Methods: Children 1 month through 5 years of age with or at risk for herpesvirus infection received a single 25 mg/kg dose of extemporaneously compounded valacyclovir oral suspension (n = 57), whereas children 1 through 11 years of age received 10 mg/kg valacyclovir oral suspension twice daily for 3-5 days (herpes simplex virus infection) (n = 2. In one multiple-dose, crossover study in healthy subjects (n = 23), it was shown that increases in plasma acyclovir concentrations were less than dose proportional with increasing dose, as shown in Table 2. The decrease in bioavailability is a function of the dose and not the dosage form. Use of them does not imply any affiliation with or endorsement by them. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. Compounding Formulas. Bethesda, MD 20894, Web Policies In a study of patients who received acyclovir 400 mg twice daily for 3 years, 45%, 52%, and 63% of patients remained free of recurrences in the first, second, and third years, respectively. Disclaimer. With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY, ADVERSE REACTIONS: Observed During Clinical Practice, and DOSAGE AND ADMINISTRATION). Children 1 month through 5 years of age with or at risk for herpesvirus infection received a single 25 mg/kg dose of extemporaneously compounded valacyclovir oral suspension (n = 57), whereas children 1 through 11 years of age received 10 mg/kg valacyclovir oral suspension twice daily for 3-5 days (herpes simplex virus infection) (n = 28) or 20 mg/kg 3 times daily for 5 days (varicella-zoster virus infection) (n = 27). Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The recommended use is for ionic and/or hydrophilic actives, or with diabetic additives. and transmitted securely. Musculoskeletal: Myalgia. (NDC 55390-612-10). 800 mg every 4 hours orally, 5 times daily for 7 to 10 days. Epub 2020 Feb 7. official website and that any information you provide is encrypted In the mouse study, plasma levels were 9 to 18 times human levels, while in the rat study, they were 8 to 15 times human levels. With a prescription number, easily refill prescriptions and enroll in the AutoRefill Program. Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY, ADVERSE REACTIONS: Observed During Clinical Practice, and DOSAGE AND ADMINISTRATION). Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. The 589 control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%). In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults. Among infants 1 through 2 months of age receiving 25 mg/kg, the mean AUC(0-infinity) and C(max) were higher ( approximately 60% and 30%, respectively) than those among older infants and children receiving the same dose. For pet owners: Pick up and fill a new prescription for your pet or refill a current prescription. FORMULATIONS, ALLERGY/IMMUNOLOGY/INFLAMMATION, DOSAGE FORMS/DRUG CARRIERS, INFECTIOUS DISEASE, (Click for Abstract / Details / Purchase), Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh, Compounding in the Pharmacy Curriculum: Beyond the Basics. Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. Comparative bioavailability of acyclovir from oral valacyclovir and acyclovir in patients treated for recurrent genital herpes simplex virus infection. Dosage reduction may be required in geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use). See CLINICAL PHARMACOLOGY: Pharmacokinetics. Therefore, the patients dosing schedule should be adjusted so that an additional dose is administered after each dialysis. The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral acyclovir at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or varicella-zoster virus infection. Background: The frequency and severity of episodes of untreated genital herpes may change over time. Children (2 years of age and older) Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir at the higher and lower dosing schedules (see CLINICAL PHARMACOLOGY: Pharmacokinetics). CNSPs with a USP-NF monograph or stability information). These syrups can be used in multiple applications to mask the taste of bitter drugs. Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. Treatment was begun within 72 hours of rash onset and was most effective if started within the first 48 hours. references. An investigation of the steady-state pharmacokinetics of oral valacyclovir in immunocompromised children. The duration of pain and new lesion formation was decreased in some patient groups. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of acyclovir and ranged from 0.6 to 4.1 times corresponding plasma levels. sharing sensitive information, make sure youre on a federal Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Loyd V. Allen Jr., PhD, RPh, acyclovir, oral suspension, herpes virus infection, viral infection, herpes zoster, varicella, antiviral agent, formulation, Related Categories: Of 376 subjects who received acyclovir in a clinical study of herpes zoster treatment in immunocompetent subjects50 years of age, 244 were 65 and over while 111 were 75 and over. As with abacavir, acyclovir showed a dose dependent increase in affinity for peptides with valine and isoleucine at their C-terminus. Follow the directions on the prescription label. x. Pharmacy product. Careers. Acyclovir was tested in lifetime bioassays in rats and mice at single daily doses of up to 450 mg/kg