Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PHENYTOIN SODIUM
VIATRIS SDN. BHD.
PHENYTOIN SODIUM
200Capsule Capsules
VIATRIS PHARMACEUTICALS LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DILANTIN ® CAPSULES Phenytoin sodium (30 mg, 100 mg) 1 WHAT IS IN THIS LEAFLET 1. What DILANTIN CAPSULES are used for 2. How DILANTIN CAPSULES work 3. Before you use DILANTIN CAPSULES 4. How to use DILANTIN CAPSULES 5. While you are using it 6. Side effects 7. Storage and Disposal of DILANTIN CAPSULES 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT DILANTIN CAPSULES ARE USED FOR DILANTIN CAPSULES are 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 CAPSULES WORK DILANTIN CAPSULES belong 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 CAPSULES - _When you must not use it_ Do not take DILANTIN CAPSULES • if you are allergic to Phenytoin or to the inactive ingredients of DILANTIN CAPSULES or other hydantoin medicines; • if you are taking Delavirdine (used in the treatment of HIV infection). _Pregnancy and lactation_ DILANTIN CAPSULES 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 CAPSULES, your doctor can help you decide whether or not to take it during pregnancy. Your doctor will prescribe DILANTIN CAPSULES only if the benefits to you outweigh the risk to your baby and will measure phenytoin levels in your body periodically. When appropriate, pregnant women and women of childbearing potential should be counseled about alternative therapeutic options. Women of childbearing potential who are not planning a pregnancy should be advised regarding the use of effective contraception during treatment. Tell your doctor if you are breastfeeding or intend to breastfeed. It is not recommended to brea Soma hati kamili
DILANTIN PHENYTOIN SODIUM 1. NAME(S) OF MEDICINAL PRODUCT Dilantin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Phenytoin sodium is an anticonvulsant drug, related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5, 5-diphenyl-2, 4-imidazolidinedione. Each phenytoin sodium capsule, for oral administration, contains 30 mg or 100 mg phenytoin sodium. 3. PHARMACEUTICAL FORM Capsules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clinical evidence indicates phenytoin is effective in controlling epilepsy, particularly of the generalised tonic-clonic type (grand mal) and psychomotor seizures. It will prevent or greatly decrease the incidence and severity of convulsive seizures in a substantial percentage of cases, and patients exhibit little tendency to become resistant to treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 suspensions (30 mg/5 mL [pediatric] and 125 mg/5 mL) 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_ . Dosage should be individualized to provide maximum benefit. In some cases, serum drug level determinations may be necessary for optimal dosage adjustments. Optimum control without clinical signs of toxicity occurs more often with serum levels between 10 mcg/mL and 20 mcg/mL, although some mild cases of tonic-clonic (grand mal) epilepsy may be controlled with lower serum levels of phenytoin. With recommended dosage, a period of 7 to 10 days may be required to achieve steady-state serum levels with phenytoin, and changes in dosage (increase or decrease) should not be carried out at intervals shorter than Soma hati kamili