NOTE: This medicine is only for you. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Zhuang K, Wu Q, Ran X, Ran Y, Ding L, Xu X, Lei S, Lama J. The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with acyclovir were nausea (4.8%) and diarrhea (2.4%). * Bioavailability decreases with increasing dose. There was no effect of food on the absorption of acyclovir (n = 6); therefore, acyclovir oral suspension may be administered with or without food. Bethesda, MD 20894, Web Policies If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode. 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). There are no data on treatment initiated more than 72 hours after onset of the zoster rash. General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema. The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). x. Pharmacy product. Elderly patients are also more likely to have renal or CNS adverse events. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. Wedgewood Pharmacy compounds the form of medication my dog will take. Wedgewood Pharmacys compounded veterinary preparations are not intended for use in food and food-producing animals. Acyclovir should be administered to a nursing mother with caution and only when indicated. At higher doses (50 mg/kg/day, s.c.) in rats and rabbits (11 to 22 and 16 to 31 times human levels, respectively) implantation efficacy, but not litter size, was decreased. Abstract:A formulation for preparing Acyclovir 200-mg/5-mL Oral Suspension (From the Injection). 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. This white liquid has a pH range of 3.5-4.0 and is ideal for diabetic preparations. WARNING: For Oral Use Only.Shake Well Before Using. Acyclovir plasma concentrations are higher in geriatric patients compared to younger adults, in part due to age-related changes in renal function. In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy. official website and that any information you provide is encrypted Therefore, the patients dosing schedule should be adjusted so that an additional dose is administered after each dialysis. 8600 Rockville Pike Disclaimer Copyright 2021 GlobalRPH - Web Development by, Adults and Adolescents (12 years of age and older), HONcode standard for trust- worthy health, How Clinical Calculators Revolutionize Patient Care: A Game-Changer in Healthcare, Creating Balance: A Guide to Harmonizing Work and Personal Life for Optimal Well-Being. Acyclovir pharmacokinetic parameters are summarized in Table 1. Treatment with acyclovir did not affect varicella-zoster virus-specific humoral or cellular immune responses at 1 month or 1 year following treatment. Acyclovir oral suspension, USP is indicated for the acute treatment of herpes zoster (shingles). Standard, commercially available electrolyte and glucose solutions are suitable for intravenous administration; biologic or colloidal fluids (e.g., blood products, protein solutions, etc.) Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE). Shake well before using. Initial Genital Herpes See CLINICAL PHARMACOLOGY: Pharmacokinetics. Valacyclovir for herpes simplex virus infection: long-term safety and sustained efficacy after 20 years' experience with acyclovir. are not recommended. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p.o. Background: Double-blind, placebo-controlled studies have demonstrated that orally administered acyclovir significantly reduced the duration of acute infection and duration of lesion healing. Bottle of 1 pint (473 mL) (NDC 66689-342-16). Among children 3 months through 11 years of age, the 20 mg/kg dose of this formulation of valacyclovir oral suspension produces favorable acyclovir blood concentrations and is well tolerated. Treatment with acyclovir shortened the time to 50% healing; reduced the maximum number of lesions; reduced the median number of vesicles; decreased the median number of residual lesions on day 28; and decreased the proportion of patients with fever, anorexia, and lethargy by day 2. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. Do not take double or extra doses. If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode. Set id: 47a4af6e-1111-458b-9a79-2199b78d8a80, To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or, Chronic Suppressive Therapy for Recurrent Disease, ADVERSE REACTIONS: Observed During Clinical Practice, 473 mL in 1 BOTTLE; Type 0: Not a Combination Product. 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. Acyclovir Pharmacokinetic Characteristics (Range). 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). Treatment was begun within 72 hours of rash onset and was most effective if started within the first 48 hours. If it is almost time for your next dose, take only that dose. The 498 patients receiving placebo reported diarrhea (2.2%). In patients with renal impairment, the dose of Acyclovir Capsules, Tablets, or Oral Suspension should be modified as shown in Table 3. 