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DRUG IMAGES
ACYCLOVIR 800 MG TABLET
ACYCLOVIR 200 MG CAPSULE
ACYCLOVIR 400 MG TABLET
The following indications for ACYCLOVIR (acyclovir) have been approved by the FDA:
Indications:
Chickenpox
Genital herpes simplex
Herpes labialis
Herpes simplex encephalitis
Herpes simplex infection
Herpes zoster
Mucocutaneous herpes simplex
Recurrent herpes genitalis
Recurrent herpes simplex labialis
Recurrent mucocutaneous herpes simplex
Suppression of recurrent herpes simplex infection
Professional Synonyms:
Encephalitis caused by human herpes simplex virus
Encephalitis due to HSV
Herpes encephalitis
Herpes genitalis
Herpes simplex type 1 infection of the lip or nares
Herpes simplex
HSV infection
HSV type 1 infection of the lip or nares
Latent varicella zoster virus infection
Latent VZV infection
Mucocutaneous herpes simplex infection
Mucocutaneous HSV infection
Prophylaxis for herpes simplex
Recurrent genital herpes simplex
Recurrent herpes labialis
Recurrent HSV type 1 infection of the lip or nares
Recurrent mucocutaneous herpes simplex infection
Recurrent mucocutaneous HSV infection
Varicella
Indications:
Chickenpox
Genital herpes simplex
Herpes labialis
Herpes simplex encephalitis
Herpes simplex infection
Herpes zoster
Mucocutaneous herpes simplex
Recurrent herpes genitalis
Recurrent herpes simplex labialis
Recurrent mucocutaneous herpes simplex
Suppression of recurrent herpes simplex infection
Professional Synonyms:
Encephalitis caused by human herpes simplex virus
Encephalitis due to HSV
Herpes encephalitis
Herpes genitalis
Herpes simplex type 1 infection of the lip or nares
Herpes simplex
HSV infection
HSV type 1 infection of the lip or nares
Latent varicella zoster virus infection
Latent VZV infection
Mucocutaneous herpes simplex infection
Mucocutaneous HSV infection
Prophylaxis for herpes simplex
Recurrent genital herpes simplex
Recurrent herpes labialis
Recurrent HSV type 1 infection of the lip or nares
Recurrent mucocutaneous herpes simplex infection
Recurrent mucocutaneous HSV infection
Varicella
The following dosing information is available for ACYCLOVIR (acyclovir):
Dosage of acyclovir sodium is expressed in terms of acyclovir. The manufacturer states that the maximum dosage of IV acyclovir is 20 mg/kg every 8 hours. The manufacturer recommends that obese patients receive IV acyclovir dosages based on ideal body weight.
In patients with impaired renal function, doses and/or frequency of administration of acyclovir must be modified in response to the degree of impairment. Generally, the decrease in total body clearance of acyclovir is directly related to the decrease in body-surface-area-corrected creatinine clearance; however, clearance of acyclovir is usually greater than predicted from creatinine clearance, since the drug undergoes some renal tubular secretion.
Based on pharmacokinetic studies of IV acyclovir in patients with renal impairment, the manufacturer recommends the following oral dosage of acyclovir based on the usual dosage regimen and the patient's creatinine clearance (see Table 1):
Table 1: Oral Dosage Adjustment in Patients with Renal Impairment.
Usual Dosage Regimen Creatinine Clearance Adjusted Dosage Regimen (mL/min per 1.73 m2) 200 mg every 4 h 5 times >10 No adjustment necessary daily 0-10 200 mg every 12 h 400 mg every 12 h >10 No adjustment necessary 0-10 200 mg every 12 h 800 mg every 4 h 5 times >25 No adjustment necessary daily 10-25 800 mg every 8 h 0-10 800 mg every 12 h
Because acyclovir is removed by hemodialysis, the manufacturer recommends that patients undergoing hemodialysis receive a supplemental oral dose of the drug immediately after each dialysis period. The manufacturer states that supplemental doses of oral acyclovir do not appear to be necessary following peritoneal dialysis.
For HIV-infected patients with impaired renal function, the following oral dosages of acyclovir have been suggested based on a usual dosage regimen of 200-800 mg every 4-6 hours and the patient's creatinine clearance (see Table 2):
Table 2: Oral Dosage Adjustment in HIV-Infected Patients with Impaired Renal Function.
