দেশ: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OXYMETAZOLINE HYDROCHLORIDE
MEDISPEC (M) SDN.BHD
OXYMETAZOLINE HYDROCHLORIDE
6 x 10ml mL
SQUARE PHARMACEUTICALS LTD
XYLOCON NASAL DROPS ® Oxymetazoline Hydrochloride USP (0.05%, 0.025%) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET? 1. What _Xylocon _ is used for 2. How _Xylocon_ works 3. Before you use _Xylocon_ 4. How to use _Xylocon_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Xylocon_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _XYLOCON_ IS USED FOR To relieve nasal congestion due to rhinitis acuta (acute cold), sinusitis (inflammation of the sinuses), eustachitis (inflammation of the mucous membrane of the eustachian tube), and otitis media (inflammation of the media ear) HOW _XYLOCON_ WORKS The active ingredient of Xylocon, Oxymetazoline hydrochloride has a decongestant effect on the mucous membrane. The application of this nasal drops into the nostrils leads to decongestion of the inflamed nasal mucosa and thus to normalization of nasal breathing. BEFORE YOU USE _Xylocon_ - _When you must not use it _ Do not use Xylocon nasal drops if: • You are hypersensitivity to the active ingredient or to any of the excipients • You are children under 12 years of age. • If you have inflammation of the skin and rhinitis sicca (chronic form of dryness of the mucous membranes in the nose) • You have narrow-angle glaucoma • You have hypertension, heart diseases or asthma • You have any metabolic disorders (eg: hyperthyroidism, diabetes) • You have Phaeochromocytoma (small vascular tumor of the adrenal medulla) _Pregnancy and lactation _ _ _ Xylocon nasal drops should only be used after the consultation with a physician during pregnancy and lactation. The recommended dosage must not be exceeded. _ _ _ _ - _Before you start to use it _ Tell your doctor if: • If you are receiving treatment with monoamine-oxidase inhibitors (MAOI’s) • If you are having heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination. • If you are on pregnancy and breastfeeding. - _Taking other medicines সম্পূর্ণ নথি পড়ুন
NAME OF PRODUCT Xylocon 0.05% Nasal Drops Xylocon 0.025% Nasal Drops NAME AND STRENGTH OF ACTIVE INGREDIENT(S) Xylocon 0.05% Nasal Drops: Each ml contains Oxymetazoline Hydrochloride USP 0.50 mg. Xylocon 0.025% Nasal Drops: Each ml contains Oxymetazoline Hydrochloride USP 0.25 mg. PRODUCT DESCRIPTION A clear colorless solution having rose-like odor, filled and sealed in plastic container. PHARMACODYNAMICS Oxymetazoline is a direct-acting sympathomimetic amine. It acts on alpha-adren- ergic receptors in the vessels of the nasal mucosa producing vasoconstriction and decongestion. Onset of action is within minutes and lasts 6-8 hours. PHARMACOKINETICS Oxymetazoline enters tissues rapidly and local vasoconstriction is normally achieved within 5-10 minutes of intranasal administration. The full effect lasts for 5-6 hours and then gradually subsides over the next 6 hours. Plasma half-life is 5-8 days with 30% of any absorbed drug being excreted in the urine unchanged and 10% being excreted in the faeces. INDICATION Rhinitis acuta , sinusitis, eustachitis and otitis media. RECOMMENDED DOSAGE _Xylocon 0.025% Nasal Drops_ Unless otherwise prescribed, instill 1 - 2 drops of the Xylocon 0.025% into each nostril, 2 - 3 times per day. Xylocon 0.025% should not be used by children younger than 1 year. Unless specifically specified by the doctor, Xylocon 0.025% should only be used for short periods of time. _Xylocon 0.05% Nasal Drops_ Unless otherwise prescribed, instill 1 - 2 drops of the Xylocon 0.05% into each nostril, 2 - 3 times per day. Xylocon 0.05% should only be used by adults and children of school age. Unless specifically specified by the doctor, Xylocon 0.05% should only be used for short periods of time. Permanent use of decongestant rhinological agents may attenuate their effect. The abuse of local rhinological agents may cause mucosal atrophy and reactive hperaemia with rhinitis medicamentosa. Longer use of oxymetazoline may cause damage to the mucosal epithelium with inhibition of ciliary activity. This may poss সম্পূর্ণ নথি পড়ুন