Trade Name: Fosphenytoin Sodium

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Pharmaceuticals LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 50 mg/mL

Storage and handling

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 from India of Fosphenytoin (Fosphenytoin Sodium) which is also known as Fosphenytoin Sodium and Manufactured by Amneal Pharmaceuticals LLC. It is available in strength of 50 mg/mL.

Fosphenytoin (Fosphenytoin Sodium) 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.

  • No data
  • WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES
  • See full prescribing information for complete boxed warning.
  • The rate of intravenous fosphenytoin sodium 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 fosphenytoin sodium.
  • Reduction in rate of administration or discontinuation of dosing may be needed , , ).
  • Dosage and Administration (2.3, 2.4) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 1/2020n n
  • Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible and .
  • Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, as short-term use, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible. n
  • No data
  • The dose, concentration, and infusion rate of fosphenytoin sodium injection should always be expressed as phenytoin sodium equivalents (PE).
  • For Status Epilepticus:
  • For Non-emergent Loading and Maintenance Dosing:
  • Intramuscular Administration:
  • Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution available as 50 mg phenytoin sodium, USP equivalents (PE) per mL in:
  • Injection: 50 mg phenytoin sodium, USP equivalents (PE)/mL available as:
  • 10 mL single-dose injection vials, each containing 500 mg PE. n
  • 2 mL single-dose injection vials, each containing 100 mg PE. n
  • Fosphenytoin sodium injection is contraindicated in patients with:
  • Hypersensitivity to fosphenytoin sodium injection, its ingredients, phenytoin, hydantoins. n
  • Sinus bradycardia, sino-atrial block, second and third degree A-V block, and Adams-Stokes syndrome. n
  • A history of prior acute hepatotoxicity attributable to fosphenytoin sodium or phenytoin. n )
  • Co-administration with delavirdine. n
  • No data
  • Dosing Errors:
  • 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 u2265 10%) are:
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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 fosphenytoin sodium with other drugs that significantly bind to serum albumin. The most significant drug interactions following administration of fosphenytoin sodium 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 fosphenytoin sodium 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. u00a0n
  • 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 fosphenytoin sodium.
  • Because fosphenytoin sodium 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 mcg/mL, ataxia at 30 mcg/mL, and dysarthria and lethargy appear when the serum concentration is over 40 mcg/mL. However, phenytoin concentrations as high as 50 mcg/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 mcg/mL, with complete recovery. Irreversible cerebellar dysfunction and atrophy have been reported after overdosage.
  • Formate and phosphate are metabolites of fosphenytoin sodium 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 fosphenytoin sodium) 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.
  • Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium, USP 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 PE.
  • The pharmacological class of the fosphenytoin sodium, USP is hydantoin derivative, and the therapeutic class is anticonvulsant.
  • Fosphenytoin sodium, USP 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. Fosphenytoin sodium, USP 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. Fosphenytoin sodium, USP 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
  • Carcinogenesis
  • [see ]
  • The carcinogenic potential of fosphenytoin has not been assessed. In carcinogenicity studies, phenytoin (active metabolite of fosphenytoin) was administered in the diet to mice (10 mg, 25 mg, or 45 mg/kg/day) and rats (25 mg, 50 mg, or 100 mg/kg/day) for 2 years. The incidences of hepatocellular tumors were increased in male and female mice at the highest dose. No increases in tumor incidence were observed in rats. The highest doses tested in these studies were associated with peak plasma phenytoin levels below human therapeutic concentrations.
  • In carcinogenicity studies reported in the literature, phenytoin was administered in the diet for 2 years at doses up to 600 ppm (approximately 160 mg/kg/day) to mice and up to 2,400 ppm (approximately 120 mg/kg/day) to rats. The incidences of hepatocellular tumors were increased in female mice at all but the lowest dose tested. No increases in tumor incidence were observed in rats.
  • Mutagenesis
  • An increase in structural chromosome aberrations were observed in cultured V79 Chinese hamster lung cells exposed to fosphenytoin in the presence of metabolic activation. No evidence of mutagenicity was observed in bacteria (Ames test) or Chinese hamster lung cells , and no evidence for clastogenic activity was observed in an mouse bone marrow micronucleus assay.
  • Impairment of Fertility
