Fosphenytoin package insert pdf

The dose, concentration, and infusion rate of cerebyx should always be expressed as phenytoin sodium equivalents pe. Glucagon administered through a parenteral route relaxes smooth muscle of the stomach, duodenum, small bowel, and colon. Nda 020450 cerebyx fosphenytoin sodium injection fda approved labeling text dated 102011. The volume of distribution of fosphenytoin increases with cerebyx dose and rate, and ranges from 4. Mk the risk or severity of adverse effects prrscribing be increased when fosphenytoin fowphenytoin combined with mk albendazole the serum concentration of the active metabolites of albendazole can be reduced when albendazole is used in. Occupational exposure has not been fully investigated. Following administration of single iv fosphenytoin doses of 400 to 1200 mg pe. Phenobarbital sodium injection, usp is a sterile solution for intramuscular or slow intravenous administration as a longacting barbiturate. Cerebyx fosphenytoin sodium dosage and administration. The amount and concentration of fosphenytoin is always expressed in terms of mg pe. Vfend is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with.

Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. However, since cmv usually causes latent infections and since foscarnet, like. Cerebyx fosphenytoin sodium injection package insert. Minimum ppe required ppe requirements hazardous drug.

Cerebyx medication page for healthcare professionals to search for scientific information on pfizer medications. Department of health and human services, centers for disease control and prevention, national institute for occupa. Fosphenytoin administered intravenously or intramuscularly is 100 percent bioavailable and is 90 to 95 percent protein bound. Mk the risk or severity of adverse effects prrscribing be increased when fosphenytoin fowphenytoin combined with mk albendazole the serum concentration of the active metabolites of albendazole can be reduced when albendazole is used in combination with. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Sep 19, 2019 when fosphenytoin sodium injection is given as an intravenous infusion, fosphenytoin sodium injection needs to be diluted and should only be administered at a rate not exceeding 150 mg pemin. Throughout all fosphenytoin injection product labeling, the amount and. Individuals with hypersensitivity to fosphenytoin sodium injection or its ingredients or to phenytoin or other hydantoins. Fosphenytoin sodium injection and other hydantoins are contraindicated in patients who have experienced phenytoin hypersensitivity see contraindications 4. For every mmol of fosphenytoin administered, one mmol of phenytoin is produced. Fosphenytoin sodium injection, usp amneal pharmaceuticals. Minimum ppe required ppe requirements hazardous drug handling.

By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. Fosphenytoin sodium reference guide for safe and effective use from the american. Each vial contains fosphenytoin sodium 150 mg equivalent to 100 mg phenytoin sodium, tromethamine tris as a buffer, hydrochloric acid or sodium hydroxide to adjust the ph to 8. The mechanism of fosphenytoin conversion has not been determined, but phosphatases probably play a major role. The conversion halflife of fosphenytoin to phenytoin is approximately 15 minutes. Fosphenytoin sodium injection, usp full prescribing information.

Fosphenytoin sodium injection, usp rx only warning amneal. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. Dec 10, 2018 phenobarbital sodium injection, usp is a sterile solution for intramuscular or slow intravenous administration as a longacting barbiturate. Sections or subsections omitted from the full prescribing information are not listed. Cerebyx fda prescribing information, side effects and uses. Prior to iv infusion, dilute cerebyx in 5% dextrose or 0. Cerebyx fosphenytoin sodium injection, for intravenous or intramuscular use. Fosphenytoin is used to prevent or control seizures. Fosphenytoin is metabolized to phenytoin, phosphate, and formate.

May 17, 2019 folic acid, np2amino4 hydroxy6pteridinyl methyl amino benzoyllglutamic acid, is a b complex vitamin containing a pteridine moiety linked by a methylene bridge to paraaminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Trileptal may be increased as clinically indicated by a maximum increment of 600 mgday at approximately weekly intervals to achieve the maximum recommended daily dose of 2400 mgday. Patients with an acute cerebrovascular event may be at increased risk of hypotension and require particularly close monitoring. Fosphenytoin sodium injection, usp is supplied in vials as a sterile solution in water for injection and tromethamine tris, buffer adjusted to ph 8. This package insert must be read carefully before product use. There is no need to perform molecular weightbased adjustments when converting between fosphenytoin and. The mechanism of action of fosphenytoin is related to the. Fosphenytoin sodium injection, usp is indicated for the control of generalized tonicclonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin can also be substituted, shortterm, for oral phenytoin. Fosphenytoin sodium injection should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Injectafer ferric carboxymaltose injection, for intravenous use initial u. Fosphenytoin should be used only when oral phenytoin administration is not possible. Venofer is indicated for the treatment of iron deficiency anemia in patients. Labeling package insert label is not available on this site.

