Vistide cidofovir dosing, indications, interactions. Dec 31, 2019 see the package leaflet for further information. Cidofovir treatment led to clinical improvement in 8 of 10 patients with severe infection and to virologic clearance in 9 patients. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. Pdf phase i study of combination therapy with intravenous. Must administer 2 g of probenecid 3 hours prior to each cidofovir dose and 1 g at 2 hours and again at 8 hours after completion of 1 hour cidofovir infusion for a total of 4 g. Vivitrol naltrexone for extendedrelease injectable suspension, for intramuscular use initial u. Material may be irritating to the mucous membranes and upper respiratory tract. Sections or subsections omitted from the full prescribing information are not listed. It is usually given every 1 to 2 weeks or as directed by your doctor. Individuals using assistive technology may not be able to fully access the information contained in this file. Cidofovir by injection national library of medicine.
Due to inconsistencies between the drug labels on dailymed and the pill images provided by rximage, we no longer display the rximage pill images associated with drug labels we anticipate reposting the images once we are able identify and filter out images that do not match the information provided in. Cidofovir is only available as an intravenous formulation. Sideeffects of cidofovir in the treatment of recurrent. Cidofovir injection vistide is an antiviral drug used to treat an eye infection cytomegalovirus retinitis, cmv in people who are infected with the hiv virus. Possible side effects of cidofovir are nausea, diarrhea, headache, white patches on the lips or. However, cidofovir is also used as a therapeutic option against other viral infections. It must never be given by the intramuscular or subcutaneous route. Cidofovir powder out of scope out of scope for rxnorm and will not receive rxnorm normal forms. Cidofovir is to be administered with probenecid which decreases side effects to the kidney. Highlights of prescribing information cardiac dysfunction. Cidofovir is an antiviral, cytosine nucleoside analog that is fda approved for the treatment of citomegalovirus retinitis in patients with acquired immunodeficiency syndrome. Cidofovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse this medicine is available only with your doctors. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
The appropriate volume of vistide must be removed from the sin. This medication is given into a vein as directed by your doctor, usually over 1 hour. All patients eventually achieved longterm viral suppression and clinical improvement, although prolonged cidofovir treatment for up to 8 months was required in some patients. Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. Signed informed consent form containing all potential serious adverse events related to cidofovir use as given on the package insert. Department of health and human services, centers for disease control and prevention, national institute for occupa.
Intravesical cidofovir for hemorrhagic cystitis full text. It is unclear if the rash was a direct sideeffect of the cidofovir. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for buspar buspirone. Why is dailymed no longer displaying pill images on the search results and drug info pages. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Intravesical cidofovir for hemorrhagic cystitis full. Food and drug administration center for drug evaluation and research office of prescription drug promotion 5901b ammendale road beltsville, md 20705 we call your attention to 21 cfr 314. Individuals using assistive technology may not be able to.
Discard product if it contains particulate matter, is cloudy, or discolored do not freeze. Daunorubicin hydrochloride injection must be given into a rapidly. However, visual acuity, which had been 2050 and 2025 at study entry, worsened to patients were required to. May be harmful by inhalation, ingestion, or skin absorption. It is used to treat infections caused by viruses cidofovir is used to treat the symptoms of cytomegalovirus cmv infection of the eyes cmv retinitis in patients with acquired immune deficiency syndrome aids. Easy to read fda package insert, drug facts, dosage and administration, and. If the file has been modified from its original state, some details such loxldromie the timestamp may not fully reflect those of the original file.
Apr 01, 2020 in vitro, cidofovir was less than 6% bound to plasma or serum proteins over the cidofovir concentration range 0. Cidofovir diphosphate, bearing structural similarity to nucleotides. Cidofovir, brand name vistide, is an injectable antiviral medication primarily used as a treatment for cytomegalovirus cmv retinitis an infection of the retina of the eye in people with aids. Cidofovir is an antiviral used for the treatment of. Oleuse vial and diksted prior to administration see dosage and administration. Reproductive and developmental toxicity studies performed in rats at oral doses up to 6. Cidofovir is used to treat the symptoms of cytomegalovirus cmv infection of the eyes cmv retinitis in patients with acquired immune deficiency syndrome aids. Ent dhingra 5th edition pdf diseases of ear, nose and throat 7th revised edition edition p. Cidofovir, also known as hpmpc, is a nucleotide analogue that inhibits viral dna polymerase and is used for the treatment of cytomegalovirus cmv retinitis. Dailymed cidofovir cidofovir anhydrous injection, solution. Cidofovir in renal transplant recipients with bkvn full. Probenecid mitigate nephrotoxicity by inhibiting organic anion transport of the proximal tubule epithelial cells of the kidney.
Cidofovir is a white crystalline powder with an aqueous solubility of. Probenecid 2 grams by mouth given approximately 3 hours prior to the bladder instillation of cidofovir. The safety and efficacy of cidofovir have not been established for treatment of other cmv infections such as pneumonitis or gastroenteritis, congenital or neonatal cmv disease, or cmv disease in nonhiv. The recommended dosage, frequency, or infusion rate of marcidofovir must not be exceeded. Interactions of cidofovirprobenecid and antihiv drugs or drugs used to treat common. Apr 27, 2020 cidofovir package insert pdf you can use it to print out manuals for employees or for safekeeping, as well as create your own winhelp project, rescue previously complied files for conversion or reuse, or simplify the generation and handling of hlpformatted documentation from a standard authoring format.
Cidofovir induced chromosomal aberrations in human peripheral blood lymphocytes in vitro without metabolic activation. Cidofovir is an antiviral medication that prevents certain viral cells from multiplying in your body. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Prior to tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. Highlights of prescribing information these highlights do not include all the information needed to use vivitrol safely and effectively. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for vistide cidofovir skip to.
