Source: Web Search Revision Year: 2012 Publisher: Manufacturer: S.C. Europharm S.A., 2 Panselelor str., Brasov, county of Brasov, 500419, Romania Marketing authorization holder: GlaxoSmithKline Consumer Healthcare, United Kingdom, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Coldrex Tablets is a combination product. Paracetamol provides analgesic and antipyretic effect, phenylephrine decreases the swollen of mucous tunic of nasal cavity, this in turn results in relief of breathing, caffeine provides overall stimulating effect, ascorbic acid (vitamin C) fills up the increased necessity of vitamin C during cold and flu.
Terpin hydrate increases the secretion of bronchial glands, results in excretion of phlegm from respiratory tract, loosen the coughing reflex.
Data on sedative effect of active ingredients is absent.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract, it is relatively uniformly distributed throughout most body fluids.
It is metabolized in liver with formation of non-active metabolites.
Half-life period is 2-3 h. It is excreted in the form of metabolites, predominantly conjugates, only 3% of which is in unchanged form.
Ascorbic acid is well absorbed from gastro-intestinal tract, binding with plasma proteins is 25%, distribution in other parts of body is wide. It is metabolized in liver and excreted with urine in form of metabolites and in unchanged form. Ascorbic acid, taken in excessive amount, rapidly excreted in unchanged form with urine.
Absorption of phenylephrine is low from gastro-intestinal tract and it undergoes the metabolism of primary passing in intestine and liver under the influence of monoamineoxidase. When phenylephrine is taken orally the bioavailability of product becomes limited. It is excreted with urine almost completely in the form of conjugate of suphuric acid.
Caffeine is highly absorbed when taken orally, maximum concentration in plasma is reached during one hour, half-life is approximately 3.5 hours. 65-80% of administered caffeine is excreted with urine in the form of 1-methylurine acid and 1-methylxantine.
Pre-clinical safety data on these active ingredients in the literature have not revealed any patient and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this Summary.
The toxicity of paracetamol has been extensively studied in numerous animal species. Pre-clinical studies in rats and mice have indicated single dose oral LD50 values of 3.7 g/kg and 338 mg/kg, respectively. Chronic toxicity in these species at large multiples of the human therapeutic dose, occurs as degeneration and necrosis of hepatic, renal and lymphoid tissue, and blood count changes. the metabolites believed responsible for these effects have also been demonstrated in m man.
Paracetamol should not, therefore, be taken for long periods of time, and in excessive doses. At normal therapeutic doses, paracetamol is not associated with genotoxic or carcinogenic risk. There is no evidence of embryo- or foeto- toxicity from paracetamol in animal studies.
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