Ciproxin Solution for Infusion 2mg/ml, 200ml

  • Name:

    Ciproxin Solution for Infusion 2mg/ml, 200ml

  • Company:
    info
  • Active Ingredients:

    Ciprofloxacin

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/09/19

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Summary of Product Characteristics last updated on medicines.ie: 9/9/2019

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Bayer Limited

Bayer Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 9 September 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 date of revision

Updated on 9 September 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 10 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 10 December 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 June 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 June 2016 SmPC

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
  • 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

Section 4.4 - was amended as follows:

Reference added to section 4.8, in the final line of the ‘Paediatric population’ paragraph

 

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).


Section 4.5 - the following text was added:  

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 ‘Cytochrome P450’ in section 4.4).

 

Zolpidem

Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not

recommended.

Section 4.8 - was amended as follows:

- Antibiotic associated colitis deleted under SOC “Infections and Infestations” and moved to SOC

“Gastrointestinal disorders”

-Addition of mania/hypomania

- Addition of DRESS to ADR list

- “arthralgia” and “arthritis” in brackets after the term “arthropathy”

Updated on 9 June 2016 PIL

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
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.4 - was amended as follows:

Reference added to section 4.8, in the final line of the ‘Paediatric population’ paragraph

 

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).


Section 4.5 - the following text was added:  

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 ‘Cytochrome P450’ in section 4.4).

 

Zolpidem

Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not

recommended.

Section 4.8 - was amended as follows:

- Antibiotic associated colitis deleted under SOC “Infections and Infestations” and moved to SOC

“Gastrointestinal disorders”

-Addition of mania/hypomania

- Addition of DRESS to ADR list

- “arthralgia” and “arthritis” in brackets after the term “arthropathy”

Updated on 18 November 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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



In section 4.4 Special warnings and precautions for use, the following section has been added:

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

In section 4.8, the following text has been added:

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

Updated on 18 November 2015 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company



In section 4.4 Special warnings and precautions for use, the following section has been added:

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

In section 4.8, the following text has been added:

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

Updated on 3 January 2014 SmPC

Reasons for updating

  • 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

Section 4.8:

Update to the wording of section 4.8, subsection Reporting of suspected adverse reactions to:

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 the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.  

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

 

Section 10:

Update of date of revision of the text to December 2013

Updated on 3 January 2014 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.8:

Update to the wording of section 4.8, subsection Reporting of suspected adverse reactions to:

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 the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.  

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

 

Section 10:

Update of date of revision of the text to December 2013

Updated on 13 November 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

For thea full list of excipients, see section 6.1.

 

 

4.2       Posology and method of administration

 

Posology

 

 

Paediatric populationChildren and adolescents

 

Indication

Daily dose in mg

Total duration of treatment (including switch to oral therapy as soon as possible)

Cystic fibrosis

10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 14 days

Complicated urinary tract infections and pyelonephritis

6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 21 days

Inhalation anthrax post-exposure curative treatment for persons requiring parenteral treatment

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 400 mg per dose.

60 days from the confirmation of Bacillus anthracis exposure

Other severe infections

10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

According to the type of infections

                                    

ElderlyGeriatric patients

ElderlyGeriatric patients should receive a dose selected according to the severity of the infection and the patient`s creatinine clearance.

 

Patients with rRenal and hepatic impairment

Recommended starting and maintenance doses for patients with impaired renal function:

 

Creatinine Clearance
[mL/min/1.73 m²]

Serum Creatinine
[
µmol/L]

Intravenous Dose
[mg]

> 60

< 124

See Usual Dosage.

30‑60

124 to 168

200‑400 mg every 12 h

< 30

> 169

200‑400 mg every 24 h

Patients on haemodialysis

> 169

200‑400 mg every 24 h (after dialysis)

Patients on peritoneal dialysis

> 169

200‑400 mg every 24 h

 

 

4.3     Contraindications

 

·                Hypersensitivity to the active substance, to other quinolones or to any of the excipients listed in (see section 6.1).

·                Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).

 

4.4     Special warnings and precautions for use

 

 

 

Paediatric populationChildren and adolescents

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.

 

Musculoskeletal System

Ciprofloxacin should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated (see section 4.8).

 

 

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.

 

(See section 4.2 ElderlyGeriatric patients, section 4.5, section 4.8, section 4.9).

 

Hypoglycemia

As with other quinolones, hypoglycemia has been reported most often in diabetic patients, predominantly in the elderly population. In all diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).

 

4.5     Interaction with other medicinal products and other forms of interaction

 

 

Glibenclamide

In particular cases, concurrent administration of ciprofloxacin and glibenclamide containing medicinal products can intensify the action of glibenclamide (hypoglycaemia).

 

4.6     Pregnancy and lactation

Breast-feedingLactation

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.

 

 

4.8       Undesirable effects

 

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.

