PHARMANIAGA PHENYTOIN SODIUM SOLUTION FOR INJECTION 250MG/5ML

PHARMANIAGA LIFESCIENCE SDN. BHD. (MALAYSIA)🇸🇬 Health Sciences Authority

Approval Date: Aug 2, 2022
Approval ID: b642caf2cdc7578d
Company: PHARMANIAGA LIFESCIENCE SDN. BHD. (MALAYSIA)
Type: Therapeutic

Approval Details

Approval Id: b642caf2cdc7578d
Drug Name: PHARMANIAGA PHENYTOIN SODIUM SOLUTION FOR INJECTION 250MG/5ML
Product Name: PHARMANIAGA PHENYTOIN SODIUM SOLUTION FOR INJECTION 250MG/5ML
Approval Number: SIN16560P
Approval Date: 2022-08-02
Registrant: GOLDPLUS UNIVERSAL PTE LTD
Licence Holder: GOLDPLUS UNIVERSAL PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: RECOMMENDED DOSAGE General: Phenytoin capsules and solution for injection are formulated with the sodium salt of phenytoin. The free acid form of phenytoin is used in the phenytoin suspension (30mg/5mL (paediatric) and 125mg/5mL) and in the phenytoin tablets. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa. Phenytoin serum level determinations may be necessary to achieve optimal dosage adjustments. Optimum control without clinical sign of toxicity occurs most often with serum levels between 10 and 20mcg/ml. Parenteral Phenytoin may be administered as a slow intravenous (IV) bolus or it may be administered via an IV infusion. Because of the risks of cardiac and local toxicity associated with intravenous phenytoin, oral phenytoin should be used whenever possible. Because of the risk of local toxicity, intravenous phenytoin should be administered directly into a large peripheral or central vein through a large-gauge catheter. Prior to the administration, the patency of the IV catheter should be tested with a flush of sterile saline. Each injection or infusion of parenteral phenytoin should then be preceded and followed by a flush of sterile saline through the same needle or catheter to avoid local venous irritation due to the alkalinity of the solution. (see Section WARNINGS AND PRECAUTIONS – Local Toxicity (including Purple Glove Syndrome) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Bolus Administration: A bolus of Phenytoin Sodium Injection should be injected slowly, not exceeding 50mg per minute in adults, into a large vein through a large-gauge needle or intravenous catheter. Each injection of intravenous phenytoin should be preceded by a saline flush and followed by an injection of sterile saline through the same needle or catheter to avoid local venous irritation due to the alkalinity of the solution. Infusion Administration: For administration by infusion, Phenytoin Sodium Injection should be diluted in 50–100ml of normal saline with the final concentration of phenytoin in the solution not exceeding 10mg/ml. Administration should commence immediately after the mixture has been prepared and must be completed within one hour (the infusion mixture should not be refrigerated). An in-line filter (0.22–0.50 microns) should be used. Each injection of intravenous phenytoin should be preceded by a saline flush and followed by an injection of sterile saline through the same needle or intravenous catheter to help reduce local venous irritation due to the alkalinity of the solution. Dosage is not to exceed 50 mg/minute, intravenously in adults, and not to exceed 1–3 mg/kg/minute in neonates and children or 50 mg/minute, whichever is slower. There is a relatively small margin between full therapeutic effect and minimally toxic doses of this drug. On those occasions when intramuscular administration may be required (i.e., postoperatively in comatose patients), a sufficient dose must be administered intramuscularly to maintain the serum level within the therapeutic range. Where oral dosage is resumed following IM usage, the oral dosage should be adjusted to compensate for the slow, continuing IM absorption to avoid toxic symptoms. To avoid drug accumulation due to absorption from the muscle depots, it is recommended that for the first week back on oral phenytoin, the oral dose be reduced to one-half of the original dose (one-third of the IM dose). Status Epilepticus: In adults a loading dose of 10 to 15 mg/kg should be administered slowly intravenously, at a rate not exceeding 50 mg per minute (this will require approximately 20 minutes in a 70 kg patient). The loading dose should be followed by a maintenance dose of 100 mg orally or intravenously every 6 to 8 hours. Absorption of phenytoin in neonates and children may be unreliable after oral administration. A loading dose of 15–20mg/kg of phenytoin intravenously will usually produce serum concentrations of phenytoin within the generally accepted therapeutic range (10–20 mcg/mL). The drug should be injected slowly intravenously at a rate not exceeding 1–3 mg/kg/minute or 50 mg/minute, whichever is slower. Dosing in Special Populations Patients with Renal or Hepatic Disease: see Section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Elderly Patients: Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required (see Section PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Continuous monitoring of the electrocardiogram and blood pressure is essential. The patient should be observed for signs of respiratory depression. Determination of phenytoin serum levels is advised when using phenytoin in the management of status epilepticus and in the subsequent establishment of maintenance dosage. Other measures including concomitant administration of an intravenous benzodiazepine such as diazepam, or intravenous short-acting barbiturate, will usually be necessary for rapid control of seizures because of the required slow rate of administration of phenytoin. If administration of parenteral phenytoin does not terminate seizures, the use of other anticonvulsants, intravenous barbiturates, general anesthesia, or 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. Neurosurgery: Prophylactic dosage – 100 to 200 mg (2 to 4 mL) intramuscularly at approximately 4 hour intervals during surgery and continued during the postoperative period. When intramuscular administration is required for a patient previously stabilized orally, compensating dosage adjustments are necessary to maintain therapeutic serum levels. When intramuscular administration is used, the drug should be given by deep intramuscular injection. An intramuscular dose 50% greater than the oral dose is necessary to maintain these levels. When the patient is returned to oral administration, the dose should be reduced by 50% of the original oral dose for one week to prevent excessive serum levels due to sustained release form intramuscular tissue sites. If the patient requires more than one week of IM phenytoin, alternative routes should be explored, such as gastric intubation. For time periods less than one week, the patient shifted back from IM administration should receive one-half the original oral dose for the same period of time the patient received IM phenytoin. Monitoring serum levels would help prevent a fall into the subtherapeutic range. Serum drug level determinations are especially helpful when possible drug interactions are suspected.
Route Of Administration: INTRAVENOUS, INTRAMUSCULAR
Indication Info: INDICATION Phenytoin Sodium Injection is indicated for the control of status epilepticus of the tonic-clonic (grand mal) type and prevention and treatment of seizures occurring during or following neurosurgery.
Contraindications: CONTRAINDICATIONS Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin, or its inactive ingredients, or other hydantoins. Because of its effect on ventricular automaticity, phenytoin is contraindicated in sinus bradycardia, sino-atrial block, second and third degree A-V block, and in patients with Adams-Stokes syndrome. Co-administration of phenytoin is contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
Atc Code: N03AB02
Atc Item Name: phenytoin
Pharma Manufacturer Name: GOLDPLUS UNIVERSAL PTE LTD
Company Detail Path: /organization/goldplus-universal-pte-ltd

Active Ingredients

Phenytoin Sodium

250mg/5mL

PHENYTOIN SODIUM

250 MG/5 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Aug 2, 2022

Approval ID

b642caf2cdc7578d

Type

Therapeutic

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