Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PSEUDOEPHEDRINE HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE
SUNWARD PHARMACEUTICAL SDN. BHD.
PSEUDOEPHEDRINE HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE
1000 Tablet Tablets; 100 Tablets; 90 Tablets; 1000 Tablets; 1000 Tablets; 100 Tablets; 500 Tablets; 500 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
POLARINE TABLET Dexchlorpheniramine maleate/Pseudoephedrine hydrochloride (2mg/60mg) _ Consumer Medication Information Leaflet (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Polarine Tablet is used for 2. How Polarine Tablet works 3. Before you use Polarine Tablet 4. How to use Polarine Tablet 5. While you are using it 6. Side effects 7. Storage & disposal of Polarine Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT POLARINE TABLET IS USED FOR It is indicated for nasal and upper respiratory tract congestion, common cold, acute sinusitis (inflammation of the sinuses) and allergic rhinitis (inflammation of the mucous membrane inside the nose). HOW POLARINE TABLET WORKS The active ingredients in the medicine are Dexchlorpheniramine maleate and Pseudoephedrine hydrochloride. Dexchlor- pheniramine maleate is anti-histamine with anti-cholinergic properties. It works by block- ing a certain natural substance (histamine) that your body makes during an allergic reaction. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose. Pseudoephedrine acts as an indirect sympatho- mimetic agent by stimulating sympathetic (ad- renergic) nerve endings to release noradrena- line. Pseudoephedrine belongs to a class of medications called nasal decongestants. It works by causing narrowing of the blood ves- sels in the nasal passages to decrease swelling and congestion. BEFORE YOU USE POLARINE TABLET _- When you must not use it _ Do not take Polarine Tablet if you: are hypersensitive to dexchlorpheniramine maleate and pseudoephedrine hydrochlo- ride, or any of the other ingredients listed at the end of the leaflet. _ _ have lower respiratory symptoms severe high blood pressure severe heart disease _Pregnancy and breastfeeding _ Tell your doctor if you are or think you may be pregnant, planning to become pregnant or if you are breastfeeding. _ _ _Elderly _ Antihistamines m Baca dokumen lengkap
PHARMACOLOGY: Dexchlorpheniramine Maleate is an anti-histamine with anti-cholinergic properties. It is capable of producing a slight to moderate sedative effect. It appears to compete with histamine for receptor sites on effector cells and are of value clinically in the prevention and relief of many allergic manifestations.It has been demonstrated that the predominant activity of the optically active isomers of chlorpheniramine is the dextro-isomer. The dextro-isomer is approximately two times more active than the racemic compound. Since dexchlorpheniramine is the dextro-isomer and active moiety of chlorpheniramine, its action and uses are similar to those of chlorpheniramine. Peak blood levels were achieved at an average time of 3 hours after administration. The half life of Dexchlorpheniramine Maleate ranged from 20 to 24 hours. The drug when given is found to be extensively metabolized. The drug and metabolites were primarily excreted in the urine, with 19% of the dose appearing in 24 hours and a total of 34% in 48 hours. Pseudoephedrine is a physiologically active stereoisomer of ephedrine that acts directly on alpha-adrenergic receptors and to a lesser degree, beta-adrenergic receptors. The alpha-adrenergic effects are believed to result from the reduced production of cyclic adenosine 3', 5' monophosphate (cyclic 3',5' AMP) by inhibition of the enzyme adenyl cyclase, whereas beta-adrenergic effects appear to be caused by the stimulation of adenyl cyclase activity. Pseudoephedrine acts on alpha-adrenergic receptors in the nasal mucosa and releases norepinephedrine, hence producing vasoconstriction of the dilated nasal arterioles resulting in shrinkage of swollen nasal mucous membranes, reduction of tissue hyperemia, oedema and nasal decongestion and an increase in nasal airway patency. Drainage of sinus secretions is increased and obstructed eustachian ostia may be opened. Relaxation of bronchial smooth muscle by stimulation of beta-adrenergic receptors may also occur. Following oral administration of 30 mg o Baca dokumen lengkap