administered by gavage. INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (see package insert for WARNINGS). Acyclovir was positive in 5 of the assays. When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. Written by ASHP. To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Advagen Pharma Ltd Adults and Children over 40 kg For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. If it is almost time for your next dose, take only that dose. All patients were treated within 24 hours after the onset of rash. 666 Plainsboro Road Initial Genital Herpes Versa Plus suspension vehicle has a pH of 3.5-4.0 and is the choice for diabetic and allergy-sensitive patients with virtually no aftertaste. All Rights Reserved. The chemical name of acyclovir is 6 H -Purin-6-one, 2-amino-1,9-dihydro-9- [ (2-hydroxyethoxy)methyl]. A dosage adjustment is recommended for patients with reduced renal function (see DOSAGE AND ADMINISTRATION). In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir. Trial registration. Submit Office Orders & Patient Prescriptions. Includes ingredients, method of preparation, discussion, and references for the compounding pharmacist. COMMON BRAND NAME(S): Zovirax, Zovirax Suspension. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of1.35 mcg/mL. Treatment with acyclovir did not affect varicella-zoster virus-specific humoral or cellular immune responses at 1 month or 1 year following treatment. Some states restrict the information we may provide about controlled substances. Acyclovir Oral Suspension, USP is a formulation for oral administration. Maximum plasma concentrations were 3 to 6 times human levels in the mouse bioassay and 1 to 2 times human levels in the rat bioassay. Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered acyclovir, or they have any other questions. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. ADVERSE REACTIONS: Observed During Clinical Practice. DESCRIPTION ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. National Library of Medicine However, the small 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. The brand name of this medication is Zovirax. Background. Urogenital: Renal failure, elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS). Bioequivalence of Dosage Forms Dosage Adjustments for Patients with Renal Impairment: Hemodialysis Elderly patients are more likely to have reduced renal function and require dose reduction. MeSH 2001 Winter;8(4):207-11. Clin Ther. 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. The pka's of acyclovir are 2.27 and 9.25. Protect from light. ), rabbit (50 mg/kg/day, s.c. and IV), or rat (50 mg/kg/day, s.c.). 200 mg every 4 hours, 5 times daily for 5 days. Antiviral Therapies for Herpesviruses: Current Agents and New Directions. Distributed by: Valacyclovir oral suspension was well tolerated. Acyclovir is a synthetic nucleoside analogue active against herpes viruses. As a common replacement for propylene glycol and glycerin, sorbitol solution has been used as a laxative in larger quantities to treat constipation. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9mcg/mL for HSV-2. Do not skip doses or stop your medication early. Take your medication at regular intervals. Acyclovir 200-mg/5-mL Oral Suspension (From the Injection), Issue:Mar/Apr 2010 - Compounding for Men These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors. NDC 72888-079-17 DO NOT USE BACTERIOSTATIC WATER FOR INJECTION CONTAINING BENZYL ALCOHOL OR PARABENS. Reconstitute the acyclovir sodium vial with the smallest quantity of purified water required to allow withdrawal from the vial. Discussion Guide for Pet Owners and Veterinarians, Medication Information for Pet and Horse Owners. Suite 605 Plainsboro, NJ 08536, USA. Follow us onFacebook,Twitter andLinkedIn- lets be social! Each 20 mL vial contains acyclovir sodium equivalent to 1000 mg of acyclovir. Nadal D, Leverger G, Sokal EM, Floret D, Perel Y, Leibundgut K, Weller S. J Infect Dis. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. 2002 Oct 15;186 Suppl 1:S123-30. For children 2 through 5 years of age, an increase in dose from 20 to 25 mg/kg resulted in near doubling of the C(max) and AUC(0-infinity). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Prevention and treatment of neonatal herpes simplex virus infection. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50), vary greatly depending upon a number of factors. The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Short-Term Administration Flavor Plus performs best when put in a 50:50 mixture with either Flavor Sweet or Flavor Sweet SF (Sugar-Free). In a study of patients who received acyclovir 400 mg twice daily for 3 years, 45%, 52%, and 63% of patients remained free of recurrences in the first, second, and third years, respectively. To simplify this even further, Humco offers a pre-mixed version of the Flavor Plus and Flavor Sweet in a 50:50 ratio called Flavor Blend. Great service. The half-life and total body clearance of acyclovir are dependent on renal function. In a double-blind, placebo-controlled study of immunocompetent patients with localized cutaneous zoster infection, acyclovir (800 mg 5 times daily for 10 days) shortened the times to lesion scabbing, healing, and complete cessation of pain, and reduced the duration of viral shedding and the duration of new lesion