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Aciclovir (UK), Acyclovir (USA) [Zovirax 200mg, 400mg, 800mg]

Drug Approvals

International Nonproprietary Names (INNs) in main languages (French, Latin, Spanish): Synonyms: Aciclovir; Aciclovirum; Aciklovír; Aciklovir; Acikloviras; Acycloguanosine; Asikloviiri; BW-248U BAN: Aciclovir USAN: Acyclovir INN: Aciclovir [rINN (en)] INN: Aciclovir [rINN (es)] INN: Aciclovir [rINN (fr)] INN: Aciclovirum [rINN (la)] INN: Ацикловир [rINN (ru)] Chemical name: 9-[(2-Hydroxyethoxy)methyl]guanine; 2-Amino-1,9-dihydro-9-(2-hydroxyethoxymethyl)-6H-purin-6-one Molecular formula: C8H11N5O3 =225.2 CAS: 59277-89-3 ATC code: D06BB03; J05AB01; S01AD03 Read code: y00js [Eyes]; y08E6 [Systemic]; y013f [Skin]; y02V1; y07f1; y07w5 [Eyes]; y07w7 [Skin]; y08DR [Systemic]



In China, Europe, and US.

European Pharmacopoeia, 6th ed. (Acidovir)

A white to almost white crystalline powder. Slightly soluble in water; very slightly soluble in alcohol; freely soluble in dimethyl sulfoxide; soluble in dilute solutions of alkali hydroxides and mineral acids.

The United States Pharmacopeia 31, 2008 (Acyclovir)

A white to off-white crystalline powder. Slightly soluble in water; insoluble in alcohol; soluble in dilute hydrochloric acid. Store in airtight containers. Protect from light and moisture.

Generic Name: Aciclovir (UK), Acyclovir (US, Canada)

Under what local brands and in what dosages is generic Acyclovir or Aciclovir sold in pharmacies of Britain, United States, and Canada?

In pharmacies of the United States, Great Britain and Canada the pharmacists offer you to buy Aciclovir (UK) or Acyclovir (US, Canada) (according to your prescription or without a prescription) under such brand names and in such strengths and dosage forms:

UK US Canada
Aciclovir 5% w/w Cream   Aciclovir Tablets 200, 400, 800mg Aciclovir 200mg/5ml & 400mg/5ml Oral Suspension Zovirax 200mg Tablets Zovirax 800mg Tablets Zovirax Cream Zovirax Eye Ointment Zovirax IV 250mg, 500mg Zovirax Suspension Acyclovir 200mg Capsuls   Acyclovir 400mg Tablets Acyclovir 800mg Tablets Zovirax 400mg Tablets Zovirax 800mg Tablets Zovirax 5% Eye Ointment Zovirax 5% Cream Acyclovir 200mg Tablets   Acyclovir 400mg Tablets Acyclovir 800mg Tablets Mylan-Acyclovir 200, 400, and 800mg Tablets Zovirax 200mg Tablets Zovirax 400mg Tablets Zovirax 5% Eye Ointment Zovirax 5% Cream

Aciclovir Sodium

Drug Approvals

INNs in main languages (French, Latin, Spanish): BAN: Aciclovir Sodium [BANM] USAN: Acyclovir Sodium INN: Aciclovir Sodium [rINNM (en)] INN: Aciclovir sódico [rINNM (es)] INN: Aciclovir Sodique [rINNM (fr)] INN: Natrii Aciclovirum [rINNM (la)] INN: Натрий Ацикловир [rINNM (ru)] Molecular formula: C8H10N5NaO3 =247.2 CAS: 69657-51-8 ATC code: D06BB03; J05AB01; S01AD03


Acyclovir is reported to be incompatible with foscarnet.


A study found that Acyclovir sodium solutions prepared with sodium chloride 0.9% and with dextrose 5% were stable for 7 and 21 days respectively when stored at 23°. Solutions stored at 4° were found to be stable for 35 days although subsequent storage at room temperature produced irreversible precipitation. Precipitation may also occur when freshly prepared solutions are refrigerated but the precipitate redissolves at room temperature. US licensed product information recommends that diluted solutions be used within 24 hours of preparation.

