Aciclovir oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of aciclovir
Drugs List
Therapeutic Indications
Uses
Herpes simplex viral (HSV) infection -immunocompromised
Herpes simplex virus (HSV) - suppression
Herpes simplex virus (HSV) infection - initial and recurrent genital herpes
Herpes simplex virus (HSV) infection - prophylaxis (in immunocompromised)
Herpes simplex virus infection in the immunocompetent: treatment
Herpes simplex virus infection in the immunocompromised - genital herpes
Herpes zoster infection in the immunocompromised: treatment
Herpes zoster virus (HZV)-treatment
Varicella zoster infection in the immunocompetent: treatment
Varicella zoster infection in the immunocompromised: treatment
Treatment of herpes simplex virus infections of the skin and mucous membranes, including initial and recurrent genital herpes
Prophylaxis of recurrent herpes simplex infections in immunocompetent patients
Prophylaxis of herpes simplex infections in immunocompromised patients
Treatment of varicella (chicken pox) and herpes zoster (shingles) infections
Unlicensed Uses
Attenuation of varicella if varicella-zoster immunoglobulin not indicated
Attenuation of varicella (chicken pox) if varicella-zoster immunoglobulin is not indicated
Dosage
Treatment should begin as soon as possible during the course of an active infection. For recurrent episodes, treatment should preferably begin during the prodromal period or when lesions first appear.
Treatment of varicella (chicken pox) should begin within 24 hours after the onset of rash.
Treatment of herpes zoster (shingles) infection is more effective if started as soon as possible after rash appears.
Doses should be spread out evenly through out the day where possible.
Adults
Treatment of herpes simplex infection
200mg five times daily (at approximately 4 hour intervals, omitting the night time dose).
Treatment should continue for five days, but may be extended in severe initial infections.
Treatment of herpes simplex infection in the immunocompromised or patients with impaired absorption
400mg five times a day.
Suppression of herpes simplex infections
200mg four times daily (every 6 hours).
OR
400mg twice a day (every 12 hours).
Dose may be reduced to 200mg two to three times a day.
Consider interrupting therapy periodically (intervals of six to twelve months) in order to observe possible changes in the condition.
Prophylaxis of herpes simplex infections in immunocompromised patients
200mg four times daily (every 6 hours).
Increase dose to 400mg four times a day in severely immunocompromised patients, or patients with impaired absorption.
Genital herpes simplex
First occurance
200mg five times a day.
OR
400mg three times a day.
Treatment should last for five days (or longer if necessary).
Recurrent infection
800mg three times a day for two days.
OR
200mg five times a day for five days.
OR
400mg three times a day for three to five days.
Genital herpes simplex in immunocompromised or HIV-positive patients
First occurance
400mg five times a day.
Treatment should last for seven to ten days (or longer if necessary).
Recurrent infection
400mg three times a day for five to ten days.
Treatment of varicella and herpes zoster infections
800mg five times a day (at approximately 4 hour intervals, omitting the night time dose), for seven days.
Attenuation of varicella zoster infection when immunoglobulin not suitable (unlicensed)
10mg/kg four times a day for seven days. Start treatment one week after exposure.
Children
Treatment of herpes simplex infection
Children aged 2 to 18 years: 200mg five times daily.
Children aged under 2 years: 100mg five times a day.
Treatment should continue for five days, this may be extended in severe initial infections.
Treatment of herpes simplex infection in the immunocompromised or patients with impaired absorption
Children aged 2 to 18 years: 400mg five times a day for five days.
Children aged 1 month to 2 years: 200mg five times a day for five days.
If new lesions appear or if healing incomplete treatment may be extended.
Prophylaxis of herpes simplex infections in immunocompromised patients
Children aged 2 to 18 years: 200mg four times daily (up to a maximum of 400mg four times a day).
Children aged under 2 years: 100mg four times a day.
The duration is determined by the duration of the period at risk.
Suppression of herpes simplex infection
Children aged 12 to 18 years: 400mg twice daily or 200mg four times daily (up to a maximum of 400mg three times daily).
Therapy should be interrupted every six to twelve months to reassess recurrence frequency.
Treatment of varicella zoster infections
Children aged 12 to 18 years: 800mg five times a day for seven days.
Children aged 6 to 12 years: 800mg four times a day for five days.
Children aged 2 to 6 years: 400mg four times a day for five days.
Children aged 1 month to 2 years: 200mg four times a day for five days.
Attenuation of varicella zoster infection when immunoglobulin not suitable (unlicensed)
Children aged 1 month to 18 years
10mg/kg bodyweight four times a day for seven days. Treatment should start one week after exposure.
Treatment of herpes zoster infection (unlicensed)
Children aged 12 to 18 years:800mg five times a day for seven days.
Children aged 6 to 12 years: 800mg four times a day for five days.
