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ZANTAC INJECTION (50MG/2ML)

Active substance: RANITIDINE HYDROCHLORIDE

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10000000084905

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Information for Heathcare Professionals

Zantac Injection 50 mg/2 ml
®

ranitidine hydrochloride
Please refer to the Summary of Product
Characteristics (SPC) for further details on this
product.

Qualitative and Quantitative Composition
Ranitidine hydrochloride HSE 56 mg/2 ml
equivalent to ranitidine 50 mg/2 ml.

Pharmaceutical Form
Injection (Aqueous solution)
A clear colourless to pale yellow liquid,
practically free from particles

Posology and Method of Administration
(See SPC section 5.2 Pharmacokinetic properties
- Special patient populations.)
• Adults (including elderly)/adolescents
(12 years and over)
Zantac Injection may be given as a slow
(over 2 minutes) intravenous injection up
to a maximum of 50 mg, after dilution to
a volume of 20 ml per 50 mg dose, which
may be repeated every 6 to 8 hours; or as an
intermittent intravenous infusion at a rate of
25 mg per hour for two hours; the infusion may
be repeated at 6 to 8 hour intervals, or as an

intramuscular injection of 50 mg (2 ml) every
6 to 8 hours.
Prophylaxis of haemorrhage from stress
ulceration or recurrent haemorrhage:
In the prophylaxis of haemorrhage from
stress ulceration in seriously ill patients or
the prophylaxis of recurrent haemorrhage
in patients bleeding from peptic ulceration,
parenteral administration may be continued
until oral feeding commences. Patients
considered to be still at risk may then be
treated with Zantac Tablets 150 mg twice daily.
In the prophylaxis of upper gastro-intestinal
haemorrhage from stress ulceration in seriously
ill patients a priming dose of 50 mg as a slow
intravenous injection followed by a continuous
intravenous infusion of 0.125-0.250 mg/kg/hr
may be preferred.
Prophylaxis of Mendleson’s syndrome:
In patients considered to be at risk of
developing acid aspiration syndrome, Zantac
Injection 50 mg may be given intramuscularly
or by slow intravenous injection 45 to
60 minutes before induction of general
anaesthesia.

• Peptic ulcer acute treatment and
gastro-oesophageal reflux

ranitidine hydrochloride

Zantac contains a medicine called ranitidine.
This belongs to a group of medicines called
H2-receptor antagonists. It lowers the amount
of acid in your stomach.
For adults (including the elderly) Zantac is
used to:
• eal and stop ulcers in the stomach,
h
or the part of the gut it empties into
(the duodenum)
• stop ulcers from bleeding
• mprove problems caused by acid in the food
i
pipe (oesophagus) or too much acid in the
stomach. Both of these can cause pain or
discomfort sometimes known as ‘indigestion’,
‘dyspepsia’ or ‘heartburn’
• top acid coming up from the stomach while
s
under anaesthetic during an operation.
For children (6 months to 18 years) Zantac is
used to:
• heal ulcers in the stomach, or the part of the
gut it empties into (the duodenum)
• heal and stop problems caused by acid in
the food pipe (oesophagus) or too much
acid in the stomach. Both of these can cause
pain or discomfort sometimes known as
“indigestion”, “dyspepsia” or “heartburn”.

2 Before you have Zantac
Do not have Zantac if:
• ou are allergic (hypersensitive) to ranitidine
y
or any of the other ingredients of Zantac
(listed in Section 6).
If you are not sure, talk to your doctor or
pharmacist before having Zantac.
Take special care with Zantac
Check with your doctor or pharmacist before
having your medicine if:
• ou have stomach cancer
y
• ou have kidney problems. You will need to
y
have a different amount of Zantac
• you have had stomach ulcers before
• you have a history of heart trouble
• you have a rare condition called acute
porphyria
• you are over 65 years old
• you have lung disease
• you are diabetic

Shelf Life
36 months unopened.

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Special Precautions for Storage
Store below 25°C, protect from light.
Zantac Injection should not be autoclaved.

Instructions for Use/Handling
Zantac Injection has been shown to be
compatible with the following intravenous
infusion fluids:0.9% Sodium Chloride BP
5% Dextrose BP
0.18% Sodium Chloride and 4% Dextrose BP
4.2% Sodium Bicarbonate BP
Hartmann’s Solution.
All unused admixtures of Zantac Injection with
infusion fluids should be discarded 24 hours
after preparation.
Although compatibility studies have only been
undertaken in polyvinyl chloride infusion
bags (in glass for Sodium Bicarbonate BP)
and a polyvinyl chloride administration set it
is considered that adequate stability would
be conferred by the use of a polyethylene
infusion bag.
Information for Healthcare Professionals Leaflet
date: January 2009

• Route of administration
Intravenous or intramuscular injection.