ADRs derived from clinical studies and post-marketing surveillance with Ciproxin (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.

 

System Organ Class

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1, 000 to < 1/100

Rare

≥ 1/10 ,000 to < 1/1 ,000

Very Rare

< 1/10 ,000

Frequency not known

(cannot be estimated from the available data)

Infections and Infestations

 

Mycotic superinfections

Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)

 

 

Blood and Lymphatic System Disorders

 

Eosinophilia

Leukopenia

Anaemia

Neutropenia

Leukocytosis

Thrombocytopenia

Thrombocytaemia

Haemolytic anaemia

Agranulocytosis

Pancytopenia (life-threatening)

Bone marrow depression (life-threatening)

 

Immune System Disorders

 

 

Allergic reaction

Allergic oedema / angiooedema

Anaphylactic reaction

Anaphylactic shock (life-threatening) (see section 4.4)

Serum sickness-like reaction

 

Metabolism and Nutrition Disorders

 

Decreased appetiteAnorexia

Hyperglycaemia

Hypoglycaemia (see section 4.4)

 

 

Psychiatric Disorders

 

Psychomotor hyperactivity / agitation

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

Psychotic reactions (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

 

Nervous System Disorders

 

Headache

Dizziness

Sleep disorders

Taste disorders

Par- and Dysaesthesia

Hypoaesthesia

Tremor

Seizures (incl. status epilepticus see section 4.4)

Vertigo

Migraine

Disturbed coordination

Gait disturbance Olfactory nerve disorders

Intracranial hypertension and pseudotumor cerebri

Peripheral neuropathy and polyneuropathy (see section 4.4)

Eye Disorders

 

 

Visual disturbances (e.g. diplopia)

Visual colour distortions

 

Ear and Labyrinth Disorders

 

 

Tinnitus

Hearing loss / Hearing impaired

 

 

Cardiac Disorders

 

 

Tachycardia

 

Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9)

Vascular Disorders

 

 

Vasodilatation

Hypotension

Syncope

Vasculitis

 

Respiratory, Thoracic and Mediastinal Disorders

 

 

Dyspnoea (including asthmatic condition)

 

 

Gastrointestinal Disorders

Nausea

Diarrhoea

Vomiting

Gastrointestinal and abdominal pains

Dyspepsia

Flatulence

 

Pancreatitis

 

Hepatobiliary Disorders

 

Increase in transaminases

Increased bilirubin

Hepatic impairment

Cholestatic icterus

Hepatitis

Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)

 

Skin and Subcutaneous Tissue Disorders

 

Rash

Pruritus

Urticaria

Photosensitivity reactions (see section 4.4)

Petechiae

Erythema multiforme

Erythema nodosum

Stevens-Johnson syndrome (potentially life-threatening)

Toxic epidermal necrolysis (potentially life-threatening)

Acute generalised exanthematous pustulosis (AGEP)

Musculoskeletal, and Connective Tissue and Bone Disorders

 

Musculoskeletal pain (e.g. extremity pain, back pain, chest pain)

Arthralgia

Myalgia

Arthritis

Increased muscle tone and cramping

Muscular weakness

Tendinitis

Tendon rupture (predominantly Achilles tendon) (see section 4.4)

Exacerbation of symptoms of myasthenia gravis (see section 4.4)

 

Renal and Urinary Disorders

 

Renal impairment

Renal failure

Haematuria

Crystalluria (see section 4.4)

Tubulointerstitial nephritis

 

 

General Disorders and Administration Site Conditions

 

Asthenia

Fever

Oedema

Sweating (hyperhidrosis)

 

 

Investigations

 

Increase in blood alkaline phosphatase

Increased amylase

 

International normalised ratio increased (in patients treated with Vitamin K antagonists)

 

Paediatric populationpatients

The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).

 

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 to the Irish Medicines Board (online at www.imb.ie, telephone 01-6764971 or using the yellow card system).

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

via the national reporting system listed in Appendix V*

[*For the printed material, please refer to the guidance of the annotated QRD template.]

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Pharmacokinetic/pharmacodynamicPK/PD relationship:

Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.

 

5.2     Pharmacokinetic properties

BiotransformationMetabolism

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.

 

10.     DATE OF REVISION OF THE TEXT

 

November 2012September 2013

 

Updated on 13 November 2013 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

For thea full list of excipients, see section 6.1.

 

 

4.2       Posology and method of administration

 

Posology

 

 

Paediatric populationChildren and adolescents

 

Indication

Daily dose in mg

Total duration of treatment (including switch to oral therapy as soon as possible)

Cystic fibrosis

10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 14 days

Complicated urinary tract infections and pyelonephritis

6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 21 days

Inhalation anthrax post-exposure curative treatment for persons requiring parenteral treatment

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 400 mg per dose.

