Presentation and Status in Health Basket
10 X 500 mg
Infections of the lower respiratory tract: 500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 7 to 14 days.
Infections of the upper respiratory tract: Acute exacerbation of chronic sinusitis and Chronic suppurative otitis media: 500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 7 to 14 days.
Malignant external otitis: 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 28 days up to 3 months.
Urinary tract infections:Uncomplicated cystitis: 250 mg twice daily to 500 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 3 days. In pre-menopausal women, 500 mg single dose may be used.
Complicated cystitis, Uncomplicated pyelonephritis: 500 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 7 days.
Complicated pyelonephritis: 500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses).
Prostatitis: 500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 2 to 4 weeks (acute) to 4 to 6 weeks (chronic).
Genital tract infections: Gonococcal urethritis and cervicitis: 500 mg as a single dose. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 1 day (single dose)
Epididymo-orchitis and pelvic inflammatory diseases: 500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): at least 14 days.
Infections of the gastro-intestinal tract and intra-abdominal infections:
Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea: 500 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 1 day.
Diarrhoea caused by Shigella dysenteriae type 1: 500 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 5 days.
Diarrhoea caused by Vibrio cholerae: 500 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 3 days.
Typhoid fever: 500 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 7 days.
Intra-abdominal infections due to Gram-negative bacteria:500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 5-14 days.
Infections of the skin and soft tissue: 500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 7 to 14 days.
Bone and joint infections: 500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): max. of 3 months.
Neutropenic patients with fever suspected to be due to a bacterial infection. Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance: 500 mg twice daily to 750 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): Therapy should be continued over the entire period of neutropenia.
Prophylaxis of invasive infections due to Neisseria meningitidis: 500 mg as a single dose. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 1 day (single dose).
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure: 500 mg twice daily. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 60 days from the confirmation of Bacillus anthracis exposure.
Cystic fibrosis: 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. 10 to 14 days.
Complicated urinary tract infections and pyelonephritis:10 mg/kg body weight twice daily to 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 10 to 21 days.
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure: 10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 500 mg per dose. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): 60 days from the confirmation of Bacillus anthracis exposure.
Other severe infections: 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin): According to the type of infections.
Elderly patients should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance.
Patients with renal and hepatic impairment
Recommended starting and maintenance doses for patients with impaired renal function:
Creatinine Clearance [mL/min/1.73 m²]> 60: Serum Creatinine [µmol/L] < 124: See Usual Dosage.
Creatinine Clearance [mL/min/1.73 m²] = 30-60: Serum Creatinine [µmol/L] = 124 to 168: 250-500 mg every 12 h.
Creatinine Clearance [mL/min/1.73 m²]< 30: Serum Creatinine [µmol/L] > 169: 250-500 mg every 24 h.
Patients on haemodialysis: Serum Creatinine [µmol/L] > 169 : 250-500 mg every 24 h (after dialysis).
Patients on peritoneal dialysis: Serum Creatinine [µmol/L] > 169 [µmol/L]: 250-500 mg every 24 h.
In patients with impaired liver function no dose adjustment is required.
Dosing in children with impaired renal and/or hepatic function has not been studied.
Broad spectrum antibiotic for infections caused by ciprofloxacin sensitive pathogens.
Lower respiratory tract infections due to Gram-negative bacteria
– Exacerbations of chronic obstructive pulmonary disease
– broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
Chronic suppurative otitis media
Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
Urinary tract infections
Genital tract infections
– Gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae
– epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
– pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
Infections of the gastro-intestinal tract (e.g. travellers’ diarrhoea)
Infections of the skin and soft tissue caused by Gram-negative bacteria
Malignant external otitis
Infections of the bones and joints
Prophylaxis of invasive infections due to Neisseria meningitides
Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Children and adolescents
Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
Complicated urinary tract infections and pyelonephritis
Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may also be used to treat severe infections in children and adolescents when there is no other alternative.
Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Hypersensitivity to the active substance, to other quinolones or to any of the excipients.
Concomitant administration of ciprofloxacin and tizanidine.
Severe infections and mixed infections with Gram-positive and anaerobic pathogens: Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens. In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents.
