Fosphenytoin Sodium (Cerebyx)

Trade Name : CEREBYX

Pfizer Laboratories Div Pfizer Inc

INJECTION, SOLUTION

Strength 50 mg/mL

FOSPHENYTOIN SODIUM Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fosphenytoin Sodium (Cerebyx) which is also known as CEREBYX and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 50 mg/mL per ml. Read more

Fosphenytoin Sodium (Cerebyx) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • The rate of intravenous CEREBYX administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous CEREBYX. Although the risk of cardiovascular toxicity increases with infusion rates above the recommended infusion rate, these events have also been reported at or below the recommended infusion rate. Reduction in rate of administration or discontinuation of dosing may be needed n
  • WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES
  • The rate of intravenous CEREBYX administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac arrhythmias.
  • Careful cardiac monitoring is needed during and after administering intravenous CEREBYX.
  • Reduction in rate of administration or discontinuation of dosing may be needed (, , )n
  • No data
  • CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible .
  • CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, as short-term use, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible. ()
  • No data
  • The dose, concentration, and infusion rate of CEREBYX should always be expressed as phenytoin sodium equivalents (PE)
  • For Status Epilepticus:
  • For Non-emergent Loading and Maintenance Dosing:
  • Intramuscular Administration:
  • CEREBYX Injection is a clear, colorless to pale yellow solution available as 50 mg phenytoin sodium equivalents (PE) per mL in:
  • Injection: 50 mg phenytoin sodium equivalents (PE)/mL available as:
  • 10 mL single-dose injection vials, each containing 500 mg PE ()
  • 2 mL single-dose injection vials, each containing 100 mg PE ()
  • CEREBYX is contraindicated in patients with:
  • Hypersensitivity to CEREBYX, its ingredients, phenytoin, hydantoins ()
  • Sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams-Stokes syndrome ()
  • A history of prior acute hepatotoxicity attributable to CEREBYX or phenytoin (, )
  • Coadministration with delavirdine ()
  • No data
  • Dosing Errors: n- .
  • Withdrawal Precipitated Seizure:
  • Serious Dermatologic Reactions:
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity:
  • Angioedema:
  • Hematopoietic Complications:
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions (incidence u226510%) are:
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or .
  • Adults:
  • Pediatrics:
  • Fosphenytoin is extensively bound to human plasma proteins. Drugs highly bound to albumin could increase the unbound fraction of fosphenytoin. Although, it is unknown whether this could result in clinically significant effects, caution is advised when administering CEREBYX with other drugs that significantly bind to serum albumin. The most significant drug interactions following administration of CEREBYX are expected to occur with drugs that interact with phenytoin. Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome P450 enzymes CYP2C9 and CYP2C19 and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. Monitoring of phenytoin serum levels is recommended when a drug interaction is suspected.
  • Phenytoin or CEREBYX is a potent inducer of hepatic drug-metabolizing enzymes.
  • Multiple drug interactions because of extensive plasma protein binding, saturable metabolism, and potent induction of hepatic enzymes (, )
  • No data
  • Pregnancy:
  • Renal and/or Hepatic Impairment or Hypoalbuminemia:
  • Nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcemia, metabolic acidosis, and death have been reported in cases of overdosage with CEREBYX.
  • Because CEREBYX is a prodrug of phenytoin, the following information about phenytoin overdosage may be helpful. Initial symptoms of acute phenytoin toxicity are nystagmus, ataxia, and dysarthria. Other signs include tremor, hyperreflexia, lethargy, slurred speech, nausea, vomiting, coma, and hypotension. Death is caused by respiratory and circulatory depression. The lethal dose of phenytoin in adults is estimated to be 2 to 5 grams. The lethal dose in pediatrics is not known.
