Highlights of prescribing information these highlights do not. Valcyte valganciclovir hydrochloride tablets, valcyte valganciclovir hydrochloride for oral solution. Ganciclovir fda label aidsinfo information on hivaids. These highlights do not include all the information needed to use valtrex safely and effectively. Zirgan should only be used in the eye do not wear contact lenses while using. Ancef prescribing information pdf ancef official prescribing information for healthcare professionals. See full prescribing information for complete boxed warning. Highlights of prescribing information these highlights do not include all of the information needed to use zirgantm safely and effectively. These highlights do not include all the information needed to. The chemical name for ganciclovir sodium is 92hydroxy1hydroxymethylethoxymethylguanine. Cytoveneiv ganciclovir, formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to offwhite lyophilized powder. Refer to the respective prescribing information of the coadministered drugs to confirm compatibilityof. Highlights of prescribing information adult patients.
This means it is changed to ganciclovir once it is absorbed into the body. This infection usually occurs in patients who have suppressed immune systems such. Ganciclovir is an antiviral drug that slows the growth and spread of the cytomegalovirus cmv. Highlights of prescribing information these highlights. Ganciclovir capsules fda prescribing information, side. Side effects of cytovene ganciclovir, warnings, uses. Ganciclovir for injection, usp ganciclovir sodium is supplied in 10 ml sterile vials, each containing ganciclovir sodium equivalent to 500 mg of ganciclovir as a white lyophilized cake or powder. It is also considered likely to cause inhibition of spermatogenesis.
Highlights of prescribing information valcytefor oral. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Ganciclovir is a polar hydrophilic compound with a solubility of 2. Draft guidance on ganciclovir this draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this topic. Zirgan is indicated for topical ophthalmic use only. Vials of vinblastine sulfate for injection usp contain 10 mg. Istodax is supplied as a kit which includes a sterile, lyophilized powder in a 10 mg singledose vial containing 11 mg of romid epsin and 22 mg of the bulking agent, povidone, usp. Highlights of prescribing information these highlights do not include all the information needed to use cytovene iv safely and effectively.
Dosage information ganciclovir comes in capsule, injectable liquid, and eye implant forms. Ganciclovir was the first antiviral agent approved for the treatment of cytomegalovirus cmv infection. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus cmv. Valtrex valacyclovir, valcyte valganciclovir, cytovene. Survival was 60% in the ganciclovir group and 80% in patients receiving cmvigiv and ganciclovir p. Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been. Ganciclovir side effects, dosage, interactions drugs.
Cytoveneiv ganciclovir sodium for injection, for intravenous use. This infection usually occurs in patients who have suppressed immune systems such as patients with aids and organ transplant patients. Ganciclovir is a white to offwhite crystalline powder with a molecular formula of c 9 h n 5 0 4 and a molecular weight of 255. Actemra subcutaneous formulation is not intended for. Accidental release measures contain spill and collect, as appropriate. Ganciclovir is used to treat cmv retinitis in people with immunosuppression caused by hiv or. It is used to prevent disease caused by a virus called cytomegalovirus cmv in people who have received organ or. Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Highlights of prescribing information these highlights do not include all the information needed to. Ganciclovir may lower the number of all types of cells in your blood, causing serious and lifethreatening problems. Ganciclovir fda prescribing information, side effects and uses.
Sections or subsections omitted from the full prescribing information. May 15, 2015 the current pi format contains two main components. Ganciclovir for injection usp is indicated for the treatment of cytomegalovirus cmv retinitis in. Highlights of prescribing information these highlights do not include all the information needed to use recarbrio safely and effectively. Dosing algorithms valganciclovir dose according to the prescribing information 7. Highlights of prescribing information adult patients should. Cytovene ganciclovir is an antiviral drug used to treat and prevent infections caused by cytomegalovirus. Myfortic mycophenolic acid delayedrelease tablets, for oral use initial u. Valcytevalganciclovirtablets, valcytevalganciclovir hydrochloride fororal solution initial u.
The product information may be subsequently updated by the member state. The most common side effects reported in patients were blurred vision, eye irritation, eye redness and punctate keratitis a specific type of eye surface irritation. Investigational entry inhibitors these entry inhibitors have not been approved by the fda. Cytomegalovirus immune globulin csl behring warnings cytogam. Ganciclovir is considered a potential human carcinogen, teratogen, and mutagen. Actemra subcutaneous formulation is not intended for intravenous. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Ganciclovir, when formulated as monosodium salt in the intravenous iv.
Pediatric dosing of ganciclovir and valganciclovir. It is widely used for the treatment of cmv infections among patients with impaired cellmediated immunity, particularly persons with poorly controlled and advanced hivaids, and recipients of solid organ and bone marrow transplantation, who. As ganciclovir is mainly renally excreted and since renal clearance decreases with age, a decrease in ganciclovir total body clearance and a prolongation of ganciclovir halflife can be anticipated in patients 65 years of age and older see dosage and administration 2. The clinical formulation is supplied in a sterile form for intravenous use only. Refer to the policy on cytotoxicbiotherapy agents administration within the clinical practice manual for further information. The lyophilized powder has an aqueous solubility of greater than 50 mgml at 25c.
Ganciclovir is available as 250 mg and 500 mg capsules. This information is generalized and not intended as specific medical advice. Recarbrio imipenem, cilastatin, and relebactamfor injection, for intravenous use initial u. Aidsinfo provides the following drug label solely as an example of the labels available for ganciclovir. The capsule form of ganciclovir should be taken by mouth with food. Oct 06, 2017 ganciclovir is a white to offwhite crystalline powder with a molecular formula of c 9 h n 5 0 4 and a molecular weight of 255. Highlights of prescribing information valacyclovir. Cytoveneiv ganciclovir sodium for injection, for intravenous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use myfortic safely and effectively. Thus, it is used judiciously and handled as a cytotoxic. Jun 01, 2019 ganciclovir is a white to offwhite crystalline powder. These highlights do not include all the information needed to use actemra safely and effectively.
Dosage information ganciclovir comes in capsule, injectable. The current pi format contains two main components. More current versions may be available on the manufacturers web site. It is widely used for the treatment of cmv infections among patients with impaired cellmediated. Highlights of prescribing information use recarbrio safely.
Thus, it is used judiciously and handled as a cytotoxic drug in the clinical setting. These highlights do not include all the information needed. Please see safety information below and additional important safety information in the full prescribing information by clicking here. Several fdaapproved drug labels may be available for ganciclovir.
Cytoveneiv is the brand name for ganciclovir sodium for injection. Reduced susceptibility to cidofovir, however, has been reported for dna polymerase mutants of cmv which are resistant to ganciclovir69. Recent studies of combined prophylaxis with cmvigiv and ganciclovir have shown reductions in the incidence of. Do not take valcyte if you have ever had a serious reaction to valganciclovir, ganciclovir as valcyte or. To date, all clinical isolates which exhibit high level resistance to.
Highlights of prescribing information these highlights do not include all the information needed to use cytoveneiv safely and effectively. Ganciclovir prescribing information from the fda web site. Zirgan is used to treat eye ulcers caused by a herpes virus important safety information. Cytomegalovirus disease in the highly active antiretroviral therapy era. Valtrex valacyclovir, valcyte valganciclovir, cytovene ganciclovir, zovirax acyclovir click on the journals name and link will take you to the pubmed abstract and publisher website, respectively. Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or. Ganciclovir is a polar hydrophilic compound with a solubility.
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