Creatinine Clearance (mL/min per Adjusted Dosage Regimen 1.73 m2) >80 No adjustment necessary 50-80 200-800 mg every 6-8 h 25-50 200-800 mg every 8-12 h 10-25 200-800 mg every 12-24 h <10 200-400 mg every 24 h Hemodialysis supplement usual dose after each hemodialysis
The manufacturer recommends the following IV dosage of acyclovir based on the patient's creatinine clearance (see Table 3):
Table 3: IV Dosage Adjustment in Patients with Renal Impairment.
Creatinine Clearance Percent of Recommended Dosing Interval (hours) (mL/min per 1.73 m2) Dose >50 100% 8 25-50 100% 12 10-25 100% 24 0-10 50% 24
The manufacturer states that patients undergoing hemodialysis may require a supplemental acyclovir dose after each dialysis period. The patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis. Alternatively in patients undergoing hemodialysis, some clinicians recommend that 2.5
mg/kg be administered every 24 hours and that an additional 2.5-mg/kg dose be administered after each dialysis period.
Other IV acyclovir dosage regimens have been suggested for patients with end-stage renal disease. In one regimen, an initial loading dose of 93-185 mg/m2, a maintenance dosage of 35-70 mg/m2 every 8 hours, and a dose of 56-185 mg/m2 immediately after dialysis have been used. Alternatively, an initial loading dose of 250-500 mg/m2, a maintenance dosage of 250-500 mg/m2 every 48 hours, and a dose of 150-500 mg/m2 immediately after dialysis have been suggested.
Because acyclovir is removed by continuous ambulatory peritoneal dialysis (CAPD) to a lesser extent than by hemodialysis, the manufacturer states that supplemental doses of acyclovir do not appear to be necessary following CAPD.
For HIV-infected patients with impaired renal function, the following IV dosages of acyclovir have been suggested based on a usual dosage regimen of 5 mg/kg every 8 hours and the patient's creatinine clearance:
Table 4: IV Dosage Adjustment in HIV-Infected Patients with Impaired Renal Function.
Creatinine Clearance (mL/min per Adjusted Dosage Regimen 1.73 m2) greater than 80 No adjustment necessary 50-80 No adjustment necessary 25-50 5 mg/kg every 12-24 hours 10-25 5 mg/kg every 12-24 hours less than 10 2.5 mg/kg every 24 hours Hemodialysis administer usual dose after hemodialysis
In patients with impaired renal function, doses and/or frequency of administration of acyclovir must be modified in response to the degree of impairment. Generally, the decrease in total body clearance of acyclovir is directly related to the decrease in body-surface-area-corrected creatinine clearance; however, clearance of acyclovir is usually greater than predicted from creatinine clearance, since the drug undergoes some renal tubular secretion.
Based on pharmacokinetic studies of IV acyclovir in patients with renal impairment, the manufacturer recommends the following oral dosage of acyclovir based on the usual dosage regimen and the patient's creatinine clearance (see Table 1):
Table 1: Oral Dosage Adjustment in Patients with Renal Impairment.
Usual Dosage Regimen Creatinine Clearance Adjusted Dosage Regimen (mL/min per 1.73 m2) 200 mg every 4 h 5 times >10 No adjustment necessary daily 0-10 200 mg every 12 h 400 mg every 12 h >10 No adjustment necessary 0-10 200 mg every 12 h 800 mg every 4 h 5 times >25 No adjustment necessary daily 10-25 800 mg every 8 h 0-10 800 mg every 12 h
Because acyclovir is removed by hemodialysis, the manufacturer recommends that patients undergoing hemodialysis receive a supplemental oral dose of the drug immediately after each dialysis period. The manufacturer states that supplemental doses of oral acyclovir do not appear to be necessary following peritoneal dialysis.
For HIV-infected patients with impaired renal function, the following oral dosages of acyclovir have been suggested based on a usual dosage regimen of 200-800 mg every 4-6 hours and the patient's creatinine clearance (see Table 2):
Table 2: Oral Dosage Adjustment in HIV-Infected Patients with Impaired Renal Function.
Creatinine Clearance (mL/min per Adjusted Dosage Regimen 1.73 m2) >80 No adjustment necessary 50-80 200-800 mg every 6-8 h 25-50 200-800 mg every 8-12 h 10-25 200-800 mg every 12-24 h <10 200-400 mg every 24 h Hemodialysis supplement usual dose after each hemodialysis
The manufacturer recommends the following IV dosage of acyclovir based on the patient's creatinine clearance (see Table 3):
Table 3: IV Dosage Adjustment in Patients with Renal Impairment.
