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Acyclovir
DrugPoint Summary
DOSING/ADMINISTRATION
Adult Dosing
Important Note
Orphan drug designation: Treatment of acute herpetic keratitis caused by Herpes Simplex Virus type 1 and 2
Bell's palsy
400 mg orally 5 times daily for 10 days plus predniSONE 1 mg/kg (minimum dose, 30 mg) orally twice daily for the first 5 days,
followed by a gradual taper down to 5 mg twice daily over the next 5 days (off-label dosage) [3]
Eczema herpeticum
(Oral) Initial episode: 200 mg orally every 4 hours 5 times per day for 10 days (FDA dosage) [5][6]
(Oral) Initial episode: 400 mg orally 3 times per day for 7 to 10 days OR 200 mg orally 5 times daily for 7 to 10 days; may extend
duration of therapy if healing is not complete after 10 days (guideline dosage) [7]
(Oral) Episodic therapy: 200 mg orally every 4 hours, 5 times daily for 5 days; Initiate therapy at the earliest sign or symptom of
recurrence (FDA dosage) [5][6]
(Oral) Episodic therapy: 400 mg orally 3 times daily for 5 days OR 800 mg orally twice daily for 5 days OR 800 mg orally 3 times
daily for 2 days; initiate treatment preferably within 1 day of lesion onset or during preceding prodrome (guideline dosage) [7].
(Oral) Suppressive therapy: 400 mg orally twice daily for up to 12 months [5][6][7]
(Topical) Initial therapy: Apply ointment topically every 3 hours (6 times per day) for 7 days in sufficient quantities to adequately
cover lesion [8]
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(Initial or recurrent) 400 mg orally 3 times daily for 5 to 14 days (guideline dosage) [9]
(Chronic suppressive therapy) 400 mg orally twice daily (guideline dosage) [9]
Apply ointment topically (using a finger cot or glove) every 3 hours (6 times per day) for 7 days in sufficient quantities to adequately
cover lesions (manufacturer dosing) [8]. The CDC discourages the use of topical therapy [7].
(3% ophthalmic ointment) Apply 1 cm ribbon in lower cul-de-sac of affected eye 5 times per day (every 3 hours while awake) until
corneal ulcer heals, then 3 times per day for 7 days (FDA dosage) [10]
(Oral) 400 mg orally 5 times daily (off-label dosage) [11][12]
(Acute localized dermatomal) 800 mg orally 5 times daily for 7 to 10 days (guideline dosage) [9]
Uncomplicated cases, 20 mg/kg (MAX, 800 mg per dose) orally 5 times daily for 5 to 7 days (guideline dosage) [9]
(Buccal tablet) Place one 50-mg tablet buccally in upper gum above incisor tooth (canine fossa) and hold with slight pressure for 30
seconds [13]
(Cream) Apply cream topically 5 times per day for 4 days [14]
Varicella
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(Infection as a result of vaccination and post-exposure prophylaxis) 800 mg orally 5 times a day for 5 to 7 days; for post-exposure
prophylaxis, begin treatment 7 to 10 days after exposure (guideline dosage) [9].
Pediatric Dosing
Important Note
Orphan drug designation: Treatment of acute herpetic keratitis caused by Herpes Simplex Virus type 1 and 2
Eczema herpeticum
(Less than 45 kg) 20 mg/kg orally 3 times daily for 5 to 14 days; MAX 400 mg/dose (guideline dose) [17]
(Adolescents) 400 mg orally twice daily for 5 to 14 days (guideline dose) [17]
Mild symptomatic gingivostomatitis: 20 mg/kg orally 3 times daily for 5 to 10 days; MAX 400 mg/dose (guideline dosage) [17]
(2 years or older, 3% ophthalmic ointment) Apply 1 cm ribbon in lower cul-de-sac of affected eye 5 times per day (every 3 hours
while awake) until corneal ulcer heals, then 3 times per day for 7 days [10]
Mild disease with no or moderate immune suppression, CDC immunologic categories 1 and 2: 20 mg/kg (MAX, 800 mg per dose)
orally 4 times daily for 7 to 10 days or until no new lesions appear for 48 hours (guideline dose) [17]
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(12 years or older) Apply cream topically 5 times per day for 4 days [14]
Varicella
(2 years or older, 40 kg or less) 20 mg/kg orally 4 times a day for 5 days [5][6]
(2 years or older, more than 40 kg) 800 mg orally 4 times a day for 5 days [5][6]
FDA Uses
Non-FDA Uses
Dose Adjustments
Renal impairment (CrCl greater than 25 mL/min/1.73 m(2) and dose regimen of 800 mg orally every 4 hours, 5 times daily): No
adjustment required [5][18]
Renal impairment (CrCl 10 to 25 mL/min/1.73 m(2) and dose regimen of 800 mg orally every 4 hours, 5 times daily): Reduce to 800
mg orally every 8 hours [5][18]
Renal impairment (CrCl less than 10 mL/min/1.73 m(2) and dose regimen of 800 mg orally every 4 hours, 5 times daily): Reduce to
800 mg orally every 12 hours [5][18]