®

1 What Zantac is and what it is used for

• Neonates (under 1 month)
(See SPC section 5.2 Pharmacokinetic properties
- Special patient populations.)

• Children/infants (6 months to 11 years)
(See SPC section 5.2 Pharmacokinetic properties
- Special patient populations.)
Zantac Injection may be given as a slow (over
2 minutes) i.v. injection up to a maximum of
50 mg every 6 to 8 hours.

Zantac Injection 50 mg/2 ml

In this leaflet:
1 What Zantac is and what it is used for
2 Before you have Zantac
3 How to have Zantac Injection
4 Possible side effects
5 How to store Zantac
6 Further information

• Prophylaxis of stress ulceration in seriously
ill patients
The recommended dose for prophylaxis
of stress ulceration is 1 mg/kg (maximum
50 mg) every 6 h to 8 h. Alternatively
treatment can be continuous, administering
125 - 250 micrograms/kg/hr as continuous
infusion.

Renal Impairment:
Accumulation of ranitidine with resulting
elevated plasma concentrations will occur
in patients with severe renal impairment
(creatinine clearance less than 50 ml/min).
Accordingly, it is recommended in such
patients that ranitidine be administered in
doses of 25 mg.

Package Leaflet: Information for the User

Read all of this leaflet carefully before you
start taking this medicine.
• eep this leaflet. You may need to
K
read it again.
• f you have any further questions, ask your
I
doctor or pharmacist.
• his medicine has been prescribed for you.
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Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• f any of the side effects gets serious, or if you
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notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Intravenous therapy in children with peptic
ulcer disease is indicated only when oral
therapy is not possible.
For acute treatment of peptic ulcer disease
and gastro-oesophageal reflux in paediatric
patients, Zantac Injection may be administered
at doses that have been shown to be effective
for these diseases in adults and effective for
acid suppression in critically ill children.
The initial dose (2 mg/kg or 2.5 mg/kg,
maximum 50 mg) may be administered as a
slow intravenous infusion over 10 minutes,
either with a syringe pump followed by a
3 ml flush with normal saline over 5 min,
or following dilution with normal saline to
20 ml. Maintenance of pH > 4 can be achieved
by intermittent infusion of 1.5 mg/kg every
6 h to 8 h. Alternatively treatment can be
continuous, administering a loading dose of
0.45 mg/kg followed by a continuous infusion
of 0.15 mg/kg/hr.

• ou have any problems with your
y
immune system.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
having this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines.
This is because Zantac can affect the way
some other medicines work. Also some other
medicines can affect the way Zantac works.
In particular tell your doctor or pharmacist if
you are taking any of the following medicines:
• lidocaine, a local anaesthetic
• propranolol, procainamide or
n-acetylprocainamide, for heart
problems
• diazepam, for worry or anxiety
problems
• phenytoin, for epilepsy
• theophylline, for breathing problems
(asthma)
• warfarin, for thinning your blood
• glipizide, for lowering blood glucose
• atazanavir or delaviridine, for treating
HIV infection
• triazolam, for insomnia
• gefitnib, for lung cancer
• ketoconazole, an anti fungal medicine,
sometimes used for treating thrush.
Midazolam is a medicine that may be given
to you just before you have an operation. Tell
the doctor you are taking Zantac before your
operation in case he or she wants to give you
midazolam.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
having Zantac.
Pregnancy and breast-feeding
If you are pregnant, might become pregnant
or are breast-feeding, you should not take
this medicine unless your doctor advises it is
essential.
Ask your doctor or pharmacist for advice before
taking any medicine, if you are pregnant or
breast-feeding.
Important information about some of the
ingredients of Zantac
Zantac Injection contains less than 23 mg of
sodium and is therefore essentially sodium-free.

3 How to have Zantac Injection
You will never be expected to give yourself this
medicine. It will always be given to you by a
person who is trained to do so.
Having this medicine
Zantac Injection will be given to you either:
• as a single injection into a muscle
• s a slow infusion into a vein. This is where
a
the drug is slowly given to you over a few
minutes
• s a continuous infusion into a vein. This is
a
where the drug is slowly given to you over a
few hours.
The usual dose for an adult (including the
elderly) and adolescents (12 years and
.
older) is 50 mg every 6 to 8 hours, as a
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single injection into a muscle.

