorganisms. For this type of infection, laciprofloxacin must be combined with other suitable antibacterial agents.
Streptococcal infections (including Streptococcus pneumoniae)
Lacrrofloxacin is not recommended for the treatment of streptococcal infections due to its insufficient efficacy.
Genital tract infections
Gonococcal urethritis and cervitis, orchid epididymitis, and high gynecological infections may be due to fluoroquinolone-resistant strains of Neisseria gonorrhoeae.
Therefore, laciprofloxacin should be administered for the treatment of gonococcal urethritis and cervicitis only if the presence of a Neisseria gonorrhoeae resistant to ciprofloxacin can be excluded.
For orchid epididymitis and upper gynecological infections, empirical treatment with ciprofloxacin should be considered only in combination with another appropriate antibiotic (eg cephalosporin) unless the presence of a strain of Neisseria gonorrhea resistant to ciprofloxacin can be excluded. If no clinical improvement is obtained after 3 days of treatment, the choice of treatment should be reconsidered.
Urinary tract infections
Escherichia coli resistance to fluoroquinolones (the pathogen most frequently responsible for urinary tract infections) varies within the Australia. Prescribers should consider the local prevalence of Escherichia coli resistance to fluoroquinolones.
A single dose of ciprofloxacin, which can be used to treat uncomplicated cystitis in postmenopausal women, is expected to be less effective than long-term treatment. This is even more to keep in mind as the rate of Escherichiacoli resistance to quinolones increases.
Intra-abdominal infections
Data on the efficacy of ciprofloxacin in the treatment of postoperative intra-abdominal infections are limited.
Traveler's diarrhea
The choice of ciprofloxacin should take into account information on the resistance of the germ in question to ciprofloxacin in the countries visited.
Osteoarticular infections
Ciprofloxacin should be used in combination with another antibiotic depending on the microbiological results.
Anthrax
Use in humans is based on in vitro sensitivity data and animal experimental data, as well as limited human data. The doctor should consult national and / or international recommendations for the treatment of anthrax.
Pediatric population
The use of ciprofloxacin in children and adolescents must follow the current official recommendations. Laciprofloxacin treatment should only be initiated by physicians experienced in the treatment of cystic fibrosis and / or severe infections in children and adolescents.
In immature animals, ciprofloxacin can cause arthropathy in the load joints. Safety data from a randomized double-blind study on the use of ciprofloxacin in children (ciprofloxacin: n = 335, mean age = 6.3 years; comparators: n = 349, mean age = 6.2 years; extremes = 1 to 17 years) showed a incidence of arthropathies suspected of being related to taking the drug (detected based on clinical signs and symptoms related to the joints) in D +42 of 7.2% and 4.6% in ciprofloxacin and comparators. After 1 year of follow-up, the incidence of treatment related arthropathies was 9.0% and 5.7% respectively. The increase over time in cases of arthropathies suspected of being related to the drug was not statistically significant between the different groups. Given the possible occurrence of adverse events in the joints and / or surrounding tissues, treatment should only be started after a careful evaluation of the benefit / risk ratio (see section Unwanted effects).
Bronchopulmonary infections in cystic fibrosis.
Children and adolescents aged 5 to 17 years were included in clinical trials. The experience in children from 1 to 5 years is more limited.
Complicated urinary tract infections and pyelonephritis
Treatment of urinary tract infections with ciprofloxacin should be considered if other treatments cannot be used and this treatment should be based on the results of microbiological examinations.
Children and adolescents aged 1 to 17 years were included in clinical trials.
Other specific serious infections
Other serious infections, according to official recommendations, or after a careful evaluation of the benefit / risk ratio when other treatments cannot be used, or after the failure of conventional treatment and when the bacteriological results justify it.
The use of laciprofloxacin in these specific serious infections, other than the infections mentioned above, has not been evaluated in clinical trials and the clinical experience in this area is limited. Therefore, caution is recommended when treating patients with this type of infection.
Hypersensitivity
Hypersensitivity and allergy reactions, including anaphylactic and anaphylactoid reactions, can occur on the first attempt (see section 4.8) and can be life threatening. In these cases, ciprofloxacin should be discontinued and appropriate medical treatment should be implemented.