Adverse Effects

Acyclovir is generally well tolerated. When given intravenously as aciclovir sodium it may cause local reactions at the injection site with inflammation and phlebitis; these reactions may be associated with extravasation that can lead to tissue necrosis. Renal impairment may be associated with systemic use of aciclovir in some patients; it is usually reversible and is reported to respond to hydration and/or dosage reduction or withdrawal, but may progress to acute renal failure. The risk of renal toxicity is increased by conditions favouring deposition of Acyclovir crystals in the tubules such as when the patient is poorly hydrated, has existing renal impairment, or when the drug is given at a high dosage or by rapid or bolus injection. Some patients taking systemic Acyclovir may have transient increases in blood concentrations of urea and creatinine although this is more acute with intravenous dosage. Occasional adverse effects after systemic use include increased serum bilirubin and liver enzymes, haematological changes, skin rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), fever, headache, dizziness, and gastrointestinal effects such as nausea, vomiting, and diarrhoea. Anaphylaxis has been reported. Hepatitis and jaundice have been reported rarely. Reversible neurological effects including lethargy, somnolence, confusion, hallucinations, agitation, tremors, psychosis, convulsions, and coma have been reported in a small number of patients, particularly in those given intravenous Acyclovir and with predisposing factors such as renal impairment; these effects may be more marked in older patients. Thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome, sometimes resulting in death, have occurred in immunocompromised patients given high parenteral doses of aciclovir. Accelerated diffuse hair loss has also been reported. Topical application of aciclovir may produce transient stinging, burning, itching, or erythema. Eye ointments may occasionally produce transient stinging, superficial punctate keratopathy blepharitis, or conjunctivitis.

Effects on the blood

There has been no evidence of bonemarrow toxicity in patients given Acyclovir after bone marrow transplantation. However, megaloblastic haematopoiesis was seen in the bone marrow of 3 patients given aciclovir for suspected or proven herpes simplex encephalitis. There has also been a report of inhibition of human peripheral blood lymphocytes in samples taken from healthy subjects given Acyclovir.

Effects on the kidneys

Aciclovir is excreted mostly by the kidney, and reaches high concentrations in the tubular lumen, but is relatively insoluble in urine and may therefore cause intratubular precipitation of crystals in the kidney. High doses, volume depletion, or pre-existing renal impairment increase the risk of Acyclovir-associated acute renal failure, which has been reported in 12 to 48% of patients in some series. Although usually asymptomatic there may be nausea, vomiting, and flank pain, together with haematuria and pyuria. Most patients recover on stopping the drug and volume replacement, though some need temporary dialysis; use of a loop diuretic may be helpful in some cases. Slow infusion and adequate hydration can help to prevent crystal precipitation, and doses should be reduced in patients with underlying renal impairment. There are also occasional reports of renal toxicity apparently unrelated to crystal precipitation.

Effects on the nervous system

Neurotoxicity, including tremor, confusion, myoclonus, agitation, lethargy, or hallucination, is an uncommon adverse effect of aciclovir, and may be hard to distinguish from progression of the underlying disease state. Renal impairment may increase the risk although no clear relationship with peak plasma concentrations has been demonstrated; cases are also more common in elderly patients and those taking other neurotoxic drugs. Of 143 patients given Acyclovir by intravenous infusion in doses ranging from 0.75 to 3.6 g/mdaily for the treatment of herpesvirus infections after bone marrow transplantation, 6 developed reversible neurological symptoms including tremor, agitation, nausea, lethargy, mild disorien-tation, autonomic instability, hemiparaesthesia, and slurred speech. EEGs were diffusely abnormal in all 6. Symptoms improved in all patients on withdrawing aciclovir; reinstituting Acyclovir in 2 produced a recurrence of symptoms. Concomitant therapy included irradiation and methotrexate intrafhecally for all 6, interferon alfa for 3, and ciclosporin for 1.

Effects on the skin

A report of vesicular lesions associated with intravenous use of aciclovir in a patient thought to have herpes simplex encephalitis. Careful evaluation is necessary to differentiate the reaction from herpetic lesions.


Acyclovir has been associated with vasculitis. In one patient it was one of many drugs given that may have caused a necrotising vasculitis. In another report an immunocompromised child with chickenpox given aciclovir by infusion developed a vasculitic rash which diminished on withdrawal of the drug.For a report of peripheral neuropathy associated with vasculitis due to the prodrug valacyclovir, see Effects on the Nervous System.


