Strepsils Max Pro Spray

Strepsils Max Pro Spray Mechanism of Action



RB (Health)


Zuellig Pharma
Full Prescribing Info
Pharmacology: Pharmacodynamics: Flurbiprofen is a propionic acid derivative NSAID which acts through inhibition of prostaglandin synthesis. In humans, flurbiprofen has potent analgesic, antipyretic and anti-inflammatory properties and the 8.75 mg dose dissolved in artificial saliva has been shown to reduce prostaglandin synthesis in cultured human respiratory cells. According to studies using the whole blood assay, flurbiprofen is a mixed COX-1/COX-2 inhibitor with some selectivity towards COX-1. Pre-clinical studies suggest that the R (-) enantiomer of flurbiprofen and related NSAIDs may act on the central nervous system; the suggested mechanism is by inhibition of induced COX-2 at the level of the spinal cord.
A single dose of flurbiprofen 8.75 mg delivered locally to the throat as three sprays has been demonstrated to relieve sore throat, including swollen and inflamed sore throats through a significant change in the severity of throat soreness area under the change (AUC) from baseline curve (mean difference (standard deviation)) for active treatment versus placebo from 0 to 2 hours (-1.82 (1.35) vs -1.13 (1.14)), 0 to 3 hours (-2.01 (1.405) vs -1.31 (1.233)) and 0 to 6 hours (-2.14 (1.551) vs -1.50 (1.385)). Significant differences in the AUC from baseline curve from 0 - 6 hours compared to placebo were also seen for other qualities of sore throat including pain intensity (-22.50 (17.894) vs -15.64 (16.413)), difficulty swallowing (-22.50 (18.260) vs -16.01 (15.451)), swollen throat (-20.97 (18.897) vs -13.80 (15.565)) and sore throat pain relief (3.24 (1.456) vs 2.47 (1.248)). The change from baseline at individual time points across the different qualities of sore throat demonstrated significance starting from 5 minutes and lasting for up to 6 hours.
For those patients taking antibiotics for Strep infection, there was statistically significant greater relief of sore throat pain intensity for flurbiprofen 8.75 mg lozenge from 7 hours and onwards after antibiotics were taken. The analgesic effect of flurbiprofen 8.75 mg lozenge was not reduced by the administration of antibiotics to treat patients with streptococcal sore throat.
Multiple-dose efficacy over 3 days has also been demonstrated. The mint-flavoured spray is easy and convenient to use and reaches the sore area of the throat, improving the ability to talk and use the voice whilst providing a soothing and coating effect for the throat.
Paediatric Population: No specific studies in children have been undertaken with Strepsils Max Pro Direct Spray 8.75 mg per dose. Efficacy and safety studies on flurbiprofen 8.75 mg lozenges have included children aged 12 - 17 years, although small sample size means that no statistical conclusions can be drawn.
Pharmacokinetics: Absorption: A single dose of flurbiprofen 8.75 mg is delivered directly to the throat as three sprays and the flurbiprofen is readily absorbed, with detection in the blood between 2 and 5 minutes and plasma concentrations peaking at 30 minutes after administration, but remaining at a mean low level of 1.6 μg/mL which is approximately 4 times lower than a 50 mg tablet dose. Strepsils Max Pro Direct Spray 8.75 mg per dose demonstrates bioequivalence to flurbiprofen 8.75 mg lozenge. Absorption of flurbiprofen can occur from the buccal cavity by passive diffusion. Rate of absorption is dependent on pharmaceutical form with peak concentrations achieved more rapidly than, but of similar magnitude to, those achieved after an equivalent swallowed dose.
Distribution: Flurbiprofen is rapidly distributed throughout the body and is extensively bound to plasma proteins.
Metabolism/Excretion: Flurbiprofen is mainly metabolised by hydroxylation and excreted via the kidneys. It has an elimination half-life of 3 to 6 hours. Flurbiprofen is excreted in very small amounts in human milk (less than 0.05 μg/ml). Approximately 20-25% of a flurbiprofen oral dose is excreted unchanged.
Special Groups: No difference in pharmacokinetic parameters between elderly and young adult volunteers has been reported following oral administration of flurbiprofen tablets. No pharmacokinetic data have been generated in children below 12 years of age following administration of Flurbiprofen 8.75 mg however, administration of both flurbiprofen syrup and suppository formulations indicate no significant differences in pharmacokinetic parameters compared with adults.
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