Musculoskeletal system
In general, ciprofloxacin should not be used in patients with a history of medical condition or condition related to quinolone treatment. In very rare cases, after isolation of the germ in question and assessment of the risk / benefit ratio, however, ciprofloxacin may be prescribed for these patients to treat certain serious infections, particularly after failure of conventional treatment or in the presence of bacterial resistance, if the results Microbiological evidence justifies the use of ciprofloxacin.
Tendinitis and rupture of the tendons (especially the Achilles tendon), sometimes bilateral, can occur with ciprofloxacin, from the first 48 hours of treatment. Inflammation and rupture of the tendons can occur up to several months after stopping treatment with ciprofloxacin. The risk of tendinopathy may increase in elderly patients or in patients treated with corticosteroids simultaneously (see section 4.8).
At least signs of tendinitis (eg, swelling or painful inflammation), treatment with ciprofloxacin should be discontinued. The affected limb should be put to rest.
Laciprofloxacin should be used with caution in patients with myasthenia gravis as symptoms may be exacerbated (see section 4.8).
Vision problems
A speech and language pathologist should be consulted immediately if vision drops or any other eye condition develops.
Photosensitivity
Laciprofloxacin can cause photosensitivity reactions. Patients treated with ciprofloxacin should be advised to avoid significant direct exposure to the sun or UV rays during treatment (see section 4.8).
Central Nervous System
Laciprofloxacin, like other quinolones, is known to trigger seizures or lower the epileptogenic threshold. Cases of epilepticus have been reported. Ciprofloxamine should be used with caution in patients with neurological disorders that may predispose them to seizures. If adjustments occur, ciprofloxacin should be discontinued (see section 4.8). Psychiatric manifestations can occur from the first administration of ciprofloxacin. In rare cases, depression or psychosis can turn into suicidal thoughts / thoughts that can lead to a suicide attempt or suicide. In such situations, the intake of ciprofloxacin should be discontinued.
Cases of polyneuropathy (based on neurological symptoms of pain, burning, sensory disorders, or muscle weakness, isolated or associated) have been reported in patients treated with laciprofloxacin. To prevent progression to irreversible damage, ciprofloxacin should be discontinued as soon as symptoms of neuropathy appear, including: pain, burning, tingling, numbness, and / or muscle weakness (see section 4.8).
Heart problems
Fluoroquinolones, including ciprofloxacin, should be used with caution in patients with known risk factors for QT prolongation, such as:
· Long congenital QT syndrome;
Concomitant therapy with medicinal products known to prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics);
Uncorrected electrolyte imbalance (eg hypokalemia, hypomagnesemia);
Heart disease (for example, heart failure, myocardial infarction, bradycardia).
Elderly patients and women may be more sensitive to treatments that prolong the QT interval. Therefore, fluoroquinolones, including ciprofloxacin, should be used with caution in these populations.
(See section Posology and method of administration Elderly patients, section Interactions with other medicinal products and other forms of interaction, section Adverse effects and section Overdose).
Aortic aneurysm and aortic dissection
Epidemiological studies report an increased risk of aortic aneurysm and aortic dissection after taking fluoroquinolones, especially in the elderly.
Therefore, fluoroquinolones should only be used after careful evaluation of the benefit / risk balance and after considering other treatment options in patients with a family history of aneurysmal disease, or in patients who have been diagnosed with aortic aneurysm and / or pre-existing aortic dissection, or with other risk factors or conditions predisposing to aortic aneurysm and aortic dissection (for example, Marfan syndrome, Ehlers-Danlos vascular syndrome, Takayasu arteritis, giant cell arteritis, Behçet disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to contact an emergency medical service immediately.
Hypoglycemia
As with other quinolones, hypoglycaemia has been reported more frequently in diabetic patients, mainly in the elderly population. Regular monitoring of blood sugar is recommended in all diabetic patients (see section 4.8).