Creatinine Clearance Percent of Recommended Dosing Interval (hours) (mL/min per 1.73 m2) Dose >50 100% 8 25-50 100% 12 10-25 100% 24 0-10 50% 24
The manufacturer states that patients undergoing hemodialysis may require a supplemental acyclovir dose after each dialysis period. The patient's dosing schedule should be adjusted so that an additional dose is administered after each dialysis. Alternatively in patients undergoing hemodialysis, some clinicians recommend that 2.5
mg/kg be administered every 24 hours and that an additional 2.5-mg/kg dose be administered after each dialysis period.
Other IV acyclovir dosage regimens have been suggested for patients with end-stage renal disease. In one regimen, an initial loading dose of 93-185 mg/m2, a maintenance dosage of 35-70 mg/m2 every 8 hours, and a dose of 56-185 mg/m2 immediately after dialysis have been used. Alternatively, an initial loading dose of 250-500 mg/m2, a maintenance dosage of 250-500 mg/m2 every 48 hours, and a dose of 150-500 mg/m2 immediately after dialysis have been suggested.
Because acyclovir is removed by continuous ambulatory peritoneal dialysis (CAPD) to a lesser extent than by hemodialysis, the manufacturer states that supplemental doses of acyclovir do not appear to be necessary following CAPD.
For HIV-infected patients with impaired renal function, the following IV dosages of acyclovir have been suggested based on a usual dosage regimen of 5 mg/kg every 8 hours and the patient's creatinine clearance:
Table 4: IV Dosage Adjustment in HIV-Infected Patients with Impaired Renal Function.
Creatinine Clearance (mL/min per Adjusted Dosage Regimen 1.73 m2) greater than 80 No adjustment necessary 50-80 No adjustment necessary 25-50 5 mg/kg every 12-24 hours 10-25 5 mg/kg every 12-24 hours less than 10 2.5 mg/kg every 24 hours Hemodialysis administer usual dose after hemodialysis
Acyclovir 5% cream is applied topically to affected areas of the lips and surrounding skin. The cream should not be applied to the eye, inside the mouth or nose, or to mucous membranes. Acyclovir 5% ointment is applied topically to the skin.
The ointment should not be applied to the eye. A finger cot or rubber glove should be used when applying the ointment to prevent autoinoculation of other sites and transmission of the virus to other individuals.
The ointment should not be applied to the eye. A finger cot or rubber glove should be used when applying the ointment to prevent autoinoculation of other sites and transmission of the virus to other individuals.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ACYCLOVIR 400 MG TABLET | Maintenance | Adults take 1 tablet (400 mg) by oral route every 8 hours |
| ACYCLOVIR 800 MG TABLET | Maintenance | Adults take 1 tablet (800 mg) by oral route 5 times per day for 10 days |
| ACYCLOVIR 200 MG CAPSULE | Maintenance | Adults take 1 capsule (200 mg) by oral route every 4 hours 5 times per day |
| ACYCLOVIR 5% OINTMENT | Maintenance | Adults apply to the affected area(s) by topical route every 3 hours 6 times per day |
| ACYCLOVIR 5% CREAM | Maintenance | Adults apply to the affected area(s) by topical route 5 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ACYCLOVIR 5% CREAM | Maintenance | Adults apply to the affected area(s) by topical route 5 times per day |
| ACYCLOVIR 5% OINTMENT | Maintenance | Adults apply to the affected area(s) by topical route every 3 hours 6 times per day |
| ACYCLOVIR 200 MG CAPSULE | Maintenance | Adults take 1 capsule (200 mg) by oral route every 4 hours 5 times per day |
| ACYCLOVIR 400 MG TABLET | Maintenance | Adults take 1 tablet (400 mg) by oral route every 8 hours |
| ACYCLOVIR 800 MG TABLET | Maintenance | Adults take 1 tablet (800 mg) by oral route 5 times per day for 10 days |
The following drug interaction information is available for ACYCLOVIR (acyclovir):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Varicella; Zoster Live Vaccine/Acyclovir; Famciclovir; Valacyclovir SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Acyclovir, famciclovir, and valacyclovir inhibit varicella zoster virus activity and may prevent the body from developing an immune response to the live vaccine. CLINICAL EFFECTS: Administration of antiviral agents active against varicella zoster virus may decrease the efficacy of live, attenuated varicella or zoster vaccines.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: CDC immunization guidelines recommend acyclovir, famciclovir or valacyclovir discontinuation at least 24 hours prior to administration of varicella or zoster vaccines, if possible. Delay use or resumption of antiviral therapy for 14 days after vaccination.(1) DISCUSSION: Acyclovir, famciclovir, valacyclovir inhibit varicella zoster virus activity and may prevent the body from developing an immune response to the live vaccine, decreasing the efficacy of efficacy of live, attenuated varicella or zoster vaccines.(1) |
PROQUAD, VARIVAX VACCINE |
