Ciprofloxacin 2 mg/ml solution for infusion

Main information

  • Trade name:
  • Ciprofloxacin 2 mg/ml solution for infusion
  • Dosage:
  • 2 milligram(s)/millilitre
  • Pharmaceutical form:
  • Solution for infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ciprofloxacin 2 mg/ml solution for infusion
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Fluoroquinolones; ciprofloxacin

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not marketed
  • Authorization number:
  • PA0437/057/001
  • Authorization date:
  • 01-06-2007
  • Last update:
  • 12-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

2018-0036933

Page 1 of 12

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin 2 mg/ml solution for infusion

ciprofloxacin

Read all of this leaflet carefully before you are given this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may

harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

What Ciprofloxacin is and what it is used for

What you need to know before you are given ciprofloxacin

How to use Ciprofloxacin

Possible side effects

How to store ciprofloxacin

Contents of the pack and other information

1.

What Ciprofloxacin is and what it is used for

Ciprofloxacin contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic

belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause

infections. It only works with specific strains of bacteria.

Adults

Ciprofloxacin is used in adults to treat the following bacterial infections:

respiratory tract infections

long lasting or recurring ear or sinus infections

urinary tract infections

genital tract infections in men and women

gastro-intestinal tract infections and intra-abdominal infections

skin and soft tissue infections

bone and joint infections

anthrax inhalation exposure

Ciprofloxacin may be used in the management of patients with low white blood cell

counts (neutropenia) who have a fever that is suspected to be due to a bacterial

infection.

2018-0036933

Page 2 of 12

If you have a severe infection or one that is caused by more than one type of bacterium,

you may be given additional antibiotic treatment in addition to Ciprofloxacin.

Children and adolescents

Ciprofloxacin is used in children and adolescents, under specialist medical supervision,

to treat the following bacterial infections:

lung and bronchial infections in children and adolescents suffering from cystic

fibrosis

complicated urinary tract infections, including infections that have reached the

kidneys (pyelonephritis)

anthrax inhalation exposure

Ciprofloxacin may also be used to treat other specific severe infections in children and

adolescents when your doctor considered this necessary.

2.

What you need to know before you are given Ciprofloxacin

You must not be given Ciprofloxacin:

if you are allergic to the active substance, to other quinolone drugs or to any of the

other ingredients of this medicine (listed in Section 6)

if you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin)

Warnings and precautions:

Talk to your doctor before you are given Ciprofloxacin:

if you have ever had kidney problems because your treatment may need to be

adjusted.

if you suffer from epilepsy or other neurological conditions.

if you have a history of tendon problems during previous treatment with antibiotics

such as Ciprofloxacin.

if you are diabetic because you may experience a risk of hypoglycaemia with

ciprofloxacin.

if you have myasthenia gravis (a type of muscle weakness) because symptoms can

be exacerbated.

if you have heart problems. Caution should be taken when using Ciprofloxacin, if you

were born with or have family history of prolonged QT interval (seen on ECG,

electrical recording of the heart), have salt imbalance in the blood (especially low

level of potassium or magnesium in the blood), have a very slow heart rhythm (called

‘bradycardia’), have a weak heart (heart failure), have a history of heart attack

(myocardial infarction), you are female or elderly or you are taking other medicines

that result in abnormal ECG changes (see section 2: Other medicines and

Ciprofloxacin).

2018-0036933

Page 3 of 12

If you or a member of your family is known to have a deficiency in glucose-6-

phosphate dehydrogenase (G6PD), since you may experience a risk of anaemia with

ciprofloxacin.

For the treatment of some genital tract infections, your doctor can prescribe another

antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days

of treatment, please consult your doctor.

While under treatment with Ciprofloxacin

Tell your doctor immediately, if any of the following occurs during treatment with

Ciprofloxacin. Your doctor will decide whether treatment with Ciprofloxacin needs to be

stopped.

Severe, sudden allergic reaction (an anaphylactic reaction/shock, angiooedema).

Even with the first dose, there is a rare chance that you may experience a severe

allergic reaction with the following symptoms: tightness in the chest, feeling dizzy,

feeling sick or faint, or experience dizziness on standing. If this happens, tell your

doctor immediately since the administration of Ciprofloxacin will have to be

stopped.

Pain and swelling in the joints, and tendinitis may occur occasionally, particularly

if you are elderly and are also being treated with corticosteroids. Inflammation and

ruptures of tendons may occur even within the first 48 hours of treatment or up to

several months after discontinuation of Ciprofloxacin therapy. At the first sign of any

pain or inflammation stop taking Ciprofloxacin, contact your doctor and rest the

painful area. Avoid any unnecessary exercise as this might increase the risk of a

tendon rupture.

If you suffer from epilepsy or other neurological conditions such as cerebral

ischemia or stroke, you may experience side effects associated with the central

nervous system. If seizure happens, stop taking Ciprofloxacin and contact your doctor

immediately.

