Benzydamine hydrochloride, chlorhexidine gluconate.
Each 15mL contains: benzydamine hydrochloride 22.5mg, chlorhexidine gluconate 18mg.
Contains: Ethanol 70mg/mL.
Difflam-C Solution: Benzydamine hydrochloride 0.15% w/v (22.5mg/15mL) and Chlorhexidine gluconate 0.12% w/v (18mg/15mL), clear pink.
Benzydamine is 1-Benzyl-3-(3-dimethylaminopropoxy)-1H-indazole.
Benzydamine hydrochloride is a white odourless, crystalline powder with a bitter taste, soluble in water, ethanol and chloroform. It is sparingly soluble in ether and petroleum ether.
Chlorhexidine is 1,1-Hexamethylenebis (5-(4-chlorophenyl) (biguanide).
Sugar free.
Pharmacology: Benzydamine is an 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 an acid. Animal models show that when administered systemically, benzydamine is effective against pain and oedema due to inflammatory conditions. It also inhibits granuloma formation. At concentrations 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 of up to 100mg/kg. The analgesic activity of benzydamine was more pronounced in models involving an experimental inflammation 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. Chlorhexidine is a bisbiguanide antiseptic and helps to reduce the development of plaque and gingivitis when usual oral hygiene measures are interrupted. It is a strong base, with affinity for oral structures including hydroxyapatite of tooth enamel, pellicle of tooth surface, bacteria and salivary proteins. Chlorhexidine reduces dental plaque deposition and associated gingivitis as characterised by redness, swelling or bleeding of the gingiva. It also increases the number of days between aphthous ulcers and increases the rate of healing following periodontal surgery.
Mode of Action: The mechanism of anti-inflammatory action of benzydamine 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.
Following normal topical application of Difflam-C Solution chlorhexidine produces an immediate bacteriocidal effect, followed by a prolonged bacteriostatic action. Chlorhexidine is active against a wide range of micro-organisms, including Gram-positive bacteria and Gram-negative bacteria, yeast and some fungi and viruses. Chlorhexidine appears to delay bacterial growth by delayed surface action. It is attracted to and absorbed onto microbial cell walls and causes membrane leakage.
Pharmacokinetics: Absorption: Benzydamine is well absorbed following oral administration. Following topical administration of Difflam solutions and spray, benzydamine is well absorbed into the inflamed oral mucosa where it exerts anti-inflammatory and local anaesthetic actions. Plasma benzydamine levels following use of Difflam solutions are low and parallel the amount actually ingested. Chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. No detectable blood levels have been found in humans following oral use, and percutaneous absorption, if it occurs at all is insignificant.
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 7 days did not result in accumulation of benzydamine in plasma.
Approximately 30% of the applied chlorhexidine gluconate is retained into the oral cavity, and it is slowly released in the oral fluids for up to 24 hours. Chlorhexidine is poorly absorbed from the gastrointestinal tract, and is primarily excreted in the faeces.
For the temporary relief of painful conditions of the mouth and throat including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, post oro-surgical and periodontal procedures.
Chlorhexidine in Difflam-C Solution helps to reduce the development of plaque and gingivitis during the period of treatment when the usual oral hygiene measures are interrupted. Difflam-C Solution is not intended for prolonged use except under dental or medical supervision.
Difflam-C Solution should generally be used undiluted, but if stinging occurs it may be diluted with water. The solution should be expelled from the mouth after use. Uninterrupted treatment should not exceed seven days.
Dosage in Adults: When used as a gargle, the usual dose is 15mL (approximately one tablespoon) which should be gargled for at least 30 seconds at 1½ to 3 hourly intervals, as needed. When used as a rinse for oral lesions, the usual dose is 15mL (approximately one tablespoon) which should be held in the mouth and swirled around for at least 30 seconds with repeat use every 1½ to 3 hours throughout the day. Chlorhexidine in Difflam-C Solution helps to reduce the development of plaque and gingivitis during the period of treatment when usual oral hygiene measures are interrupted. If used as an alternate to usual oral hygiene procedures, Difflam-C Solution should be swirled around in the mouth for at least a minute.
Difflam-C Solution is best used after brushing the teeth to minimise chlorhexidine induced discolouration. Difflam-C Solution is not intended for prolonged use except under dental or medical supervision.
Dosage in Children: 5 to 15mL as a gargle if able to do so, or as an oral rinse.
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, possibility of systemic effects should be considered in patients with severe hepatic impairment.
Adverse CNS effects have been reported following overdosage with high doses of Difflam Solution. There is no specific antidote for benzydamine and should be excessive quantities be ingested the treatment should be symptomatic.
Patients with known hypersensitivity to benzydamine or to any of the components of the vehicle. Additionally, Difflam-C Solution is contraindicated in patients with known hypersensitivity to chlorhexidine.
Difflam-C Solution is indicated for use as a rinse or gargle. It should not be swallowed but rather should be expectorated after each use.
Difflam-C Solution contains chlorhexidine.
Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is unknown, but available literature suggests this is likely to be very rare. Difflam-C Solution should not be administered to anyone with a possible history of an allergic reaction to chlorhexidine.
If any signs or symptoms of a suspected hypersensitivity reaction such as itching, skin rash, redness, swelling, breathing difficulties, light headedness, and rapid heart rate develop, immediately stop using the product. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Difflam-C Solution should generally be used undiluted but if burning or stinging occur, it may be diluted with water. 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-C Solution. For use in patients with hepatic or renal impairment see Dosage & Administration.
Use in Children: Because of the lack of sufficient clinical experience, Difflam-C Solution is not recommended in children under 6 years of age.
Use in Pregnancy: Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage. The safety benzydamine hydrochloride has not been established in pregnant patients. Risk to benefit ratio should be established if Difflam is to be used in these patients.
Difflam-C Solution 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 taste (0.1%).
Systemic Adverse Reactions: These were very uncommon and never of a serious nature. They consisted mainly of nausea, vomiting, retching, gastrointestinal 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 or bronchospasm. The most common side effects associated with chlorhexidine gluconate oral rinses are an increase in staining of teeth and other oral surfaces, and increase in calculus formation and an alteration in taste perception. Chlorhexidine tooth staining is harmless and can be minimised by thorough brushing of teeth before administration. No serious systemic adverse reactions associated with its use have been observed in clinical testing.
Immune System Disorders: Frequency not known: Hypersensitivity including anaphylactic shock.
There are no known drug interactions with benzydamine.
Protect from light. Store below 30°C.
Shelf-Life: 2 years.
R02AX03 - benzydamine ; Belongs to the class of other throat preparations.
Difflam-C Solution gargle
100 mL x 1's
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