Држава: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CARBAMAZEPINE
HOVID BERHAD
CARBAMAZEPINE
500 Tablets; 1000 Tablets; 100 Tablets; 100 Tablets
HOVID BERHAD
_Consumer Medication Information Leaflet (RiMUP) _ CARZEPIN TABLET Carbamazepine (200 mg) 1 WHAT IS IN THIS LEAFLET 1. What Carzepin is used for 2. How Carzepin works 3. Before you use Carzepin 4. How to use Carzepin 5. While you are using Carzepin 6. Side effects 7. Storage and disposal of Carzepin 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CARZEPIN IS USED FOR Treatment of: • partial seizure with complex symptomatology (starts in one part of the brain and affects other parts of the brain that involve alertness and awareness) • generalized tonic-clonic seizures (epilepsy) • painful condition of the face called trigeminal neuralgia • painful condition of the ear, throat, tonsils and tongue called glossopharyngeal neuralgia HOW CARZEPIN WORKS The active ingredient in Carzepin Tablet, carbamazepine, is an anticonvulsant agent, which can affect the body in several different ways. The exact mechanism how it works is still unknown but it is believed to stabilize and limit the spread of the brain nerve activities. BEFORE YOU USE CARZEPIN _- When you must not use it _ Do not take this medicine: • if you are allergic (hypersensitive) to carbamazepine or similar drugs or any of the other ingredients listed at the end of the leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin • if you have any heart problem called atrioventricular (AV) heart block • if you have history of bone marrow depression • if you have blood disorders such as porphyria • if you are breastfeeding If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor. _- Before you start to use it _ _ _ Tell your doctor/pharmacist if: • you have allergies to tricyclic antidepressants • you ever had allergic reactions to other medicine • you have heart problem • you have liver prob Прочитајте комплетан документ
CARZEPIN TABLET 200MG VICAR13-var (MY) DESCRIPTION Round, 10.0 mm in diameter, white uncoated tablet, bevel-edged, flat faces, "HOVID" embossed on one face and scored on the other. COMPOSITION Carbamazepine 200 mg/tablet PHARMACODYNAMICS In animal studies, carbamazepine raises the threshold for electrically and chemically induced convulsions. After-discharge activity is reduced, especially in the amygdaloid nucleus and hippocampus, and the cortico- thalamic threshold is raised. The motor cortex is relatively unaffected. Decreased post-tetanic potentiation has been demonstrated in the rabbit spinal cord, and has decreased synaptic transmission in the spinal trigeminal nuclei in cats. Decreased appreciation of induced pain has been shown in guinea pigs and rabbits. Carbamazepine will convert ECG patterns to normal in digoxin-induced tachycardia by prolongation of A-V Conduction and reduction of Purkinje cell automaticity. In human studies, suppression of spike foci has not been demonstrated. Anticonvulsant and anti-neuralgic effects are believed to result primarily from depression of synaptic transmission. PHARMACOKINETICS ABSORPTION Carbamazepine is almost entirely absorped from the gastro-intestinal tract, the major proportion of the administered dose being recoverable in the urine. The absorption from carbamazepine tablets is slow but virtually complete. BLOOD CONCENTRATION After an oral dose of 6mg/kg, peak serum concentrations are about 4ug/ml at 7 hours and 6.5ug/ml at 3 hours. During therapy with about 12.5mg/kg daily for 6 months, mean plasma concentrations for carbamazepine and its 10, 11 -epoxide metabolite are about 5 and 1ug/ml respectively. Therapeutic concentrations are in the range 3 to 6ug/ml. Side-effects are suffered by 50% of subjects with blood concentrations in the range of 8.5 to 10ug/ml. HALF-LIFE Plasma half-life is 21 to 53 hours. In infants the half-life is reduced to 8 to 27 hours. After chronic treatment the plasma half-life is significantly reduced. DISTRIBUTION Carbamazepine enters the Прочитајте комплетан документ