You may experience symptoms of neuropathy such as pain, burning, tingling,

numbness and/or muscle weakness. If this happens, stop taking Ciprofloxacin and

contact your doctor immediately.

You may experience psychiatric reactions after first administration of ciprofloxacin.

If you suffer from depression or psychosis, your symptoms may become worse under

treatment with Ciprofloxacin. In rare cases, depression or psychosis can progress

to thoughts of suicide, suicide attempts, or completed suicide. If this happens, contact

your doctor immediately.

Hypoglycaemia has been reported most often in diabetic patients, predominantly in

elderly population. If this happens, contact your doctor immediately.

Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin, or even

several weeks after you have stopped using them. If it becomes severe or persistent

or you notice that your stool contains blood or mucus, stop taking Ciprofloxacin and

contact your doctor immediately, as this can be life-threatening. Do not take

medicines that stop or slow down bowel movements.

If your eyesight becomes impaired or if your eyes seem to be otherwise affected,

consult an eye specialist immediately.

2018-0036933

Page 4 of 12

Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under

treatment with Ciprofloxacin. Avoid exposure to strong sunlight or artificial UV light

such as sunbeds.

Tell the doctor or laboratory staff that you are taking Ciprofloxacin if you have to

provide a blood or urine sample.

If you suffer from kidney problems, tell the doctor because your dose may need to

be adjusted.

Ciprofloxacin may cause liver damage. If you notice any symptoms such as loss of

appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the

stomach, Ciprofloxacin must be stopped immediately.

Ciprofloxacin may cause a reduction in the number of white blood cells and your

resistance to infection may be decreased. If you experience an infection with

symptoms such as fever and serious deterioration of your general condition, or fever

with local infection symptoms such as sore throat/pharynx/mouth or urinary problems

you should see your doctor immediately. A blood test will be taken to check possible

reduction of white blood cells (agranulocytosis). It is important to inform your doctor

about your medicine.

Other medicines and Ciprofloxacin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any

other medicines.

Do not use Ciprofloxacin together with tizanidine, because this may cause side

effects such as low blood pressure and sleepiness (see section 2: You must not be

given Ciprofloxacin).

The following medicines are known to interact with Ciprofloxacin in your body. Using

Ciprofloxacin together with these medicines can influence the therapeutic effect of these

medicines. It can also increase the probability of experiencing side effects.

Tell your doctor if you are taking:

Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione)

or other oral anti-coagulants (to thin the blood)

probenecid (for gout)

methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)

theophylline (for breathing problems)

tizanidine (for muscle spasticity in multiple sclerosis)

olanzapine (an antipsychotic)

clozapine (an antipsychotic)

ropinirole (for Parkinson’s disease)

phenytoin (for epilepsy)

cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)

other medicines that can alter your heart rhythm: medicines that belong to the group

of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol,

dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the

group of macrolides), some antipsychotics

zolpidem (for sleep disorders)

2018-0036933

Page 5 of 12

Ciprofloxacin may increase the levels of the following medicines in your blood:

pentoxifylline (for circulatory disorders)

caffeine

duloxetine (for depression, diabetic nerve damage or incontinence)

lidocaine (for heart conditions or anaesthetic use)

sildenafil (e.g. for erectile dysfunction)

agomelatine (for depression)

Ciprofloxacin with food and drink

Food and drink does not affect your treatment with Ciprofloxacin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have

a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of Ciprofloxacin during pregnancy.

Do not take Ciprofloxacin during breast-feeding because ciprofloxacin is excreted in

breast milk and can be harmful for your child.

Driving and using machines

Ciprofloxacin may make you feel less alert. Some neurological adverse events can

occur. Therefore, make sure you know how you react to Ciprofloxacin before driving a

vehicle or operating machinery. If in doubt, talk to your doctor.

Ciprofloxacin contains glucose

Contains 9 g glucose in 200 ml solution for infusion. This should be taken into account

in patients with diabetes mellitus.

3.

How to use Ciprofloxacin

Your doctor will explain to you exactly how much Ciprofloxacin you will be given as well

as how often and for how long. This will depend on the type of infection you have and

how bad it is.

Tell your doctor if you suffer from kidney problems because your dose may need to be

adjusted.

Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.

2018-0036933

Page 6 of 12

Your doctor will give you each dose by slow infusion through a vein into your

bloodstream. For children, the infusion duration is 60 minutes. In adult patients, infusion

time is 60 minutes for 400 mg Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin.

Administering the infusion slowly helps prevent immediate side effects occurring.

Remember to drink plenty of fluids while you are taking this medicine.

If you stop your course of Ciprofloxacin, it is important that you finish the course of

treatment even if you begin to feel better after a few days. If you stop using this

medicine too soon your infection may not be completely cured and the symptoms of the

infection may return or get worse. You might also develop resistance to the antibiotic.

