3.0 mg of benzydamine hydrochloride in mL.
Each spray delivers approximately 0.5 mg of benzydamine hydrochloride. It also contains ethanol, saccharin sodium, methylhydroxybenzoate, glycerol, PEG-40 hydrogenated castor oil, purified water and mint flavouring. 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.
Difflam Forte Anti-Inflammatory Throat Spray is indicated 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.
Adults and children over 12 years: 2-4 sprays (1-2 mg) directly onto the sore/inflamed area and swallow gently. Repeat every 2 to 3 hours if necessary, not more than 6 times a day.
Children (6-12 years): 2 sprays (1 mg) directly onto the sore/inflamed area and swallow gently. Repeat every 3 hours if necessary, not more than 6 times a day.
Children under 6 years: Not recommended.
There are no known cases of overdosage with Difflam Forte Anti-Inflammatory Throat Spray. Adverse CNS effects have been reported following overdosage with high dose of Difflam solution. There is no specific antidote for benzydamine. If an excessive quantity is ingested, the treatment should be symptomatic.
Patients with known hypersensitivity to benzydamine or to the other components listed.
If a sore throat is either caused or complicated by a bacterial infection, an appropriate antibacterial therapy must be used in addition to the use of Difflam Forte Anti-Inflammatory Throat Spray.
Use in Pregnancy: Prolonged use in the third trimester of pregnancy is not recommended. Studies in animals are inadequate, but available data show no evidence of an increased occurrence of foetal damage. The safety of benzydamine hydrochloride has not been established in pregnant patients. Risk to benefit ratio should be established if Difflam Forte Anti-Inflammatory Throat Spray is to be used in these patients.
Use in Lactation: Not applicable.
Use in Children: Difflam Forte Anti-Inflammatory Throat Spray is not recommended in children under 6 years of age.
Pregnancy: Prolonged use in the third trimester of pregnancy is not recommended. Studies in animals are inadequate, but available data show no evidence of an increased occurrence of foetal damage. The safety of benzydamine hydrochloride has not been established in pregnant patients. Risk to benefit ratio should be established if Difflam Forte Anti-Inflammatory Throat Spray is to be used in these patients.
Lactation: Not applicable.
Difflam Forte Anti-Inflammatory Throat Spray is generally well-tolerated and side effects are minor.
The most commonly reported reaction is oral numbness (2.6% of treated cases). Occasional burning or stinging sensation may occur (1.4%). 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%).
There are no known drug interactions with benzydamine.
Protect from light and store below 30°C.
Shelf-life: 4 years.
A01AD02 - benzydamine ; Belongs to the class of other agents for local oral treatment.
Spray 0.3% w/v (white, metered dose, aerosol pump with a green lid) (clear solution) x 15 mL x 1's.