Lack of effects between rupatadine 10 mg and placebo on actual driving performance of healthy volunteers

Vuurman, E.F.P.M.; Theunissen, Eef L.; Oers, A. van; Leeuwen, Cees van; Jolles, Jelle

doi:10.1002/hup.856

Cited by 46 publications

(24 citation statements)

References 44 publications

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“…53 The effects of RU on driving were evaluated in a study performed on healthy human volunteers, and was compared with 50mg hydroxyzine or placebo. 54 Driving performance was assessed using a standard highway test, standard deviation of the lateral position, Stanford sleepiness scale, driving quality scale and rate of sedation. There was no difference between RU and placebo, whereas driving performance was impaired by hydroxyzine.…”

Section: Central Nervous System Cognitive and Psychomotor Effectsmentioning

confidence: 99%

Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis

Katiyar

Prakash

2008

Primary Care Respiratory Journal

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Allergic rhinitis (AR) is a disease with high prevalence. In AR, exposure to airborne allergens elicits an allergic response which involves epithelial accumulation of effector cells -e.g. mast cells and basophils -and subsequent inflammation. During the early response in AR, histamine has been found to be the most abundant mediator and it is associated with many symptoms of this disease mediated through the histamine H1 receptor. Therefore, anti-histamines have a role to play in the management of AR. However, the available antihistamines have certain well-known side effects like sedation and potential pro-arrythmic effects owing to their interactions with other drugs, as well as having poor or no effect on platelet activating factor (PAF) which also plays an important role in AR. This article is a qualitative systematic literature review on the pharmacological profile of rupatadine in order to evaluate its safety and efficacy in AR as compared to other anti-histamines. Rupatadine is a once-daily non-sedative, selective, long-acting H1 anti-histamine with antagonistic PAF effects through its interaction with specific receptors. Rupatadine significantly improves nasal symptoms in patients with AR. It has a good safety profile and is devoid of arrythmogenic effects. These properties make rupatadine a suitable first line anti-histamine for the treatment of AR.

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Section: Central Nervous System Cognitive and Psychomotor Effectsmentioning

confidence: 99%

Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis

Katiyar

Prakash

2008

Primary Care Respiratory Journal

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“…A mixed gender study showed that levocetirizine 5 mg had no acute or subchronic effect on SDLP (Verster et al 2003). The effects of rupatadine in its therapeutic dose of 10 mg (Vuurman et al 2007) were also comparable to those of placebo treatment. Bilastine was tested in 20 and 40 mg doses, both after acute dosing and repeated doses, and was found not to cause driving impairment in any of these dosing conditions (Conen et al 2010).…”

Section: Second Generation Antihistaminesmentioning

confidence: 76%

“…Hydroxizine 50 mg acutely impaired driving performance, with an SDLP increase larger than the effect of a BAC of 0.8 g/L (Vuurman et al 2007). After 8 days of treatment with hydroxizine 50 mg driving performance was still impaired, but to a lesser extent (Conen et al 2010).…”

Section: First Generation Antihistaminesmentioning

confidence: 98%

Effects of Medicinal Drugs on Fitness to Drive

Theunissen¹,

Kuypers²,

Vermeeren³

et al. 2014

Handbook of Forensic Medicine

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“…Although other approaches such as 'off-road' driving simulators or 'overthe-road' driving tests can be used to assess unwanted CNS side effects, it has been suggested that they are less sensitive to sedative effects, particularly in the case of antihistamines [50,51]. In addition, laboratory tests may provide more information of a more practical value with respect to drug effects in demanding real-life situations than more 'real' experimental settings [33].…”

Section: Discussionmentioning

confidence: 99%

Rupatadine does not potentiate the CNS depressant effects of lorazepam: randomized, double‐blind, crossover, repeated dose, placebo‐controlled study

García-Gea

Ballester

Martínez

et al. 2010

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Although one defining characteristic of second generation H1-antihistamines is their lack of CNS effects, it has been proved that some compounds of this group are not devoid of such effects.• There is evidence that second generation H1-antihistamine compounds without relevant CNS effects at therapeutic doses could increase the behavioural impairment produced by sedating drugs when both are taken concomitantly.• The evaluation of possible drug interactions is crucial, especially when both compounds could have CNS effects, due to the possible consequences at the patient safety level. WHAT THIS STUDY ADDS• The study demonstrates the lack of CNS effects after repeated administration at therapeutic doses of the unique second generation H1-antihistamine with anti-PAF activity.• The study demonstrates the lack of interaction between repeated administration of rupatadine 10 mg and a single oral dose of lorazepam 2 mg.• The study presents a useful design to evaluate the interaction between two compounds saving time and the exposure of the volunteers to medication. AIMThe main objective was to assess whether benzodiazepine intake when rupatadine plasma concentrations were at steady-state would increase the CNS depressant effects. Rupatadine is a new H1-antihistamine which also inhibits platelet activating factor (PAF) release and has been shown to be clinically effective at doses of 10 mg. METHODSSixteen healthy young volunteers took part in a crossover, randomized, double-blind, placebo controlled trial comprising two experimental periods (repeated administration for 7 days of rupatadine 10 mg or placebo as single oral daily doses, separated by a washout of 14 days). On days 5 and 7, according to a fully balanced design, a single oral dose of lorazepam 2 mg or placebo was added. CNS effects were evaluated on these days by seven objective tests of psychomotor performance and eight subjective visual analogue scales (VAS) at pre-dose and several times after drug intake. Four treatment conditions were evaluated: placebo, rupatadine 10 mg, lorazepam 2 mg and rupatadine 10 mg + lorazepam 2 mg. RESULTSSignificant CNS effects, either impairment of psychomotor performance or subjective sedation, were observed when lorazepam was administered, either alone or in combination with steady state concentrations of rupatadine. No significant differences were found between these two conditions. In addition, rupatadine was not different from placebo. All treatments were well tolerated. CONCLUSIONRepeated doses of rupatadine (10 mg orally) did not enhance the CNS depressant effects of lorazepam (2 mg orally, single dose) either in objective psychomotor tasks or in subjective evaluations.

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Lack of effects between rupatadine 10 mg and placebo on actual driving performance of healthy volunteers

Abstract: Rupatadine 10 mg is not sedating and does not impair driving performance.

Cited by 46 publications

References 44 publications

Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis

Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis

Effects of Medicinal Drugs on Fitness to Drive

Rupatadine does not potentiate the CNS depressant effects of lorazepam: randomized, double‐blind, crossover, repeated dose, placebo‐controlled study

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