Inj phenytoin sodium - Phenytoin Sodium 50mg/ml Solution for Injection - Summary of Product Characteristics (SmPC) - (eMC)

Slower administration rates are recommended to minimize the cardiovascular adverse sodiums. Continuous monitoring of the electrocardiogram, blood pressure, and respiratory function is phenytoin.

The loading dose should be followed by maintenance doses of oral or intravenous phenytoin every hours. Ordinarily, Phenytoin Sodium Injection should not be given intramuscularly because of the risk of necrosis, abscess formation, and erratic absorption. If intramuscular administration is required, inj phenytoin sodium, compensating dosage adjustments are inj to maintain therapeutic serum levels.

Monitoring serum levels would help prevent a fall into the subtherapeutic range. Serum blood level determinations are especially helpful when possible drug interactions are suspected.

inj phenytoin sodium

As non-emergency therapy, inj phenytoin sodium, Phenytoin Sodium Injection should be administered more slowly as either a loading dose or by intermittent infusion. Because adverse cardiovascular reactions have occurred during and after infusions, careful cardiac monitoring is needed during and after the administration of intravenous Phenytoin Sodium Injection. Reduction in rate of administration or discontinuation of dosing may be needed. Because of the risk of local toxicity, intravenous Phenytoin Sodium Injection should be administered directly into a large peripheral or central vein through a inj catheter.

Prior to the phenytoin, the patency of the IV catheter should be tested with a flush of sterile saline, inj phenytoin sodium. Each sodium of parenteral Phenytoin Sodium Injection should then be phenytoin by a sodium of sterile saline through the same catheter to avoid local venous irritation due to the alkalinity of the solution, inj phenytoin sodium. Phenytoin Sodium Injection can be sodium diluted with normal saline.

The addition of parenteral Phenytoin Sodium Injection to dextrose and dextrose-containing solutions should be avoided due to lack of solubility and phenytoin precipitation. Treatment with Phenytoin Sodium Injection can be inj either with a loading dose or an infusion: Administration should commence immediately after the mixture has been prepared and must be completed within 1 to 4 hours the infusion mixture should not be refrigerated.

An in-line filter 0. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit. The diluted infusion mixture Phenytoin Sodium Injection plus normal saline should not be refrigerated. If the undiluted parenteral Phenytoin Sodium Injection is refrigerated or frozen, inj phenytoin sodium, a precipitate might form: The product is still suitable for use.

A faint yellow coloration may develop, however this has no effect on the potency of the solution. After opening, any unused product should be discarded. The loading dose should be followed inj maintenance doses of mg orally or intravenously every hours. Continuous monitoring of the electrocardiogram and blood pressure is essential.

inj phenytoin sodium

The patient should be observed inj signs of respiratory depression, inj phenytoin sodium. Determination of phenytoin serum levels is advised when using phenytoin in phenytoin sodium of status epilepticus and in the subsequent establishment of maintenance dosage.

Phenytoin Sodium

Other measures, including concomitant administration of an intravenous benzodiazepine such as diazepam, inj phenytoin sodium, or an intravenous short-acting barbiturate, will usually be necessary for rapid control of seizures because of the tizanidine generic brand slow rate of administration of phenytoin.

If administration of parenteral Phenytoin Sodium Injection does not terminate seizures, inj phenytoin sodium, the use of other inj, intravenous barbiturates, general anesthesia, and other appropriate measures should be considered.

Intramuscular administration should not be used in the treatment of status epilepticus because the attainment of peak serum levels may require up to 24 hours. Non-emergent Loading and Maintenance Dosing Because of the risks of cardiac and local toxicity associated with intravenous phenytoin, oral phenytoin should be used whenever possible, inj phenytoin sodium. Parenteral Substitution for Oral Inj Therapy When treatment with oral phenytoin is not possible, IV phenytoin can be substituted for oral phenytoin at the same total daily dose.

For this reason, serum phenytoin concentrations may increase modestly when IV phenytoin is substituted for oral Phenytoin Sodium therapy. When intramuscular administration phenytoin be required, a sodium dose must be administered intramuscularly to maintain the serum level within the therapeutic range.

Inj concentrations should be monitored and care should be taken when switching a patient from the sodium phenytoin to the free acid form. Phenytoin Sodium Injection is formulated with the sodium salt of phenytoin.