There are 4 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Tizanidine/Acyclovir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Acyclovir may inhibit the metabolism of tizanidine by CYP1A2.(1) CLINICAL EFFECTS: Concurrent use of acyclovir may result in elevated levels of and effects from tizanidine, including hypotension, bradycardia, drowsiness, sedation, and decreased psychomotor function. PREDISPOSING FACTORS: The risk of anticholinergic toxicities including cognitive decline, delirium, falls and fractures is increased in geriatric patients using more than one medicine with anticholinergic properties.(2) PATIENT MANAGEMENT: The US manufacturer of tizanidine states that concurrent use of tizanidine with inhibitors of CYP1A2, such as acyclovir, should be avoided. If concurrent use is warranted, tizanidine should be initiated with a 2 mg dose and increased in 2-4 mg steps daily based on patient response to therapy.(1) If adverse reactions such as hypotension, bradycardia, or excessive drowsiness occur, reduce or discontinue tizanidine therapy.(1) DISCUSSION: In a study in 10 healthy subjects, concurrent fluvoxamine, another inhibitor of CYP1A2, increased tizanidine maximum concentration (Cmax), area-under-curve (AUC), and half-life (T1/2) by 12-fold, 33-fold, and 3-fold, respectively. Significant decreases in blood pressure and increases in drowsiness and psychomotor impairment occurred.(1) In a study in 10 healthy subjects, concurrent ciprofloxacin, another inhibitor of CYP1A2, increase tizanidine Cmax and AUC by 7-fold and 10-fold, respectively. Significant decreases in blood pressure and and increases in drowsiness and psychomotor impairment occurred.(1) |
TIZANIDINE HCL, ZANAFLEX |
| Talimogene laherparepvec/Acyclovir;Valacyclovir;Famciclovir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Talimogene laherparepvec is a live, attenuated herpes simplex virus (HSV-1) which has been modified to express human GM-CSF.(1) Acyclovir, famciclovir, and valacyclovir inhibit HSV virus activity. CLINICAL EFFECTS: Administration of antiherpetic agents may interfere with the effectiveness of talimogene laherparepvec.(1) Agents linked to this monograph are systemic formulations of acyclovir, valacyclovir and famciclovir. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid concomitant use when possible. Talimogene laherparepvec is a live, attenuated herpes simplex virus (HSV-1) which is injected into cancerous lesions where it replicates and produces GM-CSF, leading to lysis of tumors. It is sensitive to antiherpetic agents such as acyclovir, valacyclovir and famciclovir and so administration of these antivirals may impair talimogene laherparepvec effectiveness.(1) DISCUSSION: Acyclovir, famciclovir, valacyclovir inhibit herpes simplex virus activity which may impair the ability of talimogene laherparepvec to replicate and produce GM-CSF in tumors. The impact of concurrent acyclovir, famciclovir, valacyclovir and talimogene laherparepvec therapy has not been studied; patients requiring antiviral prophylaxis or treatment with acyclovir, valacyclovir and famciclovir were excluded from clinical trials.(1) |
IMLYGIC |
| Selected Nephrotoxic Agents/Foscarnet SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Foscarnet is nephrotoxic. Concurrent administration of other nephrotoxic agents may result in additive or synergistic effects on renal function.(1) Concurrent intravenous pentamidine may also result in hypocalcemia.(1) CLINICAL EFFECTS: Concurrent use of foscarnet with nephrotoxic agents such as acyclovir, adefovir, intravenous aminoglycosides, amphotericin B, cyclosporine, methotrexate, non-steroidal anti-inflammatory agents, intravenous pentamidine, tacrolimus, tenofovir, vancomycin and voclosporin may result in renal toxicity.(1) Other nephrotoxic agents include capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, and streptozocin. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of foscarnet state that concurrent administration of potentially nephrotoxic agents such as acyclovir, intravenous aminoglycosides, amphotericin B, cyclosporine, methotrexate, tacrolimus, and intravenous pentamidine should be avoided.(1) Other nephrotoxic agents include adefovir, capreomycin, cisplatin, gallium nitrate, high-dose methotrexate, non-steroidal anti-inflammatory agents, streptozocin, tenofovir, vancomycin and voclosporin. If concurrent therapy is warranted, monitor renal function closely. In patients receiving concurrent foscarnet and pentamidine, also monitor serum calcium levels and instruct patients to report severe muscle spasms, mental/mood changes, and/or seizures.(1) DISCUSSION: The safety of foscarnet has not been studied in patients receiving other known potentially nephrotoxic agents. Renal impairment is the major toxicity of foscarnet.(1) |
FOSCARNET SODIUM, FOSCAVIR |
