Acyclovir Ointment Prescribing Information. Results from the studies of carcinogenesis, mutagenesis and fertility are not included in the full prescribing information for Acyclovir Cream due to the minimal exposures of acyclovir that result from dermal application. General: The recommended dosage, frequency of applications, and length of treatment should not be exceeded (see DOSAGE AND ADMINISTRATION). Before you use Acyclovir Cream, tell your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Keep Acyclovir Cream and all medicines out of reach of children. Dosage Form; Route: Ointment; topical . The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Do not use ZOVIRAX Cream for genital herpes. Patients should be instructed that Acyclovir Cream is intended for cutaneous use only for herpes labialis of the lips and around the mouth. In the first study, median age was 37years (range 18 to 81years), 74% were female, and 94% were Caucasian. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (EC50), vary greatly depending upon a number of factors. The safety profile in patients 12 to 17 years of age was similar to that observed in adults. Using plaque-reduction assays, the IC50 against HSV isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Acyclovir Cream. No local intolerance, systemic toxicity, or contact dermatitis were observed. A single copy of these materials may be reprinted for noncommercial personal use only. ZOVIRAX Cream is supplied as follows: Store at or below 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Information on these studies is available in the full prescribing information for acyclovir capsules, tablets, and suspension and acyclovir for injection. Do not use if you are allergic to Acyclovir Cream or any of the ingredients in Acyclovir Cream. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. Tell your healthcare provider about all the medicines you take. This medication may decrease the length of. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page. Use ZOVIRAX Cream only on your affected skin. Acyclovir Cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose. Acyclovir Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation. Itching, stinging, or redness of the genital area. General Advice about Prescription Medicines. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. This inhibition 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. Acyclovir (Zovirax) is an antiviral medication used for the treatment of shingles, chickenpox, and herpes simplex virus infections (e.g., cold sores, genital herpes). Therefore, it may not be known whether they work exactly the same way they do in younger adults. This viral enzyme converts acyclovir into acyclovir monophosphate, a deoxynucleotide analogue. Acyclovir Cream has the potential for irritation and contact sensitization. It is also important to remember that acyclovir will not keep you from spreading herpes to others. A cold sore usually starts with a tingling, itchy or burning feeling. The possibility of viral resistance to acyclovir should be considered in patients who fail to respond or experience recurrent viral shedding during therapy. It is usually applied five times a day (about every 3 hours while awake) until the eye heals, and then 3 times a day for another 7 days. Dermal carcinogenicity studies were not conducted. Systemic exposure following topical administration is minimal. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy. Advise patients to apply Acyclovir Cream topically 5 times per day for 4 days. After viewing product detail pages, look here to find an easy way to navigate back to pages you are interested in. Acyclovir is available only with your doctor's prescription. Treatment should be initiated at the earliest sign or symptom of recurrence. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Advise the patient to read the FDA-approved patient labeling (Patient Information). Acyclovir Ointment, USP 5% is a white to off white ointment, free of foreign matters, free of lumps, translucent, homogeneous, and no phase separation. Results Zostrix Pain Relief Cream Maximum Strength 2 oz 2 Ounce (Pack of 1) 125 $1589 ($7.95/Ounce) List: $19.99 Save 15% on 2 select item (s) $4.75 delivery Jun 7 - 9 Only 12 left in stock - order soon. Copyright: Merative US L.P. 1973, 2023. Acyclovir levels in plasma ranged from <0.01 to 0.28 mcg/mL in 8 patients with normal renal function, and from <0.01 to 0.78 mcg/mL in 1 patient with impaired renal function. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Acyclovir is an antiviral drug active against -herpesviruses [see Microbiology (12.4)]. You should not apply other skin products to the affected area during treatment with Acyclovir Cream. It comes in many different forms, including oral pills that are usually taken 4-5 times a day, as well as topical cream or ointment that are typically applied 5-6 times a day. The quantitative relationship between the susceptibility of herpes viruses to antivirals in cell culture and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. In this uncontrolled study, acyclovir was detected in the blood of 9 patients and in the urine of all patients tested. https://www.mayoclinic.org/drugs-supplements/acyclovir-topical-route/precautions/drg-20061579, Advertising and sponsorship opportunities. Acyclovir excreted in the urine ranged from <0.02% to 9.4% of the daily dose. Systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Acyclovir is available only with your doctor's prescription. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. The effect of Acyclovir Cream has not been established in immunocompromised patients. A finger cot or rubber glove should be used when applying acyclovir ointment 5% to prevent autoinoculation of other body sites and transmission of infection to other persons. Clinical studies of acyclovir cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Systemic exposure following topical administration of acyclovir is minimal. The safety profile was similar to that observed in adults. Systemic absorption of acyclovir from Acyclovir Cream is minimal in adults. Dermal carcinogenicity studies were not conducted. Acyclovir excreted in the urine ranged from <0.02% to 9.4% of the daily dose. . Acyclovir Cream is not a cure for cold sores. Acyclovir (9- [2-hydroxymethyl]guanine) is a nucleoside analog that selectively inhibits the replication of herpes simplex virus types 1 and 2 (HSV-1, HSV-2) and varicella-zoster virus (VZV). The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Do not use ZOVIRAX Cream if you are allergic to ZOVIRAX (also known as acyclovir), VALTREX (also known as valacyclovir), or any of the ingredients of ZOVIRAX Cream. What Are the Possible Side Effects of ZOVIRAX Cream? Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing. Local pruritus occurred in 4% of these patients. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. The maximum solubility in water at 37C is 2.5mg/mL. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. The chemical name of acyclovir 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). Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. For adolescents 12 years of age and older, the dosage is the same as in adults. acyclovir, valacyclovir, Valtrex, Zovirax, tetracaine topical, Abreva, docosanol topical. The pKas of acyclovir are 2.27 and 9.25. Make sure the cap on the tube is tightly closed. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy. To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Systemic absorption of acyclovir after topical administration is minimal (see CLINICAL PHARMACOLOGY). Due to minimal systemic absorption of Acyclovir Cream, systemic drug interactions are unlikely. Avoid irritation of the cold sore area while using ZOVIRAX Cream. In the first trial, the median age of subjects was 37 years (range 18 to 81 years), 74% were female, and 94% were Caucasian. It is also used to treat non-life-threatening herpes infections of the skin and around the mouth ( cold sores) in people with a weakened immune system. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In one of these studies, which included 16 inpatients, the complete ointment or its vehicle were randomly administered in a dose of 1-cm strips (25 mg acyclovir) 4 times a day for 7 days to an intact skin surface area of 4.5 square inches. Therapy should be initiated as early as possible following onset of signs and symptoms. Therapy should be initiated as early as possible following onset of signs and symptoms. ACYCLOVIR- acyclovirointment Acyclovir Ointment 5% is intended for cutaneous use only and should not be used in the eye. ZOVIRAXCream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation. What Should I Avoid While Using ZOVIRAX Cream? The inhibitory activity of acyclovir is selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV. The occurrence rate of birth defects approximates that found in the general population. The safety profile was similar to that observed in adults. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Data are insufficient to support an estimate of their incidence or to establish causation. I. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immune compromised patients, especially with advanced HIV infection. ZOVIRAX Cream was well tolerated in studies in patients with cold sores. Acyclovir is a synthetic deoxynucleoside analogue active against herpes viruses. In addition, no drug was detected in blood and urine by radioimmunoassay (sensitivity, 0.01 mcg/mL). The following information includes only the average doses of this medicine. There are no data on the effects of acyclovir on the breastfed infant or on milk production. Each gram of Acyclovir Cream contains 50 mg (equivalent to 5% w/w) of acyclovir, USP and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum. The action you just performed triggered the security solution. Rd., Hukou, Hsinchu 303036, Taiwan (TWN), acyclovir, valacyclovir, Valtrex, Zovirax, tetracaine topical, Abreva, docosanol topical. Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The maximum solubility in water at 37C is 2.5 mg/mL. Cervical cancer can be cured if found and treated early. Systemic absorption of acyclovir after topical administration is minimal (see CLINICAL PHARMACOLOGY). Active Ingredient: Acyclovir . An open-label, uncontrolled trial with ZOVIRAX Cream 5% was conducted in 113 patients aged 12 to 17years with herpes labialis. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. This is a decision you and your doctor will make. Medically reviewed by Drugs.com. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice. The most common adverse reactions at the site of topical application were dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging on skin; each adverse reaction occurred in less than 1% of patients receiving Acyclovir Cream and placebo. USUAL DOSAGE: Apply 6 times a day (every 3 hours) for 7 days. ZOVIRAX Cream is most effective when used early, at the start of a cold sore. This could wash off the medicine. 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 9.9 mcg/mL for HSV-2. There are no data to support the use of Acyclovir Ointment 5% to prevent transmission of infection to other persons or prevent recurrent infections when applied in the absence of signs and symptoms. In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Please see Patient Information About ZOVIRAX Cream. Your doctor or pharmacist can give you additional information about ZOVIRAX Cream that was written for healthcare professionals. AdultsApply to the affected area(s), four to six times a day, for up to ten days. Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . D368A, A605V, D672N, L702H, V715G, A719T/V, S724N, L778M, E798K, V813M, N815S, V817M, G841C/S, I890M, K533E, A606V, C625R, R628C, A724V, S725G, S729N, I731F, Q732R, M789K/T, V818A, Y823C, D912V, F923L, T934A, R964H. Never leave ZOVIRAX Cream in your car in cold or hot weather. In both studies, the mean duration of the recurrent herpes labialis episode was approximately one-half day shorter in the subjects treated with ZOVIRAX Cream (n=682) compared with subjects treated with placebo (n=703) (approximately 4.5days versus 5days, respectively). Antiviral Activities: 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. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. There are no adequate and well-controlled studies of systemic acyclovir in pregnant women. Acyclovir levels in plasma ranged from <0.01 to 0.28 mcg/mL in 8 patients with normal renal function, and from <0.01 to 0.78 mcg/mL in 1 patient with impaired renal function. Acyclovir Cream, 5% is white to off white homogenous cream which contains 50 mg (equivalent to 5% w/w) acyclovir in an aqueous cream base. For non-prescription products, read the label or package ingredients carefully. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. These studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir. In this uncontrolled study, acyclovir was detected in the blood of 9 patients and in the urine of all patients tested. Plasma acyclovir concentrations were below the limit of detection (0.01M) in 5subjects and barely detectable (0.014M) in 1subject. 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