Phenytoin Injection

Description

Product Description: Phenytoin Injection is a carefully formulated pharmaceutical solution containing phenytoin sodium, a widely used antiepileptic medication. This injection is designed to provide rapid and effective control of seizures in various forms of epilepsy. Manufactured to the highest quality standards, Phenytoin Injection offers essential support for patients with epilepsy to manage their condition effectively.

Indications and Usage: Phenytoin Injection is indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures. It is used as an adjunctive therapy in the treatment of epilepsy when oral phenytoin administration is not feasible or desirable. Additionally, it may be used in the management of status epilepticus and certain cardiac arrhythmias.

Dosage and Administration: The dosage of Phenytoin Injection varies depending on the patient's age, weight, and clinical condition. It is typically administered via intravenous infusion or slow intravenous injection under the supervision of a healthcare professional. The initial loading dose and maintenance dose should be individualized based on the patient's response and serum phenytoin levels.

Dosage Forms and Strengths: Phenytoin Injection is available as a sterile solution in vials containing phenytoin sodium formulated for parenteral administration. Each vial contains a specific concentration of phenytoin sodium, allowing for accurate dosing and optimal therapeutic outcomes.

Contraindications: This product is contraindicated in patients with a known hypersensitivity to phenytoin or any of the excipients. It should not be used in patients with sinus bradycardia, sino-atrial block, second- or third-degree atrioventricular block, or Adams-Stokes syndrome. Additionally, it is contraindicated in patients with a history of acute hepatic porphyria.

Warnings and Precautions: Healthcare providers should exercise caution when administering Phenytoin Injection to patients with hepatic or renal impairment, as dosage adjustment may be necessary to prevent toxicity. Patients should be monitored closely for signs of hypersensitivity reactions, including rash, fever, and lymphadenopathy. Long-term use of phenytoin may lead to gingival hyperplasia, which requires regular dental evaluation.

Adverse Reactions/Side Effects: Common adverse reactions associated with Phenytoin Injection include dizziness, drowsiness, ataxia, and nystagmus. Gastrointestinal symptoms, such as nausea, vomiting, and constipation, may also occur. Less common adverse effects include rash, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Patients should be advised to report any unusual symptoms promptly.

Drug Interactions: Phenytoin may interact with a wide range of medications, including other antiepileptic drugs, anticoagulants, oral contraceptives, and corticosteroids. Healthcare providers should review the patient's medication profile carefully to identify potential drug interactions and adjust dosage as necessary to minimize risks.

Use In Specific Populations Description: Safety and efficacy of Phenytoin Injection in pediatric patients, pregnant women, and nursing mothers have not been established conclusively. Healthcare providers should assess the potential risks and benefits before prescribing this medication in these populations.

How Supplied/Storage and Handling: Phenytoin Injection is supplied as a sterile solution in vials for intravenous administration. It should be stored at controlled room temperature (20°C to 25°C) away from light and moisture. Care should be taken to ensure proper storage and handling to maintain the integrity of the product. Unused portions should be discarded according to standard procedures for biohazardous waste.