GMP Certified BP Aciclovir Cream 10g treatment of herpes labialis
(cold sore) in non-immunocompromised patients.
1. Name of the medicinal product
Aciclovir Cold Sore Cream
2. Qualitative and quantitative composition
Cream, containing 50 mg/g Aciclovir Ph. Eur.
For excipients, see 6.1.
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
Action Cold Sore Cream is indicated for:
- treatment of herpes labialis (cold sore) in non-immunocompromised
4.2 Posology and method of administration
Action Cold Sore Cream should be applied five times a day, every
four hours, for five or in some cases up to ten days in thin layers
on the affected skin, making sure that all lesions are adequately
If lesions have not healed after 10 days treatment, patients should
be advised to consult a doctor.
Action Cold Sore Cream is contra-indicated in patients in case of hypersensitivity to
aciclovir, valaciclovir, propylene glycol or any of the other
ingredients of the cream.
4.4 Special warnings and precautions for use
Action Cold Sore Cream should not be applied in the eye or mucosal skin of the mouth or
the vagina as it might be irritant. Particular care should be taken
to avoid accidental introduction into the eye.
Action Cold Sore Cream is for topical use only and should not be swallowed.
Paediatric and geriatric use: no unusual toxicity or
paediatric-specific problems have been observed.
In severely immunocompromised patients, (e.g. AIDS patients or bone
marrow transplant recipients) oral dosing should be considered.
These patients should be encouraged to consult a physician
concerning the treatment of any infection.
Action Cold Sore Cream must not be used for the treatment of ocular or genital herpes.
Patients with particularly severe Herpes labialis should be encouraged to seek medical advice.
Cold sore sufferers should be advised to avoid transmitting the
virus, particularly when active lesions are present,
The excipient propylene glycol can cause skin irritation and the
excipient cetyl alcohol can cause local skin reactions (e.g.
4.5 Interaction with other medicinal products and other forms of
No interactions resulting from administration of other drugs
concomitantly with topical aciclovir have been reported.
4.6 Fertility, pregnancy and lactation
The use of aciclovir should be considered only when the potential
benefits outweigh the possibility of unknown risks however the
systemic exposure to aciclovir from topical application of
aciclovir cream is very low.
A post-marketing aciclovir pregnancy registry has documented
pregnancy outcomes in women exposed to any formulation of
aciclovir. The registry findings have not shown an increase in the
number of birth defects amongst aciclovir exposed subjects compared
with the general population, and any birth defects showed no
uniqueness or consistent pattern to suggest a common cause.
Systemic administration of aciclovir in internationally accepted
standard tests did not produce embryotoxic or teratogenic effects
in rabbits, rats or mice.
In a non-standard test in rats, foetal abnormalities were observed
but only following such high subcutaneous doses that maternal
toxicity was produced. The clinical relevance of these findings is
Limited human data show that the drug does pass into breast milk
following systemic administration. However, the dosage received by
a nursing infant following maternal use of aciclovir cream or
ophthalmic ointment would be insignificant.
4.7 Effects on ability to drive and use machines
Topically applied aciclovir does not effect the ability to drive or
4.8 Undesirable effects
The following convention has been used for the classification of
undesirable effects in terms of frequency:- Very common ≥1/10,
common ≥1/100 and <1/10, uncommon 1/1000 and <1/100, rare
≥1/10,000 and <1/1000, very rare <1/10,000.
Clinical trial data have been used to assign frequency categories
to adverse reactions observed during clinical trials with aciclovir
3% ophthalmic ointment. Due to the nature of the adverse events
observed, it is not possible to determine unequivocally which
events were related to the administration of the drug and which
were related to the disease. Spontaneous reporting data has been
used as a basis for allocating frequency for those events observed
Skin and subcutaneous tissue disorders
Uncommon: Transient burning or stinging following application of
Mild drying or flaking of the skin.
Rare: Erythema. Contact dermatitis following application. Where
sensitivity tests have been conducted, the reactive substances have
most often been shown to be components of the cream rather than
Immune system disorders
Very rare: Immediate hypersensitivity reactions including
angioedema and urticaria.
Action Cold Sore Cream is usually well tolerated. Other undesirable effects that may
occur after use of Action Cold Sore Cream are redness, tension, or pain of the skin at the site of the
No untoward effects would be expected if the entire contents of the
tube containing 500 mg of aciclovir (cream) were ingested orally.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Aciclovir exerts its antiviral effect on herpes simplex viruses and
varicella-zoster virus by interfering with DNA synthesis and
inhibiting viral replication. Aciclovir is converted to aciclovir
monophosphate principally via virus-coded thymidine kinase. The
monophosphate is subsequently phosphorylated to the diphosphate via
cellular guanylate kinase and then to the triphosphate via other
cellular enzymes (e.g. phosphoglycerate kinase, pyruvate kinase,
phosphoenolpyruvate carboxykinase). The formation of the
monophosphate seems to be the rate determining step in this process
and occurs minimally in uninfected cells.
Aciclovir triphosphate acts as an inhibitor of, and substrate for,
the herpes-specified DNA polymerase, preventing further viral DNA
synthesis without affecting normal cellular processes.
5.2 Pharmacokinetic properties
After oral or intravenous administration aciclovir is widely
distributed in tissues and body fluids. However, after topical
application on intact skin no detectable levels of aciclovir in
plasma or urine are found. Also, systemic availability after
application on affected skin appears to be minimal.
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
The following excipients are used in Action Cold Sore Cream:
purified water, propylene glycol, liquid paraffin, white soft
paraffin, cetyl alcohol, dimethicone and Arlatone 983 S.
No incompatibilities are reported between topically applied
aciclovir and other drugs.
6.3 Shelf life
The shelf-life is 36 months from the date of manufacture. The
shelf-life after first opening is 4 weeks.
The expiry date is printed on the box and the tube ("Use by"). Do
not use after this date.
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
Action Cold Sore Cream is packed in aluminium tubes containing 2g of cream. The tube is
lacquered with epoxy-phenolic resin and closed by a HDPE cap.
Single tubes are packed in a carton box.
6.6 Special precautions for disposal and other handling
Before and after application of the cream it is advised to wash the
hands thoroughly, to avoid contamination of other parts of the
body. It may be advisable to use a finger cot or rubber glove.
Close the tube carefully after usage.
Action Cold Sore Cream should be applied as early as possible after
the start of an infection, ideally during the prodromal period.
Preserve in closed containers, store below 30°C