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CIPROFLOXACIN 200 MG/100 ML SOLUTION FOR INFUSION

Active substance(s): CIPROFLOXACIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin 2 mg/ml
solution for infusion
ciprofloxacin
Read all of this leaflet carefully before
you start using this medicine.
• 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.
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

1. What Ciprofloxacin is and what it is used
for
2. What you need to know before you use
Ciprofloxacin
3. How to use Ciprofloxacin
4. Possible side effects
5. How to store Ciprofloxacin
6. 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.
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 use Ciprofloxacin
Do not use Ciprofloxacin:
• If you are allergic to ciprofloxacin, to
other quinolone drugs or 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, 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).
• If you or a member of your family is
known to have a deficiency in glucose-6phosphate 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
Ciprofloxacin will have to be stopped, 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 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, stop
taking Ciprofloxacin and contact your
doctor immediately.

• You may experience symptoms of

neuropathy such as pain, burning, tingling,
numbness and/or weakness. If this
happens, stop taking Ciprofloxacin and
contact your doctor immediately.

• Hypoglycemia 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 tell your doctor
immediately. Ciprofloxacin treatment
will have to be stopped immediately, as
this can be life-threatening. Do not take
medicines that stop or slow down bowel
movements.

• Tell the doctor or laboratory staff that you

are taking Ciprofloxacin if you have to
provide a blood or urine sample.

• 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.

• If you suffer from kidney problems, tell the

doctor because your dose may need to be
adjusted.

• 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.

• If your eyesight becomes impaired or if

your eyes seem to be otherwise affected,
consult an eye specialist immediately.

Other medicines and Ciprofloxacin
Tell your doctor or pharmacist if you are
taking or 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).
The following medicines are known to
interact with Ciprofloxacin in your body. Using
Ciprofloxacin together with these medicines
can influence their 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 anti-arrhythmics (e.g. quinidine,
hydroquinidine, disopyramide, amiodarone,
sotalol, dofetilide, ibutilide), tricyclic
antidepressants, some antimicrobials (that
belong to the group of macrolides), some
antipsychotics.
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
• zolpidem
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.

Ciprofloxacin 2 mg/ml solution for infusion
ciprofloxacin

The following information is intended for medical or healthcare professionals only:
The solution should be visually inspected prior to use and only clear solutions, without
particles, should be used.
The infusion contains no preservatives. For single use only. Any remaining solution and vials
and/or bags should be adequately disposed of, in accordance with local requirements.
Ciprofloxacin is compatible with isotonic sodium chloride solution, Ringer’s solution, Ringer’s
lactate solution, 50 mg/ml (5 %) or 100 mg/ml (10 %) glucose solution and 50 mg/ml (5 %)
glucose solution with 2.25 mg/ml (0.225 %) or 4.5 mg/ml (0.45 %) sodium chloride solution
and 10% fructose solution. Compatibility with these solutions has been proven in Ciprofloxacin
concentrations of 1 mg/ml. Chemical and physical in-use stability has been demonstrated
immediately after dilution, after 24 hours at 2-8°C and after 24 hours at room temperature.
Unless compatibility is proven, the solution for infusion should always be administered
separately.

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 sodium
If you are on a low-sodium diet, take into
account that 100 ml of Ciprofloxacin contains
15.4 mmol (equivalent to
354 mg) sodium.

