Benzydamine HCl, cetylpyridinium chloride.
Honey lemon flavoured lozenges: Round, lemon yellow, flat, bevelled lozenges, firm, smooth surface with honey & lemon flavour.
Raspberry flavoured lozenges: Round, red-pink colour, flat beveled shape, firm, smooth surface, approximately 19mm diameter with Raspberry flavour.
Each lozenge contains benzydamine HCl 3.00mg and cetylpyridinium chloride 1.33mg.
Pharmacology: Benzydamine is anti-inflammatory analgesic agent structurally unrelated to the steroid group. Benzydamine differs chemically from other non-steroidal anti-inflammatory agents in that it is a base rather than acid.
Animal model show that when administered systemically, benzydamine is effective against pain and oedema due to inflammatory conditions. It also inhibits granuloma formation. At concentration used for topical treatment, benzydamine possesses local anaesthetic action. Benzydamine does not cause erosion of the gastric mucosa when given orally to rats at doses up to 100 mg/kg.
The analgesic activity of benzydamine was more pronounced in models involving an experimental inflammatory rather than in non-inflammatory pain. In common with the aspirin like drugs, benzydamine possesses an antipyretic activity.
Peripheral reflexes were transiently inhibited after intravenous administration to cats.
Isomalt is a sugar-substitute. It is a disaccharide alcohol and is an approximately equimolar mixture of glucose-mannitol and glucose-sorbitol. Isomalt produces no measurable changes in blood glucose levels.
Pharmacodynamics: The mechanism of anti-inflammatory action is not related to stimulation of the pituitary-adrenal axis. Like other non-steroidal anti-inflammatory agents, benzydamine inhibits the biosynthesis of prostaglandins under certain conditions, but its properties in this respect have not been fully elucidated. The stabilising effect on cellular membranes may also be involved in the mechanism of action.
Pharmacokinetics: Absorption: Benzydamine is well absorbed following oral administration. Following topical administration of benzydamin ehydrochloride in solution form, benzydamine is well absorbed into the inflamed oral mucosa where it exerts anti-inflammatory and local anaesthetic actions. Plasma benzydamine levels following use of benzydamine orally are low and parallel 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. Benzydamine has been detected in blood and urine following gargling with Difflam solutions. Most of the absorbed dose was eliminated in the first 24 hours. Repeated administration for 7days did not result in accumulation of 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.
Difflam Anti-inflammatory Anti-bacterial Lozenges (Honey Lemon/Raspberry) should not be chewed. They should be slowly
dissolved in the mouth. One lozenge should be sucked slowly every one to two hours as required up to a maximum
of 12 lozenges per day. Uninterrupted treatment should not exceed seven 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 metabolised in the liver the possibility of systemic effects should beconsidered in patients with severe hepatic impairment.
There are no known cases of overdosage with Difflam lozenges. Adverse CNS effects have been reported following overdosage with high doses of benzydamine hydrochloride in solution form. There is no specific antidote for benzydamine and should excessive quantities be ingested, the treatment should be symptomatic. Excess consumption of products containing isomalt may have a laxative effect.
Patients with known hypersensitivity to benzydamine or cetylpyridinium chloride or to any of the components of the vehicle.
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 Difflam Anti-inflammatory Anti-bacterial Lozenges (Honey Lemon/Raspberry).
For use in patients with hepatic or renal impairment see Dosage & Administration.
Excess consumption of products containing isomalt may have a laxative effect.
Use in Children: Because of lack of sufficient clinical experience, Difflam Anti-inflammatory Anti-bacterial Lozenges (Honey Lemon/Raspberry) are not recommended in children under 6 years of age.
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 Difflam Anti-Inflammatory Lozenges (with Antibacterial) are to be used in these patients.
Difflam in topical oral preparations is generally well tolerated and side-effects are minor. The following adverse reactions have been reported after use of benzydamine hydrochloride in solution form:
Local Adverse Reactions: The most commonly reported reaction is oral numbness (2.6%). Occasional burning or stinging sensation may occur and has been reported in 1.4% of treated cases. Other local adverse effects were less common and included dryness or thirst (0.2%), tingling (0.2%), warm feeling in mouth and altered sense of taste (<0.1%).
Systemic Adverse Reactions: These were very uncommon and never of a serious nature. They consisted mainly of nausea, vomiting, retching, gastro-intestinal disorders (0.4%), dizziness (0.1%), headache and drowsiness (<0.1%).
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.
A01AD02 - benzydamine ; Belongs to the class of other agents for local oral treatment.
Difflam Anti-Inflammatory Antibacterial Lozenges
(honey lemon/raspberry flavour) 16's
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