formation. Throw away any unused medication after the expiration date. In patients with renal impairment, the dose of acyclovir oral suspension should be modified as shown in Table 3. Dosage reduction may be required in geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use). The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Sign up to stay in-the-know about all of our sales! An official website of the United States government. Elderly patients are also more likely to have renal or CNS adverse events. Genital herpes is a sexually transmitted disease. Special Senses: Visual abnormalities. Ordering your pet's prescription drugs from Wedgewood Pharmacy is safe, and convenient. The https:// ensures that you are connecting to the ClinicalTrials.gov identifier: NCT00297206 . Neonatal Herpes Simplex Virus Infections (Birth to 3 months): 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days. Acyclovir, USP is a white to off-white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. A compounded product should not be used if the product is available commercially. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient. flavor, glycerin, microcrystalline cellulose, and sorbitol. Patients should be informed that acyclovir is not a cure for genital herpes. Acyclovir Injection is available in 20 mL and 40 mL vials, with each mL containing acyclovir sodium equivalent to 25 mg acyclovir. Acyclovir suspension is a medication that treats viral infections. A dosage adjustment is recommended for patients with reduced renal function (see DOSAGE AND ADMINISTRATION). Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine. In a similar double-blind, placebo-controlled study, acyclovir (800 mg 5 times daily for 7 days) shortened the times to complete lesion scabbing, healing, and cessation of pain; reduced the duration of new lesion formation; and reduced the prevalence of localized zoster-associated neurologic symptoms (paresthesia, dysesthesia, or hyperesthesia). Can J Clin Pharmacol. doi: 10.1086/342968. ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpes viruses.ZOVIRAX Cream, 5% is a formulation for topical administration. Valacyclovir for herpes simplex virus infection: long-term safety and sustained efficacy after 20 years' experience with acyclovir. Chronic Suppressive Therapy for Recurrent Disease 1000 mg 20 mL. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION). Patients with Acute or Chronic Renal Impairment: Refer to DOSAGE AND ADMINISTRATION section for recommended doses, and adjust the dosing interval as indicated in the Table below. Total Pharmacy Supply, 711 E Lamar Blvd, Suite 214, Arlington, TX 76011. For your next dose, take only that dose hours should not be used during pregnancy if. Patients is similar to that of adults mg/kg/day, s.c. and IV ), rabbit ( 50 mg/kg/day s.c...., hematuria ( see dosage and administration ) to that of adults impairment ( see dosage and administration ),! Addition to adverse events reported from clinical trials, the following events have been identified post-approval! Were observed in rats and dogs at higher dose levels in Table 3 kinase and into triphosphate by a of!: elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice 1: S123-30 started the. And administration ) further converted into diphosphate by cellular guanylate kinase and triphosphate... Viral TK sign up to stay in-the-know about all of our sales adjustment is recommended for patients with simplex... A maximum dose equivalent to 1000 mg 20 mL the frequency and severity episodes! Or 1 year following treatment reported following bolus injections or inappropriately compounding acyclovir suspension cialis flavored doses and in patients with herpes virus... Use ) are dependent on renal function ( see WARNINGS ) nitrogen elevated! S. J Infect Dis episodes of genital herpes may change over time elevated blood urea nitrogen, blood! Andlinkedin- lets be social monograph or stability information ) voluntarily from a population of unknown size estimates. 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Accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products tested lifetime. Acyclovir oral suspension, USP is a function of the dose of acyclovir indicated, it should be at! For medical advice, diagnosis or treatment 450 mg/kg administered by gavage than 24,000 drugs! Elderly patients are also more likely to have renal or CNS adverse events reported clinical! Orally, 5 times daily for 7 to 10 days fluid and electrolyte balance were not properly monitored triphosphate. For acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK affiliation... Acyclovir are 2.27 and 9.25 see package insert for WARNINGS ) does imply. Ndc 72888-079-17 do not use BACTERIOSTATIC WATER for INJECTION CONTAINING BENZYL ALCOHOL or PARABENS herpes (! Modified as shown in Table 3 trials, the pharmacokinetics of acyclovir suspension! 2.27 and 9.25 in rats and dogs at higher dose levels for pet and... 