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ZOVIRAX IV 250MG

Active substance(s): ACICLOVIR

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DEVCOMP-0004046

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Zovirax I.V. 250 mg
Zovirax I.V. 500 mg

DEVCOMP-0004046
GSK-ITA-Parma-ITPAR

aciclovir

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

United Kingdom-GBR
Zovirax

DOSAGE AND ADMINISTRATION INFORMATION ONLY
Please refer to the Summary of Product Characteristics (SPC) for complete
prescribing information.
N/A
Qualitative and Quantitative Composition
250 mg aciclovir or 500 mg aciclovir in each vial
Excipients with known effect:
Sodium hydroxide

D00055LEA

N/A

Pharmaceutical Form
Intravenous injection

N/A
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Therapeutic indications
Zovirax I.V. is indicated for the treatment of Herpes simplex infections
in immunocompromised patients and severe initial genital herpes in the
non-immunocompromised.
Zovirax I.V. is indicated for the prophylaxis of Herpes simplex infections in
immunocompromised patients.
Zovirax I.V. is indicated for the treatment of Varicella zoster infections.
Zovirax I.V. is indicated for the treatment of herpes encephalitis.
Zovirax I.V. is indicated for the treatment of Herpes simplex infections in the
neonate and infant up to 3 months of age.
Posology and method of administration
Route of administration: Slow intravenous infusion over 1 hour.
A course of treatment with Zovirax I.V. usually lasts 5 days, but this may
be adjusted according to the patient’s condition and response to therapy.
Treatment for herpes encephalitis usually lasts 10 days. Treatment for
neonatal herpes usually lasts 14 days for mucocutaneous (skin-eye-mouth)
infections and 21 days for disseminated or central nervous system disease.
The duration of prophylactic administration of Zovirax I.V. is determined by
the duration of the period at risk.
Dosage in adults:
Patients with Herpes simplex (except herpes encephalitis) or Varicella zoster
infections should be given Zovirax I.V. in doses of 5 mg/kg body weight
every 8 hours provided renal function is not impaired (see Dosage in renal
impairment).
Immunocompromised patients with Varicella zoster infections or patients with
herpes encephalitis should be given Zovirax I.V. in doses of 10 mg/kg body
weight every 8 hours provided renal function is not impaired (see Dosage in
renal impairment).
In obese patients dosed with intravenous aciclovir based on their actual
body weight, higher plasma concentrations may be obtained (see SPC
section 5.2 Pharmacokinetic properties). Consideration should therefore be
given to dosage reduction in obese patients and especially in those with renal
impairment or the elderly.
Dosage in children: The dose of Zovirax I.V. for children aged between
3 months and 12 years is calculated on the basis of body surface area.
Children 3 months of age or older with Herpes simplex (except herpes
encephalitis) or Varicella zoster infections should be given Zovirax I.V. in
doses of 250 mg per square metre of body surface area every 8 hours if renal
function is not impaired.
In immunocompromised children with Varicella zoster infections or children
with herpes encephalitis, Zovirax I.V. should be given in doses of 500 mg
per square metre body surface area every 8 hours if renal function is not
impaired.

The dosage of Zovirax I.V. in neonates and infants up to 3 months of age is
calculated on the basis of body weight.
The recommended regimen for infants treated for known or suspected
neonatal herpes is aciclovir 20 mg/kg body weight IV every 8 hours for
21 days for disseminated and CNS disease, or for 14 days for disease limited
to the skin and mucous membranes.
Infants and children with impaired renal function require an appropriately
modified dose, according to the degree of impairment (see Dosage in renal
impairment).
Dosage in the elderly:
The possibility of renal impairment in the elderly must be considered and
dosage should be adjusted accordingly (see Dosage in renal impairment
below).
Adequate hydration should be maintained.
Dosage in renal impairment:
Caution is advised when administering Zovirax I.V. to patients with impaired
renal function. Adequate hydration should be maintained.
Dosage adjustment for patients with renal impairment is based on creatinine
clearance, in units of ml/min for adults and adolescents and in units of
ml/min/1.73m2 for infants and children less than 13 years of age. The
following adjustments in dosage are suggested:
Dosage adjustments in adults and adolescents:
Creatinine Clearance
Dosage
25 to 50 ml/min
The dose recommended above (5 or 10 mg/kg
body weight) should be given every 12 hours.
10 to 25 ml/min
The dose recommended above (5 or 10 mg/kg
body weight) should be given every 24 hours.
0(anuric) to 10 ml/min In patients receiving continuous ambulatory
peritoneal dialysis (CAPD) the dose recommended
above (5 or 10 mg/kg body weight) should be
halved and administered every 24 hours.