| Selected MATE Substrates/MATE Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inhibitors of the Multidrug and Toxin Extrusion (MATE) renal protein transporters in the kidneys may inhibit the transport of MATE substrates.(1) Acyclovir, cephalexin, and valacyclovir are MATE substrates. CLINICAL EFFECTS: Concurrent use of MATE renal transporter inhibitors may result in increased levels of and toxicity from MATE substrates.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid concurrent use of acyclovir, cephalexin, or valacyclovir with MATE renal transporter inhibitors. If concurrent use cannot be avoided, monitor for toxicity of the MATE substrate and consider dosage reduction of the MATE substrate.(1) DISCUSSION: Based upon in vitro data, risdiplam is expected to produce clinically significant inhibition of MATE1 and MATE2-K transporters at clinically relevant concentrations.(1) Selected MATE substrates linked include: acyclovir, cephalexin, and valacyclovir.(1,2) MATE inhibitors include: cimetidine, pyrimethamine, risdiplam, and vandetanib.(2) |
CAPRELSA, CIMETIDINE, DARAPRIM, EVRYSDI, PYRIMETHAMINE |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Tenofovir/Selected Nephrotoxic Agents SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tenofovir and other nephrotoxic agents may result in additive or synergistic effects on renal function and increase nephrotoxicity risk.(1) CLINICAL EFFECTS: Concurrent use of tenofovir and other nephrotoxic agents may result in renal toxicity and acute renal failure.(1) Reports of acute renal failure and Fanconi syndrome have been reported with tenofovir use.(2,3) However, this has been reported in 3 case reports and the renal failure may have been complicated by other pre-existing conditions.(2) PREDISPOSING FACTORS: Pre-existing renal dysfunction, long duration of use, low body weight, concomitant use of drugs that may increase tenofovir levels may increase the risk of nephrotoxicity.(1) PATIENT MANAGEMENT: The US prescribing information for tenofovir recommends avoiding concurrent or recent use of a nephrotoxic agent.(3) Evaluate renal function prior to initiation of concurrent therapy and continue renal function monitoring during therapy. Dose adjustments may be required for impaired renal function. Tenofovir should be avoided with high-dose or multiple NSAIDs. Alternatives to NSAIDs should be considered in patients at risk for renal dysfunction.(3) Patients receiving concurrent NSAIDs with tenofovir should be monitored for possible renal toxicity.(1,2) The dosing interval should be adjusted in patients with a baseline creatinine clearance of less than 50 ml/min.(1-3) DISCUSSION: From March 18, 2003 to December 1, 2005, Health Canada received 10 reports of nephrotoxic reactions with tenofovir. Three of these occurred following the addition of a NSAID to tenofovir therapy. In the first report, a patient maintained on tenofovir for 29 months developed acute renal failure and acute tubular necrosis requiring dialysis 5 days after beginning indomethacin (100 mg rectally twice daily). In the second report, a patient maintained on tenofovir for 7 months developed acute renal failure and acute tubular necrosis after taking 90 tablets of naproxen (375 mg) over 2 months. The patient died. In the third report, a patient maintained on tenofovir for over a year developed acute renal failure and nephrotic syndrome after 2 months of valdecoxib (20 mg daily) therapy. Symptoms subsided following discontinuation of valdecoxib.(1) |
BIKTARVY, CIMDUO, COMPLERA, DELSTRIGO, DESCOVY, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EMTRICITABINE-TENOFOVIR DISOP, GENVOYA, ODEFSEY, STRIBILD, SYMFI, SYMFI LO, SYMTUZA, TENOFOVIR DISOPROXIL FUMARATE, TRUVADA, VEMLIDY, VIREAD |
The following contraindication information is available for ACYCLOVIR (acyclovir):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Dehydration |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
| No disease contraindications |
The following adverse reaction information is available for ACYCLOVIR (acyclovir):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 32 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute cognitive impairment Aggressive behavior Anaphylaxis Anemia Angioedema Coma Delirium Drug-induced psychosis Dysarthria Encephalopathy Erythema multiforme Fever Hallucinations Hematuria Hemolytic uremic syndrome Hepatitis Hyperbilirubinemia Jaundice Leukopenia Lymphadenopathy Peripheral edema Pruritus of skin Renal failure Seizure disorder Skin rash Stevens-johnson syndrome Thrombocytopenic disorder Thrombotic thrombocytopenic purpura Toxic epidermal necrolysis Urticaria Visual changes |
There are 26 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Dry skin Malaise Nausea Skin irritation Stinging of skin |
Abdominal pain with cramps Agitation Alopecia Cheilosis Diarrhea Dizziness Drowsy Gastrointestinal irritation Headache disorder Myalgia Paresthesia Pruritus of skin Vomiting |
| Rare/Very Rare |
|---|
|
Ataxia Contact dermatitis Eczema Pain Renal pain Skin photosensitivity Tremor |
The following precautions are available for ACYCLOVIR (acyclovir):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Acyclovir has not been shown to be teratogenic in standard tests following subcutaneous administration in rats and rabbits, IV administration in rabbits, and oral administration in mice. However, in nonstandard tests in rats, fetal abnormalities, principally involving the head and tail, were observed at higher subcutaneous acyclovir dosages, which also were associated with maternal toxicity. The drug crosses the placenta in humans following oral or IV administration.