Streptococcal Infections (including Streptococcus pneumoniae): Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Genital tract infections: Gonococcal urethritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates.
Therefore, ciprofloxacin should be administered for the treatment of gonococcal urethritis or cervicitis only if ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.
For epididymo-orchitis and pelvic inflammatory diseases, empirical ciprofloxacin should only be considered in combination with another appropriate antibacterial agent (e.g. a cephalosporin) unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Urinary tract infections: Resistance to fluoroquinolones of Escherichia coli – the most common pathogen involved in urinary tract infections – varies geographically. Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones.
The single dose of ciprofloxacin that may be used in uncomplicated cystitis in pre-menopausal women is expected to be associated with lower efficacy than the longer treatment duration. This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones.
Intra-abdominal infections: There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Travellers’ diarrhoea: The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
Infections of the bones and joints: Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Inhalational anthrax: Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.
Paediatric population: The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%. Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.0% and 5.7%. The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups. Treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue.
Broncho-pulmonary infections in cystic fibrosis: Clinical trials have included children and adolescents aged 5-17 years. More limited experience is available in treating children between 1 and 5 years of age.
Complicated urinary tract infections and pyelonephritis: Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.
Clinical trials have included children and adolescents aged 1-17 years.
Other specific severe infections: Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.
The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited. Consequently, caution is advised when treating patients with these infections.
Hypersensitivity: Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur following a single dose and may be life-threatening. If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required.
Musculoskeletal System: Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment. Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.
Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, even within the first 48 hours of treatment. Inflammation and ruptures of tendon may occur even up to several months after discontinuation of ciprofloxacin therapy. The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroids.
At any sign of tendinitis (e.g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued. Care should be taken to keep the affected limb at rest.
Ciprofloxacin should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated.
Aortic aneurysm and dissection: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Vision disorders: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Photosensitivity: Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment.
Central Nervous System: Ciprofloxacin like other quinolones are known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. Ciprofloxacin should be used with caution in patients with CNS disorders which may be predisposed to seizure. If seizures occur ciprofloxacin should be discontinued. Psychiatric reactions may occur even after first administration of ciprofloxacin. In rare cases, depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide. In the occurrence of such cases, ciprofloxacin should be discontinued.
Cases of polyneuropathy (based on neurological symptoms such as pain, burning, sensory disturbances or muscle weakness, alone or in combination) have been reported in patients receiving ciprofloxacin. Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness, and/or weakness in order to prevent the development of an irreversible condition.
Cardiac disorders: Caution should be taken when using fluoroquinolones, including ciprofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example:
– congenital long QT syndrome
– concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics)
– uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)
– cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including ciprofloxacin, in these populations.
Dysglycaemia: As with all quinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycaemia have been reported, usually in elderly diabetic patients, receiving concomitant treatment with an oral hypoglycaemic agent (e.g. glibenclamide) or with insulin. Cases of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended.
Gastrointestinal System: The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment. In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated. Anti-peristaltic drugs are contraindicated in this situation.
Renal and urinary system: Crystalluria related to the use of ciprofloxacin has been reported. Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Impaired renal function: Since ciprofloxacin is largely excreted unchanged via renal pathway dose adjustment is needed in patients with impaired renal function to avoid an increase in adverse drug reactions due to accumulation of ciprofloxacin.
Hepatobiliary system: Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin. In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.
Glucose-6-phosphate dehydrogenase deficiency: Haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk. In this case, potential occurrence of haemolysis should be monitored.
Resistance: During or following a course of treatment with ciprofloxacin, bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection. There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.
Cytochrome P450: Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine). Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary.
Co-administration of ciprofloxacin and tizanidine is contra-indicated.
Methotrexate: The concomitant use of ciprofloxacin with methotrexate is not recommended.
Interaction with tests: The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.
The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.
ADRs derived from clinical studies and post-marketing surveillance with ciprofloxacin (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below. The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
Very common ≥ 1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000; Frequency not known (cannot be estimated from the available data).
