Benzydamine hydrochloride, cetylpyridinium chloride.
Each lozenge contains: Benzydamine HCl 3 mg, Cetylpyridinium Chloride 1.33 mg.
Pharmacology: Pharmacodynamics: Benzydamine HCl: The mechanism of anti-inflammatory action is not related to stimulation of the pituitary-adrenal axis. Like other nonsteroidal anti-inflammatory agents, Benzydamine inhibits the biosynthesis of prostaglandins under certain conditions, but its properties in this aspect have not been fully elucidated. The stabilizing effect on cellular membranes may also be involved in the mechanism of action.
Cetylpyridinium Chloride: Cetylpyridinium Chloride (CPC) is a quarternary pyridinium antiseptic with actions and uses similar to those of other cationic surfactants. It is used chiefly as lozenges or solutions for the treatment of minor infections of the mouth and throat. It is a broad-spectrum antimicrobial agent with a long history of use to promote gingival health.
As a cationic surfactant, cetylpyridinium chloride dissociate in aqueous solution into a relatively large and complex cation, which is responsible for the surface activity, and a smaller inactive anion. In addition to emulsifying and detergent properties, quaternary ammonium compounds have bactericidal activity against Gram-positive and, at a higher concentration, against some Gram-negative bacteria. They are ineffective against bacterial spores, have variable antifungal activity, and are effective against some viruses.
Quaternary ammonium compounds are most effective in natural or slightly alkaline solution and their bactericidal activity is appreciably reduced in acid media; their activity is enhanced by alcohols. CPC is a broad-spectrum antimicrobial agent with a long history of use to promote gingival health. It penetrates the cell membrane, causing leakage of cell components, disruption of bacterial metabolism, inhibition of cell growth, and ultimately cell death.
Pharmacokinetics: Absorption: Benzydamine is well absorbed following oral administration. Benzydamine is well absorbed into the inflamed oral mucosa where it exerts anti-inflammatory and local anesthetic actions. Plasma Benzydamine levels following the use of Benzydamine orally are low and parallel to the amount actually ingested.
Excretion: Benzydamine and its metabolites are excreted largely in the urine.
Metabolism is largely by oxidative pathways, although dealkylation can be shown. Most of the absorbed dose was eliminated in the first 24 hours. Repeated administration for 7 days did not result in the accumulation of 7 Benzydamine in plasma.
For the temporary relief of painful conditions of the oral cavity including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, post-orosurgical and periodontal procedures, pharyngitis, swelling, redness and inflammatory conditions.
For oral use only.
The lozenges should not be chewed. They should be slowly dissolved in the mouth. One lozenge should be sucked slowly every 1 to 2 hours as required up to a maximum of 12 hours per day. Uninterrupted treatment should not exceed 7 days.
With Impaired Renal Function: Since absorbed benzydamine and its metabolites are excreted in the urine, the possibility of systemic effects should be considered in patients with severe renal impairment.
With Impaired Liver Function: Since absorbed benzydamine is highly metabolized in the liver, the possibility of systemic effects should be considered in patients with severe hepatic impairment.
There are no known cases of overdosage with this lozenge. There is no specific antidote for Benzydamine and should excessive quantities be ingested, the treatment should be symptomatic.
Patients with known hypersensitivity to Benzydamine or CPC or any other ingredients in this product.
If a sore throat is either caused or complicated by a bacterial infection, appropriate antibacterial therapy should be considered in addition to the use of this lozenge.
Because of the lack of sufficient clinical experience, it is not recommended in children under 6 years old.
With Impaired Renal Function: Since absorbed Benzydamine and its metabolites are excreted in the urine, the possibility of systemic effects should be considered in patients with severe renal impairment.
With Impaired Liver Function: Since absorbed Benzydamine is highly metabolized in the liver, the possibility of systemic effects should be considered in patients with severe hepatic impairment.
Excess consumption of products containing isomalt may have a laxative effect.
If symptoms persist, consult a doctor.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage. The safety of Benzydamine hydrochloride has not been established in pregnant and lactating patients. Risk to benefit ratio should be established if this lozenge is to be used in these patients.
The following adverse reactions have been reported after the use of Benzydamine hydrochloride.
Local Adverse Reactions:
The most commonly reported reaction is oral numbness with occasional burning or stinging sensation.
Other local adverse effects were less common and include dryness or thirst, tingling, warm feeling in mouth and altered sense of taste.
Systemic Adverse Reactions:
These were very uncommon and never of a serious nature. They consisted mainly of nausea, vomiting, retching, gastrointestinal disorders, dizziness, headache and drowsiness.
Hypersensitivity reactions occur very rarely but may be associated with pruritus, rash, urticaria, photodermatitis and occasionally laryngospasm.
There are no known drug interactions with Benzydamine.
Store below 30°C. Protect from light and moisture.
Shelf Life: 3 years from the date of manufacture.
R02AX03 - benzydamine ; Belongs to the class of other throat preparations.
(fruity flavour; sugar-free) 2 × 6's