There are no adequate and controlled studies to date using acyclovir in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. There are no adequate and controlled studies to date using acyclovir in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg daily orally), rabbit (50 mg/kg daily subcutaneously or IV), or rat (50 mg/kg daily subcutaneously).
These dosages resulted in plasma concentrations that were 106, 11, and 22 times, respectively, the steady-state plasma concentrations observed in humans receiving 200 or 800 mg of acyclovir orally 5 times daily. However, in nonstandard tests in rats, fetal abnormalities (e.g., head and tail anomalies) and maternal toxicity were observed with subcutaneous acyclovir. Acyclovir crosses the placenta in humans and the clinical relevance of these animal findings currently is not known.
IV acyclovir has been used during the second or third trimester of pregnancy without apparent adverse effects to the fetus. The US Centers for Disease Control and Prevention (CDC) state that first clinical episodes of genital herpes occurring during pregnancy may be treated with oral acyclovir and that use of IV acyclovir therapy may be indicated for the treatment of severe maternal HSV infections. Preliminary data suggest that acyclovir treatment late in pregnancy might reduce the frequency of cesarean sections among women who have recurrent genital herpes by diminishing the frequency of recurrences at term.
The risk for HSV is high in infants born to women who acquired genital herpes in late pregnancy, and such women should be managed in consultation with an HSV specialist. Some experts recommend acyclovir therapy in this circumstance, some recommend routine cesarean section to reduce the risk for neonatal HSV, and others recommend both. (See Pregnant Women under Uses: Genital Herpes.) Many clinicians do not recommend use of oral acyclovir in pregnant adolescents or women with uncomplicated varicella because the risk or benefit to the fetus currently is not known.
However, other clinicians recommend use of oral acyclovir for the treatment of varicella in pregnant women, especially during the second and third trimesters. In addition, use of IV acyclovir is recommended in pregnant women with serious complications of varicella such as extensive cutaneous disease, high fever, or systemic symptoms. It is not known whether acyclovir administered to the mother prevents congenital varicella syndrome (i.e., low birthweight, hypotrophic limbs, ocular abnormalities, brain damage, mental retardation) in the neonate.
To monitor fetal outcomes of pregnant women exposed either inadvertently or intentionally to systemic acyclovir, the manufacturer established a prospective registry of acyclovir use during pregnancy and collected data from 1984 to April 1999. A total of 749 pregnancies were followed over this time period involving 756 outcomes, and comparison of registry data with birth defect surveillance data revealed no evidence of an increased risk for birth defects in infants of mothers treated with acyclovir during the first trimester of pregnancy. However, the sample size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.
There are no adequate and controlled studies to date using acyclovir in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. There are no adequate and controlled studies to date using acyclovir in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg daily orally), rabbit (50 mg/kg daily subcutaneously or IV), or rat (50 mg/kg daily subcutaneously).
These dosages resulted in plasma concentrations that were 106, 11, and 22 times, respectively, the steady-state plasma concentrations observed in humans receiving 200 or 800 mg of acyclovir orally 5 times daily. However, in nonstandard tests in rats, fetal abnormalities (e.g., head and tail anomalies) and maternal toxicity were observed with subcutaneous acyclovir. Acyclovir crosses the placenta in humans and the clinical relevance of these animal findings currently is not known.
