Consumer medicine information

1. Why am I using Aciclovir Accord?

Aciclovir Accord contains the active ingredient aciclovir. Aciclovir belongs to a group of medicines called antivirals. It works by preventing the reproduction of the virus which is causing the condition.
Aciclovir Accord is used for the management of several different infections caused by viruses, such as herpes and shingles.
For more information, see Section 1. Why am I using Aciclovir Accord? in the full CMI.

2. What should I know before I use Aciclovir Accord?

Do not use if you have ever had an allergic reaction to aciclovir, valaciclovir or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Aciclovir Accord? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Aciclovir Accord and affect how it works.
See Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Aciclovir Accord?

Aciclovir Accord is an injection and will be given to you by your doctor or nurse.
More instructions can be found in Section 4. How do I use Aciclovir Accord? in the full CMI.

5. What should I know while using Aciclovir Accord?

6. Are there any side effects?

Side effects may include discomfort or swelling, redness or heat at the injection site, fatigue, headaches, nausea and/or vomiting, loss of appetite, pins and needles sensation on skin, feeling unwell. Serious side effects may include difficulty breathing, swelling of the face, lips, tongue or other parts of the body (allergic reaction), abdominal pain, diarrhoea or bloody diarrhoea, abnormal bleeding or bruising, blood in stool or urine, dark coloured urine, seizures or tremors, confusion, delusion, loss of coordination, difficulty in speech, yellowing of the skin or eyes, fever. For more information, including what to do if you have any side effects. For more information, including what to do if you have any side effects, see 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Aciclovir.

2 Qualitative and Quantitative Composition

Aciclovir sodium is a synthetic acyclic purine nucleoside analogue. Aciclovir sodium is a white crystalline powder.
Aciclovir Accord contains the equivalent of 25 mg/mL of aciclovir; the aciclovir is present as aciclovir sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Aciclovir Accord is a clear colourless or almost colourless sterile solution. Aciclovir Accord has a pH of approximately 11.

4 Clinical Particulars

4.9 Overdose

There is little experience concerning overdosage with aciclovir. Effects from overdosage may be expected to be similar in nature but more severe effects to those described under Section 4.8 Adverse Effects (Undesirable Effects).
Overdosage has been reported following administration of bolus injections, or inappropriately high doses and in patients whose fluid and electrolyte balance was not properly monitored. This has resulted in elevations in serum urea and creatinine and subsequent renal failure. Neurological effects including lethargy, confusion, hallucinations, agitation, seizure and coma have been reported rarely in association with overdosage.
Precipitation of aciclovir in renal tubules may occur when the solubility (2.5 mg/mL) in the intratubular fluid is exceeded (see Section 4.4 Special Warnings and Precautions for Use). In the event of overdosage, adequate hydration is essential to reduce the possibility of crystal formation in the urine. It is recommended that urine output is maintained at greater than 500 mL per gram of drug infused to prevent precipitation of aciclovir in the renal tubules. Patients should be observed closely for signs of toxicity.
Aciclovir can be removed from the circulation by haemodialysis: a 6 hour haemodialysis results in a 60% decrease in plasma aciclovir concentration.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) or the national Poisons Centre on 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Aciclovir was clastogenic in Chinese hamster cells in vivo, at exposure levels also causing nephrotoxicity (500 and 100 mg/kg parenteral dose). There was also an increase, though not statistically significant, in chromosomal damage at maximum tolerated doses (100 mg/kg) of aciclovir in rats. No activity was found in a dominant lethal study in mice or in 4 microbial assays. Positive results were obtained in 2 of 7 genetic toxicity assays using mammalian cells in vitro (positive in human lymphocytes in vitro and one locus in mouse lymphoma cells negative at 2 other loci in mouse lymphoma cells, and 3 loci in a Chinese hamster ovary cell line). The results of these mutagenicity tests in vitro and in vivo suggest that aciclovir is unlikely to pose a genetic threat to man at therapeutic dose levels.
Carcinogenicity. Aciclovir was positive in one of two mouse cell transformation systems in vitro. Inoculation of the transformed cells into immune-suppressed mice resulted in tumours. These data are suggestive of an oncogenic potential. However, the validity of this type of study is unclear.
Lifetime oral dosing studies in mice and rats gave no evidence for oncogenicity, but in these species the absorption of oral aciclovir is poor and possibly self limiting.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSACISOD.gif CAS number. 69657-51-8.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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