Difflam For Children Throat Spray

Clear colourless liquid with a typical mint flavour.
Each 1 mL contains Benzydamine hydrochloride 1.5 mg.
Each spray delivers approximately 0.25 mg of benzydamine hydrochloride.
Excipients/Inactive Ingredients: Ethanol, glycerol, methyl parahydroxybenzoate, mint flavour, saccharin, sodium hydrogen carbonate, polysorbate 20, purified water.
It does not contain gluten, lactose, sugar or colour.

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 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 an antipyretic activity. Peripheral reflexes were transiently inhibited after intravenous administration to cats.
Pharmacodynamics: 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 stabilizing effect on cellular membranes may also be involved in the mechanism of action.
Pharmacokinetics: Benzydamine is well absorbed following oral administration. Following topical administration, benzydamine is well absorbed into the inflamed oral mucosa where it exerts anti-inflammatory and local anaesthetic actions. Plasma benzydamine levels following use are low and proportionate to the amount actually ingested.
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 of solution form. Most of the absorbed dose is eliminated in the first 24 hours. Repeated administration for 7 days does not result in accumulation of benzydamine in plasma.

For the temporary relief of pain due to inflammatory of the mouth and throat including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, pharyngitis, swelling, redness, inflammatory conditions, post-orosurgical and periodontal procedures.

Recommended Dose: Children over 12 years: 4-8 sprays (1-2 mg) directly onto the sore/inflamed area and swallow gently. Repeat every 1½ to 3 hours as necessary.
Children (6-12 years): 4 sprays (1 mg) directly onto the sore/inflamed area and swallow gently. Repeat every 1½ to 3 hours as necessary.
Children under 6 years: One spray per 4 kg body weight, at a maximum of 4 sprays. Repeat every 1½ to 3 hours as necessary.
Uninterrupted treatment should not exceed seven days, unless under medical supervision.
Cleaning instructions: After use, wipe the nozzle with a clean tissue to prevent blockage.
Mode of Administration: For topical use.

Overdose and Treatment: There are no known cases of overdosage with Difflam For Children Throat Spray (1.5 mg/mL). Adverse CNS effects have been reported following overdosage with high dose of benzydamine hydrochloride in solution form.
There is no specific antidote for benzydamine hydrochloride and should excessive quantities be ingested, the treatment should be symptomatic.

Patients with known hypersensitivity to benzydamine hydrochloride or to any other ingredients listed in Description.

If a sore throat is either caused or complicated by a bacterial infection, an appropriate antibacterial therapy should be considered in addition to the use of Difflam For Children Throat Spray (1.5 mg/mL).
Before using the product, tell the doctor or pharmacist if the patient has any of the following conditions: liver problems or kidney problems.

Use In Pregnancy: Difflam Spray should not be used in pregnancy unless considered essential by the physician. There is no evidence of a teratogenic effect in animal studies.
Use In Lactation: Difflam Spray should not be used in lactation unless considered essential by the physician.

The most commonly reported reaction is oral numbness and has been reported in 2.6% of treated cases. Occasional burning or stinging sensation may occur (1.4%). Other local adverse effects are less common and included dryness or thirst (0.2%), tingling (0.2%), warm feeling in mouth and altered sense of taste (0.1%).
Systemic side effects are rare. These include 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 rash, urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.

There are no known drug interactions with benzydamine.

Storage Condition: Store below 30°C.

Preparations for Oral Ulceration & Inflammation

R02AX03 - benzydamine ; Belongs to the class of other throat preparations.

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