Infections and Infestations Uncommon: Mycotic super-infections
Blood and Lymphatic System Disorders Uncommon: Eosinophilia; Rare: Leukopenia, Anaemia, Neutropenia, Leukocytosis, Thrombocytopenia, Thrombocythaemia; Very rare: Haemolytic anaemia, Agranulocytosis, Pancytopenia (life-threatening), Bone marrow depression (life-threatening)
Immune System Disorders Rare: Allergic reaction, Allergic oedema / angioedema; Very rare: Anaphylactic reaction, Anaphylactic shock (life-threatening), Serum sickness-like reaction
Endocrine disorders Frequency not known: Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
Metabolism and Nutrition Disorders Uncommon: Decreased appetite; Rare: Hyperglycaemia, Hypoglycaemia
Psychiatric Disorders Uncommon: Psychomotor hyperactivity / agitation; Rare: Confusion and disorientation, Anxiety reaction, Abnormal dreams, Depression (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide), Hallucinations; Very rare: Psychotic reactions (potentially culminating in suicidal ideations/ thoughts or suicide attempts and completed suicide); Frequency not known: Mania, incl. hypomania
Nervous System Disorders Uncommon: Headache, Dizziness, Sleep disorders, Taste disorders; Rare: Par- and Dysaesthesia, Hypoaesthesia, Tremor, Seizures (including status epilepticus), Vertigo; Very rare: Migraine, Disturbed coordination, Gait disturbance, Olfactory nerve disorders, Intracranial hypertension and pseudotumor cerebri; Frequency not known: Peripheral neuropathy and polyneuropathy
Eye Disorders Rare: Visual disturbances (e.g. diplopia); Very rare: Visual colour distortions
Ear and Labyrinth Disorders Rare: Tinnitus, Hearing loss / Hearing impaired
Cardiac Disorders Rare: Tachycardia; Frequency not known: Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged
Vascular Disorders Rare: Vasodilatation, Hypotension, Syncope; Very rare: Vasculitis
Respiratory, Thoracic and Mediastinal Disorders Rare: Dyspnoea (including asthmatic condition)
Gastrointestinal Disorders Common: Nausea, Diarrhoea; Uncommon: Vomiting, Gastrointestinal and abdominal pains, Dyspepsia, Flatulence; Rare: Antibiotic associated colitis (very rarely with possible fatal outcome), Very rare: Pancreatitis
Hepatobiliary Disorders Uncommon: Increase in transaminases, Increased bilirubin; Rare: Hepatic impairment, Cholestatic icterus, Hepatitis; Very rare: Liver necrosis (very rarely progressing to life-threatening hepatic failure)
Skin and Subcutaneous Tissue Disorders Uncommon: Rash, Pruritus, Urticaria; Rare: Photosensitivity reactions; Very rare: Petechiae, Erythema multiforme, Erythema nodosum, Stevens-Johnson syndrome (potentially life-threatening), Toxic epidermal necrolysis (potentially life-threatening); Frequency not known: Acute generalised exanthematous pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Musculo-skeletal and Connective Tissue Disorders Uncommon: Musculo-skeletal pain (e.g. extremity pain, back pain, chest pain), Arthralgia; Rare: Myalgia, Arthritis, Increased muscle tone and cramping; Very rare: Muscular weakness, Tendinitis, Tendon rupture (predominantly Achilles tendon), Exacerbation of symptoms of myasthenia gravis
Renal and Urinary Disorders Uncommon: Renal impairment; Rare: Renal failure, Haematuria, Crystalluria, Tubulointerstitial nephritis
General Disorders and Administration Site Conditions Uncommon: Asthenia, Fever; Rare: Oedema, Sweating (hyperhidrosis)
Investigations Uncommon: Increase in blood alkaline phosphatase; Rare: Increased amylase; Frequency not known: International normalised ratio increased (in patients treated with Vitamin K antagonists)
Paediatric population: The incidence of arthropathy (arthralgia, arthritis), mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly.
Effects of other products on ciprofloxacin
Drugs known to prolong QT interval: Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Chelation Complex Formation: The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e.g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e.g. sevelamer or lanthanum carbonate), sucralfate or antacids, and highly buffered drugs (e.g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin. Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 6 hours after these preparations. The restriction does not apply to antacids belonging to the class of H2 receptor blockers.