Renal impairment (CrCl greater than 10 mL/min/1.73 m(2) and dose regimen of 400 mg orally every 12 hours): No adjustment
required [5][18]
Renal impairment (CrCl 10 mL/min/1.73 m(2) or less and dose regimen of 400 mg orally every 12 hours): Reduce to 200 mg orally
every 12 hours [5][18]
Renal impairment (CrCl greater than 10 mL/min/1.73 m(2) and dose regimen 200 mg orally every 4 hours, 5 times daily): No
adjustment required [5][18]
Renal impairment (CrCl 10 mL/min/1.73 m(2) or less and dose regimen of 200 mg orally every 4 hours, 5 times daily): Reduce to
200 mg orally every 12 hours [5][18]
Renal impairment (CrCl less than 10 mL/min and HIV infection and chronic kidney disease or ESRD): 200 mg orally every 12 hours
[19]
Hepatic impairment: No specific recommendations are available [5][18].
Geriatric (reduced renal function): Adjustment may be necessary [5][18]
Hemodialysis: Administer renally adjusted dosage regimen; adjust dosing schedule so that an additional dose is administered after
each dialysis session [5][18]
Peritoneal dialysis: Administer renally adjusted dosage regimen; a supplemental dose after dialysis is not necessary [5][18]
Continuous ambulatory peritoneal dialysis, herpes zoster or varicella infection: 600 mg or 800 mg orally once daily [20]
Administration
Buccal
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apply within 1 hour after onset of prodromal symptoms and before signs of lesions appear [13]
place with dry finger immediately after removing from blister; place on upper gum just above incisor tooth (canine fossa) on the
same side of mouth as symptoms; face rounded side of tablet towards gum for comfort, but either side of tablet can be applied; hold
with slight pressure for 30 seconds for adhesion [13]
if tablet does not adhere or falls off within first 6 hours, reapply the same tablet immediately; if repositioning fails, place a new
tablet [13]
if tablet is swallowed within first 6 hours, drink a glass of water and apply a new tablet; if tablet falls off or is swallowed after the
first 6 hours, reapplication is not needed [13]
Ophthalmic
Pull down lower lid of affected eye to form a pocket; apply ointment in the pocket, then close eye for 1 to 2 minutes; may wipe
away any excess ointment [10]
Oral
Topical
(ointment) apply sufficient quantity with finger cot or rubber glove to adequately cover lesions; dose size per application should
approximate a one-half inch ribbon per 4 square inches of surface area [8]
Comparative Efficacy
No results available
Place In Therapy
No results available
MEDICATION SAFETY
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Contraindications
Hypersensitivity to acyclovir, milk protein concentrate, or any other component of the product with the buccal tablet [13]
Hypersensitivity to acyclovir or valacyclovir with oral capsule, tablet, suspension, or ophthalmic ointment [10][5][6], or any
component of the product with the topical cream [14]
Hypersensitivity to any component of the product with the topical ointment [8]
Precautions
Dermatologic: Contact sensitization or irritation has been reported with topical cream [14]
Dermatologic: Cutaneous use only; avoid contact with eyes when using topical ointment or cream [8], the inside of the mouth, or
nose with topical cream [14]
Hematologic: Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), resulting in fatalities, has been
reported in immunocompromised patients with oral capsule, tablet, and suspension [5][6]
Renal: Renal failure, with some fatal cases, has been reported with oral capsule, tablet, and suspension [5][6]
Renal: Renal impairment; dose adjustment recommended, and maintain adequate hydration when using oral capsule, tablet, or
suspension [5][6]
Adverse Effects
Common
Serious
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No results available
REMS
No results available
Definitions
Severity:
Minor The interaction would have limited clinical effects. Manifestations may include
an increase in the frequency or severity of the side effects but generally
would not require a Major alteration in therapy.
Unknown.
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Unknown
Documentation:
Excellent Controlled studies have clearly established the existence of the interaction.
Good Documentation strongly suggests the interaction exists,
but well-controlled studies are lacking.
Fair Available documentation is poor, but pharmacologic considerations lead
clinicians to suspect the interaction exists; or, documentation is good for a
pharmacologically similar drug.