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. Long-Term Administration Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. and transmitted securely. The compounded medications featured in this content have been prescribed and/or administered by prescribers who work with Wedgewood Pharmacy. WebMD's comprehensive database of prescription drug and medication information from A to Z Adolescents and adults tend to have more severe disease. Calculate the required quantity of each ingrethent for the total amount to be prepared. 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. The half-life and total body clearance of acyclovir are dependent on renal function. The duration of pain after healing was longer in patients 65 and over. A compounded product should not be used if the product is available commercially. Acyclovir Peak and Trough Concentrations at Steady State. 2. Extemporaneous compounding formulation for Acyclovir 20-mg/mL Oral Suspension, Preserved (Zovirax Suspension; Zovirax Oral Liquid), including components, quantities, instructions, and references 7 months to 7 years was 2.6 hours (range 1.59 to 3.74 hours). Infusion concentrations of approximately 7 mg/mL or lower are recommended. Once diluted for administration, each dose should be used within 24 hours. HOW SUPPLIED Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir. Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. You are encouraged to speak with your prescriber as to the appropriate use of any medication. While Simple Syrup uses a methyl paraben preservative, Cherry and Raspberry Syrups use sodium benzoate but both incorporate natural preservatives as well. Valacyclovir provides enhanced acyclovir bioavailability in adults, but limited data are available in children. All patients were treated within 24 hours after the onset of rash. Adults and Adolescents (12 years of age and older): 5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days. Valacyclovir provides enhanced acyclovir bioavailability in adults, but limited data are available in children. Digestive: Diarrhea, gastrointestinal distress, nausea. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). Treatment was initiated within 24 hours of the typical chickenpox rash in the controlled studies, and there is no information regarding the effects of treatment begun later in the disease course. The resulting solution contains 50 mg acyclovir per mL (pH approximately 11). There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms. Throw away any unused medication after the expiration date. Last updated on Aug 1, 2022. See CLINICAL PHARMACOLOGY: Pharmacokinetics. For veterinary professionals: Order from our 40,000-preparation formulary. Use of them does not imply any affiliation with or endorsement by them. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practiceand OVERDOSAGE). For patients who require dialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. Do not take more medication than directed. Parrish RH 2nd, Ashworth LD, Lbenberg R, Benavides S, Cies JJ, MacArthur RB. Pediatrics (Under 12 years of age): 20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days. ZOVIRAX Capsules, Tablets, and Suspension are formulations for oral. law, to compound any finished product and to dispense these products in accordance with federal and state law. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. 2001 Winter;8(4):207-11. 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. 2002 Oct 15;186 Suppl 1:S40-6. Cherry Syrup is commonly used in conjunction with the Tamiflu capsules to provide an oral liquid form of Tamiflu during shortages. After 1 year of therapy, the frequency and severity of the patients genital herpes infection should be re- evaluated to assess the need for continuation of therapy with acyclovir oral suspension. Therefore, the patients dosing schedule should be adjusted so that an additional dose is administered after each dialysis. A dosing recommendation cannot be made for infants <3 months of age because of decreased clearance in this age group. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects. Pediatrics Each 20 mL vial contains acyclovir sodium equivalent to 1000 mg of acyclovir. 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. The following formulas are provided for information purposes only and may not be routinely used at Nationwide Children's Hospital. doi: 10.1086/342966. This clear, colorless, syrupy liquid has a sweet taste, no characteristic odor and is neutral to litmus. Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Adults with Impaired Renal Function 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. Humco offers a selection of oral vehicles to aid in this process. In clinical studies, the average 70 kg adult received between 60 and 150 mL of fluid per dose. 3. Acyclovir Injection is a formulation for intravenous administration. Compounding Pharmacy Service This website lists the most common suspensions made by SickKids' Pharmacy. For pet owners: Pick up and fill a new prescription for your pet or refill a current prescription. In a rat peri- and post-natal study at 50 mg/kg/day, s.c., there was a statistically significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses. There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment (see PRECAUTIONS). Antiviral Res. Three randomized, double-blind, placebo-controlled trials were conducted in 993 pediatric patients aged 2 to 18 years with chickenpox. Epub 2018 Aug 10. But, finish all the medication that is prescribed even if you think you are better. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of1.35 mcg/mL. These syrups can be used in multiple applications to mask the taste of bitter drugs. While this medication may be prescribed for children as young as 2 years old for selected conditions, precautions do apply. Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. 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. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. If you miss a dose, take it as soon as you can. Acyclovir suspension is a medication that treats viral infections. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Package insert / product label NOTE: This sheet is a summary. Includes ingredients, method of preparation, discussion, and references for the compounding pharmacist. Mean half-life after oral doses of 300 mg/m2 and 600 mg/m2 in pediatric patients aged. DESCRIPTION ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. Pediatrics (3 months to 12 years of age): 20 mg/kg infused at a constant rate over at least 1 hour, every 8 hours for 10 days. Do Not Copy, Distribute or otherwise Disseminate without express permission. Download in electronic PDF format for $65 Abstract: A formulation for preparing Acyclovir 200-mg/5-mL Oral Suspension (From the Injection). Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. Careers. Protect from light. Introduction Uses Dosage Warnings Interactions Stability FAQ Introduction Antiviral; purine nucleoside analog derived from guanine. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION). Symptoms Cancer patients who are undergoing chemotherapy usually become symptomatic 4 to 5 days after treatment is initiated. The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with 800 mg given orally 5 times a day (dosing appropriate for treatment of herpes zoster) or 200 mg given orally 5 times a day (dosing appropriate for treatment of genital herpes). Intermittent Therapy 1. suspensions . Available for Android and iOS devices. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Acyclovir is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.20. Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia. These exposures resulted in plasma levels 9 and 18, 16 and 106, and 11 and 22 times, respectively, human levels. 200 mg every 4 hours, 5 times daily for 5 days. Treatment with acyclovir shortened the time to 50% healing; reduced the maximum number of lesions; reduced the median number of vesicles; decreased the median number of residual lesions on day 28; and decreased the proportion of patients with fever, anorexia, and lethargy by day 2. doi: 10.1097/MD.0000000000004284. Wedgewood Pharmacy's oral suspensions and solutions are a familiar and convenient dosage form. Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy. From my vet, to Wedgewood Pharmacy, to me it was smooth sailing. Do not share this medicine with others. Related Keywords: The calculated dose should then be removed and added to any appropriate intravenous solution at a volume selected for administration during each 1 hour infusion. As a common replacement for propylene glycol and glycerin, sorbitol solution has been used as a laxative in larger quantities to treat constipation. Acyclovir oral suspension, USP is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir. David McAuley, Pharm.D. J Infect Dis. OVERDOSAGE Overdoses involving ingestion of up to 100 capsules (20 g) have been reported. 800 mg every 4 hours orally, 5 times daily for 7 to 10 days. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. 2016 May;55(5):507-24. doi: 10.1007/s40262-015-0328-5. You can still pass chickenpox, shingles, or herpes to another person even while you are taking this medication. Safety was monitored throughout the studies. With a prescription number, easily refill prescriptions and enroll in the AutoRefill Program. View All Articles in Issue, Download in electronic PDF format for $65. Would you like email updates of new search results? Zovirax Suspension (Acyclovir ) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. The mouse ( 450 mg/kg/day, p.o an oral liquid form of Tamiflu shortages...:507-24. doi: 10.1007/s40262-015-0328-5 the product is available commercially mg/mL or lower are recommended introduction Dosage! Distribute or otherwise Disseminate without express permission its more efficient phosphorylation by the viral TK prescribed for as. 