Difflam Lozenges 3 mg

Difflam Lozenges 3 mg

benzydamine

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Benzydamine HCl.
Description
Difflam Lozenges 3 mg also contain isomalt and saccharin sodium as inactive ingredients.
Benzydamine is 1-benzyl-3-(3-dimethylaminopropoxy)-1H-indazole.
Benzydamine HCl 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.
Action
Pharmacology: Benzydamine is an anti-inflammatory analgesic agent structurally unrelated to the steroid group. It 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 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 possesses antipyretic activity. Peripheral reflexes were transiently inhibited after IV 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 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.
Pharmacokinetics: Absorption: Benzydamine is well absorbed following oral administration. Following topical administration of benzydamine HCl 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 Solution. 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 the plasma.
Indications/Uses
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.
Dosage/Direction for Use
Difflam Lozenges 3 mg should not be chewed. It should be slowly dissolved in the mouth. 1 lozenge should be sucked slowly every 1 or 2 hrs as required up to a maximum of 12 lozenges/day. Uninterrupted treatment should not exceed 7 days.
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 Hepatic Function: Since absorbed benzydamine is highly metabolised in the liver, the possibility of systemic effects should be considered in patients with severe hepatic impairment.
Difflam Lozenges 3 mg are sugar-free, therefore, suitable for diabetic patients.
Overdosage
There are no known cases of overdosage. Adverse central nervous system effects have been reported following overdosage with high doses of benzydamine HCl in solution form. There is no specific antidote for benzydamine and should excessive quantities be ingested, the treatment should be symptomatic. Excessive consumption of products containing isomalt may have a laxative effect.
Contraindications
Patients with known hypersensitivity to benzydamine or any of the components of the vehicle.
Special Precautions
Difflam Lozenges 3 mg should not be chewed. They should be slowly dissolved in the mouth.
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 Lozenges 3 mg.
For use in patients with hepatic or renal impairment, see 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 fetal damage. The safety of benzydamine HCl has not been established in pregnant patients. Risk-to-benefit ratio should be established if Difflam Lozenges 3 mg are to be used in these patients.
Use in Children: Because of the lack of sufficient clinical experience, Difflam Lozenges 3 mg is not recommended in children <6 years.
Adverse Reactions
Difflam Lozenges 3 mg are generally well tolerated and side effects are minor.
Hypersensitivity reactions occur very rarely but may be associated with pruritis, rash, urticaria, photodermatitis and occasionally laryngospasm.
Drug Interactions
There are no known drug interactions with benzydamine.
Storage
Store below 30°C.
Shelf-Life: 3 years.
ATC Classification
A01AD02 - benzydamine ; Belongs to the class of other agents for local oral treatment.
Presentation/Packing
Loz 3 mg (green, mint fresh flavour) x 16's.
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