Ciprofloxacin Mylan 2mg/1ml solution for infusion
- Name:
Ciprofloxacin Mylan 2mg/1ml solution for infusion
- Company:
Gerard Laboratories
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/07/19

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Gerard Laboratories

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Updated on 19 July 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 July 2019 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 14 March 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 14 March 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 December 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 21 December 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2018 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 23 April 2018 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
Updated on 18 January 2018 SPC
Reasons for updating
- Change to section 6.2 - Incompatibilities
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Unless compatibility with other solutions/drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discoloration.
Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solutions (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of ciprofloxacin solutions: 3.5 – 4.6).
10. DATE OF REVISION OF THE TEXT
Updated on 18 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 29 June 2016 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
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 (see section 4.8).
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). Co-administration of ciprofloxacin and tizanidine is contra-indicated. 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 (see section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Effects of ciprofloxacin on other medicinal products:
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 (see section 4.4).
Zolpidem
Co-administration ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.
4.8 Undesirable effects
System Organ Class
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Common ≥ 1/100 to < 1/10
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Uncommon ≥ 1/1 000 to < 1/100
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Rare ≥ 1/10 000 to < 1/1 000
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Very Rare < 1/10 000
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Frequency not known (cannot be Estimated from available data) |
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Infections and Infestations
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Mycotic superinfections
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Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
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Blood and Lymphatic System Disorders
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Eosinophilia
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Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
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Haemolytic anaemia Agranulocy tosis Pancytopenia (life-threatening) Bone marrow depression (life-threatening)
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Immune System Disorders
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Allergic reaction Allergic oedema / angiooedema
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Anaphylactic reaction Anaphylactic shock (life-threatening) (see section 4.4) Serum sickness-like reaction
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Metabolism and Nutrition Disorders
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Anorexia
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Hyperglycaemia Hypoglycaemia (see section 4.4)
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Increased bilirubin
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Hepatitis
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progressing to life-threatening hepatic failure) (see section 4.4)
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Skin and Subcutaneous Tissue Disorders
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Rash Pruritus Urticaria
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Photosensitivity reactions (see section 4.4)
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Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life-threatening) Toxic epidermal necrolysis (potentially life-threatening)
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Acute generalised exanthematous pustulosis (AGEP) ,
DRESS
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Musculoskeletal and Connective Tissue Disorders
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Musculoskeletal pain (e.g. extremity pain, back pain, chest pain) Arthralgia
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Myalgia Arthritis Increased muscle tone and cramping
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Muscular weakness Tendinitis Tendon rupture (predominantly Achilles tendon) (see section 4.4) Exacerbation of symptoms of myasthenia gravis (see section 4.4)
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Renal and Urinary Disorders
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Renal impairment
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Renal failure Haematuria Crystalluria (see section 4.4) Tubulointerstitial nephritis
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General Disorders and Administration Site Conditions
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Injection and infusion site reactions (only intravenous administration)
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Asthenia Fever
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Oedema Sweating (hyperhidrosis)
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Investigations
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Increase in blood alkaline phosphatase
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Prothrombin level abnormal, Increased amylase
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International normalised ratio increased (in patients treated with Vitamin K antagonists)
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Psychiatric Disorders
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Psychomotor hyperactivity / agitation
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Confusion and disorientation Anxiety reaction Abnormal dreams Depression (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4) Hallucinations
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Psychotic reactions (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)
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Mania, hypomania
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Nervous System Disorders
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Headache Dizziness Sleep disorders Taste disorders
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Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (incl. status epilepticus see section 4.4) Vertigo
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Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension and pseudotumor cerebri
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Peripheral neuropathy and polyneuropathy (see section 4.4)
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Eye Disorders
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Visual disturbances (e.g. diplopia)
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Visual colour distortions
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Ear and Labyrinth Disorders
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Tinnitus Hearing loss / Hearing impaired
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Cardiac Disorders
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Tachycardia
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Ventricular arrhythmia, torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9).
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Vascular Disorders
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Vasodilatation Hypotension Syncope
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Vasculitis
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Respiratory, Thoracic and Mediastinal Disorders
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Dyspnoea (including asthmatic condition)
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Gastrointestinal Disorders
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Nausea Diarrhoea
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Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
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Antibiotic associated diarrhea incl. pseudomembraneous colitis (see section 4.4)
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Pancreatitis
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Hepatobiliary Disorders
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Increase in transaminases
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Hepatic impairment Cholestatic icterus
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Liver necrosis (very rarely
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4.9 Overdose
Symptoms
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.
Management
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
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. Calcium or magnesium containing antacids may theoretically reduce the absorption of ciprofloxacin in overdoses.
Patients should be kept well hydrated.
Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.
5.2 Pharmacokinetic properties
Metabolism Biotransformation
Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.
Paediatric patients populations
The pharmacokinetic data in paediatric patients are limited.
In a study in children Cmax and AUC were not age-dependent (above one year of age). No notable increase in Cmax and AUC upon multiple dosing (10 mg/kg three times daily) was observed.
In 10 children with severe sepsis Cmax was 6.1 mg/L (range 4.6-8.3 mg/L) after a 1-hour intravenous infusion of 10 mg/kg in children aged less than 1 year compared to 7.2 mg/L (range 4.7-11.8 mg/L) for children between 1 and 5 years of age. The AUC values were 17.4 mg*h/L (range 11.8-32.0 mg*h/L) and 16.5 mg*h/L (range 11.0-23.8 mg*h/L) in the respective age groups.
These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean half-life in children is approx. 4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.
Updated on 28 June 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 28 June 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to dosage and administration
Updated on 6 October 2015 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Urinary tract infections
Resistance to fluoroquinolones of
Escherichia coli - the most common pathogen involved in urinary
tract infections - varies across the European Union. Prescribers are advised to take into account the
local prevalence of resistance in
Escherichia coli to fluoroquinolones.
Children and adolescentsPaediatric population
The use of ciprofloxacin in children and adolescents should follow available official guidance.
Hypoglycaemia
As with other quinolones, hypoglycaemia has been reported most often in diabetic patients,
predominantly in the older population. In all diabetic patients, careful monitoring of blood glucose is
recommended
.
Section 4.5
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 C
max and AUC of ciprofloxacin.
Section 4.6
Breast-feeding
Section 4.8
Metabolism and Nutrition Disorders
Rare HyperglycaemiaHypoglycaemia (see section 4.4)
Nervous System Disorder
Very Rare: Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension and pseudo tumorcerebri
Frequency not known
Peripheral neuropathy and poly neuropathy
Updated on 6 October 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 13 January 2015 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Vision Disorders
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see section 4.8)
Reporting side effects details update to include name change from IMB to HPRA
Updated on 13 January 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 21 May 2014 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 May 2014 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilence, Earlsfort Terrace, IRL- Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie
Updated on 16 May 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 2 November 2012 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Class labelling - implementation of wording changes for which no few additional data are submitted by the MAH
PSUR - implementation of wording changes for which no few additional data are submitted by the MAH
Updated on 26 October 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
Updated on 13 August 2012 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 14 July 2011 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)