Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
MEDISPEC (M) SDN.BHD
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
100 ml
Unison Laboratories Co. Ltd.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ UNIHIST SYRUP _ _ Brompheniramine maleate 4 mg ; Phenylephrine hydrochloride 10 mg Page no. 1 WHAT IS IN THIS LEAFLET 1. What UNIHIST is used for 2. How UNIHIST works 3. Before you use UNIHIST 4. How to use UNIHIST 5. While you are using it 6. Side effects 7. Storage and Disposal of UNIHIST 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT UNIHIST IS USED FOR For the symptomatic relief of nasal congestion due to cough and cold and allergic conditions, mainly rhinitis [inflammation of the nasal mucous membranes]. HOW UNIHIST WORKS _ _ Brompheniramine/ phenylephrine is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure. BEFORE YOU USE UNIHIST _-When you must not use it _ _ _ If you are allergic (hypersensitive) to Brompheniramine or Phenylephrine or to any other drugs of similar chemical structure. If you are allergic (hypersensitive) to any of the other ingredients of UNIHIST. If you are pregnant and breast- feeding UNIHIST should be used only if the potential benefit to the patient outweighs the possible risk to the fetus. UNIHIST should be used only if the potential benefit to the patient outweighs the possible risk to the infant. Do not use this medicine if any of the above applies to you. If you are not sure, get advice from your doctor or pharmacist before taking UNIHIST. _-Before you start to use it _ _ _ Inform your doctor in cases of: Liver or kidney problems Epilepsy Severe hyperthyroidism (pathologically excessive production of thyroid hormones) Severe ischemic heart disease Diabetes mellitus or prostatic hyperplasia [nonmalignant (noncancerous) enlargement of the prostate gland, a common occurrence in older men] should also av Đọc toàn bộ tài liệu
FRONT BACK 13 cm. 19 cm. ANTIHISTAMINE (H1-RECEPTOR)/ DECONGESTANT Each 5 mL contains: BROMPHENIRAMINE MALEATE 4 MG PHENYLEPHRINE HYDROCHLORIDE 10 MG PRODUCT DESCRIPTION: Clear, purple syrup with grape flavor MECHANISM OF ACTION : @ _PHARMACOLOGY_ Antihistaminic (H 1 -receptor): Antihistamines used in the treatment of allergy act by competing with histamine for H 1 -receptor sites on effector cells. They thereby prevent, but do not reverse, responses mediated by histamine alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal and oral mucosa. Decongestant: Sympathomimetic amines act on alpha-adrenergic receptors in the mucosa of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal passages. _PHARMACOKINETICS_ Absorption: Phenylephrine has reduced bioavailability (about 38%) from gastrointestinal tract because of first pass metabolism by monoamine oxidase in the stomach and liver. Biotransformation: Antihistamines - Hepatic (cytochrome P-450 system); some renal; Sympathomimetic amines – Phenylephrine: Extensive in the intestinal wall and in the liver. Sulfate conjugates are formed largely in the intestinal wall. Also, undergoes oxidative deamination by monoamine oxidase. Half-life: Brompheniramine - 25 hours; Phenylephrine - 2.1 to 3.4 hours. Onset of action: Most first generation antihistamines: 15 to 60 minutes. Time to peak concentration: Brompheniramine - 2 to 5 hours; Phenylephrine - 0.75 to 2 hours (to achieve peak levels ranging from 0.9 to 298 ng/mL, respectively). Time to peak effect: Brompheniramine - 3 to 9 hours; Elimination: Antihistamines - Renal. Most of the antihistamines studied are excreted as metabolites within 24 hours; Phenylephrine: 2.6% of the administered oral dose is excreted unchanged; 80 to 86% of unchanged Phenylephrine and metabolites are recovered in 48 hours after oral administration. INDICATION: For the symptomatic relief of nasal conge Đọc toàn bộ tài liệu