IV acyclovir has been used during the second or third trimester of pregnancy without apparent adverse effects to the fetus. The US Centers for Disease Control and Prevention (CDC) state that first clinical episodes of genital herpes occurring during pregnancy may be treated with oral acyclovir and that use of IV acyclovir therapy may be indicated for the treatment of severe maternal HSV infections. Preliminary data suggest that acyclovir treatment late in pregnancy might reduce the frequency of cesarean sections among women who have recurrent genital herpes by diminishing the frequency of recurrences at term.
The risk for HSV is high in infants born to women who acquired genital herpes in late pregnancy, and such women should be managed in consultation with an HSV specialist. Some experts recommend acyclovir therapy in this circumstance, some recommend routine cesarean section to reduce the risk for neonatal HSV, and others recommend both. (See Pregnant Women under Uses: Genital Herpes.) Many clinicians do not recommend use of oral acyclovir in pregnant adolescents or women with uncomplicated varicella because the risk or benefit to the fetus currently is not known.
However, other clinicians recommend use of oral acyclovir for the treatment of varicella in pregnant women, especially during the second and third trimesters. In addition, use of IV acyclovir is recommended in pregnant women with serious complications of varicella such as extensive cutaneous disease, high fever, or systemic symptoms. It is not known whether acyclovir administered to the mother prevents congenital varicella syndrome (i.e., low birthweight, hypotrophic limbs, ocular abnormalities, brain damage, mental retardation) in the neonate.
To monitor fetal outcomes of pregnant women exposed either inadvertently or intentionally to systemic acyclovir, the manufacturer established a prospective registry of acyclovir use during pregnancy and collected data from 1984 to April 1999. A total of 749 pregnancies were followed over this time period involving 756 outcomes, and comparison of registry data with birth defect surveillance data revealed no evidence of an increased risk for birth defects in infants of mothers treated with acyclovir during the first trimester of pregnancy. However, the sample size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.
Although it is not known whether acyclovir is distributed into milk following topical application, the drug is distributed into milk following oral or IV administration. Following oral administration of acyclovir in 2 nursing women, milk acyclovir concentrations were 0.6-4.1
times the simultaneous maternal plasma drug concentrations. Therefore, acyclovir ointment and cream should be used with caution in nursing women. Women who have active herpetic lesions near or on the breast should avoid nursing.
Limited data indicate that acyclovir is distributed into milk, generally in concentrations greater than concurrent maternal plasma concentrations, and can be absorbed by nursing infants. Acyclovir should be administered to nursing women with caution and only when indicated.
times the simultaneous maternal plasma drug concentrations. Therefore, acyclovir ointment and cream should be used with caution in nursing women. Women who have active herpetic lesions near or on the breast should avoid nursing.
Limited data indicate that acyclovir is distributed into milk, generally in concentrations greater than concurrent maternal plasma concentrations, and can be absorbed by nursing infants. Acyclovir should be administered to nursing women with caution and only when indicated.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ACYCLOVIR (acyclovir):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ACYCLOVIR (acyclovir)'s list of indications:
| Chickenpox | |
| B01 | Varicella [chickenpox] |
| B01.9 | Varicella without complication |
| Genital herpes simplex | |
| A60 | Anogenital herpesviral [herpes simplex] infections |
| A60.0 | Herpesviral infection of genitalia and urogenital tract |
| A60.00 | Herpesviral infection of urogenital system, unspecified |
| A60.01 | Herpesviral infection of penis |
| A60.02 | Herpesviral infection of other male genital organs |
| A60.03 | Herpesviral cervicitis |
| A60.04 | Herpesviral vulvovaginitis |
| A60.09 | Herpesviral infection of other urogenital tract |
| A60.9 | Anogenital herpesviral infection, unspecified |