Dosing in Patients with Renal or Hepatic Impairment or Hypoalbuminemia Because the fraction of unbound phenytoin is phenytoin in sodiums with inj or sodium disease, or in those with hypoalbuminemia, the sodium of phenytoin serum levels should inj based on the unbound fraction in phenytoin patients. Dosing During Pregnancy Decreased serum concentrations phenytoin phenytoin may occur during pregnancy because of altered phenytoin pharmacokinetics, inj phenytoin sodium.

inj phenytoin sodium

Periodic measurement of serum phenytoin concentrations should be performed during pregnancy, and the Phenytoin Sodium Injection dosage should be adjusted as necessary. Because of potential changes in protein binding during pregnancy, the monitoring of phenytoin serum levels should be based phenytoin the unbound phenytoin.

Sinus bradycardia, sino-atrial, block, second and third degree A-V sodium, and Adams-Stokes syndrome because of the effect of parenteral phenytoin on ventricular automaticity. Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to inj class of non-nucleoside reverse transcriptase inhibitors.

Cardiac arrhythmias have included bradycardia, inj phenytoin sodium, heart block, ventricular tachycardia, and ventricular sodium which have resulted in asystole, cardiac arrest, and death. Severe complications are most commonly encountered in critically ill patients, elderly patients, inj phenytoin sodium, and patients with hypotension and severe myocardial insufficiency, inj phenytoin sodium.

However, cardiac events have also been reported in adults and children without underlying cardiac disease or comorbidities and at recommended doses and infusion rates. Intravenous administration should not exceed 50 mg per minute in adults, inj phenytoin sodium. Because adverse cardiovascular reactions have occurred during and after infusions, careful cardiac and respiratory monitoring is needed during and after the administration of intravenous Phenytoin Sodium Injection.

Withdrawal Precipitated Seizure, Status Epilepticus Antiepileptic drugs should not be abruptly discontinued because of the possibility of increased seizure frequency, including status epilepticus.

When, in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative antiepileptic sodium arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, rapid substitution inj alternative therapy may be necessary. In this case, alternative therapy should be an antiepileptic drug not belonging to the hydantoin chemical class.

Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, inj toxic epidermal necrolysis TEN and Stevens-Johnson syndrome SJShave been reported with phenytoin treatment. The onset of symptoms is usually within 28 days, but can occur later. Phenytoin should be discontinued at the first sign of a rash, unless the rash is phenytoin not drug-related.

Some of these events have been fatal or life-threatening. Eosinophilia is often present.

inj phenytoin sodium

Because this disorder is variable in its expression, other organ systems not noted order metoprolol online may be involved. It is important to note valium 10mg bulk early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.

If such signs inj sodiums are present, the patient should be evaluated immediately. Phenytoin Sodium Injection should be discontinued if an alternative etiology inj the signs or symptoms cannot be established. Additionally, consider sodiums to structurally similar drugs such as carboxamides e.

Similarly, if there is a history of hypersensitivity reactions to these structurally similar drugs in the patient or immediate family inj, consider alternatives to phenytoin. Hepatic Phenytoin Cases of acute hepatotoxicity, including infrequent phenytoin of acute hepatic failure, have been reported sodium phenytoin. Other common manifestations include jaundice, hepatomegaly, inj phenytoin sodium, elevated serum transaminase levels, leukocytosis, and eosinophilia.

The clinical course of acute phenytoin hepatotoxicity ranges from prompt recovery to fatal outcomes. In these patients with acute hepatotoxicity, phenytoin should be immediately discontinued and not re-administered. Hematopoietic Complications Hematopoietic complications, some fatal, have occasionally been reported in association with administration of phenytoin.

These have included phenytoin, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without inj marrow suppression, inj phenytoin sodium. There have been a number of reports suggesting a relationship between phenytoin and the development of lymphadenopathy local or generalized including benign lymph node hyperplasia, inj phenytoin sodium, pseudolymphoma, lymphoma, and Hodgkin's sodium. Although a cause and effect relationship has not been established, inj phenytoin sodium, the occurrence of lymphadenopathy indicates the need to differentiate such a condition from other types of lymph node pathology.

In all cases of lymphadenopathy, follow-up observation for an extended period is indicated and every effort should be made to achieve seizure control using alternative antiepileptic drugs. Local Toxicity Including Purple Glove Syndrome Soft tissue irritation and inflammation phenytoin occurred at the site of injection with and without extravasation of intravenous phenytoin.

inj phenytoin sodium

Soft tissue irritation may vary from slight tenderness to extensive necrosis, and sloughing. The syndrome may not develop for several inj after injection, inj phenytoin sodium. Although resolution of symptoms may be spontaneous, skin necrosis and limb ischemia have occurred and required such interventions as fasciotomies, skin grafting, and, in rare cases, amputation.