60 days from the confirmation of Bacillus anthracis exposure

Other severe infections

10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

According to the type of infections

                                    

ElderlyGeriatric patients

ElderlyGeriatric patients should receive a dose selected according to the severity of the infection and the patient`s creatinine clearance.

 

Patients with rRenal and hepatic impairment

Recommended starting and maintenance doses for patients with impaired renal function:

 

Creatinine Clearance
[mL/min/1.73 m²]

Serum Creatinine
[
µmol/L]

Intravenous Dose
[mg]

> 60

< 124

See Usual Dosage.

30‑60

124 to 168

200‑400 mg every 12 h

< 30

> 169

200‑400 mg every 24 h

Patients on haemodialysis

> 169

200‑400 mg every 24 h (after dialysis)

Patients on peritoneal dialysis

> 169

200‑400 mg every 24 h

 

 

4.3     Contraindications

 

·                Hypersensitivity to the active substance, to other quinolones or to any of the excipients listed in (see section 6.1).

·                Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).

 

4.4     Special warnings and precautions for use

 

 

 

Paediatric populationChildren and adolescents

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.

 

Musculoskeletal System

Ciprofloxacin should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated (see section 4.8).

 

 

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.

 

(See section 4.2 ElderlyGeriatric patients, section 4.5, section 4.8, section 4.9).

 

Hypoglycemia

As with other quinolones, hypoglycemia has been reported most often in diabetic patients, predominantly in the elderly population. In all diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).

 

4.5     Interaction with other medicinal products and other forms of interaction

 

 

Glibenclamide

In particular cases, concurrent administration of ciprofloxacin and glibenclamide containing medicinal products can intensify the action of glibenclamide (hypoglycaemia).

 

4.6     Pregnancy and lactation

Breast-feedingLactation

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.

 

 

4.8       Undesirable effects

 

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.

ADRs derived from clinical studies and post-marketing surveillance with Ciproxin (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.

 

System Organ Class

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1, 000 to < 1/100

Rare

≥ 1/10 ,000 to < 1/1 ,000

Very Rare

< 1/10 ,000

Frequency not known

(cannot be estimated from the available data)

Infections and Infestations

 

Mycotic superinfections

Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)

 

 

Blood and Lymphatic System Disorders

 

Eosinophilia

Leukopenia

Anaemia

Neutropenia

Leukocytosis

Thrombocytopenia

Thrombocytaemia

Haemolytic anaemia

Agranulocytosis

Pancytopenia (life-threatening)

Bone marrow depression (life-threatening)

 

Immune System Disorders

 

 

Allergic reaction

Allergic oedema / angiooedema

Anaphylactic reaction

Anaphylactic shock (life-threatening) (see section 4.4)

Serum sickness-like reaction

 

Metabolism and Nutrition Disorders

 

Decreased appetiteAnorexia

Hyperglycaemia

Hypoglycaemia (see section 4.4)

 

 

Psychiatric Disorders

 

Psychomotor hyperactivity / agitation

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

Psychotic reactions (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

 

Nervous System Disorders

 

Headache

Dizziness

Sleep disorders

Taste disorders

Par- and Dysaesthesia

Hypoaesthesia

Tremor

Seizures (incl. status epilepticus see section 4.4)

Vertigo

Migraine

Disturbed coordination

Gait disturbance Olfactory nerve disorders

Intracranial hypertension and pseudotumor cerebri

Peripheral neuropathy and polyneuropathy (see section 4.4)

Eye Disorders

 

 

Visual disturbances (e.g. diplopia)

Visual colour distortions

 

Ear and Labyrinth Disorders

 

 

Tinnitus

Hearing loss / Hearing impaired

 

 

Cardiac Disorders

 

 

Tachycardia

 

Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9)

Vascular Disorders

 

 

Vasodilatation

Hypotension

Syncope

Vasculitis

 

Respiratory, Thoracic and Mediastinal Disorders

 

 

Dyspnoea (including asthmatic condition)

 

 

Gastrointestinal Disorders

Nausea

Diarrhoea

Vomiting

Gastrointestinal and abdominal pains

Dyspepsia

Flatulence

 

Pancreatitis

 

Hepatobiliary Disorders

 

Increase in transaminases

Increased bilirubin

Hepatic impairment

Cholestatic icterus

Hepatitis

Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)

 

Skin and Subcutaneous Tissue Disorders

 

Rash

Pruritus

Urticaria

Photosensitivity reactions (see section 4.4)

Petechiae

Erythema multiforme

Erythema nodosum

Stevens-Johnson syndrome (potentially life-threatening)

Toxic epidermal necrolysis (potentially life-threatening)

Acute generalised exanthematous pustulosis (AGEP)

Musculoskeletal, and Connective Tissue and Bone Disorders

 

Musculoskeletal pain (e.g. extremity pain, back pain, chest pain)

