Difflam Forte Throat Spray

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What is Difflam Forte Throat Spray ?

Difflam Forte Throat Spray is an oral and throat pain relief spray that is indicated for temporary relief from sore throat, tonsillitis, pharyngitis, radiation mucositis, apthous ulcers, inflamatory conditions, post orosurgical and periodontal procedures.

Active Ingredient

Each mL of Difflam Forte Anti-inflammatory Throat Spray contains benzydamine hydrochloride 3 mg.
Each spray delivers approximately 0.5 mg of benzydamine hydrochloride.

Composition

It contains benzydamine hydrochloride, ethanol, saccharin sodium, methyl hydroxybenzoate, glycerol, PEG-40, hydrogenated castor oil, purified water and mint flavouring.

It does not contain gluten, lactose, sugar or colour.

Indication

Difflam Forte Anti-Inflammatory Throat Spray is indicated for temporary relief of pain due to inflammation of the mouth and throat including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, pharyngitis, swelling, redness, inflammatory conditions, post orosurgical and periodontal procedures.

Dosage and Administration

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 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.

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.

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 during breastfeeding

Use of benzydamine hydrochloride during lactation has not been established in humans. Seek your doctor’s advice if you are breastfeeding or likely to breastfeed during your course of medication.

Use in Children

Because of the lack of sufficient clinical experience, Difflam Forte Anti-inflammatory Throat Spray is not recommended in children under 6 years of age.

Pharmacology

Benzydamine HCL (benzydamine) is an anti-inflammatory analgesic agent structurally unrelated to the steroid group. Benzydamine differs chemically from other non-steroidal anti-inflammatory agents (NSAIDs) 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 dose 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 stabilising effect on cellular membrances 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 local mucosa where it exerts anti-inflammatory and local anaesthetic actions. Plasma benzydamine levels following use are low and proprtionate 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.

What should I do if I forget to take Difflam Forte Throat Spray?

In general, if you forget to use Difflam Forte Throat Spray, used as soon as you remember without having to double the dose.

Overdosage

There are no known cases of overdosage with Difflam Forte Anti-Inflammatory Throat Spray. Adverse CNS effects have been reported following overdosage with high doses of Difflam Solution. There is no specific antidote for benzydamine. If an excessive quantity is ingested, the treatment should be symptomatic.

Precautions

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.

Adverse Reactions

Difflam Forte Anti-Inflammatory Throat Spray 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% 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 Adverse Reactions:

These were uncommon and consisted mainly of 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 pruritus, rash, urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.

Adverse reactions that require immediate attention to your doctor or pharmacist

Severe stomach pain or discomfort, severe headache, rash, urticaria, skin inflammation, difficulty breathing.

Drug Interactions

  • There are no known drug interactions with benzydamine.

Contraindications

Patients with known hypersensitivity to benzydamine hydrochloride or to any other ingredients present in Difflam Forte Anti-Inflammatory Throat Spray.

Storage

Protect from light and store below 30°C. Shelf life: 4 years

Other information

Thai drug registration number : 1C 37/61  Read more about the meaning of Thai registration number.

Pharmaceutical Dosage Form: OROMUCOSAL SPRAY, SOLUTION

 Packaging: White metered dose pump with a green lid containing 15 mL of clear solution

Poisons schedule: S2

Category by point of use: Topical Medication

Category by legislation class: Dangerous Drug

Manufactued by: AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA, ANCONA (AN), Italy

Imported by: Inova Pharmaceuticals (Thailand) LTD.98 Sathorn Square Office Tower, 19th Floor, Unit 1901 North Sathorn Road, Silom, Bangrak, Bangkok Tel. 02-119-4300

Where to buy Difflam Forte Throat Spray ?

Due to Difflam Forte Throat Spray is a dangerous drug, it is only available in modern pharmacies and must be delivered by a pharmacist.

Reference

  • Labels and documentation of Difflam Forte Throat Spray, Revision date: March 2019
  • Product information authorised verification system, Food and Drug Administration, Ministry of Health, Thailand
  • MIMS