Unknown Unknown.
IV Compatibility (single)
No results available
Pregnancy Category
B[13] (FDA)
B3[32] (AUS)
Breast Feeding
Monitoring
genital herpes: reduction in the duration of acute genital herpes infection, lesion healing, pain, and viral shedding is indicative of
efficacy; long-term therapy effectiveness is measured by the prevention or reduction in the frequency or severity of genital herpes
recurrence
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genital herpes: need for continued treatment; after one year of therapy [5][6]
herpes labialis (cold sores): reduction in mean duration of recurrent episode and prevention of cold sore lesion progression are
indicative of efficacy
herpes zoster (shingles): reduced duration of viral shedding and new lesion formation, shortened time to complete cessation of pain,
lesion scabbing and healing, and decreased incidence of shingles-related neurologic symptoms (ie, paresthesia, dysesthesia,
hyperesthesia) are indicative of efficacy
varicella (chickenpox): shortened time to rash healing, reduction in number of lesions, vesicles, and residual lesions, and alleviation
of fever, anorexia, and lethargy are indicative of efficacy
Do Not Confuse
Zovirax - Doribax[1]
Zovirax - Zostrix[2]
Zovirax - Zyvox[2]
MECHANISM OF ACTION
Mechanism of Action
Acyclovir is a synthetic purine nucleoside analog with inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and
varicella-zoster virus (VZV). Acyclovir triphosphate, a converted form of acyclovir, stops replication of herpes viral DNA by competitive
inhibition of viral DNA polymerase, incorporation into and termination of the growing viral DNA chain, and inactivation of the viral
DNA polymerase [13][8][5][14][6].
PHARMACOKINETICS
Pharmacokinetics
Absorption
Distribution
Metabolism
Excretion
PATIENT EDUCATION
Medication Counseling
Advise patient to maintain adequate hydration with oral therapy to prevent renal toxicity [5][6].
Counsel patient that drug does not prevent reinfection or disease transmission of genital herpes [5][8][6].
Instruct patient to abstain from sex during acute outbreaks of genital herpes and to always use condoms, as the disease can also be
transmitted in the absence of symptoms [5][6].
Ophthalmic side effects may include eye pain (stinging), punctate keratitis and follicular conjunctivitis [10].
Oral side effects may include diarrhea, nausea, vomiting, malaise, or renal failure [5][6].
Buccal side effects may include headache and application site pain [13].
Topical side effects may include local application reactions such as a burning sensation, dryness (cream), pruritus, or stinging [8]
[14].
Teach patient proper technique and placement of product being used [10][13].
Instruct patient to avoid use of topical ointment or cream in the eye or inside the mouth or nose [8][14].
Advise patient to apply ointment with a finger cot or rubber glove to prevent transmission of virus [8].
Patient Handouts
TOXICOLOGY
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Clinical Effects
USES: Substances include acyclovir, famciclovir, and penciclovir. Famciclovir is a prodrug of penciclovir. Ganciclovir, valganciclovir,
and valacyclovir are covered in separate managements. Acyclovir and related medications are used for prophylaxis and treatment of
herpes virus infections, including varicella infection. PHARMACOLOGY: These drugs are acyclic analogues of the natural nucleoside
guanosine. They are activated via monophosphorylation by virus-induced thymidine kinase and then will undergo 2 additional
phosphorylations. The triphosphate forms inhibit herpes viral DNA synthesis but do not inhibit DNA synthesis in uninfected cells
because the initial phosphorylation only occurs in herpes-infected cells. TOXICOLOGY: At high concentrations, acyclovir precipitates
as crystals in the urine, causing nephropathy. The mechanism for neurologic toxicity is not understood. EPIDEMIOLOGY: Overdose is
uncommon; most reported toxicity is from high therapeutic doses. Severe toxicity is very rare, and there are no reported deaths from
overdose. MILD TO MODERATE TOXICITY: Most patients who ingest these agents in overdose experience only mild or moderate
effects. The primary manifestations are nausea, vomiting, and headache. Renal injury has been reported. SEVERE TOXICITY: Most
toxicity from these agents is from therapeutic or high therapeutic doses (particularly in patients with renal insufficiency) rather than
inadvertent or intentional oral overdose. Neurotoxicity predominates and may include lethargy, confusion, ataxia, nystagmus,
dysarthria, hallucinations, myoclonus, agitation, and in severe cases, seizures or coma. Renal failure can also develop and is usually
transient. ADVERSE EFFECTS: ORAL: Nausea, vomiting, and headaches are common. IV: Adverse effects include neurotoxicity which
resembles an extension of viral infection into the central nervous system. Most commonly, mental status changes and involuntary
movements occur. Lethargy, fatigue, irritability, depression, agitation, occasional myoclonus with muscle fasciculations, hyperactive
tendon reflexes, tremor, stupor and coma have been reported following intravenous acyclovir, particularly rapid infusions. Psychosis
and neuropsychiatric symptoms have also been described with IV acyclovir administration. Neurotoxicity is generally reversible. Local
inflammation at injection site or phlebitis, renal injury and acute renal failure, agitation, coma, seizures, and lethargy may occur with
acute or repeated administration to patients with renal insufficiency. Obstructive nephropathy as a result of acyclovir crystalluria may
develop following high-dose therapy. Leukopenia has occasionally been reported as an adverse effect following therapeutic doses.