Different doses may also be given to you
as a slow infusion or continuous infusion,
depending on what condition you are being
treated for.
Children and infants (6 months to 11 years):
Your doctor will give Zantac by a slow injection
into a vein. The maximum dose is 50 mg every
6 or 8 hours. It is usually only given while your
child is unable to take Zantac by mouth.
If you are given more Zantac than you should
Your doctor or nurse will give you Zantac
Injection so it is unlikely that you will receive
too much. If you think you have been given
too much or have missed a dose, tell your
doctor or nurse.

4 Possible side effects
Like all medicines, Zantac can cause side effects,
although not everybody gets them.
The following side effects may happen with
this medicine.
Stop taking Zantac and see a doctor
straight away, if you notice any of the
following serious side effects, you may
need urgent medical treatment:
• allergic reactions, the signs may include:
- rash, itching or hives on the skin
- swelling of your face, lips, tongue or
other parts of the body
- chest pain, shortness of breath,
wheezing or having trouble breathing
- unexplained fever and feeling faint,
especially when standing up
• kidney problems, which can lead to
back pain, fever, pain when passing
urine, blood in the urine and changes
in blood tests
• evere stomach pain, this may be a sign of
s
something called ‘pancreatitis’
• slow or irregular heartbeat
a
Check with your doctor at your next visit if you
notice any of the following:
Uncommon (affects less than 1 in 100 people)
• stomach pain
• constipation
• feeling sick (nausea)
Rare side effects that may show up in
blood tests:
• ncrease of serum creatinine in the blood
i
(kidney function test)
• alse results in blood tests called ‘liver
f
function tests’
• rash on its own
a
Check with your doctor as soon as possible if
you notice any of the following:
Very rare (affect less than 1 in 10,000 people)
• here can be changes in the level of certain
t
substances in your blood. This can lead to you
feeling unusually tired or short of breath and
being more likely to bruise or get an infection
• eeling depressed, confused, seeing or
f
hearing unexplained things (hallucinations)
• eadache (sometimes severe)
h
• eeling dizzy or having blurred vision
f
• our joints or muscles are painful or swollen
y
or you cannot control their movement
• our small blood vessels can become swollen
y
(known as ‘vasculitis’). Signs of this can
include: a rash, swollen joints or kidney
problems
• our liver can become swollen. This can lead
y
to: nausea (feeling sick) or vomiting (being
sick), loss of appetite or generally feeling
unwell, itching, fever, yellowing of the skin
and eyes or dark coloured urine
• lushing or marks on your skin that look like
f
targets
• unexplained hair loss
• diarrhoea
• impotence

Zantac is a registered trademark of the
GlaxoSmithKline group of companies
© 2009 GlaxoSmithKline group of companies

• reast tenderness and/or breast
b
enlargement
• breast discharge.
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor.

5 How to store Zantac
• eep out of the reach and sight of children.
K
• o not use Zantac after the expiry date which
D
is stated on the label.
The expiry date refers to the last day of
that month.
• Do not store above 25°C
• Protect from light
• edicines should not be disposed of via
M
household waste. Ask your pharmacist how
to dispose of medicines no longer required.
These measures will help to protect the
environment.

6 Further information
What Zantac contains:
• he active substance is ranitidine (as the
T
hydrochloride) 50 mg
• he other ingredients are sodium chloride,
T
potassium dihydrogen orthophosphate,
disodium hydrogen orthophosphate and
Water for Injections.
What Zantac looks like and contents of the
pack
Zantac Injection is a clear, colourless to pale
yellow liquid. You shouldn’t be able to see any
particles in it.
Cartons contain five 2 ml glass ampoules.
Marketing Authorisation Holder and
Manufacturer
Product licence held by GlaxoSmithKline
UK, Stockley Park West, Uxbridge,
Middlesex UB11 1BT.
Manufactured by GlaxoSmithKline S.p.A.,
San Polo di Torrile, Parma, Italy.
The information provided applies only to
Zantac Injection 50 mg/2 ml
Other formats:
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name Zantac Injection 50 mg/2 ml
Reference number 10949/0109
This is a service provided by the Royal National
Institute of the Blind.
Leaflet date: July 2010
Zantac is a registered trademark of the
GlaxoSmithKline group of companies
© 2010 GlaxoSmithKline group of companies

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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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