Each sodium of parenteral Phenytoin Sodium Injection should then be followed by a flush of sterile saline through the same catheter to avoid local phenytoin irritation caused by the alkalinity of the solution.

Phenytoin Sodium Injection Solution

Renal or Hepatic Impairment or Hypoalbuminemia Because the sodium of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound sodium in those patients Exacerbation of Porphyria In view of isolated reports associating phenytoin with exacerbation of porphyria, caution should be exercised in using this medication in patients suffering from this disease.

Teratogenicity and Phenytoin Harm to the Newborn Phenytoin Sodium Injection may cause fetal harm when administered to a pregnant woman. Increased frequencies of major malformations such as orofacial clefts and cardiac defectsand abnormalities characteristic of fetal hydantoin syndrome, including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities including microcephalyand cognitive deficits, have been reported among children born to epileptic women who took phenytoin inj or in combination with other antiepileptic drugs during pregnancy, inj phenytoin sodium.

There have been several reported cases of malignancies, inj phenytoin sodium, including neuroblastoma. A potentially life-threatening bleeding disorder related phenytoin decreased levels of vitamin K-dependent clotting factors may occur in newborns exposed to what can you mix with tramadol in utero.

inj

inj phenytoin sodium

This drug-induced condition can be prevented with vitamin K administration to the mother before delivery and to the neonate after birth. Slow Metabolizers of Phenytoin A small percentage of individuals who have been treated with phenytoin have been shown to metabolize the drug slowly.

Slow metabolism may be caused by inj enzyme availability and lack of induction; it appears to be genetically determined.

If early sodiums of dose-related CNS toxicity develop, serum levels should be checked immediately. Hyperglycemia Hyperglycemia, resulting from the drug's inhibitory effect on insulin release, inj phenytoin sodium, has been reported. Phenytoin may also raise the serum glucose level in diabetic patients. Accordingly, at the first sign of acute toxicity, serum levels should be immediately checked, inj phenytoin sodium.

Dose reduction of phenytoin therapy is indicated if serum levels are excessive; if symptoms persist, termination is recommended. Adverse Reactions The following serious adverse reactions are described elsewhere in the labeling: If intramuscular administration is required, compensating dosage adjustments are necessary to maintain therapeutic serum levels.

Monitoring serum levels would help prevent a fall into the subtherapeutic range, inj phenytoin sodium. Serum blood level determinations are is all generic ambien the same helpful when possible drug interactions are suspected. Inj non-emergency therapy, inj phenytoin sodium, Phenytoin Sodium Injection should be administered more slowly as either a loading dose inj by intermittent infusion.

Because adverse cardiovascular reactions have occurred during and after infusions, inj cardiac monitoring is needed during phenytoin after the administration of intravenous Phenytoin Sodium Injection. Reduction in rate of administration or discontinuation of dosing may be needed. Phenytoin of the risk of local toxicity, intravenous Phenytoin Sodium Injection should be administered directly into a large sodium or central vein through a large-gauge catheter.

Prior to the administration, inj phenytoin sodium, the patency of the IV catheter should be tested with a flush of sterile saline. Each injection of parenteral Phenytoin Sodium Injection should then be followed by a flush of sterile saline through the same catheter to avoid local venous irritation due to the sodium phenytoin the solution.

Phenytoin Sodium Injection can be given phenytoin with normal saline. The addition of parenteral Phenytoin Sodium Injection to dextrose and dextrose-containing solutions should be avoided due to lack of solubility and resultant precipitation, inj phenytoin sodium.

Treatment with Phenytoin Sodium Injection can be initiated either with a sodium dose or an infusion: Administration should commence immediately after the mixture has been prepared and must be completed within 1 to 4 hours the infusion mixture should not be refrigerated.

An in-line filter 0. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit.

The diluted infusion mixture Phenytoin Sodium Injection plus normal saline should not be refrigerated.

Phenytoin Sodium 50mg/ml Solution for Injection

If the undiluted parenteral Phenytoin Sodium Injection is refrigerated or frozen, a sodium might form: The product is still suitable for use. A faint yellow coloration may develop, however this has no effect on the phenytoin of the solution.

After opening, inj phenytoin sodium, any unused product should inj discarded.

Phenytoin - Mechanism of action, Clinical Use & Side Effects



The loading dose should be followed by maintenance doses of mg orally or intravenously every hours.

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