Children aged 2 to 6 years:400mg four times a day for five days.
Children aged 1 month to 2 years: 200mg four times a day for five days.
Patients with Renal Impairment
Treatment of herpes simplex infection
Moderate renal impairment (GFR above 10ml/minute): No dosage adjustment required.
Severe renal impairment (GFR less than 10ml/minute): 200mg every 12 hours.
Treatment of herpes zoster infections
Mild renal impairment (GFR between 25 and 50ml/minute): No dosage adjustment required.
Moderate renal impairment (GFR between 10 and 25ml/minute): 800mg every 8 hours.
Severe renal impairment (GFR less than 10ml/minute): 800mg every 12 hours.
Consider intravenous therapy for herpes zoster infection in severely immunocompromised patients.
Administration
For oral administration.
Dispersible tablets should be dispersed in a minimum of 50 ml of water or swallow whole with a small amount of water.
Contraindications
None known
Precautions and Warnings
Elderly
Breastfeeding
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Lactose intolerance
Pregnancy
Renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Not all presentations are licensed for all indications
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain propylene glycol
Some formulations may contain alcohol
Monitor renal function prior to initiating treatment
Elderly: Monitor renal function and consider dose modification
Maintain hydration and urinary output
Monitor for signs of neurological toxicity
Not licensed for all indications in all age groups
Reduce dose in patients with glomerular filtration rate below 25ml/min
The elderly and patients with renal impairment have an increased risk of developing neurological adverse effects and should be closely monitored during treatment. These reactions generally resolved after treatment cessation.
In severely immunocompromised patients, prolonged or repeated courses of aciclovir may result in viral strains with reduced sensitivity, which may not respond to continued aciclovir treatment.
Pregnancy and Lactation
Pregnancy
Use aciclovir with caution in pregnancy.
There is substantial experience regarding the systemic use of aciclovir during human pregnancy. There are no reports of adverse effects to the foetus which are attributable to the use the aciclovir, at maternally non toxic doses. Briggs indicates that use in disseminated (intravenous treatment) and genital (oral treatment) Herpes simplex infection can prevent adverse foetal outcomes.
Schaefer recommends the use of oral aciclovir for the treatment of first-episode genital herpes in pregnant women. This may prevent neonatal infection by vertical transmission of the virus. Intravenous aciclovir should be used for the treatment of life-threatening maternal infections such as varicella pneumonia or disseminated herpes simplex infection.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use aciclovir with caution in breastfeeding.
Aciclovir transfers into human breast milk, the dosage of aciclovir presented in the milk is expected to be only 1% of a typical infant dosage (at maximum maternal dose). Aciclovir is not expected to cause any adverse effects in breastfed infants.
Both Briggs and Schaefer advise that continued breastfeeding is safe.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal pain
Acute renal failure
Agitation
Anaemia
Anaphylaxis
Angioedema
Ataxia
Blood urea increased
Coma
Confusion
Convulsions
Diarrhoea
Dizziness
Drowsiness
Dysarthria
Dyspnoea
Encephalopathy
Erythema multiforme
Fatigue
Fever
Hair loss
Hallucinations
Headache
Hepatitis
Increases in hepatic enzymes
Jaundice
Leucopenia
Nausea
Photosensitivity
Pruritus
Psychotic symptoms
Rash
Renal pain
Serum bilirubin increased
Serum creatinine increased
Somnolence
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Tremor
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2015
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia..
Summary of Product Characteristics: Aciclovir tablets 200 mg. Actavis UK Ltd. Revised June 2015.
Summary of Product Characteristics: Aciclovir tablets 400 mg. Actavis UK Ltd. Revised June 2015.
Summary of Product Characteristics: Aciclovir tablets 800 mg. Actavis UK Ltd. Revised June 2015.
Summary of Product Characteristics: Aciclovir tablets 200 mg/ 400 mg/ 800 mg. Wockhardt UK Ltd. Revised August 2015.
Summary of Product Characteristics: Aciclovir Suspension 200 mg/5 ml. Rosemont Pharmaceuticals. Revised April 2013.
Summary of Product Characteristics: Aciclovir Suspension 400 mg/5 ml. Rosemont Pharmaceuticals. Revised April 2013.
Summary of Product Characteristics. Zovirax Suspension. GlaxoSmithKline UK. Revised March 2015.
Summary of Product Characteristics: Zovirax Double-Strength Suspension. GlaxoSmithKline UK. Revised March 2015.
Summary of Product Characteristics: Zovirax Tablets 200 mg. GlaxoSmithKline UK. Revised March 2015.
Summary of Product Characteristics: Zovirax Tablets 800 mg. GlaxoSmithKline UK. Revised March 2015.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 June 2017
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Acyclovir. Last revised: 10 March 2015
Last accessed: 18 November 2015
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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