Systemic aciclovir should be used with caution and in reduced doses in patients with renal impairment. The elderly and patients with existing renal impairment should be closely monitored for neurological adverse effects. Adequate hydration should be maintained in patients given parenteral or high oral doses of Acyclovir. 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. Intravenous Acyclovir should also be used with caution in patients with underlying neurological abnormalities, with significant hypoxia, or with serious hepatic or electrolyte abnormalities.

Breast feeding

Aciclovir is distributed into breast milk and in some instances higher concentrations are obtained than in maternal serum. Licensed product information reports that a maternal oral dose of 200 mg five times daily could expose a breast-fed infant to 300 micrograms/kg daily and advises caution when giving nursing mothers Acyclovir. However, no adverse effects have been seen in breast-fed infants whose mothers were taking aciclovir, and the American Academy of Pediatrics considersthat it is therefore usually compatible with breast feeding.


The incidence of congenital abnormality and spontaneous fetal loss in 1246 cases of prenatal exposure to Acyclovir did not significantly differ from those in the general population.

Sodium content

Each g of Acyclovir sodium represents 4.05 mmol of sodium.


Probenecid is reported to block the renal clearance of aciclovir. The risk of renal impairment is increased by use with other nephrotoxic drugs.


Use of zidovudine with Acyclovir is not generally associated with additional toxicity. However, there is a report of a patient who had overwhelming fatigue when given aciclovir and zidovudine together; no such effect occurred when each drug was given alone. Former product information for interferon alfa-nl reported progressive renal failure in patients also given Acyclovir.


For reference to evidence that aciclovir inhibits theophylline metabolism, resulting in accumulation.

Antiviral Action

Acyclovir is active against herpes simplex virus type 1 and type 2 and against varicella-zoster virus. This activity requires intracellular conversion of aciclovir by viral thymidine kinase to the monophosphate with subsequent conversion by cellular enzymes to the diphosphate and the active triphosphate. This active form inhibits viral DNA synthesis and replication by inhibiting the herpesvirus DNA polymerase enzyme as well as being incorporated into viral DNA. This process is highly selective for infected cells. Studies in animals and in vitro have found various sensitivities but show that target viruses are inhibited by concentrations of Acyclovir that are readily achieved clinically. Herpes simplex virus type 1 appears to be the most susceptible, then type 2, followed by varicella-zoster virus. The Epstein-Barr virus and CMV are also susceptible to aciclovir to a lesser extent. However, for CMV it does not appear to be activated by thymidine kinase and may act via a different mechanism. Epstein-Barr virus may have reduced thymidine kinase activity but its DNA polymerase is very sensitive to inhibition by Acyclovir triphosphate, which may account for the partial activity. Acyclovir has no activity against latent viruses, but there is some evidence that it inhibits latent herpes simplex virus at an early stage of reactivation.


Herpes simplex virus develops resistance to aciclovir in vitro and in vivo by selection of mutants deficient in thymidine kinase. Other mechanisms of resistance include altered substrate specificity of thymidine kinase and reduced sensitivity of viral DNA polymerase. Resistance has also been reported with varicella-zoster virus, probably by similar mechanisms. Although occasional treatment failures have been reported, resistance has not yet emerged as a major problem in treating herpes simplex infections. However, resistant viruses are more likely to be a problem in patients with a suppressed immune response; AIDS patients may be particularly prone to Acyclovir-resistant mucocutaneous herpes simplex virus infections. Viruses resistant to aciclovir because of absence of thymidine kinase may be cross-resistant to other antivirals phosphorylated by this enzyme, such as brivudine, idoxuridine, and ganciclovir. Viruses resistant because of altered substrate specificity of thymidine kinase may display cross-resistance to brivudine; those with altered DNA polymerase sensitivity may be resistant to brivudine and vidarabine. However, those viruses with altered enzyme specificity or sensitivity tend to have variable cross-resistance patterns and may be relatively susceptible to the aforementioned antivirals.


