D Throat Spray

Benzydamine hydrochloride.

Each ml of D Throat Spray 0.15% (Lemon flavor) contains benzydamine hydrochloride 1.5 mg (Each spray provides approximately 0.25 mg of benzydamine hydrochloride).
Each ml of D Throat Spray 0.3% (Lemon flavor) contains benzydamine hydrochloride 3 mg (Each spray provides approximately 0.5 mg of benzydamine hydrochloride).
Each ml of D Throat Spray 0.3% (Mint flavor) contains benzydamine hydrochloride 3 mg (Each spray provides approximately 0.5 mg of benzydamine hydrochloride).
Excipients/Inactive Ingredients: Menthol, glycerin, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methylparaben, alcohol, flavor and purified water.

Pharmacology: Pharmacodynamics: Mechanism of action: Benzydamine hydrochloride is a nonsteroidal anti-inflammatory drug (NSAID) but it differs chemically from other NSAIDs in that it is a base rather than an acid. Benzydamine reduces local pain and inflammation by inhibiting prostaglandin synthesis which does not interfere with arachidonic acid metabolism, and stabilizing the cellular membrane, inhibition of granuloma formation as demonstrated by the inhibition of granule release from neutrophils and the stabilization of lysosomes. At concentrations used for topical treatment, benzydamine possesses local anaesthetic action. The local anesthetic activity of this compound has been related to an interaction with cationic channels.
The relation of dose and pharmacodynamic responses: No information.
Mechanism of toxicity: No information.
Pharmacokinetics: Absorption: Benzydamine hydrochloride is well absorbed into the oral mucosa. Following oral administration, benzydamine is rapidly absorbed from the gastrointestinal tract and maximum plasma levels reached after 2-4 hours.
Distribution: The most important aspect of the tissue distribution of benzydamine is its tendency to concentrate at the site of inflammation. After intravenous or intramuscular injection in dairy cows, benzydamine was rapidly transferred to milk.
Metabolism and elimination: About half of the benzydamine is excreted unchanged via the kidney at a rate of 10% of the dose within the first 24 hours. The remainder is metabolised, mostly to N-Oxide.
Toxicology: Preclinical safety data: There are no available for preclinical safety data.

For the temporary relief of painful conditions 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: Spray directly onto sore/inflamed area in the mouth and swallow gently.
D Throat Spray 0.15%: Adults and children over 12 years: 4-8 sprays, repeat every 1½ to 3 hours if necessary.
Children 6-12 year: 4 sprays, repeat every 1½-3 hours if necessary.
Children under 6 years: One spray to be administered per 4 kg body weight, up to a maximum of 4 sprays, repeat every 1½-3 hours if necessary.
D Throat Spray 0.3%: Adults and children over 12 years: 2-4 sprays, repeat every 2 to 3 hours if necessary but not more than 6 times a day.
Children 6-12 years: 2 sprays, repeat every 2-3 hours if necessary but not more than 6 times a day.
Children under 6 years: Not recommended for children under 6 years.
Renal function impairment: There is no required for dosage adjustment in patient with renal function impairment.
Hepatic function impairment: There is no providing information about dosage adjustments.
Mode of Administration: Spray directly onto sore/inflamed area in the mouth and swallow gently. After use, wipe the nozzle with the clean tissue to prevent blockage.

Overdose and Treatment: The product with 0.15% benzydamine hydrochloride is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. No special measures are required (for D Throat Spray 0.15% only).
The product with 0.3% benzydamine hydrochloride has no known cases of overdosage. Adverse CNS effects have been reported following overdosage with high dose of another product contained benzydamine hydrochloride solution (for D Throat Spray 0.3% only).
There is no specific antidote for benzydamine hydrochloride. If an excessive quantity is ingested, the treatment should be symptomatic.
It has been reported a 6-year old girl had hallucinations after receiving 500 mg of benzydamine orally; it had been intended as a vaginal douche for pruritus vulva; recovery was spontaneous.

