Difflam-C Anti-inflammatory Antiseptic Solution

Difflam-C Anti-inflammatory Antiseptic Solution

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Benzydamine HCl, chlorhexidine gluconate.
Description
Each 15-mL solution contains benzydamine hydrochloride 22.5 mg (0.15% w/v) and chlorhexidine gluconate 18 mg (0.12% w/v).
Benzydamine is 1-benzyl-3-(3-dimethylaminopropoxy)-1H-indazole. It is a white, odourless, crystalline powder with a bitter taste, soluble in water, ethanol, methanol and chloroform. It is sparingly soluble in ether and petroleum ether.
Chlorhexidine is 1,1-hexamethylene bis[5-(4-chlorophenyl)biguanide].
Action
Pharmacology: Benzydamine is an anti-inflammatory analgesic agent structurally unrelated to the steroid group. Benzydamine differs chemically from other nonsteroidal 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 100 mg/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 possess an antipyretic activity. Peripheral reflexes were transiently inhibited after IV 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 characterized 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 nonsteroidal 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, chlorhexidine produces an immediate bacteriocidal effect, followed by a prolonged bacteriostatic action. Chlorhexidine is active against a wide range of microorganisms, including gram-positive and gram-negative bacteria, yeast and some fungi and viruses. Chlorhexidine appears to delay bacterial growth by a 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-C solutions and spray, benzydamine is well absorbed into the inflamed local mucosa where it exerts anti-inflammatory and local anaesthetic actions. Plasma benzydamine levels following use of Difflam-C 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-C. Most of the absorbed dose was eliminated in the first 24 hrs. Repeated administration for 7 days did not result in accumulation of benzydamine in plasma.
Approximately 30% of the applied chlorhexidine gluconate is retained in the oral cavity, and it is slowly released into the oral fluids for up to 24 hrs. Chlorhexidine is poorly absorbed from the gastrointestinal tract and is primarily excreted in the faeces.
Indications/Uses
Relief of painful conditions of the mouth and throat including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, post-orosurgical and periodontal procedures.
Reduces the development of plaque and gingivitis during the period of treatment when the usual oral hygiene measures are interrupted. Difflam-C is not intended for prolonged use except under dental or medical supervision.
Dosage/Direction for Use
Difflam-C 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 7 days.
Adults: Solution: Usual dose is 15 mL (approximately 1 tbsp) which should be gargled for at least 30 sec at 1½- to 3-hourly intervals, as needed.
Rinse for Oral Lesions: Usual dose is again 15 mL (approximately 1 tbsp) which should be held in the mouth and swirled around for at least 30 sec, with repeat use every 1½-3 hrs 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 procedure. Difflam-C solution should be swirled around in the mouth for at least 1 min, Difflam-C is best used after brushing the teeth to minimize chlorhexidine-induced discoloration. Difflam-C solution is not intended for prolonged use except under the dental or medical supervision.
Children: 5-15 mL as a gargle if able to do so, or as an oral rinse.
Patients 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.
Patients with Impaired Liver Function: Since absorbed benzydamine is highly metabolised in the liver, the possibility of systemic effects should be considered in patients with severe hepatic impairment.
Overdosage
Adverse CNS effects have been reported following overdosage with high doses of Difflam-C. There is no specific antidote for benzydamine and should excessive quantities be ingested, the treatment should be symptomatic.
Contraindications
Hypersensitivity to benzydamine or to any of the components of the vehicle; hypersensitivity to chlorhexidine.
Special Precautions
Difflam-C is indicated for use as a rinse or gargle. It should not be swallowed but rather should be expectorated after each use. Difflam-C 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.
For use in patients with hepatic or renal impairment, see also Dosage & Administration.
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 of benzydamine HCl has not been established in pregnant patients. Risk to benefit ratio should be established if Difflam-C is to be used in these patients.
Use in children: Because of the lack of sufficient clinical experience, Difflam-C is not recommended in children <6 years.
Adverse Reactions
Difflam-C solution is generally well tolerated and adverse effects are minor.
The following adverse reactions have been reported after use of benzydamine HCl in solution form:
Local: 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: 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%).
The most common adverse effects associated with chlorhexidine gluconate oral rinses are an increase in staining of teeth and other oral surfaces, an 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.
Drug Interactions
There are no known drug interactions with benzydamine.
Storage
Store below 30°C. Protect from light.
Shelf-Life: 2 years.
ATC Classification
A01AD02 - benzydamine ; Belongs to the class of other agents for local oral treatment.
Presentation/Packing
Soln (pleasant-tasting, clear, pink) 100 mL x 1's, 200 mL x 1's.
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