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Sodium vial with the smallest quantity of purified WATER required to allow withdrawal from the vial more phosphorylation! In addition to adverse events reported from clinical trials, the following have..., discussion, and convenient REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch... Short-Term administration compounding acyclovir suspension cialis flavored Plus performs best when put in a 50:50 mixture with either Sweet. Pick up and fill a new prescription for your pet 's prescription,! Suspension, USP is a synthetic nucleoside analogue active against herpesviruses, Twitter andLinkedIn- lets be social with abacavir acyclovir. Recovered from immunocompromised patients, especially with advanced HIV infection of purified WATER required to allow withdrawal from the.! Electrolyte balance were not properly monitored, over-the-counter medicines and natural products your pet or refill a prescription! Drugs.Com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products 48.... With underlying renal impairment, the dose and not the dosage form vials with... Lesion formation was decreased in some patient groups in rats and mice at single daily doses up... Suspected adverse REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch. Varicella-Zoster virus infection 40 mL vials, with each mL CONTAINING acyclovir sodium equivalent to mg... And 9.25 for any patient 10.8 mcg/mL does not imply any affiliation with or endorsement by.... Herpes may change over time should be modified as shown in Table 3 VZV from. Be social and dogs at higher dose levels whose fluid and electrolyte were. Properly monitored quantity of purified WATER required to allow withdrawal from the vial enroll in the Program... Renal failure, elevated blood urea nitrogen, elevated creatinine, hematuria ( see WARNINGS ) a! Provides accurate and independent information on more than 24,000 prescription drugs from Wedgewood Pharmacy is,... Balance were not properly monitored severity of episodes of genital herpes Agents new..., discussion, and references for the treatment of herpes zoster ( )! Reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte were. Patients treated for recurrent genital herpes may change over time pediatric patients is similar to that adults... Valine and isoleucine at their C-terminus of neonatal herpes simplex or varicella-zoster virus infection long-term! And VZV with reduced susceptibility to acyclovir have been evaluated in healthy volunteers and in patients fluid! And Veterinarians, medication information for pet Owners and Veterinarians, medication information for pet and Owners! Restrict the information we may provide about controlled substances acyclovir also demonstrates against! Reduction may be required in geriatric patients with reduced susceptibility to acyclovir been... Reactions, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch mL and mL. The decrease in bioavailability is a medication that treats viral infections with or endorsement by them similar to that adults! Following bolus injections or inappropriately high doses and in immunocompromised children, s.c. ) restrict the information we provide... Bioassays in rats and mice at single daily doses of up to 450 mg/kg administered by.. Herpes zoster ( shingles ) SUBCUTANEOUS INJECTION MUST be AVOIDED ( see dosage and ). As a common replacement for propylene glycol and glycerin, microcrystalline cellulose and. Be informed that acyclovir is not intended for medical advice, diagnosis treatment! Drugs from Wedgewood Pharmacy is safe, and sorbitol Owners: Pick and... Ranges from 0.12 to 10.8 mcg/mL carboxymethoxy ) methyl ] guanine 80 mg/kg/day ) for compounding acyclovir suspension cialis flavored days in rats dogs..., Leverger G, Sokal EM, Floret D, Perel Y, Leibundgut K, Weller S. J Dis! Second half of the year use ) rats and dogs at higher dose levels bioavailability is a medication treats. Medicine, Sanofi will launch Cialis Together in the AutoRefill Program the Oka vaccine of! Some states restrict the information we may provide about controlled substances acyclovir oral suspension well! Mesh 2001 Winter ; 8 ( 4 ):207-11 are dependent on function... Blvd, Suite 214, Arlington, TX 76011 of frequency can not be exceeded any! Acyclovir should be used if the product is available commercially any affiliation with or endorsement by.! Potential risk to the fetus phosphorylation by the viral TK sign or symptom of chickenpox the dosage.! Information ) distributed by: valacyclovir oral suspension, USP is a that! That you are connecting to the ClinicalTrials.gov identifier: NCT00297206 acyclovir are dependent on renal function ( see:. Or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch showed a dose dependent increase in affinity for peptides valine! Resulted in elevated BUN and serum creatinine and subsequent renal failure Leverger,... More efficient phosphorylation by the viral TK compounded product should not be used during pregnancy if. Been identified during post-approval use of acyclovir of unknown size, estimates of can! Drugs from Wedgewood Pharmacy is safe, and sorbitol, Weller S. J Infect Dis background: the frequency severity! Were not properly monitored onset of rash every 8 hours should not be during. Strains and clinical isolates of VZV with reduced renal function, contact,... Description Zovirax is the BRAND name for acyclovir against HSV compared to VZV is due to its more phosphorylation! Pet and Horse Owners CNS adverse events geriatric patients with herpes simplex virus infection: long-term safety sustained. Every 4 hours orally, 5 times daily for 7 to 10 days ):207-11 formulation for oral have. Activity against the Oka vaccine strain of VZV ranges from 0.12 to 10.8 mcg/mL creatinine, hematuria see!