Food and Dairy Products: Dietary calcium as part of a meal does not significantly affect absorption. However, the concurrent administration of dairy products or mineral-fortified drinks alone (e.g. milk, yoghurt, calcium-fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.
Probenecid: Probenecid interferes with renal secretion of ciprofloxacin. Co-administration of probenecid and ciprofloxacin increases ciprofloxacin serum concentrations.
Metoclopramide: Metoclopramide accelerates the absorption of ciprofloxacin (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of ciprofloxacin.
Omeprazole: Concomitant administration of ciprofloxacin and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of ciprofloxacin.
Effects of ciprofloxacin on other medicinal products
Tizanidine: Tizanidine must not be administered together with ciprofloxacin. In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase: 7-fold, range: 4 to 21-fold; AUC increase: 10-fold, range: 6 to 24-fold) when given concomitantly with ciprofloxacin. Increased serum tizanidine concentration is associated with a potentiated hypotensive and sedative effect.
Methotrexate: Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions. The concomitant use is not recommended.
Theophylline: Concurrent administration of ciprofloxacin and theophylline can cause an undesirable increase in serum theophylline concentration. This can lead to theophylline-induced side effects that may rarely be life threatening or fatal. During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary.
Other xanthine derivatives: On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Phenytoin: Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Cyclosporin: A transient rise in the concentration of serum creatinine was observed when ciprofloxacin and cyclosporin containing medicinal products were administered simultaneously. Therefore, it is frequently (twice a week) necessary to control the serum creatinine concentrations in these patients.
Vitamin K antagonists: Simultaneous administration of ciprofloxacin with a vitamin K antagonist may augment its anti-coagulant effects. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalised ratio) is difficult to assess. The INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with a vitamin K antagonist (e.g., warfarin, acenocoumarol, phenprocoumon or fluindione).
Duloxetine: In clinical studies, it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in an increase of AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration.
Ropinirole: It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring of ropinirole-related side effects and dose adjustment as appropriate is recommended during and shortly after co-administration with ciprofloxacin.
Lidocaine: It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with ciprofloxacin, a moderate inhibitor of CYP450 1A2 isozyme, reduces clearance of intravenous lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with ciprofloxacin associated with side effects may occur upon concomitant administration.
Clozapine: Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised.
Sildenafil: Cmax and AUC of sildenafil were increased approximately twofold in healthy subjects after an oral dose of 50 mg given concomitantly with 500 mg ciprofloxacin. Therefore, caution should be used prescribing ciprofloxacin concomitantly with sildenafil taking into consideration the risks and the benefits.
Agomelatine: In clinical studies, it was demonstrated that fluvoxamine, as a strong inhibitor of the CYP450 1A2 isoenzyme, markedly inhibits the metabolism of agomelatine resulting in a 60-fold increase of agomelatine exposure. Although no clinical data are available for a possible interaction with ciprofloxacin, a moderate inhibitor of CYP450 1A2, similar effects can be expected upon concomitant administration.
Zolpidem: Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.
NSAIDS: Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies and in postmarketing.
Oral antidiabetic drugs: Hypoglycemia sometimes severe has been reported when ciprofloxacin and oral antidiabetic agents, mainly sulfonylureas (for example, glibenclamide), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. Fatalities have been reported. Monitor blood glucose when ciprofloxacin is co-administered with oral antidiabetic drugs.
Pregnancy and Lactation
Pregnancy: The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus. As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.
Lactation: Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.
An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria. Reversible renal toxicity has been reported.
Apart from routine emergency measures, e.g. ventricular emptying followed by medical carbon, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patients should be kept well hydrated. Calcium or magnesium containing antacids may theoretically reduce the absorption of ciprofloxacin in overdoses.
Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Each caplet of Ciprodex 500 contains approximately 46 mg lactose.
Dietary calcium as part of a meal does not significantly affect absorption. However, the concurrent administration of dairy products or mineral-fortified drinks alone (e.g. milk, yoghurt, calcium-fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.
See prescribing information for full details.