Do not take this medicinal product with patients who have known hypersensitivity to Benzydamine hydrochloride or any component of this formulation.

According to Ministry of Public Health Announcement: 1. Do not use this product in patients with acute asthma, urticarial or nasal cavity inflammation due to hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs).
2. Pregnant women during their last trimester should avoid using this product without prescription by a doctor.
3. Do not use this product in patients having bleeding in their stomach or intestine or having perforation.
4. Do not use this product in patients with severe liver or kidney diseases.
5. Do not use this product in patients with a dengue fever.
6. This product may increase a risk of bleeding or ulcers in the stomach and intestine.
7. This product may increase a risk of ischemic stroke and angina especially when used at a high dose for a long period of time.
8. This product may cause a side effect which is edema. Therefore, it should be carefully used in patients with heart diseases and kidney dysfunction.
9. Be careful to use this product in patients with hypertension and in elders.
10. This product affects platelet aggregation. Thus, it should be avoided in patients suspected to have a dengue fever or platelet abnormalities due to other causes.

1. Use caution in patients with renal function impairment.
2. Avoid contact with the eyes.
3. If sore throat is either caused or complicated by a bacterial infection, an appropriate antibacterial therapy must be used in addition to use of this medicinal product.
4. D Throat Spray 0.15% and 0.3% (Lemon flavor) contains 10% ethanol.
D Throat Spray 0.3% (Mint flavor) contains 15% ethanol.
Effects on ability to drive and use machines: No data available on this product.
Use in pregnancy & lactation: Use caution in pregnancy and breast-feeding.

Pregnancy: 1. The safety of this medicinal product for use in human pregnancy has not been established. This product should be used when potential benefit outweighs possible risk to the fetus.
2. Prolonged use in the third trimester of pregnancy is not recommended.
3. Studies in animals are inadequate, but available data show no evidence of an increased occurrence of fetal damage. Teratology studies were negative in mice and rats. The production of maternal toxicity in late pregnancy in rats was associated with a decrease in litter size and live births.
Lactation: It has no known if benzydamine is excreted in breast milk. After intravenous or intramuscular injection in dairy cows, benzydamine was rapidly transferred to milk. This medicinal product should be used with caution to patient with breast-feeding.

The most common side effects are numbness and a stinging feeling in the mouth.
Respiratory, thoracic and mediastinal disorders: Very rare (may affect less than 1 in 10,000): Laryngospasm or bronchospasm.
Gastrointestinal disorders: Uncommon (may affect up to 1 in 1000 but less than 1 in 100 people): Oral numbness and a stinging feeling in the mouth, nausea, vomiting, retching, dryness or thirst, warm feeling in the mouth and alter sense of taste.
The stinging has been reported to disappear upon continuation of the treatment, however if it persists it is recommended that treatment be discontinued.
Skin and subcutaneous tissue disorders: Very rare (may affect less than 1 in 10,000): Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash.
Frequency not known: Angioedema.
Methylparaben may cause allergic reactions (possibly delayed).
Immune system disorders: Frequency not known: Anaphylactic reaction which can be potentially life threatening.
Effects on the kidneys: A 57-year-old woman who had used 400 g of a topical cream containing benzydamine hydrochloride 3% over a period of 4 months was found to have raised plasma concentrations of creatinine and urea consistent with a substantial reduction in glomerular filtration rate.

This medicinal product has no known interactions with other medicines.

How to use D Throat Spray: 1. Remove the cover holding the bottle firmly.
2. Turn the nozzle either left or right, up towards the patient.
3. Activate the pump, by spraying 2-3 times in air away from the patient.
4. Press the pump firmly to spray directly into the throat.

Keep these medicinal products in the original package.
Store in an upright position.
Store below 30°C and protect from sunlight and moisture.
Do not refrigerate or freeze.

Preparations for Oral Ulceration & Inflammation

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

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