Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LORATADINE
STADPHARM SDN. BHD.
LORATADINE
100 Tablets; 20Tablet Tablets
STELLAPHARM J.V. Co., LTD. - BRANCH 1
LORASTAD 10 TABLETS Active ingredient: Loratadine (10mg) _ _ Page no. 1 _ Consumer Medication Information Leaflet (RiMUP)_ _ _ WHAT IS IN THIS LEAFLET 1. What Lorastad 10 Tablets is used for. 2. How Lorastad 10 Tablets works. 3. Before you use Lorastad 10 Tablets. 4. How to use Lorastad 10 Tablets. 5. While you are using Lorastad 10 Tablets. 6. Side effects. 7. Storage and disposal of Lorastad 10 Tablets. 8. Product description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT LORASTAD 10 TABLETS IS USED FOR Lorastad 10 Tablets is used to relieve symptoms associated with an allergic inflammation of the nasal airways occuring during specific seasons (seasonal allergic rhinitis) such as sneezing, watery nose, itching as well as eye itching and burning. It is also used for the control of symptoms and signs of idiopathic chronic urticaria (a common allergic disorder including red, itchy, lumpy skin rash that occurs year round and the cause of that is not known or that arises spontaneously) and other allergic skin disorders. HOW LORASTAD 10 TABLETS WORKS Loratadine belongs to a class of medicines known as antihistamines which help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced in the body. BEFORE YOU USE LORASTAD 10 TABLETS _When you must not use it _ - If you have have shown hypersensitivity or unusual and unexpected sensitivity to any components of Lorastad 10 Tablets - Children under the age of 2 years. _ _ _Before you start to use it _ If any of the situations mentioned below apply to you, you should tell your doctor before taking this drug: - If you have severe liver problem, you should take the medicine with a lower initial dose. - If you are pregnant women. - If you are in breast-feeding. _Taking other medicines _ Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription _. _ You should tell your doctor if you are receiving other drug Baca dokumen lengkap
_Active ingredient:_ _Other ingredients:_ Each tablet contains Loratadine 10 mg. Human histamine skin wheal studies following single and repeated 10 mg oral doses of Loratadine have shown that the drug exhibits an antihistaminic effect beginning within 1 to 3 hours, reaching a maximum at 8 to 12 hours, and lasting in excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing with Loratadine. PHARMACOLOGY Whole body autoradiographic studies in rats and monkeys, radiolabeled tissue distribution studies in mice and rats, and _in vivo_ radioligand studies in mice have shown that neither Loratadine nor its metabolites readily cross the blood-brain barrier. Radioligand binding studies with guinea pig pulmonary and brain H1-receptors indicate that there was preferential binding to peripheral versus central nervous system H1-receptors. Pharmacokinetic studies showed that Loratadine rapidly disintegrating tablets provide plasma concentrations of Loratadine descarboethoxyloratadine similar to those achieved with Loratadine tablets. Following oral administration of 10 mg Loratadine once daily for 10 days with each dosage forms in a randomized crossover comparison in 24 normal adult subjects, similar mean exposures (AUC) and peak plasma concentrations (Cmax) of Loratadine were observed Loratadine rapidly disintegrating tablets mean AUC and Cmax were 11% and 6% greater than that of the Loratadine tablet values, respectively. Descarboethoxyloratadine bioequivalence was demonstrated between the two formulations. After 10 days of dosing, mean peak plasma concentrations were attained at 1.3 hours and 2.3 hours (Tmax) for parent and metabolite, respectively. Loratadine is a potent long acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity. PHARMACOKINETICS Repeated application of Loratadine rapidly disintegrating tablets to the hamster cheek pouch did not cause local irritation. Loratadine was rapidly absorbed following oral administration of 10 mg tablets, on Baca dokumen lengkap