Each ml contains phenobarbital sodium either 65 mg or mg, alcohol 0. Feb 01, 2020 the volume of distribution of fosphenytoin increases with cerebyx dose and rate, and ranges from 4. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for tikosyn dofetilide. Dec 23, 2019 fosphenytoin sodium injection should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Intravenous phenytoin or phosphenytoin will be administered by the administration routes, at the. Fosphenytoin injection, usp 100 mg pe2 ml sodium store under. Nov 09, 2018 fosphenytoin is an anticonvulsant that works by slowing down impulses in the brain that cause seizures. Dec 21, 2016 ascorbic acid injection is a clear, colorless to slightly yellow sterile solution of ascorbic acid in water for injection, for intravenous, intramuscular or subcutaneous use.

Products with particulate matter or discoloration should not be used. Folic acid injection, usp is a sterile, nonpyrogenic solution of sodium folate prepared by the addition of sodium hydroxide to folic acid in water for injection intended for. Csl behring immune globulin intravenous human, 10%. The dose should be increased by 5 mgkgday every third day to the recommended daily dose shown in the table below. Fosphenytoin injection, usp 100 mg pe2 ml sodium store. Fosphenytoin fda prescribing information, side effects. Dec 10, 2018 phenytoin sodium injection, usp is a sterile solution containing in each ml phenytoin sodium 50 mg, propylene glycol 0.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container. Glucagon acts only on liver glycogen, converting it to glucose. Ndc 6332340302 400302 fosphenytoin sodium injection, usp 100 mg pe2 ml 50 mg peml pe phenytoin sodium equivalents for im or iv use rx only 2mlsingle use vials sterile each vial contains fosphenytoin sodium 150 mg equivalent to 100 mg phenytoin sodium, tromethamine tris as a buffer, hydrochloric acid or sodium hydroxide to adjust the ph to 8. Call your abbott representative this package insert must be read carefully before product use. Phenytoin sodium injection, usp is a sterile solution containing in each ml phenytoin sodium 50 mg, propylene glycol 0. Full prescribing information 1 indications and usage rotarix is indicated for the prevention of rotavirus gastroenteritis caused by g1 and nong1 types g3, g4, and g9 when administered as a 2dose series see clinical studies 14. Range of maintenance doses of trileptal for pediatrics by weight during monotherapy from to weight in kg dose mgday dose mgday 20 600 900. Package insert folic acid injection 5 mgml usp anemia. The recommended dose of yervoy ipilimumab is 3 mgkg administered intravenously iv over 90 minutes every 3 weeks for a maximum of 4 doses. Folic acid, np2amino4 hydroxy6pteridinyl methyl amino benzoyllglutamic acid, is a b complex vitamin containing a pteridine moiety linked by a methylene bridge to paraaminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Ndc 6332340302 400302 fosphenytoin sodium injection, usp 100 mg pe2 ml 50 mg peml pe phenytoin sodium equivalents for im or iv use rx only 2mlsingle use vials sterile.

Use caution when administering cerebyx because of the risk of dosing errors see warnings and precautions 5. Esophageal candidiasis serious fungal infections caused by scedosporium apiospermum and fusarium species including fusarium solani, in patients intolerant of, or refractory. Minimum ppe required handling only no alteration contained crushsplit crushsplit minimum ppe required abacavir susp 2 ziagenepzicomtrizivir low abacavir tablet 2 ziagenepzicomtrizivir universal low moderate acitretin capsule 3 soriatane universal moderate anastrazole tablet 1 arimidex low moderate high android capsule 3 methyltestosterone universal moderate. This increases the fraction of phenytoin unbound up to 30% unbound during the period required for conversion of fosphenytoin to phenytoin approximately 0. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Jun 17, 2019 fosphenytoin package insert pdf 7 drug interactions. Phenytoin sodium is related to the barbiturates in chemical structure, but has a fivemembered ring. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose see clinical studies 14. Venofer iron sucrose injection, usp is an established and effective treatment for chronic kidney disease ckd patients experiencing iron deficiency anemia.

