Warnings for special population
Pregnancy
This medicine is not recommended for use in pregnant women unless absolutely necessary. Your doctor will determine the best course of treatment after evaluating the potential benefits and risks associated with the use of this medicine.
Breast-feeding
This medicine is not recommended for use in breastfeeding women unless absolutely necessary. Your doctor will determine the best course of treatment after evaluating the potential benefits and risks associated with the use of this medicine.
General warnings
Other medicines
This medicine may interact with many other medicines and may cause significant side effects. Hence, it is advised that you report all your current medicines to your doctor, including any herbs and supplements, before receiving this medicine.
Phenytoin equivalence
The dose of this medicine is always expressed in terms of phenytoin equivalence (PE) i.e., 1 mg PE is equivalent to 1 mg of phenytoin. Hence, dose adjustments are not recommended when switching from fosphenytoin to phenytoin or vice versa.
Liver diseases
This medicine should be used with caution in patients with a history of liver diseases due to the increased risk of worsening of the patient's condition. Close monitoring of liver function tests, appropriate dose adjustments, or replacement with a suitable alternative may be necessary based on the patient's clinical condition.
Kidney diseases
This medicine should be used with caution in patients with a history of kidney diseases due to the increased risk of worsening of the patient's condition. Close monitoring of kidney function tests, appropriate dose adjustments, or replacement with a suitable alternative may be necessary based on the patient's clinical condition.
Elevated blood glucose levels
This medicine should be used with caution in patients suffering from diabetes or patients predisposed to hyperglycemia due to the increased risk of elevated blood glucose levels. Close monitoring of blood sugar levels, appropriate dose adjustments, or replacement with a suitable alternative may be necessary based on the clinical condition of the patient.
Abrupt withdrawal
Use of this medicine should not be discontinued abruptly since this may increase the frequency of seizures. It is advised to reduce the dose gradually except in the event of severe allergic reactions where an alternative therapy may be necessary.
Cardiovascular events
Use of this medicine has been associated with a severe fall in blood pressure and heart rhythm disorders. Hence, it is recommended to use this medicine only in cases where oral phenytoin cannot be administered. The patient should be switched to oral phenytoin as soon as possible (within 5 days).
CNS events
Use of this medicine may cause delirium, psychosis, encephalopathy, etc. in some patients. Close monitoring of serum concentrations of this medicine is advised during therapy. Appropriate corrective measures, dose adjustments, or replacement with a suitable alternative may be necessary based on the patient's clinical condition.
Severe allergic reactions
Use of this medicine may cause severe and potentially life-threatening allergic reactions such as Stevens-Jonhson syndrome or toxic epidermal necrolysis in some patients. Use of this medicine should be discontinued and alternative therapy should be initiated if signs and symptoms suggestive of a severe allergic reaction occur.
Local toxicity
Use of this medicine may cause edema, discoloration, and pain near the injection site (Purple glove syndrome). These symptoms may develop for up to several days after the last administration of this medicine. Report any such symptoms to the doctor immediately.