  • There are marked variations among individuals with respect to serum phenytoin concentrations where toxicity occurs. Lateral gaze nystagmus usually appears at 20 u00b5g/mL, ataxia at 30 u00b5g/mL, and dysarthria and lethargy appear when the serum concentration is over 40 u00b5g/mL. However, phenytoin concentrations as high as 50 u00b5g/mL have been reported without evidence of toxicity. As much as 25 times the therapeutic phenytoin dose has been taken, resulting in serum phenytoin concentrations over 100 u00b5g/mL, with complete recovery. Irreversible cerebellar dysfunction and atrophy have been reported after overdosage.
  • Formate and phosphate are metabolites of CEREBYX and therefore may contribute to signs of toxicity following overdosage. Signs of formate toxicity are similar to those of methanol toxicity and are associated with severe anion-gap metabolic acidosis. Large amounts of phosphate, delivered rapidly, could potentially cause hypocalcemia with paresthesia, muscle spasms, and seizures. Ionized free calcium levels can be measured and, if low, used to guide treatment.
  • Treatment:
  • The adequacy of the respiratory and circulatory systems should be carefully observed, and appropriate supportive measures employed. Hemodialysis can be considered since phenytoin (the active metabolite of CEREBYX) is not completely bound to plasma proteins. Total exchange transfusion has been used in the treatment of severe intoxication in children.
  • In acute overdosage the possibility of other CNS depressants, including alcohol, should be borne in mind.
  • CEREBYX (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PEn
  • The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant.
  • CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE and 10 mL vials containing a total of 500 mg PE, for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution.
  • The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is:
  • The molecular weight of fosphenytoin is 406.24.
  • No data
  • No data
  • Infusion tolerance was evaluated in clinical studies. One double-blind study assessed infusion-site tolerance of equivalent loading doses (15 to 20 mg PE/kg) of CEREBYX infused at 150 mg PE/min or phenytoin infused at 50 mg/min. The study demonstrated better local tolerance (pain and burning at the infusion site), fewer disruptions of the infusion, and a shorter infusion period for CEREBYX-treated patients (Table 8).
  • CEREBYX-treated patients, however, experienced more systemic sensory disturbances . Infusion disruptions in CEREBYX-treated patients were primarily due to systemic burning, pruritus, and/or paresthesia while those in phenytoin-treated patients were primarily due to pain and burning at the infusion site (see ). In a double-blind study investigating temporary substitution of CEREBYX for oral phenytoin, IM CEREBYX was as well-tolerated as IM placebo. IM CEREBYX resulted in a slight increase in transient, mild to moderate local itching (23% of CEREBYX-treated patients vs 11% of IM placebo-treated patients at any time during the study). This study also demonstrated that equimolar doses of IM CEREBYX may be substituted for oral phenytoin sodium with no dosage adjustments needed when initiating IM or returning to oral therapy. In contrast, switching between IM and oral phenytoin requires dosage adjustments because of slow and erratic phenytoin absorption from muscle.
  • No data
  • No data
  • Distributed byPfizer LabsDivision of Pfizer IncNew York, NY 10017
  • Novaplus is a registered trademark of Vizient, Inc.
  • LAB-0731-18.0
  • NDC 0069-5474-0110 mL Single-dose Vial
  • Cerebyxn (fosphenytoin sodium) Injection
  • 500 mg PE/10 mL(50 mg PE/mL)(PE = phenytoin sodium equivalents)
  • NDC 0069-5474-02Contains 10 of NDC 0069-5474-01
  • 10 Single-dose Vials (10 mL each)
  • Cerebyxn (fosphenytoin sodium) Injection
  • For Intramuscular or Intravenous Use
  • 500 mg PE/10 mL(50 mg PE/mL)(PE = phenytoin sodium equivalents)
  • Rx only
  • novaplusn
  • NDC 0069-5471-01n n
  • Cerebyxn- (fosphenytoinsodium)Injection
  • 100 mg PE/2 mL
  • NDC 0069-5471-02 Contains 25 of NDC 0069-5471-01
  • 25 Single-dose Vials (2 mL each)
  • Cerebyxn (fosphenytoin sodium) Injection
  • For Intramuscular or Intravenous Use
  • 100 mg PE/2 mL (50 mg PE/mL) (PE = phenytoin sodium equivalents)
  • Rx only
  • novaplusn

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