Download product insert pdfdownload safety data sheet sds pdf. Highlights of prescribing information these highlights do not include all the information needed to usegilenya safely and effectively. Cerebyx fosphenytoin sodium pfizer medical information us. Fosphenytoin side effects, dosage, interactions drugs. Standard solution and sample solution fosphenytoin sodium is a prodrug. A daily dose of 1200 mgday has been shown in one study to be effective in patients in whom.

Fosphenytoin sodium injection, usp 100 mg pe2 ml fda. Pharmacokinetics of fosphenytoin in patients with hepatic or renal. Product monograph cerebyx fosphenytoin sodium injection, 75. The amount and concentration of fosphenytoin is always expressed in terms of mg of phenytoin sodium equivalents mg pe.

Dec 09, 2019 cerebyx fosphenytoin sodium injection is a prodrug intended for parenteral administration. Pharmacology and pharmacokinetics of fosphenytoin neurology. Drug research unit of the department of clinical pharmacy and fdepartment of medicine, university. Invasive aspergillosis candidemia in nonneutropenics and other deep tissue candida infections. Fosphenytoin is a prodrug of phenytoin that is rapidly converted to phenytoin. Fosphenytoin displaces phenytoin from protein binding sites.

Ascorbic acid injection is a clear, colorless to slightly yellow sterile solution of ascorbic acid in water for injection, for intravenous, intramuscular or subcutaneous use. Minimum ppe required handling only no alteration contained crushsplit crushsplit minimum ppe required abacavir susp 2 ziagenepzicomtrizivir low abacavir tablet 2 ziagenepzicomtrizivir universal low moderate. Fosphenytoin is extensively bound to human plasma proteins. See full prescribing information for recommended dosages of concomitant dexamethasone and 5ht3 antagonist for hec and mec.

Fosphenytoin, a watersoluble prodrug of the antiepileptic drug phenytoin, is entirely and rapidly converted to this antiepileptic drug. Prescribing information pdf, search, whats new, other resources. Phenytoinfosphenytoin administration guidelines purpose. Treatment is nonspecific since there is no known antidote to fosphenytoin sodium or phenytoin overdose. This page should automatically displaydownload the products full prescribing information. Do not confuse the concentration of cerebyx with the total amount of drug in the vial.

Highlights of prescribing information emend capsules and. When fosphenytoin sodium injection is given as an intravenous infusion, fosphenytoin sodium injection needs to be diluted and should only be administered at a rate not exceeding 150 mg pemin. Highlights of prescribing information these highlights do not. One of the first fosphenytoin clinical studies enrolled neurosurgical patients and investigated the safety, tolerability, and pharmacokinetics of fosphenytoin compared to iv phenytoin. Niosh list of antitneoplastic and other hazardous drugs in. However, fosphenytoin displaces phenytoin from plasma protein binding sites. The hydrolysis of fosphenytoin to phenytoin yields two metabolites, phosphate and. Ensure that correct volume of drug in ml is withdrawn from vial. Niosh list of antineoplastic and other hazardous drugs in healthcare settings 2014. Fosphenytoin sodium injection, usp is a clear, colorless sterile solution. Cardiovascular risk associated with rapid infusion rates see full prescribing information for complete boxed warning the rate of intravenous cerebyx administration should not exceed 150 mg phenytoin sodium equivalents pe per minute in adults and 2 mg pekgmin or 150 mg pemin, whichever is slower in pediatric patients because of the risk of severe hypotension and cardiac. The purpose of this issuance is to establish safe guidelines for administration of iv phenytoin and fosphenytoin using either intravenous push or intravenous infusion.