Usp 23, acyclovir tablets usp 23, acyl, acyrax, acyvir, aklovir, alovir. The bp secretariat prepares monographs by working with. Cefoxitin for injection, usp to reduce the development of drugresistant bacteria and maintain the effectiveness of cefoxitin for injection and other antibacterial drugs, cefoxitin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Acyclovir ointment fda prescribing information, side. The extended stability monographs and parenteral nutrition monographs in this edition rep. Due to the similarity of the chemical structure of valganciclovir and that of acyclovir and its prodrug valacyclovir, a crosshypersensitivity reaction between these drugs is possible. Biowaiver monographs for immediate release solid oral dosage.
The risks of basing a be assessment on in vitro rather than in vivo study results for the approval of new ir solid oral dosage forms containing aciclovir biowaiving, including both reformulated products and new multisource products, are evaluated under consideration of its biopharmaceutical and. Acyclovir sodium injection 4product monograph page of 39 herpes simplex infections in immunocompromised patients a multicentre trial using intravenous acyclovir at a dose of 250 mgm2 every 8 hours infused over 1 hour 750 mgm2day for 7 days was conducted in 98 immunocompromised patients with oro facial, esophageal, genital and other localized infections 52 treated with acyclovir and. The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase tk encoded by hsv and vzv. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 hsv1, 2 hsv2, and varicellazoster virus vzv. Tolerancesnot less than 75% q of the labeled amount of assay preparationdissolve about 100 mg of acyclovir, acc8h11n5o3 is dissolved in 45 minutes. Due to the similarity of the chemical structure of ganciclovir and that of acyclovir and its prodrug valacyclovir, a crosshypersensitivity reaction between these drugs is possible. Acyclovir is a white, crystalline powder with the molecular formula c 8 h 11 n 5 o 3 and a molecular weight of 225. Due to the similarity of the chemical structure of ganciclovir and that of acyclovir and its pro. Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Zovirax acyclovir is contraindicated for patients who develop hypersensitivity or who are hypersensitive to acyclovir, valacyclovir or any other components of zovirax. A vast amount of practicerelated information is available to todays healthcare practitioner. Literature data relevant to the decision to allow a waiver of in vivo bioequivalence be testing biowaiver for the approval of immediate release ir solid oral dosage forms containing. Quantity of c8h11n5o3 obtained in the assay q quantity of acyclovir. Acyclovir concentrations had a delayed appearance undetectable at 5 hours and were below the concentrations required for antiviral activity range.
The retention time of the major peak in the sample solution corresponds to that of the standard solution, as obtained in the assay assay valacyclovir hydrochloride procedure buffer. Acyclovir is a synthetic analog of the purine nucleoside, guanosine, with potent antiviral activity against herpes simplex viruses type 1 and 2, varicellazoster virus and other viruses of the herpesvirus family. After conversion in vivo to the active metabolite acyclovir triphosphate by viral thymidine kinase, acyclovir competitively inhibits viral dna polymerase by incorporating into the. Acyclovir is widely distributed into tissues and body fluids. Usp monographs for bulk drug substances and other ingredients provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations. Acyclovir capsules, usp and acyclovir tablets, usp are formulations for oral administration. Alpharma, acyclovir capsules usp 23, acyclovircophar, acyclovir for injection usp 23, acyclovirmepha, acyclovir ointment usp 23, acyclovir oral suspension usp 23, acyclovir tablets usp 23, acyl, acyrax, acyvir, aklovir, alovir, antiherpes. The common technical document ctd equivalents are given in brackets. Commentary usp 39nf 34, second supplement june 1, 2016 in. Each gram of acyclovir ointment, usp 5% contains 50 mg of acyclovir, usp in a polyethylene glycol peg base.
By continuing to browse this website you are agreeing to our use of cookies. Acyclovirresistant hsv or vzv usually resistant to famciclovir and valacyclovir, but may be susceptible to foscarnet. Acyclovir resistant hsv or vzv usually resistant to famciclovir and valacyclovir, but may be susceptible to foscarnet. This valacyclovir hydrochloride revision bulletin supersedes the currently official monograph and will be incorporated in the second supplement to usp 34nf 29. Proceed as directed in the usp acyclovir related compound a rs in diluent assay. Acyclovir is a synthetic purine nucleoside analogue with inhibitory activity against herpes simplex virus types 1 hsv1, 2 hsv2, and varicellazoster virus vzv.
Abandoned application number us482,668 inventor shingai majuru moses oyewumi. May 01, 2017 usp monographs for bulk drug substances and other ingredients provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations. Advise patients that acyclovir is not a cure for genital herpes and there are no data evaluating whether acyclovir prevents transmission of genital herpes to others. Biowaiver monographs for immediate release solid oral.
