Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE; SODIUM CITRATE/TRISODIUM CITRATE
HOVID BERHAD
DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE; SODIUM CITRATE/TRISODIUM CITRATE
100ml ml; 120ml ml; 100ml mL; 120ml mL
HOVID BERHAD
Not Applicable Baca dokumen lengkapnya
VIHOV12-var CP PHARMA DIPHENHYDRAMINE EXPECTORANT DESCRIPTION Brown, viscous liquid with raspberry flavour COMPOSITION Each 5 ml contains: Diphenhydramine Hydrochloride 14.0 mg Ammonium Chloride 135.0 mg Sodium Citrate 57.0 mg ACTIONS AND PHARMACOLOGY Diphenhydramine, an antihistamine, acts by competing with histamine for H1-receptor sites on effector cells. Its muscarinic actions provide a drying effect on the nasal mucosa. It also suppresses the cough reflex by a direct effect on the cough center in the medulla of the brain. Both ammonium chloride and sodium citrate are useful ingredients in expectorants. It is readily absorbed orally, metabolised in the liver and excreted in the urine. PHARMACOKINETICS • ABSORPTION: Diphenhydramine and sodium citrate is readily absorbed after oral administration. When taken orally, ammonium chloride is rapidly absorbed from the gastrointestinal tract. • BLOOD CONCENTRATION: After an oral dose of 50 mg of the hydrochloride as a solution, plasma concentrations of 50 to 54 ng/ml are attained at 1 hour; at 2 hours, the respective plasma concentrations are 64 to 70 ng/ml. • HALF LIFE: The plasma half life after an oral dose of diphenhydramine is 13 to 21 hours. • DISTRIBUTION: 98% of diphenhydramine is bound to plasma proteins. • METABOLIC REACTIONS: Diphenhydramine is extensively metabolised. About 50% of an oral dose is metabolised in the liver before reaching the general circulation. Reactions include N-dealkylation and deamination. The ammonium ion (from ammonium chloride) is converted into urea in the liver; the anion thus liberated into the bloodstream and extracellular fluids causes a metabolic acidosis and decreases the pH of the urine. Sodium citrate is oxidised in the tissues and is partly excreted as carbon dioxide. • EXCRETION: In the urine up to 3% of a dose is excreted unchanged, up to 13% as basic amines and up to 65% as diphenylmethane metabolites. The major urinary metabolite appear to be diphenylmethoxyacetic acid in free or conjugated form. Ammonium c Baca dokumen lengkapnya