Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PHENYTOIN SODIUM
UPJOHN (MALAYSIA) SDN. BHD.
PHENYTOIN SODIUM
237 ml
PHARMACIA & UPJOHN CO
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DILANTIN ORAL SUSPENSION Phenytoin (125 mg/5 mL) 1 WHAT IS IN THIS LEAFLET 1. What DILANTIN ORAL SUSPENSION is used for 2. How DILANTIN ORAL SUSPENSION works 3. Before you use DILANTIN ORAL SUSPENSION 4. How to use DILANTIN ORAL SUSPENSION 5. While you are using it 6. Side Effects 7. Storage and Disposal of DILANTIN ORAL SUSPENSION 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT DILANTIN ORAL SUSPENSION IS USED FOR DILANTIN ORAL SUSPENSION is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. HOW DILANTIN ORAL SUSPENSION WORKS DILANTIN ORAL SUSPENSION belongs to a group of medicines called anticonvulsants. These drugs are thought to work by controlling brain chemicals, which send signals to nerves so that seizures do not happen. BEFORE YOU USE DILANTIN ORAL SUSPENSION - _When you must not use it_ Do not take DILANTIN ORAL SUSPENSION: - if you have a history of allergy to Phenytoin or to the inactive ingredients of DILANTIN ORAL SUSPENSION or other hydantoin medicines. Allergic reactions include a condition called angioedema which causes: - swelling of the area beneath the skin or mucosa - if you have a history of liver injury caused by phenytoin - if you are taking delavirdine (used in the treatment of HIV infection). _Pregnancy and lactation_ DILANTIN ORAL SUSPENSION crosses the placenta and may affect your developing baby if you take it during pregnancy. However, it is very important to control your fits while you are pregnant. If it is necessary for you to take DILANTIN ORAL SUSPENSION, your doctor can help you decide whether or not to take it during pregnancy. Your doctor may ask you - to get serum phenytoin levels checked. - to take vitamin K before delivery and give vitamin K to the new born after birth. Tell your doctor if you are breastfeeding or intend to bre Les hele dokumentet
Pfizer Confidential 1 1. NAME OF MEDICINAL PRODUCT Dilantin Oral Suspension 125 mg/5 mL. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of suspension contains 125 mg phenytoin, USP. 3. PHARMACEUTICAL FORM Phenytoin Oral Suspension 125 mg/5 mL will be provided as an opaque orange suspension with an orange–vanilla-banana odor. The drug product is packaged in a round amber glass bottle, having a polypropylene cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Phenytoin is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. ADULT DOSAGE: The recommended starting dosage for adult patients who have received no previous treatment is 5 mL (125 mg/5 mL), or one teaspoonful, by mouth three times daily. Adjust the dosage to suit individual requirements, up to a maximum of 25 mL daily (See DOSAGE ADJUSTMENTS). PEDIATRIC DOSAGE: The recommended starting dosage for pediatric patients is 5 mg/kg/day by mouth in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily in divided doses. A recommended daily maintenance dosage is usually 4 to 8 mg/kg/day in equally divided doses. Children over 6 years and adolescents may require the minimum adult dose (300 mg/day). DOSAGE ADJUSTMENTS: Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations may be necessary for optimal dosage adjustments. Trough levels provide information about clinically effective serum level range and confirm patient compliance, and are obtained just prior to the patient’s next scheduled dose. Peak levels indicate an individual’s threshold for emergence of dose-related side effects and are obtained at the time of expected peak concentration. T Les hele dokumentet