Skip to Content

CIPROFLOXACIN 2MG/ML SOLUTION FOR INFUSION

Active substance(s): CIPROFLOXACIN LACTATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Ciprofloxacin 2 mg/ml Solution for Infusion
Ciprofloxacin
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•K
 eep this leaflet. You may need to read it again.
• I f you have any further questions, ask your doctor
or pharmacist or nurse.
•T
 his 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 any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist. See section 4.
What is in this leaflet:
1. W
 hat Ciprofloxacin 2 mg/ml Solution for Infusion
is and what it is used for
2. W
 hat you need to know before you are given
Ciprofloxacin 2 mg/ml Solution for Infusion
3. H
 ow to use Ciprofloxacin 2 mg/ml Solution for
Infusion
4. Possible side effects
5. H
 ow to store Ciprofloxacin 2 mg/ml Solution for
Infusion
6. Contents of the pack and other information
1. What Ciprofloxacin 2 mg/ml Solution for
Infusion is and what it is used for
Ciprofloxacin 2 mg/ml Solution for Infusion is an
antibiotic belonging to the fluoroquinolone family.
The active substance is ciprofloxacin. Ciprofloxacin
works by killing bacteria that cause infections. It
only works with specific strains of bacteria.












Adults
Ciprofloxacin 2 mg/ml Solution for Infusion is used
in adults to treat the following bacterial infections:
• r espiratory tract infections
• long lasting or recurring ear or sinus infections
•u
 rinary tract infections.
•g
 enital tract infections in men and women
•g
 astro-intestinal tract infections and intraabdominal infections
• s kin and soft tissue infections
•b
 one and joint infections
•a
 nthrax 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 2 mg/ml Solution for Infusion.

Children and adolescents
Ciprofloxacin 2 mg/ml Solution for Infusion 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
• c omplicated urinary tract infections, including
infections that have reached the kidneys
(pyelonephritis)
•a
 nthrax inhalation exposure
Ciprofloxacin 2 mg/ml Solution for Infusion 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 take
Ciprofloxacin 2 mg/ml Solution for Infusion
You must not be given Ciprofloxacin 2 mg/ml
Solution for Infusion:
− if you are allergic to the active substance
ciprofloxacin, 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 2 mg/ml Solution for
Infusion )
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Ciprofloxacin 2 mg/ml Solution for Infusion
• 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 2 mg/ml Solution for Infusion,
• 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 (arrythmias). 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 Other medicines and
Ciprofloxacin 2 mg/ml Solution for Infusion).
• I f 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 2
mg/ml Solution for Infusion
Tell your doctor immediately, if any of the following
occurs during treatment with Ciprofloxacin 2 mg/ml
Solution for Infusion. Your doctor will decide whether
treatment with Ciprofloxacin 2 mg/ml Solution for
Infusion needs to be stopped.
•S
 evere, sudden allergic reaction (an
anaphylactic reaction/shock, angio-oedema). 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 2 mg/ml Solution for Infusion
will have to be stopped.
•P
 ain 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 2 mg/ml Solution for
Infusion will have to be stopped, rest the painful
area. Avoid any unnecessary exercise as this might
increase the risk of a tendon rupture.
• I f 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 2 mg/ml Solution for Infusion
and contact your doctor immediately.
•Y
 ou 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 2 mg/ml Solution for Infusion. In
rare cases, depression or psychosis can progress to
thoughts of suicide, suicide attempts, or completed
suicide If this happens, stop taking Ciprofloxacin
2 mg/ml Solution for Infusion and contact your
doctor immediately.
Y
 ou may experience symptoms of neuropathy
such as pain, burning, tingling, numbness and/or
weakness. If this happens, stop taking Ciprofloxacin
2 mg/ml Solution for Infusion and contact your
doctor immediately.
H
 ypoglycemia has been reported most often
in diabetic patients, predominantly in elderly
population. If this happens, contact your doctor
immediately
D
 iarrhoea may develop while you are on
antibiotics, including Ciprofloxacin 2 mg/ml
Solution for Infusion, 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 2 mg/ml Solution for Infusion
treatment will have to be stopped immediately, as
this can be life-threatening. Do not take medicines
that stop or slow down bowel movements.
T
 ell the doctor or laboratory staff that you are
taking Ciprofloxacin 2 mg/ml Solution for Infusion
if you have to provide a blood or urine sample.
C
 iprofloxacin 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for
Infusion must be stopped immediately.
C
 iprofloxacin 2 mg/ml Solution for Infusion 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.
Y
 our skin becomes more sensitive to sunlight
or ultraviolet (UV) light under treatment with
Ciprofloxacin 2 mg/ml Solution for Infusion. Avoid
exposure to strong sunlight or artificial UV light
such as sunbeds.
I f your eyesight becomes impaired or if your eyes
seem to be otherwise affected, consult an eye
specialist immediately.
I f you suffer from kidney problems, tell the
doctor because your dose may need to be
adjusted.