In patients receiving haemodialysis the dose
recommended above (5 or 10 mg/kg body weight)
should be halved and administered every 24 hours
and after dialysis.
Dosage adjustments in infants and children:
Creatinine Clearance
Dosage
25 to 50 ml/min/1.73m2 The dose recommended above (250 or 500 mg/m2
body surface area or 20 mg/kg body weight)
should be given every 12 hours.
10 to 25 ml/min/1.73m2 The dose recommended above (250 or 500 mg/m2
body surface area or 20 mg/kg body weight)
should be given every 24 hours.
0(anuric) to
In patients receiving continuous ambulatory
peritoneal dialysis (CAPD) the dose recommended
10 ml/min/1.73m2
above (250 or 500 mg/m2 body surface area or
20 mg/kg body weight) should be halved and
administered every 24 hours.

In patients receiving haemodialysis the dose
recommended above (250 or 500 mg/m2 body
surface area or 20 mg/kg body weight) should be
halved and administered every 24 hours and after
dialysis
Contraindications
Hypersensitivity to aciclovir or valaciclovir or to any of the excipients.
Special warnings and precautions for use
Use in patients with renal impairment and in elderly patients:
Adequate hydration should be maintained in patients given i.v. or high oral
doses of aciclovir.
Intravenous doses should be given by infusion over one hour to avoid
precipitation of aciclovir in the kidney; rapid or bolus injection should be
avoided.
The risk of renal impairment is increased by use with other nephrotoxic drugs.
Care is required if administering i.v. aciclovir with other nephrotoxic drugs.

Package leaflet: Information for the user

I.V. 250 mg and 500 mg
aciclovir

Read all of this leaflet carefully before you start having 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.
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In this leaflet:
1 What Zovirax is and what it is used for
2 What you need to know before you have Zovirax
3 How to have Zovirax
4 Possible side effects
5 How to store Zovirax
6 Contents of the pack and other information

1 What Zovirax is and what it is used for
Zovirax I.V. (called ‘Zovirax’ in this leaflet) contains a medicine called
aciclovir. This belongs to a group of medicines called antivirals. It works
by killing or stopping the growth of viruses.
Zovirax can be used to:
• treat chickenpox
• treat severe cases of genital herpes
• treat and stop cold sores and genital herpes in people whose
immune systems work less well, which means their bodies are less
able to fight infections
• treat serious virus infections in children up to 3 months of age. This
can rarely be caused by the virus responsible for cold sore infection
and genital herpes.
• treat inflammation of the brain. This can rarely be caused by the
virus responsible for cold sore infection and genital herpes.

Warnings and precautions
Talk to your doctor or pharmacist before having Zovirax if:
• you have kidney problems
• you are over 65 years of age.
If you are not sure if the above apply to you, talk to your doctor or
pharmacist before taking Zovirax.
It is important that you drink plenty of water while taking Zovirax
Other medicines and Zovirax
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines obtained
without a prescription, including herbal medicines.
In particular tell your doctor or pharmacist if you are taking any of the
following medicines:
• probenecid, used to treat gout
• cimetidine, used to treat stomach ulcers
• tacrolimus, ciclosporin or mycophenolate mofetil, used to stop your
body rejecting transplanted organs.
Pregnancy, breast-feeding and fertility
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.
Zovirax contains sodium
Zovirax contains 26 mg sodium per dose. To be taken into consideration
by patients on a controlled sodium diet.

3 How to have Zovirax
How your medicine is given
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.
Before the medicine is given to you it will be diluted.
Zovirax will be given to you as a continuous infusion into your vein. This
is where the drug is slowly given to you over a period of time.
The dose you will be given, the frequency and the duration of the dose
will depend on:
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2 
What you need to know before you have Zovirax
Do not have Zovirax:
• if you are allergic to aciclovir or valaciclovir or any of the other
ingredients of this medicine (listed in Section 6).
Do not take Zovirax if the above applies to you. If you are not sure, talk
to your doctor or pharmacist before having Zovirax.

• the type of infection you have
• your weight
• your age.
Your doctor may adjust the dose of Zovirax if:
• you have kidney problems. If you have kidney problems, it is important
you receive plenty of fluids while you are being treated with Zovirax.
Talk to your doctor before having Zovirax if any of the above apply.