If you have any further questions about the use of this medicine, ask your doctor or

pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets

them.

The following section contains the most serious side effects that you can recognise

yourself:

Stop taking Ciprofloxacin and contact your doctor immediately in order to consider

another antibiotic treatment if you notice any of the following serious side effects:

Uncommon (may affect up to 1 in 100 people)

seizure (see section 2: Warnings and precautions)

Rare (may affect up to 1 in 1,000 people)

severe, sudden allergic reaction with symptoms such as tightness in the chest,

feeling dizzy, sick or faint, or experience dizziness when standing up

(anaphylactic shock) (see section 2: Warnings and precautions)

tendon rupture, particularly affecting the large tendon at the back of the ankle

(Achilles tendon) (see section 2: Warnings and precautions)

Very rare (may affect up to 1 in 10,000 people)

severe, sudden allergic reaction with symptoms such as tightness in the chest,

feeling dizzy, sick or faint, or experience dizziness when standing up

(anaphylactic reaction) (see section 2: Warnings and precautions)

muscle weakness, inflammation of the tendons which could lead to rupture of the

tendon, particularly affecting the large tendon at the back of the ankle (Achilles

tendon) (see section 2: Warnings and precautions)

a serious life-threatening skin rash, usually in the form of blisters or ulcers in the

mouth, throat, nose, eyes and other mucous membranes such as genitals which

may progress to widespread blistering or peeling of the skin (Stevens-Johnson

syndrome, toxic epidermal necrolysis).

2018-0036933

Page 7 of 12

Not known (frequency cannot be estimated from the available data)

unusual feelings of pain, burning tingling, numbness or muscle weakness in the

extremities (neuropathy) (see section 2: Warnings and precautions)

a drug reaction that causes rash, fever, inflammation of internal organs,

hematologic abnormalities and systemic illness (DRESS Drug Reaction with

Eosinophilia and Systemic Symptoms, AGEP Acute Generalised Exanthematous

Pustulosis).

Other side effects which have been observed during treatment with Ciprofloxacin are

listed below by how likely they are:

Common (may affect up to 1 in 10 people)

nausea, diarrhoea, vomiting

joint pain and joint inflammation in children

local reaction at the injection site, rash

temporary increased amounts of substances in the blood (transaminases)

Uncommon (may affect up to 1 in 100 people)

joint pain in adults

fungal superinfections

a high concentration of eosinophils, a type of white blood cell,

increased or decreased amounts of a blood clotting factor (thrombocytes)

decreased appetite

hyperactivity, agitation, confusion, disorientation, hallucinations

headache, dizziness, sleeping problems, taste disorders, pins and needles,

unusual sensitivity to stimuli of the senses, giddiness

eyesight problems including double vision

loss of hearing

rapid heartbeat (tachycardia)

expansion of the blood vessels (vasodilation), low blood pressure

abdominal pain, digestive problems such as stomach upset

(indigestion/heartburn), wind

liver disorders, increased amounts of one substance in the blood (bilirubin),

jaundice (cholestatic icterus)

itching, hives

poor kidney function, kidney failure

pains in your muscles and bones, feeling unwell (asthenia), fever, fluid retention

increase in blood alkaline phosphatase (a certain substance in the blood)

Rare (may affect up to 1 in 1,000 people)

muscle pain, inflammation of the joints, increased muscle tone and cramping

inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare

cases) (see section 2: Warnings and precautions)

2018-0036933

Page 8 of 12

changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a

drop in the number of red and white blood cells and platelets (pancytopenia),

which may be fatal, bone-marrow depression which may also be fatal

allergic reaction, allergic swelling (oedema), rapid swelling of the skin and

mucous membranes (angiooedema) (see section 2: Warnings and precautions)

increased blood sugar (hyperglycemia)

decreased blood sugar (hypoglycaemia) (see section 2: Warnings and

precautions)

anxiety reaction, strange dreams, depression (potentially leading to thoughts of

suicide, suicide attempts, or completed suicide), mental disturbances (psychotic

reactions potentially leading to thoughts of suicide, suicide attempts, or

completed suicide) (see section 2: Warnings and precautions)

decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory

disorders)

tinnitus, impaired hearing

fainting, inflammation of the blood vessel (vasculitis)

shortness of breath including asthmatic symptoms

pancreatitis

hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening

liver failure (see section 2: Warnings and precautions)

sensitivity to light (see section 2: Warnings and precautions), small, pin-point

bleeding under the skin (petechiae)

blood or crystals in the urine, urinary tract inflammation

excessive sweating

increased levels of the enzyme amylase

Very rare (may affect up to 1 in 10,000 people)

a special type of reduced red blood cell count (haemolytic anaemia); a

dangerous drop in a type of white blood cells (agranulocytosis) (see section 2:

Warnings and precautions)

allergic reaction called serum sickness-like reaction (see section 2: Warnings and

precautions)

disturbed coordination, unsteady walk (gait disturbance), pressure on the brain

(intracranial pressure and pseudotumor cerebri)

visual colour distortions

various skin eruptions or rashes

worsening of the symptoms of myasthenia gravis (see section 2: Warnings and

precautions)

Not known (frequency cannot be estimated from the available data)

feeling highly excited (mania) or feeling great optimism and overactivity

(hypomania)

abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of

the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical

activity of the heart)

influence on blood clotting (in patients treated with Vitamin K antagonists)

2018-0036933

Page 9 of 12

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly via:

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google

Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store Ciprofloxacin

Your medicine will be stored and administered by healthcare professionals, who will

follow this guidance:

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after “EXP”.

The expiry date refers to the last day of that month.

Keep the infusion bag within the sealed outer foil wrap before use, in order to protect

from light and evaporation.

For single use only. Use immediately after first opening the infusion bag.

Do not store above 25

C. Do not refrigerate or freeze.

At cool storage temperatures precipitation may occur, which will re-dissolve at room

temperature (15°C – 25°C).

From a microbiological point of view, unless the method of opening and mixing with co-

infusion solutions precludes the risk of microbial contamination, the product should be

used immediately. If not used immediately, in-use storage times and conditions are the

responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Ask your

pharmacist how to throw away medicines you no longer use. These measures will help

protect the environment.

2018-0036933

Page 10 of 12

6.

Contents of the pack and other information

What Ciprofloxacin contains

The active substance is ciprofloxacin.

1 ml solution contains: 2 mg ciprofloxacin (as ciprofloxacin lactate).

The other ingredients are:

glucose monohydrate

50% lactic acid

hydrochloric acid

water for injections.

What Ciprofloxacin looks like and the contents of the pack

Solution for infusion.

Clear, nearly colourless to slightly yellowish solution.

It is available in transparent infusion (PVC or polyolefin) bags that contain 50 ml, 100 ml

or 200 ml sterile solution of ciprofloxacin 2 mg/ml. The bags are sealed in an outer

packaging of a double sheet of metallised polyethylene terephthalate.

Pack sizes:

5 x 50 ml, 10 x 50 ml, 50 x 50 ml

5 x 100 ml, 10 x 100 ml, 50 x 100 ml

5 x 200 ml, 10 x 200 ml, 20 x 200 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder and company responsible for batch release is

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK.

The manufacturer is Biomendi, S.A., Pol ind. De Bernedo s/n. Bernedo (Álava), Spain

This medicinal product is authorised in the Member States of the EEA under the

following names:

Austria:

Ciprofloxacin Pfizer 2 mg/ml Infusionslösung

Ireland:

Ciprofloxacin 2 mg/ml Solution for Infusion

Sweden:

Ciprofloxacin Pfizer 2 mg/ml, infusionsvätska, lösning

United Kingdom:

Ciprofloxacin 2 mg/ml Solution for Infusion

2018-0036933

Page 11 of 12

This leaflet was last revised in

UK 02/2018

IE 05/2018

Ref gxCI 3_1

For any further information about this medicinal product, please contact:

Medical Information, Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead,

SL6 6RJ, UK Tel: 0800 088 5133

-----------------------------------------------------------------------------------------------------------------

The following information is intended for medical or healthcare professionals only:

For single use only. Discard any remaining solution after use. Keep the infusion bag

within the sealed outer foil wrap before use, in order to protect it from light and

evaporation. The opened pack should be used immediately

Ciprofloxacin should be administered by intravenous infusion. For children, the infusion

duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg

Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin. Slow infusion into a large vein

will minimise patient discomfort and reduce the risk of venous irritation. The infusion

solution can be infused either directly or after mixing with other compatible infusion

solutions.

Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion

solution must always be administered separately. The visual signs of incompatibility are

e.g. precipitation, clouding, and discolouration.

Incompatibility appears with all infusion solutions/drugs that are physically or chemically

unstable at the pH of the solution (e.g. penicillin, heparin solutions), especially in

combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion

solutions: 3.9-4.5).

After intravenous initiation of treatment, the treatment can be continued orally as well.

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective against viral

infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is called

resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant

and therefore delay your cure or decrease antibiotic efficacy if you do not respect

appropriate:

dosage

2018-0036933

Page 12 of 12

schedules

duration of treatment

Consequently, to preserve the efficacy of this drug:

1 - Use antibiotics only when prescribed.

2 - Strictly follow the prescription.

3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a

similar illness.

4 - Never give your antibiotic to another person; maybe it is not adapted to her/his

illness.

5 - After completion of treatment, return all unused drugs to your chemist’s shop to

ensure they will be disposed of correctly.