  • Fosphenytoin was administered to male and female rats during mating and continuing in females throughout gestation and lactation at doses of 50 mg PE/kg or higher. No effects on fertility were observed in males. In females, altered estrous cycles, delayed mating, prolonged gestation length, and developmental toxicity were observed at all doses, which were associated with maternal toxicity. The lowest dose tested is approximately 40% of the maximum human loading dose on a mg/m basis.
  • Infusion tolerance was evaluated in clinical studies. One double-blind study assessed infusion-site tolerance of equivalent loading doses (15 mg to 20 mg PE/kg) of fosphenytoin sodium 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 fosphenytoin sodium-treated patients (Table 8).
  • Table 8: Infusion Tolerance of Equivalent Loading Doses of IV Fosphenytoin Sodium and IV Phenytoin
  • Fosphenytoin sodium-treated patients, however, experienced more systemic sensory disturbances . Infusion disruptions in fosphenytoin sodium-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 Table 8). In a double-blind study investigating temporary substitution of fosphenytoin sodium for oral phenytoin, IM fosphenytoin sodium was as well-tolerated as IM placebo. IM fosphenytoin sodium resulted in a slight increase in transient, mild to moderate local itching (23% of fosphenytoin sodium-treated patients vs. 11% of IM placebo-treated patients at any time during the study). This study also demonstrated that equimolar doses of IM fosphenytoin sodium 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
  • Cardiovascular Risk Associated with Rapid Infusion
  • Inform patients that rapid intravenous administration of fosphenytoin sodium increases the risk of adverse cardiovascular reactions, including severe hypotension and cardiac arrhythmias. Cardiac arrhythmias have included bradycardia, heart block, ventricular tachycardia, and ventricular fibrillation which have resulted in asystole, cardiac arrest, and death. Patients should report cardiac signs or symptoms to their healthcare provider .
  • Withdrawal of Antiepileptic Drugs
  • Advise patients not to discontinue use of fosphenytoin sodium without consulting with their healthcare provider. Fosphenytoin sodium should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus .
  • Serious Dermatologic Reactions
  • Advise patients of the early signs and symptoms of severe cutaneous adverse reactions and to report any occurrence immediately to a physician .
  • Potential Signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Other Systemic Reactions
  • Advise patients of the early toxic signs and symptoms of potential hematologic, dermatologic, hypersensitivity, or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy, facial swelling, and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. Advise the patient that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician. In addition, advise the patient that these signs and symptoms should be reported even if mild or when occurring after extended use .
  • Angioedema
  • Advise patients to discontinue fosphenytoin sodium and seek immediate medical care if they develop signs or symptoms of angioedema such as facial, perioral, or upper airway swelling .
  • Hyperglycemia
  • Advise patients that fosphenytoin sodium may cause an increase in blood glucose levels .
  • Effects of Alcohol Use and Other Drugs and Over-the-Counter Drug Interactions
  • Caution patients against the use of other drugs or alcoholic beverages without first seeking their physicianu2019s advice .
  • Inform patients that certain over-the-counter medications (e.g., cimetidine and omeprazole), vitamins (e.g., folic acid), and herbal supplements (e.g., St. Johnu2019s wort) can alter their phenytoin levels.
  • Use in Pregnancy
  • Inform pregnant women and women of childbearing potential that use of fosphenytoin sodium during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), cardiac defects, dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using fosphenytoin sodium, keeping in mind that there is a potential for decreased hormonal contraceptive efficacy .
  • Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breastfeeding or intend to breastfeed during therapy .
  • Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy .
  • This productu2019s label may have been updated. For current full prescribing information, please visit www.amneal.com.
  • Brands listed are the trademarks of their respective owners.
  • Made in India.
  • Manufactured by:n n
  • Ahmedabad 382213, INDIA
  • Distributed by:n Bridgewater, NJu00a0 08807
  • Rev. 01-2021-07
  • NDC 70121-1381-1
  • Fosphenytoin Sodium Injection, USP
  • 100 mg PE*/2 mL (50 mg PE/mL)n
  • Rx only
  • Amneal Pharmaceuticals LLC
  • NDC 70121-1381-5
  • Fosphenytoin Sodium Injection, USP
  • 100 mg PE*/2 mL (50 mg PE/mL)n
  • Rx only
  • Amneal Pharmaceuticals LLC
  • Arrayn- Array
  • NDC 70121-1390-1
  • Fosphenytoin Sodium Injection, USP
  • 500 mg PE*/10 mL (50 mg PE/mL)n
  • Rx only
  • Amneal Pharmaceuticals LLC
  • Arrayn- Array
  • NDC 70121-1390-7
  • Fosphenytoin Sodium Injection, USP
  • 500 mg PE*/10 mL (50 mg PE/mL)n
  • Rx only
  • Amneal Pharmaceuticals LLCn

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