Ceftriaxone 1g Powder for solution for injection | Contains the active ingredient Ceftriaxone sodium USP solution for infusion
Consumer
Medicine Information
SETRAXONE
® 1 gm Injection
Contains the active
ingredient Ceftriaxone sodium USP
solution for infusion.
What is in this
leaflet
·
This
leaflet answers some common questions about Setraxone injection. It does not
contain all the available information.
·
It
does not take the place of talking to your doctor or pharmacist.
·
All
medicines have risks and benefits. Your doctor has weighed the risks of you
being given Setraxone injection against the benefits they expect it will have
for you.
If you have any concerns about
being given this medicine, ask your doctor or pharmacist.
Keep this leaflet.
What Setraxone is
used for
·
Setraxone
is an antibiotic used to treat infections in different parts of the body caused
by bacteria.
·
Setraxone
is also used to prevent infections before, during and after surgery.
·
Setraxone
will not work against infections caused by viruses such as colds or the flu.
·
Setraxone
belongs to a group of antibiotics called cephalosporins.
These antibiotics work by killing the bacteria that
are causing your infection or by stopping bacteria from growing.
Your doctor may have prescribed Setraxone for
another reason
Ask your doctor if you have any questions
why Setraxone has been prescribed for you.
This medicine is available only with a doctor's
prescription. Setraxone is not addictive.
Before you are given Setraxone
When you
must not be given it
Do not use Setraxone if:
•
you have had an allergic reaction to Setraxone,
other cephalosporins or any of the ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic reaction may
include severe skin rash, itching, hives, dry skin, swelling of the face, lips,
mouth or throat which may cause difficulty in swallowing or breathing, swelling
of the hands, feet or ankles.
•
you
have had a serious allergic reaction to penicillins.
You may have an increased chance of being allergic
to Setraxone if you are allergic to
penicillins.
In newborns, Setraxone should not
be given if they require (or are expected to require) treatment with calcium
containing intravenous solutions, including parenteral nutrition (intravenous nutrition).
Setraxone should not be
given to preterm newborns or newborns with certain liver disorders.
If you are not sure if you
should start using Setraxone, contact your doctor.
Before you
are given it
Your doctor must know
about all the following before you are given Setraxone.
You must tell your doctor if:
1. you have any type of
allergic reaction to penicillin medicines
You may have an increased chance of being allergic
to Setraxone if you are allergic to penicillins.
2. you have had an allergy or over-reaction
to lignocaine or other anaesthetic drugs
These substances may be used to dissolve Setraxone
before administration.
3. you are allergic to any other medicines
or any other substances such as foods, preservatives or dyes
4. you have or have ever had any medical
conditions including:
•
kidney
disease
•
bowel
conditions e.g. inflammation of the large bowel.
•
diarrhoea
associated with previous use of antibiotics
•
previous
infection of your intestine with a bacteria called Clostridium difficile.
5. you are pregnant, intend to become
pregnant, are breast feeding or plan to breast feed
Your doctor will discuss the risks and benefits of
using Setraxone during pregnancy or when breastfeeding.
If you have not told your doctor about
any of the above, tell them before you are given Setraxone.
Taking other medicines
Tell your doctor if you
are taking any other medicines including any that you have bought from a
These include:
•
chloramphenicol,
vancomycin, aminoglycosides, medicines used to treat infections
•
fluconazole,
a medicine used to treat fungal infections
•
amsacrine,
a medicine used to treat cancer
These medicines may be affected by Setraxone, or may
affect how well it works. You may need to take different amounts of your
medicine, or you may need to take different medicines. Your doctor will advise you.
Talk to your doctor about the
need for an additional method of contraception while using Setraxone.
Some antibiotics may decrease the effectiveness of
some birth control pills, although this has not been shown with Setraxone.
Your doctor and pharmacist have more information on
medicines to be careful with or avoid while being given Setraxone.
How Setraxone is given
Setraxone can be given in two ways:
•
as
a slow injection into a vein
•
as
a deep injection into a large Muscle
Setraxone must only be given by a
doctor or nurse. Setraxone should not be mixed or administered with calcium containing
solutions, even via different infusion lines.
Your doctor will decide what dose and for how long
you will receive Setraxone. This depends on your infection and other factors,
such as your weight. For most infections, Setraxone is usually given once a day.
The length of treatment usually is 4-14 days.
Sometimes only a single dose of Setraxone is
required for the treatment and prevention of certain
infections.
If too much Setraxone is given, you may experience
symptoms such as skin reactions, chills, diarrhoea,
stomach upsets, headache or dizziness.