Gastrointestinal system
The appearance of severe and persistent diarrhea during or after treatment (even several weeks after treatment) can be a sign of colitis associated with antibiotics (which implies the prognosis of life and can lead to death) and requires immediate treatment ( see section Undesirable effects). In this case, taking deciprofloxacin should be discontinued immediately and appropriate treatment should be started. The use of drugs that inhibit peristalsis is contraindicated in this situation.
Renal and urinary system
There have been reports of crystalluria related to the use of ciprofloxacin (see section 4.8). Patients taking ciprofloxacin should be adequately hydrated and excessive alkalinity in the urine should be avoided.
Renal insufficiency
Laciprofloxacin is mainly excreted unchanged in the kidney. Therefore, dose adjustment is necessary in patients with renal impairment, as mentioned in the Dosage and method of administration section, to avoid an increase in undesirable effects due to accumulation of ciprofloxacin.
Hepatobiliary system
Cases of liver necrosis and life-threatening liver failure have been reported with ciprofloxacin (see section 4.8). For any signs and symptoms of liver attack (such as anorexia, jaundice, dark urine, itching, or a tender abdomen), treatment should be discontinued.
Glucose-6-phosphate dehydrogenase deficiency
In patients with glucose-6-phosphate dehydrogenase deficiency, acute hemolysis has been reported with cyciprofloxacin. Ciprofloxacin should be avoided in these patients unless the expected benefit of treatment is greater than the potential risk of hemolysis. In this case, the possible occurrence of hemolysis should be evaluated.
Resistance
Isolation of a ciprofloxacin resistant bacterium, with or without apparent clinical infection, can occur during or after treatment with ciprofloxacin.
There may be a particular risk of selecting ciprofloxacin resistant bacteria for long-term treatment, treatment of nosocomial infections, and / or infections caused by Staphylococcus and Pseudomonas.
Cytochrome P450
Laciprofloxacin inhibits CYP1A2 and, therefore, may increase the concentration of substances metabolized and administered concomitantly in the enzyme (for example, theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine). Therefore, if these substances are used at the same time as ciprofloxacin, the clinical signs of a possible overdose should be closely monitored and it may be necessary to determine the serum concentrations of the products (eg theophylline) (see section Interactions with others medicines). and other forms of interaction). Co-administration of ciprofloxacin and tizanidine is contraindicated.
Methotrexate
The concomitant use of ciprofloxacin and methotrexate is not recommended (see section Interactions with other medicinal products and other forms of interaction).
Laboratory tests interactions.
The in vitro activity of ciprofloxacin against Mycobacterium tuberculosis may falsely deny bacteriological tests in patients treated with ciprofloxacin.
ANSMS alert from 04/10/2019:
(Fluoro) quinolones used systemically or by inhalation should be prescribed with special caution in the elderly, patients with renal failure, patients who have received organic solid transplants, and those treated simultaneously with corticosteroids, due to the risk of tendinitis. and fluoroquinolone-induced tendon rupture may be greater in these patients. Concomitant use of corticosteroids and fluoroquinolones should be avoided.
Patients should discontinue treatment at the first sign of a serious side effect such as tendonitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and the central nervous system, and contact their doctor for more advice.
Mechanism of action: how does it work?
Pharmacotherapeutic group: Fluoroquinolone, ATC code: J01MA02.
Mechanism of action
Ciprofloxacin is an antibiotic that belongs to the group of fluoroquinolones. Its bactericidal activity results from the inhibition of topoisomerase type II (DNA gyrase) and topoisomerase IV, necessary for the replication, transcription, repair and recombination of bacterial DNA.
Pharmacokinetic / pharmacodynamic relationship
Efficacy depends mainly on the relationship between the maximum serum concentration (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for the pathogen in question and the relationship between the area under the curve (AUC) and the MIC.
Mechanism of resistance
In vitro resistance can be developed by successive mutations leading to modifications of the ciprofloxacin target sites in DNA gyrase and topoisomerase IV. The degree of cross resistance between ciprofloxacin and other fluoroquinolones is variable. Individual mutations do not necessarily result in clinical resistance, but multiple mutations generally result in clinical resistance to several or even all active substances in this therapeutic class.