Arthralgia

Myalgia

Arthritis

Increased muscle tone and cramping

Muscular weakness

Tendinitis

Tendon rupture (predominantly Achilles tendon) (see section 4.4)

Exacerbation of symptoms of myasthenia gravis (see section 4.4)

 

Renal and Urinary Disorders

 

Renal impairment

Renal failure

Haematuria

Crystalluria (see section 4.4)

Tubulointerstitial nephritis

 

 

General Disorders and Administration Site Conditions

 

Asthenia

Fever

Oedema

Sweating (hyperhidrosis)

 

 

Investigations

 

Increase in blood alkaline phosphatase

Increased amylase

 

International normalised ratio increased (in patients treated with Vitamin K antagonists)

 

Paediatric populationpatients

The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).

 

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 to the Irish Medicines Board (online at www.imb.ie, telephone 01-6764971 or using the yellow card system).

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

via the national reporting system listed in Appendix V*

[*For the printed material, please refer to the guidance of the annotated QRD template.]

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Pharmacokinetic/pharmacodynamicPK/PD relationship:

Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.

 

5.2     Pharmacokinetic properties

BiotransformationMetabolism

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.

 

10.     DATE OF REVISION OF THE TEXT

 

November 2012September 2013

 

Updated on 21 December 2012 SmPC

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 4.5 - 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
  • 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

Changes for www.medicines.ie

Deleted text

Inserted text

 

4.             Clinical particulars

4.1          Therapeutic indications

Ciproxin Solution for Infusion 2mg/ml is indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Adults

·         Lower respiratory tract infections due to Gram-negative bacteria

-          exacerbations of chronic obstructive pulmonary disease

-          broncho-pulmonary infections in cystic fibrosis or in bronchiectasis

-          pneumonia

 

·         Chronic suppurative otitis media

 

·         Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria

 

·         Urinary tract infections

 

·         Epididymo-orchitis including cases due to Neisseria gonorrhoeae

 

·         Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae

In the above genital tract infections when thought or known to be due to Neisseria gonorrhoeae it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing.

              Genital tract infections

-               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)

 

·         Intra-abdominal infections

 

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

 

·         Malignant external otitis

 

·         Infections of the bones and joints

 

·         Treatment of infections in neutropenic patients

 

·         Prophylaxis of infections in neutropenic patients

 

·         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.

4.2          Posology and method of administration

…………………………….

Urinary tract infections
(see section 4.4)

Complicated and uncomplicated pyelonephritis

400 mg twice daily to 400 mg three times a day

7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)

Prostatitis

400 mg twice daily to 400 mg three times a day

2 to 4 weeks (acute)

………………………………

Treatment of infections or prophylaxis of infections in neutropenic patients

Neutropenic patients with fever that is suspected to be due to a bacterial infection.

Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.

400 mg twice daily to 400 mg three times a day

Therapy should be continued over the entire period of neutropenia

 

 

4.4          Special warnings and precautions for use

……………………………….

Genital tract infections

Epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Ciprofloxacin should be co-administered with another appropriate antibacterial agent unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.

Epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates.

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 across the European Union. Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones.

……………………..

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, as soon as 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 (see section 4.8).

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 (see section 4.8).

………………………………………..

Central Nervous System

Ciprofloxacin like other qQuinolones 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 (see section 4.8). Psychiatric reactions may occur even after the first administration of ciprofloxacin. In rare cases, depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide self-endangering behaviour. In the occurrence of such these 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 (see section 4.8).

 

Cardiac disorders

Since ciprofloxacin is associated with cases of QT prolongation (see section 4.8), caution should be exercised when treating patients at risk for torsades de pointes arrhythmia.

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.

 

 (See section 4.2 Geriatric patients, section 4.5, section 4.8, section 4.9).

… ……………………………….

Impaired renal function

Since ciprofloxacin is largely excreted unchanged via renal pathway dose adjustment is needed in patients with impaired renal function as described in section 4.2 to avoid an increase in adverse drug reactions due to accumulation of ciprofloxacin

……………….

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)……….

4.5          Interaction with other medicinal products and other forms of interaction

Effects of other medicinal 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) (see section 4.4).

…………………………..

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 antagonistsOral anticoagulants

Simultaneous administration of ciprofloxacin with a vitamin K antagonist warfarin may augment its anti-coagulant effects. There have been many reports of increases in oral anti-coagulant activity in patients receiving antibacterial agents, including fluoroquinolones. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin the fluoroquinolone to the increase in INR (international normalised ratio) is difficult to assess. It is recommended that tThe 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)an oral anticoagulant agent.

Glibenclamide

In particular cases, concurrent administration of ciprofloxacin and glibenclamide containing medicinal products can intensify the action of glibenclamide (hypoglycaemia).

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 (see section 4.4).

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