TOPICAL: Mild pain, burning, stinging, and itching. OCULAR: Mild irritation.
Range of Toxicity
TOXICITY: A toxic dose has not been established for these agents. ACYCLOVIR: ADULT: Overdose ingestions up to 20 grams have
been reported, associated with the development of lethargy, agitation, seizures, and coma. PEDIATRIC: A 2-year-old received 800 mg
acyclovir IV and developed transient neurotoxicity, but recovered. Two neonates, who received 65 mg/kg and 100 mg/kg acyclovir IV
had no evidence of toxicity. Transient nephrotoxicity developed in a neonate who received acyclovir 100 mg/kg IV three times daily
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for 4 days, and another who received 750 mg/kg IV. THERAPEUTIC DOSE: Varies with indication. ACYCLOVIR: ADULT: Oral dose is
200 to 800 mg 4 to 5 times daily. The IV dose is 5 to 10 mg/kg every 8 hours. PEDIATRIC: ORAL: 2 yrs and older, less than 40 kg:
20 mg/kg 4 times daily; greater than 40 kg: 800 mg 4 times daily. IV (birth to 12 yrs of age): 10 to 20 mg/kg every 8 hours.
FAMCICLOVIR: ADULT: 500 mg to 2 g daily divided in 2 or 3 doses. PENCICLOVIR: ADULT: Apply topically every 2 hours while
awake.
Treatment
Support: MANAGEMENT OF MILD TO MODERATE TOXICITY: Patients generally do well with supportive care. Nausea and vomiting
should be treated with antiemetics. Rashes should be treated with supportive care, discontinuation of the offending agent, and
consideration of antihistamines and corticosteroids. With massive overdose, hydrate patients and monitor renal function.
MANAGEMENT OF SEVERE TOXICITY: Supportive care remains the mainstay of care in severe toxicity. Seizures should be treated
with benzodiazepines as first line therapy, followed by barbiturates or propofol, if seizures persist. Hydrate patients and monitor urine
output and renal function. Airway protection should be employed as need for patients with coma.
Decontamination: PREHOSPITAL: No pre-hospital decontamination is indicated. HOSPITAL: Activated charcoal should be considered
in patients with recent, large overdose if they are awake, alert, and willing to drink the charcoal. Gastric lavage has no role, as
toxicity is not life threatening.
Airway management: Central respiratory failure is not expected with oral overdose of acyclovir. Patients with profound CNS
depression or recurrent seizures require airway management, but this is exceedingly rare.
Antidote: None
Monitoring of patient: Monitor renal function and urine output in patients receiving IV acyclovir with suspected toxicity or after
massive oral overdose.
Enhanced elimination procedure: Acyclovir and famciclovir have low protein binding and volumes of distribution, and can be removed
by hemodialysis. Hemodialysis has been used to reduce serum acyclovir concentrations in patients with toxicity, but is rarely indicated
as patients do well with supportive care.
Patient disposition: HOME CRITERIA: Asymptomatic patients with inadvertent ingestion of these products may be observed at home.
OBSERVATION CRITERIA: Patients with deliberate overdose and symptomatic patients should be sent to a healthcare facility for
evaluation and treatment. Patients should be observed for 6 hours, primarily monitoring signs of co-ingestant toxicity or development
of significant CNS depression. Follow-up renal function tests should be obtained in patients with massive overdose. ADMISSION
CRITERIA: Admit patients with severe toxicity characterized by CNS effects or renal injury. CONSULT CRITERIA: Consider consultation
with nephrology for patients with renal injury.
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ABOUT
How Supplied
Generic
Sitavig
Buccal Tablet: 50 MG
Zovirax
Drug Properties
No results available
No results available
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Trade Names
Zovirax
Sitavig
Avaclyr
Regulatory Status
RX
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