Alpharma, acyclovir capsules usp 23, acyclovir cophar, acyclovir for injection usp 23, acyclovir mepha, acyclovir ointment usp 23, acyclovir oral suspension usp 23, acyclovir tablets usp 23, acyl, acyrax, acyvir, aklovir, alovir, antiherpes. Us20120238591a1 us482,668 us2012482668a us2012238591a1 us 20120238591 a1 us20120238591 a1 us 20120238591a1 us 2012482668 a us2012482668 a us 2012482668a us 2012238591 a1 us2012238591 a1 us 2012238591a1 authority us united states prior art keywords acyclovir snac mg pharmaceutical composition beagles prior art date 20061201 legal status the. Acyclovir standard solution dissolve an accurately weighed quantity of usp acyclovir rs in solution a, and dilute quantitatively, and stepwise if necessary, with solution a to obtain a solution having a known concentration of about 5 g per ml. Acyclovir should be applied within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labialis. For a complete listing, see dosage forms, composition and packaging section of the product monograph. Acyclovir, usp is a white, crystalline powder with the molecular formula c 8 h 11 n 5 o 3 and a molecular weight of 225. Each capsule of zovirax contains 200 mg of acyclovir and the inactive ingredients. Jun 21, 2019 acyclovir resistant hsv or vzv usually resistant to famciclovir and valacyclovir, but may be susceptible to foscarnet. Jan 01, 2020 acyclovir ointment usp, 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation. Acyclovir is metabolized to 9carboxymethoxymethylguanine cmmg and 8 hydroxy acyclovir 8ohacv by oxidation and hydroxylation.
Acyclovir sodium injection 4product monograph page of 39 herpes simplex infections in immunocompromised patients a multicentre trial using intravenous acyclovir at a dose of 250 mgm2 every 8 hours infused over 1 hour 750 mgm2day for 7 days was conducted in 98 immunocompromised patients with oro. Zovirax capsules, tablets, and suspension are formulations for oral administration. The pdf revision bulletin has not changed from the original posting. Usp 23, acyclovirmepha, acyclovir ointment usp 23, acyclovir oral suspension. Each capsule of acyclovir contains 200 mg of acyclovir, usp and the inactive ingredients lactose monohydrate, magnesium stearate, and pregelatinized starch. Dissolve 5 mg ofaciclovir crs and 5 mg of aciclovir impurity a crsin a mixture of 20 volumes ofglacial acetic acid r and 80 volumes of water rand dilute to 25. It is a sterile, aqueous solution for intravenous infusion, containing 50 mg acyclovir per ml in water for injection, usp. The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase tk.
Acyclovir inhibits viral dna synthesis and must be phosphorylated intracellularly to be active. Aciclovir injection is an aqueous solution for injec tion. Alpharma, acyclovir capsules usp 23, acyclovir cophar, acyclovir for injection usp 23, acyclovir mepha, acyclovir ointment usp 23, acyclovir oral suspension. System suitability preparation 1 dissolve accurately weighed quantities of usp acyclovir rs and guanine in 0. Acyclovir acyclovir sodium dose, indications, adverse.
Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed. Usp endotoxin rs identification usp sumatriptan succinate rs 2s usp35 a. The systemic absorption of acyclovir following topical application of cream has not been evaluated in patients id. Usp monographs for bulk drug substances and other ingredients.
Common pharmacopeial calculations in usp monographs. Ganciclovir for injection product monograph page 4 of 53. Zovirax acyclovir tablets zovirax acyclovir suspension description zovirax is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. Tablet should be placed to the upper gum just above the incisor tooth canine fossa and held in place with a slight pressure over the upper lip for 30 seconds to ensure adhesion. Each gram of acyclovir ointment usp, 5% contains 50 mg of acyclovir in a polyethylene glycol peg base. Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in. Zovirax cream is a herpes simplex virus hsv nucleoside analogue dna polymerase inhibitor indicated for the. Plasma protein binding is relatively low at 9 to 24%.
These monographs appear in the uspnf the 2016 editionusp 40nf 35became official on may 1, 2017. Each capsule contains 200 mg of acyclovir and the inactive ingredients. Systemic absorption of acyclovir from zovirax cream is minimal in adults. Acyclovir ointment usp, 5% is intended for cutaneous use only and should not be used in the eye. A biowaiver monograph of aciclovir based on literature data is presented. Commentaries biowaiver monographs for immediate release solid oral dosage forms. Cps at a glance an alphabetical, crossreferenced index of brand and generic names of products available in canada including references to cpha monographs. The recommended dosage, frequency of applications, and length of treatment should not be exceeded see dosage and. Acyclovir is slowly and poorly absorbed from the gastrointestinal tract and bioavailability decreases with increasing dose. Acyclovir ointment usp, 5% is a formulation for topical administration. Download the valacyclovir hydrochloride revision bulletin the third item in the list above delete the limit of total unspecified impurities nmt 0.
Acyclovir sodium injection is a synthetic nucleoside analog, active against herpes viruses. Apoacyclovir tablets product monograph page 4 of 37 contraindications apoacyclovir acyclovir tablets usp is contraindicated for patients who develop hypersensitivity or who are hypersensitive to acyclovir, valacyclovir or any other components of the formulations of apoacyclovir. System suitability solution 1 dissolve accurately weighed quantities of usp acyclovir rs and guanine in 0. The extended stability monographs and parenteral nutrition monographs in. Acyclovir sodium injection 4product monograph page of 39 herpes simplex infections in immunocompromised patients a multicentre trial using intravenous acyclovir at a dose of 250 mgm2 every 8 hours infused over 1 hour 750 mgm2day for 7 days was conducted in 98 immunocompromised patients with oro facial, esophageal, genital and other localized infections 52. Also integrated into this section are products discontinued between 2000 and 20. The 2016 editionusp 40nf 35became official on may 1, 2017. Procedure determine the amount of c8h11n5o3 dissolved from uv absorption at the wavelength of maximum absorbance at about 254 nm on filtered. The risks of basing a be assessment on in vitro rather than in vivo. Information was also obtained from regulatory documents published by the emea, 4 the fda, 3 and the who.
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