Mechanisms of resistance by membrane impermeability and / or active efflux can have variable effects on bacterial sensitivity to fluoroquinolones according to their physicochemical properties and according to the affinity of transport systems for the various antibiotics of this therapeutic class. All in vitro resistance mechanisms are frequently observed in clinical isolates. Resistance to other families of antibiotics by mechanisms such as those that affect membrane permeability (common with Pseudomonas aeruginosa) and outflow mechanisms, can alter the sensitivity of bacteria to ciprofloxacin.
Resistance to plasmids encoded by the qnr genes has been observed.
Spectrum of antibacterial activity
The critical concentrations separate the sensitive strains from the intermediate sensitivity strains, and the second from the resistant strains:
EUCAST Recommendations
Microorganisms | Sensitive | Resistant |
Enterobacteriaceae | S ≤ 0.5 mg / l | R plus 1 mg / l |
Pseudomonas spp. | S ≤ 0.5 mg / l | R plus 1 mg / l |
Acinetobacter spp. | S ≤ 1 mg / l | R plus 1 mg / l |
Staphylococcus spp.1 | S ≤ 1 mg / l | R plus 1 mg / l |
Haemophilus influenzae and Moraxella catarrhalis | S ≤ 0.5 mg / l | R plus 0.5 mg / l |
Neisseria gonorrhoeae | S ≤ 0.03 mg / l | R plus 0.06 mg / l |
Neisseria meningitidis | S ≤ 0.03 mg / l | R plus 0.06 mg / l |
Critical concentrations not related to species * | S ≤ 0.5 mg / l | R plus 1 mg / l |
1 Staphylococcus spp. - the critical concentrations defined for ciprofloxacin correspond to a treatment with high doses.
* Critical concentrations not related to species have been determined mainly on the basis of PK / PD data and are independent of the MIC distribution of specific species. They only apply to species for which a species-specific critical concentration has not been defined and not to those for which a sensitivity test is not recommended.
The prevalence of acquired resistance may vary by geography and time for certain species; Therefore, it is useful to have information on the prevalence of local resistance, especially for the treatment of serious infections. If necessary, specialized advice should be obtained when the interest of the drug in certain types of infections can be questioned due to the prevalence level of local resistance.
Classification of the species according to the sensitivity to ciprofloxacin (see section Warnings and precautions for use for streptococci)
USUALLY SENSITIVE SPECIES |
Bacillus anthracis gram positive aerobic (1) |
Aerobic gram-negative aerobic sp. Brucella spp. Citrobacter koseri Francisella tularensis Haemophilus ducreyi Haemophilus influenzae * Legionella spp. Moraxella catarrhalis * Neisseria meningitidis Pasteurella spp. Salmonella spp. * Shigella spp. * Vibrio spp. Yersinia pestis |
Anaerobic mobiluncus |
Other Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) |
INCONSISTENTLY SENSITIVE SPECIES ACQUIRED RESISTANCE ≥ 10% |
Enterococcus faecalis aerobic gram-positive ($) Staphylococcus spp. * (two) |
Acinetobacter baumannii aerobic gram negative + Burkholderia cepacia + * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorr. Pseudomonas aeruginosa * Pseudomonas fluorescens Serratia marcescens * |
Anaerobes Peptostreptococcus spp. Propionibacterium acnes |
NATURALLY RESISTANT SPECIES |
Gram-positive aerobic actinomyces Enteroccus faecium Listeria monocytogenes |
Gram-negative aerobes Stenotrophomonas maltophilia |
Anaerobes With the exception of those listed above |
Other Mycoplasma genitalium Ureaplasma urealitycum |
* Clinical efficacy has been demonstrated for sensitive isolates in approved clinical indications. + Resistance rate ≥ 50% in one or more EU countries ($) Naturally intermediate sensitivity in the absence of an acquired resistance mechanism (1) Animal studies have been conducted on experimental infections by inhalation Bacillus anthracis spores; These studies show that antibiotic therapy, started soon after exposure, makes it possible to prevent disease onset if treatment continues until the amount of persistent spores in the body falls below the infection dose. Recommended use in humans is based primarily on in vitro sensitivity data and experimental data from animals, as well as limited human data. A two-month period of orally administered ciprofloxacin at a dose of 500 mg twice daily in adults is considered to be effective in preventing anthrax in humans. The doctor should consult the national and / or international recommendations on the treatment of anthrax. (2) Methicillin-resistant strains of S. aureus frequently express co-resistance to fluoroquinolones. The frequency of methicillin resistance is around 20 to 50% of all staphylococci and is generally highest in hospitals. |
Interactions: do not take this medicine with ..