Οther medicines and Ciprofloxacin 2 mg/ml
Solution for Infusion:
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines.
You must tell your doctor if you are taking other
medicines that can alter your heart rhythm:
•m
 edicines 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.
Do not use Ciprofloxacin 2 mg/ml Solution
for Infusion 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 2 mg/ml Solution
for Infusion if you are”).
The following medicines are known to interact
with Ciprofloxacin 2 mg/ml Solution for Infusion in
your body. Using Ciprofloxacin 2 mg/ml Solution
for Infusion 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:
•V
 itamin K antagonists (e.g. warfarin,
acenocoumarol, phenprocoumon or fluindione) or
other oral anticoagulants (to thin blood)
•p
 robenecid (for gout)
•m
 ethotrexate, (for certain types of cancer,
psoriasis, rheumatoid arthritis).
• theophylline, (for breathing problems)
• tizanidine, (for muscle spasticity in multiple
sclerosis)
•o
 lanzapine (an antipsychotic)
• c lozapine (an antipsychotic)
• r opinirole (for Parkinson’s disease)
•p
 henytoin (for epilepsy).
• c yclosporin (for skin conditions, rheumatoid
arthritis and in organ transplantation)
Ciprofloxacin 2 mg/ml Solution for Infusion may
increase the levels of the following medicines in
your blood:
• pentoxifylline

(for circulatory disorders)
• c affeine
•d
 uloxetine (for depression, diabetic nerve damage
or incontinence)
• lidocaine (for heart conditions or anaesthetic use)
• s ildenafil (e.g. for erectile dysfunction)
Taking Ciprofloxacin 2mg/ml Solution for
Infusion with food and drink
Food and drink does not affect your treatment with
Ciprofloxacin 2 mg/ml Solution for Infusion.
Pregnancy and breast-feeding
It is preferable to avoid the use of Ciprofloxacin 2
mg/ml Solution for Infusion during pregnancy. Tell
your doctor if you are planning to get pregnant.
Do not take Ciprofloxacin 2 mg/ml Solution for
Infusion during breast feeding because ciprofloxacin
is excreted in breast milk and can be harmful for
your child.
Driving and using machines
Ciprofloxacin 2 mg/ml Solution for Infusion may
make you feel less alert. Some neurological adverse
events can occur. Therefore, make sure you know
how you react to Ciprofloxacin 2 mg/ml Solution
for Infusion before driving a vehicle or operating
machinery. If in doubt, talk to your doctor.
Important information about some of the
ingredients of Ciprofloxacin 2 mg/ml Solution
for Infusion
This medicinal product contains 177/354/708 mg
(7.7/15.4/30.8 mmol) sodium per 50/100/200
milliliter of solution.
To be taken into consideration by patients on a
controlled sodium diet.
3. How to take Ciprofloxacin 2mg/ml
Solution for Infusion
Your doctor will explain to you exactly how much
Ciprofloxacin 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for Infusion and 30
minutes for 200 mg Ciprofloxacin 2 mg/ml Solution
for Infusion. Administering the infusion slowly helps
prevent immediate side effects occurring.
Remember to drink plenty of fluids while you are
taking Ciprofloxacin 2mg/ml Solution for Infusion.
If you stop your course of Ciprofloxacin 2
mg/ml Solution for Infusion
 I t 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 more questions about 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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, tell
your doctor or pharmacist.
See your doctor immediately if you notice
any of the following side effects during
treatment with Ciprofloxacin, which may be
serious, and for which you may need urgent
medical treatment:
•S
 evere, sudden allergic reaction (an
anaphylactic reaction/shock, angio-oedema). 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 2 mg/ml Solution for Infusion
will have to be stopped.
•M
 uscle 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).
•S
 udden onset of a severe rash or blistering
or peeling skin, which may be associated with
a high fever and joint pains. These may indicate
severe, sometimes life-threatening reactions (e.g.
Stevens-Johnson syndrome or toxic epidermal
necrolysis).
•P
 sychiatric reactions after first administration
of ciprofloxacin. If you suffer from depression
or psychosis, your symptoms may become
worse under treatment with Ciprofloxacin 2 mg/
ml Solution for Infusion. In rare cases, depression
or psychosis can progress to thoughts of suicide,
suicide attempts, or completed suicide. If this
happens, stop taking Ciprofloxacin 2 mg/ml
Solution for Infusion and contact your doctor
immediately.
•S
 ymptoms of neuropathy such as pain, burning,
tingling, numbness and/or weakness. If
this happens, stop taking Ciprofloxacin 2 mg/
ml Solution for Infusion and contact your doctor
immediately.
•D
 iarrhoea may develop while you are on
antibiotics, including Ciprofloxacin 2 mg/ml
Solution for Infusion, 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 2 mg/ml Solution for Infusion
treatment will have to be stopped immediately, as
this can be life-threatening. Do not take medicines
that stop or slow down bowel movements.
•C
 iprofloxacin 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for
Infusion must be stopped immediately.
• I f your eyesight becomes impaired or if your
eyes seem to be otherwise affected, consult an
eye specialist immediately.
Other side effects may occur. If any of the following
occurs during treatment with Ciprofloxacin.
Tell your doctor as soon as possible.
Common side effects (may affect up to 1 in 10
people):
-

nausea, vomiting
joint pains in children
local reaction at the injection site, rash
temporary increased amounts of substances in the
blood (transaminases)