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DEVCOMP-0004046
GSK-ITA-Parma-ITPAR
United Kingdom-GBR
Zovirax
N/A
D00055LEA

N/A
N/A
1
K

0

0

Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted
in patients with renal impairment (see SPC section 4.2 Posology and method
of administration). Elderly patients are likely to have reduced renal function
and therefore the need for dose adjustment must be considered in this
group of patients. Both elderly patients and patients with renal impairment
are at increased risk of developing neurological side effects and should be
closely monitored for evidence of these effects. In the reported cases, these
reactions were generally reversible on discontinuation of treatment (see SPC
section 4.8 Undesirable effects). Prolonged or repeated courses of aciclovir in
severely immune-compromised individuals may result in the selection of virus
strains with reduced sensitivity, which may not respond to continued aciclovir
treatment (see SPC section 5.1).
In patients receiving Zovirax I.V. at higher doses (e.g. for herpes encephalitis)
specific care regarding renal function should be taken, particularly when
patients are dehydrated or have any renal impairment.
Reconstituted Zovirax I.V. has a pH of approximately 11 and should not be
administered by mouth. Product contains sodium (26mg, approx. 1,13mmol).
To be taken into consideration by patients on a controlled sodium diet.
Zovirax I.V. contains no antimicrobial preservative. Reconstitution and
dilution should therefore be carried out under full aseptic conditions
immediately before use and any unused solution discarded. The
.
reconstituted or diluted solutions should not be refrigerated.
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Interaction with other medicinal products and other forms of
interaction
Aciclovir is eliminated primarily unchanged in the urine via active renal
tubular secretion. Any drugs administered concurrently that compete with
this mechanism may increase aciclovir plasma concentrations. Probenecid
and cimetidine increase the AUC of aciclovir by this mechanism and reduce
aciclovir renal clearance. However no dosage adjustment is necessary because
of the wide therapeutic index of aciclovir.
In patients receiving intravenous Zovirax caution is required during
concurrent administration with drugs which compete with aciclovir for
elimination, because of the potential for increased plasma levels of one or
both drugs or their metabolites. Increases in plasma AUCs of aciclovir and
of the inactive metabolite of mycophenolate mofetil, an immunosuppressant
agent used in transplant patients, have been shown when the drugs are
coadministered.
If lithium is administered concurrently with high dose aciclovir IV, the lithium
serum concentration should be closely monitored because of the risk of
lithium toxicity.
Care is also required (with monitoring for changes in renal function) if
administering intravenous Zovirax with drugs which affect other aspects of
renal physiology (e.g. ciclosporin, tacrolimus).
An experimental study on five male subjects indicates that concomitant
therapy with aciclovir increases AUC of totally administered theophylline with
approximately 50%. It is recommended to measure plasma concentrations
during concomitant therapy with aciclovir.
Overdose
Overdosage of intravenenous aciclovir has resulted in elevations of serum
creatinine, blood urea nitrogen and subsequent renal failure. Neurological
effects including confusion, hallucinations, agitation, seizures and coma have
been described in association with overdosage. Patients should be observed
closely for signs of toxicity. Haemodialysis significantly enhances the removal
of aciclovir from the blood and may, therefore, be considered an option in the
management of overdose of this drug.
List of excipients
Sodium hydroxide (used to adjust pH)
Incompatibilities
None known

Instructions for use/handling
Reconstitution: Zovirax I.V. should be reconstituted using the following
volumes of either Water for Injections BP or Sodium Chloride Intravenous
Injection BP (0.9% w/v) to provide a solution containing 25 mg aciclovir
per ml:
Formulation
Volume of fluid for reconstitution
250 mg vial
10 ml
500 mg vial
20 ml
From the calculated dose, determine the appropriate number and strength of
vials to be used. To reconstitute each vial add the recommended volume of
infusion fluid and shake gently until the contents of the vial have dissolved
completely.
Administration: The required dose of Zovirax I.V. should be administered by
slow intravenous infusion over a one-hour period.
After reconstitution Zovirax I.V. may be administered by a controlled-rate
infusion pump.
Alternatively, the reconstituted solution may be further diluted to give
an aciclovir concentration of not greater than 5 mg/ml (0.5% w/v) for
administration by infusion:
Add the required volume of reconstituted solution to the chosen infusion
solution, as recommended below, and shake well to ensure adequate mixing
occurs.
For children and neonates, where it is advisable to keep the volume of
infusion fluid to a minimum, it is recommended that dilution is on the basis
of 4 ml reconstituted solution (100 mg aciclovir) added to 20 ml of infusion
fluid.
For adults, it is recommended that infusion bags containing 100 ml of
infusion fluid are used, even when this would give an aciclovir concentration
substantially below 0.5% w/v. Thus one 100 ml infusion bag may be used
for any dose between 250 mg and 500 mg aciclovir (10 and 20 ml of
reconstituted solution) but a second bag must be used for doses between
500 mg and 1000 mg.
When diluted in accordance with the recommended schedules, Zovirax I.V. is
known to be compatible with the following infusion fluids and stable for up
to 12 hours at room temperature (15°C to 25°C):
Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion BP
Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous
Infusion BP
Compound Sodium Lactate Intravenous Infusion BP (Hartmann’s Solution).
Zovirax I.V. when diluted in accordance with the above schedule will give an
aciclovir concentration not greater than 0.5% w/v.
Since no antimicrobial preservative is included, reconstitution and dilution
must be carried out under full aseptic conditions, immediately before use, and
any unused solution discarded.
Should any visible turbidity or crystallisation appear in the solution before or
during infusion, the preparation should be discarded.
Marketing Authorisation Holder
The Wellcome Foundation Ltd, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Marketing Authorisation Number
PL 00003/0159
Information for the Healthcare Professional Leaflet date: January 2015