Effects of other products on ciprofloxacin
Medications known to prolong the QT interval
Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients treated with medicinal products known to prolong the QT interval (for example, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4).
Formation of complexes by chelation.
Simultaneous administration of ciprofloxacin (oral) and medicinal products containing polyvalent cations, as well as mineral supplements (for example, calcium, magnesium, aluminum, iron), polymeric phosphate binders (for example, sevelamer or carbonate). lanthanum), sucralfate or antacids, and highly buffered medications (eg, didanosine tablets) that contain magnesium, aluminum, or calcium, reduce the absorption of ciprofloxacin. Therefore, ciprofloxacin should be administered 1 to 2 hours before or at least 4 hours after these substances. This restriction does not apply to antacids in the H2 receptor antagonist family.
Food and dairy products.
The calcium in the diet present in a meal does not significantly affect the absorption of the product. On the other hand, the ingestion of dairy products or drinks enriched with minerals (for example, milk, yogurt, orange juice enriched with calcium) administered without food at the same time as ciprofloxacin should be avoided because the absorption of Ciprofloxacin can be reduced.
Probenecid
Probenecid interferes with the renal secretion of ciprofloxacin. Co-administration of probenecid and ciprofloxacin increases the serum concentration of ciprofloxacin.
Metoclopramide
Metoclopramide accelerates the absorption of ciprofloxacin (oral), resulting in a decreased Tmax of ciprofloxacin. No effect on the bioavailability of ciprofloxacin was observed.
Omeprazole
Co-administration of ciprofloxacin and omeprazole-containing medicinal products leads to a slight decrease in the maximum concentration and area under the curve of ciprofloxacin.
Effects of ciprofloxacin on other medications.
Tizanidine
Tizanidine should not be administered in combination with ciprofloxacin (see section 4.3). In a clinical trial in healthy subjects, an increase in serum tizanidine concentration (increase in C max: by a factor of 7, range: 4 to 21; increase in area under the curve: d '' A factor of 10, extremes: 6 to 24) during concomitant administration of ciprofloxacin. The increase in serum tizanidine concentration is associated with an increase in hypotensive and sedative effects.
Methotrexate
Renal tubular transport of methotrexate can be inhibited by concomitant administration of ciprofloxacin, which can lead to an increase in plasma methotrexate levels and an increased risk of toxic reactions associated with methotrexate. Therefore, the concomitant use of these two drugs is not recommended (see section 4.4).
Theophylline
Co-administration of ciprofloxacin and theophylline can cause an overdose of theophylline and cause theophylline side effects, which are rarely fatal or life-threatening. During such a combination, theophyllinemia should be controlled and the theophylline dose should be reduced if necessary (see Warnings and precautions for use section).
Other xanthine derivatives
When co-administered with ciprofloxacin and caffeine or pentoxifylline (oxpentiphylline), an increase in the serum concentration of these xanthide derivatives has been reported.
Phenytoin
Co-administration of ciprofloxacin and phenytoin can increase or decrease serum levels of phenytoin, therefore it is recommended to control the concentration of the drug.
Cyclosporine
A transient increase in serum creatinine has been observed with co-administration of ciprofloxacin and cyclosporine-containing drugs. Therefore, serum creatinine needs to be checked frequently (twice weekly) in these patients.