| Herpes labialis | |
| B00.1 | Herpesviral vesicular dermatitis |
| Herpes simplex encephalitis | |
| B00.4 | Herpesviral encephalitis |
| Herpes simplex infection | |
| A60 | Anogenital herpesviral [herpes simplex] infections |
| A60.0 | Herpesviral infection of genitalia and urogenital tract |
| A60.00 | Herpesviral infection of urogenital system, unspecified |
| A60.01 | Herpesviral infection of penis |
| A60.02 | Herpesviral infection of other male genital organs |
| A60.03 | Herpesviral cervicitis |
| A60.04 | Herpesviral vulvovaginitis |
| A60.09 | Herpesviral infection of other urogenital tract |
| A60.1 | Herpesviral infection of perianal skin and rectum |
| A60.9 | Anogenital herpesviral infection, unspecified |
| B00 | Herpesviral [herpes simplex] infections |
| B00.1 | Herpesviral vesicular dermatitis |
| B00.2 | Herpesviral gingivostomatitis and pharyngotonsillitis |
| B00.9 | Herpesviral infection, unspecified |
| Herpes zoster | |
| B02 | Zoster [herpes zoster] |
| B02.0 | Zoster encephalitis |
| B02.1 | Zoster meningitis |
| B02.2 | Zoster with other nervous system involvement |
| B02.3 | Zoster ocular disease |
| B02.30 | Zoster ocular disease, unspecified |
| B02.31 | Zoster conjunctivitis |
| B02.32 | Zoster iridocyclitis |
| B02.33 | Zoster keratitis |
| B02.34 | Zoster scleritis |
| B02.39 | Other herpes zoster eye disease |
| B02.7 | Disseminated zoster |
| B02.8 | Zoster with other complications |
| B02.9 | Zoster without complications |
| Mucocutaneous herpes simplex | |
| A60 | Anogenital herpesviral [herpes simplex] infections |
| A60.0 | Herpesviral infection of genitalia and urogenital tract |
| A60.00 | Herpesviral infection of urogenital system, unspecified |
| A60.01 | Herpesviral infection of penis |
| A60.02 | Herpesviral infection of other male genital organs |
| A60.03 | Herpesviral cervicitis |
| A60.04 | Herpesviral vulvovaginitis |
| A60.09 | Herpesviral infection of other urogenital tract |
| A60.1 | Herpesviral infection of perianal skin and rectum |
| A60.9 | Anogenital herpesviral infection, unspecified |
| B00.1 | Herpesviral vesicular dermatitis |
| B00.2 | Herpesviral gingivostomatitis and pharyngotonsillitis |
| B00.89 | Other herpesviral infection |
| Recurrent herpes genitalis | |
| A60 | Anogenital herpesviral [herpes simplex] infections |
| A60.0 | Herpesviral infection of genitalia and urogenital tract |
| A60.00 | Herpesviral infection of urogenital system, unspecified |
| A60.01 | Herpesviral infection of penis |
| A60.02 | Herpesviral infection of other male genital organs |
| A60.03 | Herpesviral cervicitis |
| A60.04 | Herpesviral vulvovaginitis |
| A60.09 | Herpesviral infection of other urogenital tract |
| A60.9 | Anogenital herpesviral infection, unspecified |
| Recurrent herpes simplex labialis | |
| B00.1 | Herpesviral vesicular dermatitis |
| Recurrent mucocutaneous herpes simplex | |
| A60 | Anogenital herpesviral [herpes simplex] infections |
| A60.0 | Herpesviral infection of genitalia and urogenital tract |
| A60.00 | Herpesviral infection of urogenital system, unspecified |
| A60.01 | Herpesviral infection of penis |
| A60.02 | Herpesviral infection of other male genital organs |
| A60.03 | Herpesviral cervicitis |
| A60.04 | Herpesviral vulvovaginitis |
| A60.09 | Herpesviral infection of other urogenital tract |
| A60.1 | Herpesviral infection of perianal skin and rectum |
| A60.9 | Anogenital herpesviral infection, unspecified |
| B00.1 | Herpesviral vesicular dermatitis |
| B00.2 | Herpesviral gingivostomatitis and pharyngotonsillitis |
| B00.89 | Other herpesviral infection |
| Suppression of recurrent herpes simplex infection | |
| A60 | Anogenital herpesviral [herpes simplex] infections |
| A60.0 | Herpesviral infection of genitalia and urogenital tract |
| A60.00 | Herpesviral infection of urogenital system, unspecified |
| A60.01 | Herpesviral infection of penis |
| A60.02 | Herpesviral infection of other male genital organs |
| A60.03 | Herpesviral cervicitis |
| A60.04 | Herpesviral vulvovaginitis |
| A60.09 | Herpesviral infection of other urogenital tract |
| A60.1 | Herpesviral infection of perianal skin and rectum |
| A60.9 | Anogenital herpesviral infection, unspecified |
| B00.2 | Herpesviral gingivostomatitis and pharyngotonsillitis |
| B00.89 | Other herpesviral infection |
| B00.9 | Herpesviral infection, unspecified |
Formulary Reference Tool