Uncommon side effects (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)
- loss of appetite (anorexia)
- 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
- 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
- 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 side effects (may affect up to 1 in 1000
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)
- increased blood sugar (hyperglycemia)
- decreased blood sugar (hypoglycaemia) (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
-p
 ancreatitis
- sensitivity to light (see Section 2: Warnings and
precautions), small, pin-point bleeding under the
skin (petechiae)
- blood or crystals in the urine (see Section
2: Warnings and precautions), urinary tract
inflammation
-e
 xcessive sweating
Very rare side effects (may affect up to 1 in
10000 people):
-a
 special type of reduced red blood cell count
(haemolytic anaemia); a dangerous drop in a type
of white blood cells (agranulocytosis )
- disturbed coordination, unsteady walk (gait
disturbance), pressure on the brain (intracranial
pressure and pseudotumor cerebri)
- visual colour distortions

-m
 uscle weakness, tendon inflammation,
worsening of the symptoms of myasthenia gravis
(see Section 2: Warnings and precautions)
Frequency not known (cannot be estimated from
the available data)
-A
 bnormal 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)
-p
 ustular rash
- influence on blood clotting (in patients treated
with Vitamin K antagonists)
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 the Yellow Card Scheme at:
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 2 mg/ml
Solution for Infusion
Keep out of the sight and reach of children.
Do not use Ciprofloxacin 2 mg/ml Solution for
Infusion after the expiry date which is stated on the
carton after “EXP”: The expiry date refers to the
last day of that month.
Do not refrigerate or freeze.
Keep the container in the outer carton in order to
protect from light.
Do not throw away any medicinesvia wastewater
or household waste. Ask your pharmacist
how to throw away medicines you no longer
required. These measures will help to protect the
environment.
6. Contents of the pack and other information
What Ciprofloxacin 2 mg/ml Solution for
Infusion contains
The active ingredient is ciprofloxacin (as
ciprofloxacin lactate).
1 ml solution for infusion contains 2 mg of
Ciprofloxacin (as lactate).
The other ingredients are: Lactic Acid (90%),
Sodium Chloride, Hydrochloric Acid 1N, Water for
Injections.
What Ciprofloxacin 2 mg/ml Solution for
Infusion looks like and contents of the pack
Ciprofloxacin 2mg/ml Solution for Infusion is
supplied in a transparent Type I glass vial with
rubber stopper and aluminium cap. The appearance
of the product is a clear yellowish to slightly yellow,
odourless solution free from foreign bodies with a
pH 3.9 – 4.5.
Pack sizes:
One vial with
50 ml solution for infusion contains 100 mg
ciprofloxacin (as lactate).
100 ml solution for infusion contains 200 mg
ciprofloxacin (as lactate).
200 ml solution for infusion contains 400 mg
ciprofloxacin (as lactate).
Not all pack sizes may be marketed.
Marketing
Authorisation
Manufacturer

Holder

and

Marketing Authorisation Holder(s)

For United Kingdom:
Pharmathen S.A., 153 51, Pallini-Attiki, Greece
tel.: +30.210.6665067
fax: +30.210.6666749
e-mail: info@pharmathen.com
For Greece
Pharmathen Hellas S.A., 153 51, Pallini, Attiki
Tel.: +30 210 66 64 805
Fax: +30 210 66 64 804      
E-mail: info@pharmathen.com
Manufacturer(s)
Pharmathen S.A., 153 51, Pallini-Attiki, Greece
tel.: +30.210.6665067
fax: +30.210.6666749
e-mail: info@pharmathen.com
And
ANFARM HELLAS S.A., Sximatari Viotias, Sximatari
Viotias 32009, Greece
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Greece Ladinin
United Kingdom Ciprofloxacin 2mg/ml Solution for
Infusion
This leaflet was last revised in 09/2016.
Detailed information on this medicine is available on
the web site of MA.
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:
- dosages
- schedules
- duration of treatment
Consequently, to preserve the efficacy of this drug:
1 - Use antibiotics only when prescribed.
2 - Strictly follow the prescription.
3-D
 o not re-use an antibiotic without medical
prescription, even if you want to treat a similar
illness.
4-N
 ever give your antibiotic to another person;
maybe it is not adapted to her/his illness.
5-A
 fter completion of treatment, return all unused
drugs to your chemist’s shop to ensure they will
be disposed of correctly.
The following information is intended for
medical or healthcare professionals only:
Ciprofloxacin 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for Infusion
and 30 minutes for 200 mg Ciprofloxacin 2 mg/ml
Solution for Infusion. 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.

Expand view ⇕

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.

Hide