While you are using Setraxone
Things you must do
If the symptoms of your
infection do not improve within a few days, or if they become worse, tell your doctor.
If you get severe diarrhoea tell your
doctor, pharmacist or nurse immediately. Do this even if it occurs several
weeks after
Setraxone has been stopped.
Diarrhoea may mean that you have a serious
condition affecting your bowel. You may need urgent medical care.
Do not take any diarrhea medicine without first checking with your
doctor.
If you get a sore or furry white mouth
or tongue while using or soon after stopping Setraxone, tell your doctor. Also
tell your doctor if you get vaginal itching or discharge.
This may mean that you have a fungal infection
called thrush. Sometimes the use of Setraxone allows fungi to grow and the
above symptoms to occur. Setraxone does not work against fungi.
If you become pregnant while using
Setraxone, tell your doctor. If you have to test your urine for sugar while you
are being given Setraxone, make sure your doctor knows which type of test you
use.
Setraxone may affect the results of some of these
tests.
If you have any blood tests tell your
doctor you are being given Setraxone.
Complete blood counts should be done at regular
intervals as Setraxone may affect the results of
some blood tests.
Tell all doctors, dentists and pharmacists
who are treating you that you are using Setraxone.
Things you must not do
Do not give Setraxone to
anyone else even if they seem to have the same condition as you.
Do not use Setraxone to
treat other complaints unless your doctor says to.
Things to be careful of
Be careful driving or operating machinery
until you know how Setraxone affects you.
Setraxone generally does not cause any problems with
your ability to drive or operate machinery. However, as with many other medicines,
Setraxone may cause dizziness in some people.
Storage
Setraxone will be stored in the pharmacy or on the
ward. The powder for injection is kept in a cool dry place where the
temperature stays below 30°C.
Side Effects
·
Tell your doctor or pharmacist as soon as possible
if you do not feel well while you are using Setraxone.
·
Setraxone
helps most people with infections but it may have unwanted side effects in a
few people.
All medicines
can have side effects. Sometimes they are serious, most of the time they are
not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer
any questions you may have.
While using it
Tell your doctor if you notice
any of the following and they worry you:
•
white,
furry, sore tongue and mouth (oral thrush)
•
sore
and itchy vagina and/or discharge (vaginal thrush)
•
a
hard lump, swelling, pain or tenderness at the injection site
•
diarrhoea,
feeling sick, vomiting
•
altered
sense of taste
•
headache,
dizziness
•
fast
or irregular heart beat.
Tell your doctor immediately or
go to casualty at your nearest hospital if you notice any of the following:
•
severe
skin rash, itching or hives
•
red,
peeling or dry skin
•
swelling
of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing,
swelling of the hands, feet or ankles
•
tiredness,
headaches, being short of breath when exercising, dizziness, looking pale and yellowing
of the skin and/or eyes
•
severe
diarrhoea (that may contain blood
and mucous), stomach pain, and
fever.
These are serious side effects. You may need urgent
medical attention. Serious side effects are rare.
After finishing it
Tell your doctor immediately if you
notice any of the following side effects, particularly if they occur several
weeks after stopping treatment with Setraxone:
•
severe
abdominal cramps or stomach cramps
•
watery
and severe diarrhoea
•
raised
temperature (fever) in combination with one or both of the above.
These are rare but serious side effects. You may
have a serious condition affecting your bowel.
Therefore, you may need urgent medical attention.
However, this side effect is rare.
Do not take any diarrhea medicine
without first checking with your doctor.
Other side effects not listed
above may also occur in some patients.
Tell your doctor if you notice anything
else that is making you feel unwell.
Ask your doctor or pharmacist if you
don't understand anything in this list.
Do not be alarmed by this list of possible side
effects. You may not experience any of them.
Product Description
What Setraxone looks like
Setraxone is available as a white to yellowish-orange
powder. It is reconstituted before injection into a vein or muscle.
Ingredients
Setraxone does not contain gluten, lactose, sucrose,
tartrazine or any other azo dyes.
Active ingredients - Ceftriaxone as the sodium salt
•
each
1 gram Setraxone vial contains 1 gram Ceftriaxone
Dosage Forms And Strengths
Setraxone 1 gram and 2 gram come in packs of 1 vial.
Available Dosage
Forms:
•
1
gram vial
•
2
gram vial
Manufacturer:
Setraxone® Injection is made in India by:
Taj
Pharmaceuticals Limited.
This leaflet was prepared on Feb. 2014.
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