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.
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 using 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 furhter questions on the
use of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If you experience the following
side effects, contact your doctor
immediately (see section 2 Warnings
and precautions):
• Severe, sudden allergic reaction (an
anaphylactic reaction/shock, angiooedema).
• Muscle pain and/or weakness,
inflammation of the joints and joint pain,
increased muscle tone and cramping,
inflammation of the tendons or tendon
rupture, particularly affecting the large
tendon at the back of the ankle (Achilles
tendon) - see section 2
• Side effects associated with the central
nervous system, if you suffer from
epilepsy or other neurological conditions
• Psychiatric reactions after first
administration of ciprofloxacin, if you suffer
from depression or psychosis
• Unusual feelings of pain, burning tingling,
numbness of muscle weakness in the
extremities (neuropathy) - see section 2
• Hypoglycemia if you are diabetic
• Severe or persistent diarrhoea or you
notice that your stool contains blood or
mucus
• Loss of appetite, jaundice (yellowing of the
skin), dark urine, itching, or tenderness of
the stomach
• 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
Impairment of your eyesight or if your
eyes seem to be otherwise affected.
Common (may affect up to 1 in 10 people):
• nausea, diarrhoea, vomiting
• joint pains 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):
• fungal superinfections
• a high concentration of eosinophils, a type
of white blood cell, increased or decreased
amounts of a blood cloting 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, seizures
(see Section 2: Warnings and precautions),
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
• joint pain in adults
• 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):
• inflammation of the bowel (colitis) linked to
antibiotic use (can be fatal in rare cases)
(see Section 2: Warnings and precautions)
• 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, bonemarrow depression which may
also be fatal (see Section 2: Warnings and
precautions)
• allergic reaction, allergic swelling
(oedema), rapid swelling of the skin and
mucous membranes (angiooedema),
severe allergic reaction (anaphylactic
shock) which can be life-threatening (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
• sensitivity to light (see Section 2: Warnings
and precautions), small, pin-point bleeding
under the skin (petechiae)
• muscle pain and/or weakness,
inflammation of the joints and joint pain,
increased muscle tone and cramping,
inflammation of the tendons or tendon
rupture, particularly affecting the large
tendon at the back of the ankle (Achilles
tendon) (see Section 2: Warnings and
precautions)
• blood or crystals in the urine (see Section
2: Warnings and precautions), 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)
• severe allergic reaction (anaphylactic
reaction, anaphylactic shock, serum
sickness) which can be fatal (see Section
2: Warnings and precautions)
• disturbed coordination, unsteady walk
(gait disturbance), pressure on the brain
(intracranial pressure and pseusotumor
cerebri)
• visual colour distortions
• various skin eruptions or rashes (e.g. the
potentially fatal Stevens-Johnson syndrome
or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation,
worsening of the symptoms of myasthenia
gravis (see Section 2: Warnings and
precautions)
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
• 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)
• pustular rash
• influence on blood clotting (in patients
treated with Vitamin K antagonists)
• feeling highly excited (mania) or
feeling great optimism and overactivity
(hypomania)
• hypersensitivity reaction called DRESS
(Drug Reaction with Eosinophilia and
Systemic Symptoms)
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 Yellow
Card Scheme
Website: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide
more information on the safety of this
medicine.

5. How to store Ciprofloxacin
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 packaging after “EXP”.
The expiry date refers to the last day of that
month.
Do not refrigerate or freeze.
Keep the vial/bag in the outer carton/
aluminium overpouch until time of use in
order to protect from light.

6. Contents of the pack and
other information
What Ciprofloxacin contains
The active substance is Ciprofloxacin lactate.
Each vial of 100 ml contains 200 mg of
ciprofloxacin.
Each bag of 200 ml contains 400 mg of
ciprofloxacin.
The other ingredients are: lactic acid (E270),
sodium chloride, hydrochloric acid (E507) for
pH adjustment and water for injections.
What Ciprofloxacin looks like and
contents of the pack
Ciprofloxacin is a sterile, clear and colourless
to slightly yellow solution for infusion.
It is contained in a type I or II, clear,
colourless glass vial containing 100 ml
solution and/or a polypropylene infusion bag
containing 200 ml solution.
Marketing Authorization Holder and
Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.º 8, 8A e 8B –
Fervença
2705-906 Terrugem SNT
Portugal
Tel.: +351 219 608 410
Fax: +351 219 615 102
geral@hikma.pt
Distributed by:
Consilient Health (UK) Ltd.
No. 1 Church Road, Richmond upon Thames,
Surrey, TW9 2QE
This medicinal product is authorised in
the Member States of the EEA under the
following names:

Austria:
Ciprofloxacin Hikma 2 mg/ml Lösung zur
Intravenösen Infusion
Germany:
Ciprofloxacin Hikma 2 mg/ml
Infusionslösung
Ireland:
Truoxin I.V. 200 mg/100 ml &
400 mg/200 ml Solution for Infusion
Italy:
Ciprofloxacin Hikma 2 mg/ml Soluzione
per Infusione
United Kingdom:
Ciprofloxacin 2 mg/ml Solution for Infusion
The Netherlands:
Ciprofloxacine Hikma 2 mg/ml
Oplossing voor Intraveneuze Infusie
This leaflet was last revised in July 2016

P0457

&
The diluted solutions should be inspected visually for particulate matter and discoloration prior
to administration. Only clear and colourless solutions should be used.
Handling glass vials:
Ciprofloxacin 2 mg/ml may be infused via a suitable cannula directly or diluted with any of the
fluids in the list above.
Handling plastic bags:
Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The
inner bag maintains the sterility of the product.
To open, tear overwrap down side at slit and remove solution container. Some opacity of the
plastic due to moisture absorption during the sterilization process may be observed. This is
normal and does not affect the solution quality or safety. The opacity will diminish gradually.
After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are
found, discard solution as sterility may be impaired.
CAUTION: Do not use plastic containers in series connections. Such use could result in air
embolism due to residual air being drawn from the primary container before administration of
the fluid from the secondary container is completed.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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