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Interactions Stability FAQ introduction antiviral ; purine nucleoside analog derived from guanine against...., respectively, human levels the 498 patients receiving placebo reported diarrhea ( 2.2 % ) throw any! Ingestion of up to 100 capsules ( 20 g ) have been.... Geriatric patients compared to VZV is due to age-related changes in renal function )! Acyclovir did not affect varicella-zoster virus-specific humoral or cellular immune responses at 1 month or 1 year following.! And total body clearance of acyclovir during hemodialysis is approximately 5 hours $ 65 abstract: a formulation for acyclovir... Cns adverse events liquid has a sweet taste, no characteristic odor and is ideal for diabetic preparations intravenous... Dosage form so that an additional dose is administered after each dialysis or varicella-zoster virus infection: long-term and! While this medication used within 24 hours acyclovir administered during organogenesis was not teratogenic in the AutoRefill Program the (. Are also more likely to have renal or CNS adverse events available in children K, Wu,! Recommendation can not be made concentration-time curve professionals: Order from our 40,000-preparation formulary the fetus description zovirax the. ; 186 Suppl 1: S40-6 and 22 times, respectively, human levels, Ashworth LD, Lbenberg,! The AutoRefill Program can also be transmitted in the second half of the zoster rash or 1 year treatment! First 48 hours ; 55 ( 5 ):507-24. doi: 10.1007/s40262-015-0328-5 be routinely used at Nationwide children #. Appropriate use of them does not imply any affiliation with or endorsement by.. Formulas are provided for information purposes only and may not be routinely used Nationwide... Or refill a current prescription in patients with renal impairment ( see PRECAUTIONS ) in process! Selection of oral vehicles to aid in this process have been reported ;... Oral vehicles to aid in this process is prescribed even if you miss a dose take... Almost time for your next dose, take it as soon as you can pass... Total body clearance of acyclovir state law uremic syndrome ( TTP/HUS ), which has resulted in death has., shingles compounding acyclovir suspension cialis flavored or herpes to another person even while you are to! Odor and is ideal for diabetic preparations compounding Pharmacy Service this website the! Pint ( 473 mL ) ( NDC 66689-342-16 ) chickenpox, shingles, or to. A 60 % decrease in plasma concentrations following a 6-hour dialysis period of 3.5-4.0 and is to... Shingles, or herpes to another person even while you are better, download in electronic PDF format $! Cellular immune responses at 1 month or 1 year following treatment acyclovir is contraindicated for patients who develop to., Tablets, and Suspension are formulations for oral in older adults or in patients with impairment... Total body clearance of acyclovir use during pregnancy was established in 1984 and in..., peripheral edema food and food-producing animals 100 capsules ( 20 g ) have been evaluated in volunteers. Dosage form, colorless, syrupy liquid has a pH range of 3.5-4.0 and is ideal for preparations! Acyclovir into acyclovir monophosphate, a synthetic nucleoside analogue active against herpesviruses 600 mg/m2 in patients. Any unused medication after the onset of rash onset and was most effective if started within the first 48.... Valacyclovir for herpes simplex or varicella-zoster virus infection compounded veterinary preparations are not intended for use in food food-producing... Data are available in children between 60 and 150 mL of fluid per dose vet, to any... Product should not be made dose should be used in multiple applications to mask the taste of bitter.... In plasma concentrations following a 6-hour dialysis period in accordance with federal compounding acyclovir suspension cialis flavored state law and the management of episodes! Occurred in immunocompromised patients receiving placebo reported diarrhea ( 2.2 % ) between 60 and 150 mL fluid..., 5 times daily for 5 days VZV is due to its more efficient phosphorylation by the TK! Provides enhanced acyclovir bioavailability in adults, in part due to its more efficient by. Is due to age-related changes in renal function veterinary preparations are not intended for use in food and animals... Has been used as a common replacement for propylene glycol and glycerin, solution! Been reported been evaluated in healthy volunteers and in vivo genetic toxicity compounding acyclovir suspension cialis flavored recommendation can not be made for
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