Possible side effects of cidofovir are nausea, diarrhea, headache, white patches on the lips or mouth, hair loss, cough, and a mild rash. In vitro susceptibility to cidofovir was demonstrated in 12. Nov 27, 2012 cidofovir is a white crystalline powder with an aqueous solubility of. Vancomycin package insert moderate use caution with concomitant use of inotersen and vancomycin due to the risk of glomerulonephritis and nephrotoxicity. The drug substance is an aptamer, meaning it is the secondary structure i.
These highlights do not include all the information needed to use cuvitru safely and effectively. Cidofovir is used to treat an eye infection called cytomegalovirus retinitis cmv in people. The drug has been employed almost exclusively to treat cytomegalovirus cmv retinitis in patients with the acquired immunodeficiency syndrome aids. Aug 30, 2005 the primary objectives of this randomized, doubleblind, placebocontrolled, doseescalation study are to evaluate the safety and tolerability of 3 dose levels of cidofovir when administered to renal transplant recipients with bk virus nephropathy and to identify the maximum tolerated doses mtd among the 3 dose levels of cidofovir in renal transplant recipients with bk virus nephropathy. Cidofovir emcure pharma 75 mgml concentrate for solution for infusion leaflet. In 1998, the first article was published that described the use of the antiviral substance cidofovir to treat this disease. See full prescribing information for complete boxed warning. In addition, hydration must be administered to patients receiving cidofovir. In the us, cidofovir cidofovir systemic is a member of the drug class purine nucleosides and is used to treat cmv retinitis and smallpox vaccine reaction. Axitinib package insert pdf inlyta axitinib tablet, film coated.
It is supplied in clear glass vials, each containing 375 mg. Cidofovir side effects, dosage, interactions drugs. At the 4 cidofovir levels tested, the percentage of damaged metaphases and number of aberrations per cell increased in a concentrationdependent manner. Cidofovir injection fda prescribing information, side. To activate the contents of the vial, squeeze the bottom of the diluent container gently to inflate the portion of. Apr 07, 2020 ent dhingra 5th edition pdf diseases of ear, nose and throat 7th revised edition edition p. What you need to know before you use cidofovir cidofovir must be administered by a healthcare professional.
Highlights of prescribing information reported cases. The included articles have reported few sideeffects. Cidofovir injection, 75 mgml, packaged in 375 mg5 ml singleuse vials. Argatroban package insert pdf store in original package until time of use. In vitro, cidofovir was less than 6% bound to plasma or serum proteins over the cidofovir concentration range 0. Nov 09, 2018 cidofovir is an antiviral medication that prevents certain viral cells from multiplying in your body. To ensure proper dosing, it is important that you follow the preparation and administration instructions outlined in. Cidofovir injection is a sterile, hypertonic aqueous solution for intravenous infusion only. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for vistide cidofovir. However, the world champion, rajzmanasserted himself as world champion with his tremendous abilities.
The drug is also used to prevent a relapse of cmv after the initial treatment. After incorporation into the host cell, cidofovir is phosphorylated by pyruvate kinases to its active metabolite cidofovir diphosphate. Cidofovir usp is a white crystalline powder with an aqueous solubility of. These highlights do not include all the information needed to use advate safely and effectively.
The primary objectives of this randomized, doubleblind, placebocontrolled, doseescalation study are to evaluate the safety and tolerability of 3 dose levels of cidofovir when administered to renal transplant recipients with bk virus nephropathy and to identify the maximum tolerated doses mtd among the 3 dose levels of cidofovir in renal transplant recipients with bk virus nephropathy. Niosh list of antineoplastic and other hazardous drugs in. Cidofovir cidofovir anhydrous injection, solution dailymed. Tell your doctor if you are taking or have recently taken any other medications that may cause kidney damage, some of which include amikacin, amphotericin b abelcet, ambisome, foscarnet foscavir, gentamicin, pentamidine pentam 300, tobramycin, vancomycin vancocin, and. Prospective trial with cidofovir at 1 mgkg intravenously 3 times weekly in the treatment of adv infections in hsct recipients. Pdf clinical and in vitro evaluation of cidofovir for. The pharmacokinetics of cidofovir without probenecid were evaluated in 27. Vistide is a sterile, hypertonic aqueous solution for intravenous infusion only.
The median time to complete or good response was 21 days, and the median time to negative viral culture was 2. Daunorubicin hydrochloride injection rx only warnings 1. Cidofovir injection vistide side effects, medical uses. This clause will help to protect sellers who must use reasonable endeavours to obtain a certificate in circumstances where either the country of import changes its requirements or, at. Tell your doctor if you have or have ever had kidney disease. Although the results are promising, there remains some concern about the potential carcinogenicity of cidofovir. Women of childbearing potential women who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy must agree to use 2. Apr 28, 2019 reproductive and developmental toxicity studies performed in rats at oral doses up to 6. Cidofovir anhydrous is an anhydrous form of cidofovir, a synthetic, acyclic monophosphate nucleotide analog of deoxycytidine with antiviral activity, mostly used against cytomegalovirus cmv. Cidofovir was the first nucleotide analogue approved for clinical use. Mar 10, 2020 macugen package insert pdf characterisation. Cidofovir injection, usp is a sterile, hypertonic aqueous solution for intravenous infusion only. May 06, 2008 recurrent respiratory papillomatosis rrp is a chronic and difficult to treat disease of the larynx. Severe local tissue necrosis will occur if there is extravasation during administration.
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