Acyclovir is poorly absorbed from the gastrointestinal tract after oral doses. Bioavailability of oral aciclovir is about 10 to 20%; orally active prodrugs such as valac-iclovir have been developed to overcome this poor absorption. After intravenous dosage as Acyclovir sodium it is widely distributed to body tissues and fluids including the CSF where concentrations achieved are about 50% of those achieved in plasma. Protein binding is reported to range from 9 to 33%. Acyclovir is excreted largely unchanged in the urine, by glomerular filtration and some active tubular secretion, with up to 14% appearing in the urine as the inactive metabolite 9-carboxymethoxymethylguanine. In patients with normal renal function, the half-life is about 2 to 3 hours. In patients with chronic renal failure, this value is increased and may be up to 19.5 hours in anu-ric patients. During haemodialysis the half-life has been reported to be reduced to 5.7 hours, with 60% of a dose of aciclovir being removed. Faecal excretion may account for about 2% of a dose. Probenecid increases the half-life and the area under the plasma concentration-time curve of Acyclovir. Aciclovir crosses the placenta and is distributed into breast milk in concentrations about 3 times higher than those in maternal serum. Absorption of Acyclovir is usually slight after topical application to intact skin, although it may be increased by changes in formulation. Acyclovir is absorbed after application of a 3% ointment to the eye giving a relatively high concentration in the aqueous humour but negligible amounts in the blood.


The pharmacokinetics of oral aciclovir and its distribution into the eye.

Uses and Administration

Acyclovir is a synthetic purine nucleoside analogue structurally related to guanine. It is used mainly for the treatment and prophylaxis of viral infections due to herpes simplex virus types 1 and 2 and varicella-zoster virus (herpes zoster and chickenpox). Herpes simplex infections, including herpes keratitis, herpes labialis, and genital herpes, respond to aciclovir by the intravenous, oral, or topical route, given as soon as possible after symptoms appear. Both initial and recurrent infections can be successfully treated. Prolonged treatment can reduce the incidence of recurrence which is particularly important in immuno-compromised patients. However, when prolonged treatment is withdrawn, infections may recur. Acyclovir also improves the healing of herpes zoster lesions and reduces acute pain when given intravenously or by mouth; use to prevent postherpetic neuralgia is controversial. Beneficial effects maybe more marked in immunocompromised patients. Acyclovir is given by intravenous infusion as the sodium salt over 1 hour. Doses are expressed in terms of the base. Aciclovir sodium 1.1 g is equivalentto about 1 g of aciclovir. Solutions for infusion are usually prepared to give a concentration of aciclovir of 25 or 50 mg/mL; this must then be further diluted to a final concentration not greater than about 5 mg/mL (0.5%). Alternatively, a solution containing 25 mg/mL may be given by injection using a controlled-rate infusion pump, over 1 hour. In obese patients the dose should be calculated on the basis of ideal body-weight, to avoid overdosage. For herpes simplex infections in the immunocompromised, and for severe initial genital herpes, or for prophylaxis of herpes simplex infections in immunocompromised patients the dose by the intravenous route is 5 mg/kg given every 8 hours, and recommended periods of treatment range from 5 to 7 days. A higher dose of 10 mg/kg every 8 hours is given in the treatment of herpes simplex encephalitis, and treatment is usually continued for 10 days. For varicella-zoster infections in immunocompetent patients, a dose of 5 mg/kg every 8 hours may also be given. In immunocompromised patients the higher dose of 10 mg/kg every 8 hours should be used. Oral doses of Acyclovir also vary according to indication.

In herpes simplex infections:

  • for treatment of primary infections, including genital herpes, the usual oral dose is 200 mg five times daily (usually every 4 hours while awake) for 5 to 10 days
  • severely immunocompromised patients or those with impaired absorption may be given 400 mg five times daily for 5 days
  • for suppression of recurrent herpes simplex in immunocompetent patients, the oral dose is 800 mg daily in two to four divided doses; dosage reduction to 400 to 600 mg daily can be tried. Higher doses of 1 g daily have also been used. Therapy should be interrupted every 6 to 12 months for reassessment of the condition

Chronic suppressive treatment is not suitable for mild or infrequent recurrences of herpes simplex. In such cases episodic treatment of recurrences may be preferred; a dose of 200 mg five times daily for 5 days has been recommended, preferably begun during the prodromal period. For prophylaxis of herpes simplex in immunocompromised patients, the dose is 200 to 400 mg four times daily. The usual oral dose of aciclovir for treatment of chickenpox is 800 mg four or five times daily for 5 to 7 days; for herpes zoster 800 mg five times daily may be given for 7 to 10 days. In herpes simplex infections of the skin, including genital herpes and herpes labialis, topical treatment with an ointment or cream containing Acyclovir 5% may be applied 5 or 6 times daily for periods of 5 to 10 days, preferably beginning in the prodromal period as soon as signs or symptoms occur. In herpes simplex keratitis a 3% eye ointment may be applied 5 times daily until 3 days after healing. Doses should be reduced in renal impairment (see below). For details of doses in children, see Administration in Children, below.