Nature and contents of container
Type I glass vials closed with butyl or bromobutyl rubber stoppers secured by
aluminium collars.
17 ml-nominal capacity of vial containing 250 mg aciclovir.
25 ml-nominal capacity of vial containing 500 mg aciclovir.

If you are given too much Zovirax
If you think you have been given too much Zovirax, talk to your doctor or
nurse straight away.
If you have been given too much Zovirax you may:
• feel confused or agitated
• have hallucinations (seeing or hearing things that aren’t there)
• have fits
• become unconscious (coma).

4 Possible side effects

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Like all medicines, this medicine can cause side effects, although not
everybody gets them. The following side effects may happen with this
medicine:
Allergic reactions (may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop taking Zovirax and see a doctor
straight away. The signs may include:
• rash, itching or hives on your skin
• swelling of your face, lips, tongue or other parts of your body
• shortness of breath, wheezing or trouble breathing
• unexplained fever (high temperature) and feeling faint, especially when
standing up.
Other side effects include:
Common (may affect up to 1 in 10 people)
• feeling or being sick
• itchy, hive-like rash
• skin reaction after exposure to light (photosensitivity)
• itching
• swelling, redness and tenderness at the site of injection.
• Increase in the liver enzymes.
Uncommon (may affect up to 1 in 100 people)
• reduced numbers of red blood cells (anaemia)
• reduced numbers of white blood cells (leukopenia)
• reduced numbers of blood platelets (cells that help the blood to clot)
(thrombocytopenia).
Very rare (may affect up to 1 in 10,000 people)
• headache or feeling dizzy
• diarrhoea or stomach pains
• feeling tired
• fever
• effects on some blood urine tests
• feeling weak
• feeling agitated or confused
• shaking or tremors
• hallucinations (seeing or hearing things that aren’t there)
• fits
• feeling unusually sleepy or drowsy
• unsteadiness when walking and lack of coordination
• difficulty speaking
• inability to think or judge clearly
• unconsciousness (coma)
• paralysis of part or all of your body
• disturbances of behaviour, speech and eye movements
• stiff neck and sensitivity to light
• inflammation of the liver (hepatitis)
• yellowing of your skin and whites of your eyes (jaundice)
• kidney problems where you pass little or no urine
• pain in your lower back, the kidney area of your back or just above your
hip (renal pain).

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 Zovirax
• Keep this medicine out of the sight and reach of children.
• Store below 25°C.
• Do not use Zovirax after the expiry date which is stated on the carton
after Exp. The expiry date refers to the last day of that month.
• Prepare immediately before use.
• Discard unused solution.
• 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.

6 Contents of the pack and other information
What Zovirax I.V. contains
• The active substance is aciclovir.
• The other ingredient is sodium hydroxide.
What Zovirax looks like and contents of the pack
Zovirax I.V. is supplied in glass vials, containing an off-white powder. The
250 mg strength is available in 17 ml vials, in a box containing 5 vials. The
500 mg strength is available in 24 ml vials, in a box containing 5 vials.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
The Wellcome Foundation Ltd, Stockley Park West, Uxbridge, Middlesex,
UB11 1BT
Manufacturer
GlaxoSmithKline Manufacturing S.p.A., Parma 43056, Italy
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
Zovirax I.V. 250 mg

Zovirax I.V. 500 mg
Reference number 00003/0159
This is a service provided by the Royal National Institute of Blind
People.
This leaflet was last revised in January 2015.
Zovirax is a registered trade mark of the GSK group of companies.
© 2015 GSK group of companies. All rights reserved.
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DEVCOMP-0004046

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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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