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ADVERSE EFFECTS/SAFETY DATA

ADVERSE EFFECTS/SAFETY DATA

Pre-clinical Toxicology

The toxicity of Sinupret is regarded as very low. The acute toxicity is low after administration in rats and rabbits, the no-effect level was 60-100 times the recommended human dose.1

In chronic toxicity tests, oral administration of up to 1000 mg/kg/day in rats did not produce clinical, macroscopic, ophthalmic, weight, or food intake changes. No animals died during the study.36

In reproductive toxicity tests, there were no Sinupret-induced negative effects on breeding rats or their off-spring. Mating behavior, fertility, litter size, and developmental body weight were normal.37 High doses of Sinupret during organogenesis did not cause any toxicity to the embryo or fetus.38

The non-mutagenicity of Sinupret was verified with the Ames test, the micronucleus assay in vivo, and with the unscheduled DNA synthesis test in vivo.1,39 The results demonstrate that Sinupret is non-mutagenic and does not contain any carcinogenic substances.1,40

Human Safety Data

According to information from the manufacturer, Sinupret has been safely used in millions of doses over 35 years.41 Reported side effects include gastrointestinal (GI) disorders and hypersensitivity (allergic) reactions. In these cases, intake of Sinupret should be discontinued and a physician should be consulted. At the first sign of a hypersensitivity reaction Sinupret should not be taken again. According to the manufacturer, the incidence of adverse drug reactions in clinical trials is 1%, based on 6849 patients.31 The incidence of spontaneous adverse drug reactions in the period from 1973 to October 2008 is approximately 1 per 1,000,000 treatments, based on the sum of approximately 214 million treatments.31

A post-marketing surveillance study of 3187 patients who were 1–94 years old reported that the AE rate was 0.8% (8/1013) for Sinupret (product type not specified), compared with the AE rate of 1.0% (3/313) for ambroxol, 4.3% (12/277) for N-acetylcysteine, and 5.8% (4/69) for myrtol.42,43 When a second medication was prescribed concomitantly, the AE rate for all of the compounds increased.43 The rate of AEs was 3.4% (27/792) when Sinupret was taken with concomitant medication (medications not specified).43 In the post-surveillance study, 8 of the 1013 patients treated with Sinupret without concomitant medication reported GI symptoms (n = 7) or dizziness (n = 1) as AEs.43 Three of these cases were determined to be probably caused by Sinupret (it is unclear which cases), 1 was determined to be not caused by Sinupret (it is unclear which case), 1 case had a questionable association, and 3 cases did not have enough information for an assessment to be made.43