Antivitamins K
Co-administration of ciprofloxacin and antivitamins K may increase the anticoagulant effects of the latter. The risk may vary depending on the infectious context, age and general condition of the patient and it is difficult to determine the proportion of ciprofloxacin in the increase of the INR ("International normalized index"). The INR should be checked frequently during and immediately after the simultaneous administration of ciprofloxacin and an antivitamin K (for example, warfarin, acenocoumarol, phenprocoumon, fluindione).
Duloxetine
Concomitant use of duloxetine with potent CYA450 1A2 isoenzyme inhibitors, such as fluvoxamine, has been shown in clinical trials to lead to an increase in the area under the curve and the maximum concentration. duloxetine Even if no clinical data are available on this possible interaction with ciprofloxacin, similar effects can be expected with simultaneous administration (see section 4.4).
Ropinirole
Concomitant use of ropinirole and ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, has been shown in a clinical trial to increase ropinirole C max and AUC by 60% and 84%, respectively. Control of ropinirole-related adverse reactions and dose adjustment are recommended during and immediately after concurrent administration of ciprofloxacin (see section 4.4).
Lidocaine
The simultaneous use of lidocaine-containing medicinal products with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, has been shown to reduce clearance of intravenously administered lidocaine by 22% in healthy subjects. Even if lidocaine treatment is well tolerated, a possible interaction with ciprofloxacin, with side effects, may occur with concurrent administration.
Clozapine
After concomitant administration of 250 mg of ciprofloxacin and clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31% respectively. Clinical monitoring and dose adjustment of clozapine is recommended during and immediately after concurrent administration of ciprofloxacin (see section 4.4).
Sildenafil
The maximum concentration and area under the curve of sildenafil are approximately doubled, in healthy subjects, after the simultaneous administration of a dose of 50 mg orally and 500 mg of ciprofloxacin. Therefore, the prescription of ciprofloxacin concomitantly with sildenafil should be done with caution, taking into account the risks and benefits.
Agomelatine
Fluvoxamine, a potent inhibitor of CYP450 1A2 isoenzyme, has been shown in clinical trials to markedly inhibit the metabolism of agomelatine, resulting in 60 times greater exposure to agomelatine. Although no clinical data are available on a possible interaction with ciprofloxacin, a moderate inhibitor of CYP450 isoenzyme 1A2, similar effects can be expected with co-administration (see section 4.4). "Cytochrome P450").
Zolpidem
Co-administration of ciprofloxacin may increase zolpidem blood levels: simultaneous use is not recommended.
Incompatibilities
Aimlessly.
How to react in case of overdose?
After an overdose of 12 g, mild symptoms of toxicity have been described. Acute renal failure has been reported after an acute overdose of 16 g.
Symptoms of an overdose are: dizziness, tremors, headache, asthenia, seizures, hallucinations, confusion, abdominal discomfort, kidney and liver failure, as well as crystalluria and hematuria. Reversible renal toxicity has been described.
In addition to standard emergency measures, such as gastric lavage followed by administration of medicinal charcoal, it is recommended to monitor kidney function, especially urine pH, and acidify, if necessary, to avoid crystalluria. Patients should benefit from a adequate hydration. Antacids that contain calcium or magnesium can theoretically reduce the absorption of ciprofloxacin in case of overdose.
Hemodialysis or peritoneal dialysis only removes ciprofloxacin in small amounts (less than 10%).
In case of overdose, symptomatic treatment should be started. ECG monitoring should be performed due to possible QT interval prolongation.
Cipro: Pregnancy, lactation and fertility
Pregnancy
Available data on the administration of ciprofloxacin in pregnant women do not show any fetal / neonatal malformation or toxicity of ciprofloxacin. Animal studies show no direct or indirect toxic effects on reproduction. In the prenatal phase and in young animals, effects on immature cartilage have been observed during quinolone exposure. Therefore, the occurrence of joint damage caused by the drug in the cartilage of the human body / immature fetus cannot be excluded (see section Preclinical safety data).
As a precaution, it is best to avoid using ciprofloxacin during pregnancy.
Breastfeeding
Ciprofloxacin is excreted in breast milk. Given the potential risk of joint damage, ciprofloxacin should not be used during lactation.
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