Administration in children

Acyclovir is licensed for use in infants and children for the treatment of herpes simplex and varicella-zoster infections, and for the prophylaxis of herpes simplex infections in the immunocompromised. It may be given by slow intravenous infusion over 1 hour, or orally. Recommended intravenous doses vary according to country and age of the patient. In the UK the 8-hourly dose for children aged 3 months to 12 years is calculated by body-surface. The usual course of treatment is 5 to 10 days:

  • herpes simplex and varicella-zoster infections in immunocompetent patients: 250 mg/m
  • varicella-zoster infection in immunocompromised children or those with herpes simplex encephalitis: 500 mg/m

In the USA, the 8-hourly intravenous dose for children aged 3 months to 12 years is calculated by body-weight:

  • herpes simplex infections: 10 mg/kg for 7 days
  • varicella-zoster infections in immunocompromised children: 20 mg/kg for 7 days
  • herpes simplex encephalitis: 20 mg/kg for 10 days

In the UK and the USA the intravenous dose for neonates and infants up to 3 months of age is calculated by body-weight; an 8-hourly intravenous dose of 10 mg/kg may be given for the treatment of herpes simplex infections. Treatment for neonatal herpes simplex usually continues for 7 or 10 days. Higher intravenous doses of up to 20 mg/kg for at least 7 days have been recommended by the BNFC in neonates with varicella-zoster infections. A similar dose given for 14 days (21 days if CNS involvement) is also recommended in the treatment of disseminated herpes simplex in neonates and infants up to 3 months of age. In the UK the following oral doses are permitted in the treatment of herpes simplex infections, and in the prophylaxis of herpes simplex infections in the immunocompromised:

  • 2 years and over: usual adult dose (see above)
  • under 2 years: half usual adult dose

In the UK and the USA the oral doses for the treatment of chickenpox are:

  • over 2 years: 20 mg/kg, up to a maximum of 800 mg, four times daily for 5 days

Alternatively, the following oral doses may be used:

  • under 2 years: 200 mg four times daily
  • 2 to 5 years: 400 mg four times daily
  • 6 years and over: 800 mg four times daily

Administration in renal impairment

Doses of aciclovir should be reduced in renal impairment according to creatinine clearance (CC) and licensed product information gives the following guidance: intravenous dosage:

  • CC between 25 and 50 mL/minute: the interval between infusions may be increased to 12 hours
  • CC 10 to 25 mL/minute: the interval between infusions may be increased to 24 hours
  • CC less than 10 mL/minute: patients on peritoneal dialysis should receive half the usual appropriate dose given once every 24 hours; patients on haemodialysis should receive half the usual dose every 24 hours plus an extra half-dose after haemodialysis

Oral dosage:

  • CC less than 10 mL/minute: herpes simplex infections: 200 mg every 12 hours; varicella-zoster infections: 800 mg every 12 hours
  • CC between 10 and 25 mL/minute: varicella-zoster infections: 800 mg three times daily every 8 hours

Erythema multiforme

For patients with recurrent erythema multiforme associated with herpes simplex infection a 5-day course of oral aciclovir at the start of the infection has been proposed to prevent the subsequent skin lesions. If this fails, a 6-month course of oral Acyclovir has been found to be of benefit,even if the association with herpes is not obvious. It should be noted, however, that erythema multiforme may occur as an adverse effect of systemic aciclovir.


British Pharmacopoeia 2008: Aciclovir Cream; Aciclovir Eye Ointment; Aciclovir Intravenous Infusion; Aciclovir Oral Suspension; Aciclovir Tablets; Dispersible Aciclovir Tablet; The United States Pharmacopeia 31, 2008: Acyclovir Capsules; Acyclovir for Injection; Acyclovir Ointment; Acyclovir Oral Suspension; Acyclovir Tablets.

Proprietary Preparations:

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