Dosage/Direction for Use
Oral Inflammation, oropharyngeal Adult: For the symptomatic relief of mouth and throat pain and irritation: As loz: Dissolve 1 loz slowly in the mouth tid. Alternatively, suck 1 loz 1-2 hourly or as needed (Max: 12 loz daily). Dosing may vary between countries, refer to detailed product guideline for specific dosing information. Max treatment duration: 7 days. Child: For the symptomatic relief of mouth and throat pain and irritation: As loz: >6 years Same as adult dose. Oral Pain, oropharyngeal Adult: For the symptomatic relief of mouth and throat pain and irritation: As loz: Dissolve 1 loz slowly in the mouth tid. Alternatively, suck 1 loz 1-2 hourly or as needed (Max: 12 loz daily). Dosing may vary between countries, refer to detailed product guideline for specific dosing information. Max treatment duration: 7 days. Child: For the symptomatic relief of mouth and throat pain and irritation: As loz: >6 years Same as adult dose. Mouth/Throat Pain, oropharyngeal Adult: In conditions such as mouth ulcer, sore throat, mouth or gums, and dental pain: As 0.15% w/v spray: 4-8 sprays 1.5-3 hourly. In conditions such as laryngitis, mucositis due to radiation therapy, and post-operative cases: As 0.30% w/v spray: 2-4 sprays 1.5-3 hourly. In conditions including pharyngitis or pharyngitis after tonsillectomy, use of nasogastric tube, aphthous ulcers or oral ulcer caused by radiation therapy, and after dental operation: As 0.15% w/v mouthwash or gargle: Rinse or gargle 15 mL 1.5-3 hourly as required. May dilute solution with equal volume of water if stinging occurs. Max treatment duration for all dosage forms: 7 days. Child: In conditions such as mouth ulcer, sore throat, mouth or gums, and dental pain: As 0.15% w/v spray: <6 years 1 spray/4 kg body weight (Max 4 sprays) 1.5-3 hourly; 6-12 years 4 sprays 1.5-3 hourly. Max treatment duration: 7 days; >12 years Same as adult dose. In conditions such as laryngitis, mucositis due to radiation therapy, and post-operative cases: As 0.30% w/v spray: <6 years >8 kg: 1 spray/8 kg body weight (Max 2 sprays) 1.5-3 hourly; 6-12 years 2 sprays 1.5-3 hourly; >12 years Same as adult dose. In conditions including pharyngitis or pharyngitis after tonsillectomy, use of nasogastric tube, aphthous ulcers or oral ulcer caused by radiation therapy, and after dental operation: As 0.15% w/v mouthwash or gargle: ≥13 years Same as adult dose. Mouth/Throat Inflammation, oropharyngeal Adult: In conditions such as mouth ulcer, sore throat, mouth or gums, and dental pain: As 0.15% w/v spray: 4-8 sprays 1.5-3 hourly. In conditions such as laryngitis, mucositis due to radiation therapy, and post-operative cases: As 0.30% w/v spray: 2-4 sprays 1.5-3 hourly. In conditions including pharyngitis or pharyngitis after tonsillectomy, use of nasogastric tube, aphthous ulcers or oral ulcer caused by radiation therapy, and after dental operation: As 0.15% w/v mouthwash or gargle: Rinse or gargle 15 mL 1.5-3 hourly as required. May dilute solution with equal volume of water if stinging occurs. Max treatment duration for all dosage forms: 7 days. Child: In conditions such as mouth ulcer, sore throat, mouth or gums, and dental pain: As 0.15% w/v spray: <6 years 1 spray/4 kg body weight (Max 4 sprays) 1.5-3 hourly; 6-12 years 4 sprays 1.5-3 hourly. Max treatment duration: 7 days; >12 years Same as adult dose. In conditions such as laryngitis, mucositis due to radiation therapy, and post-operative cases: As 0.30% w/v spray: <6 years >8 kg: 1 spray/8 kg body weight (Max 2 sprays) 1.5-3 hourly; 6-12 years 2 sprays 1.5-3 hourly; >12 years Same as adult dose. In conditions including pharyngitis or pharyngitis after tonsillectomy, use of nasogastric tube, aphthous ulcers or oral ulcer caused by radiation therapy, and after dental operation: As 0.15% w/v mouthwash or gargle: ≥13 years Same as adult dose. Topical/Cutaneous Pain and inflammation associated with musculoskeletal and joint disorders Adult: As 3% cream: Apply 35-85 mm (1-2 g) onto the affected area tid, or for up to 6 times daily at the prescriber's discretion in severe conditions. Max treatment duration: 10 days. |
Contraindications
Hypersensitivity to benzydamine, aspirin, or other NSAIDs.
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Special Precautions
Patient with existing or history of bronchial asthma, untreated bacterial throat infection. Renal and severe hepatic impairment. Children. Patient Counselling Cream: Avoid smoking or going near naked flames due to risk of burns.
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Adverse Reactions
Significant: Local irritation and burning sensation. Rarely, bronchospasm.
Gastrointestinal disorders: Oral hypoaesthesia, dry mouth; nausea, vomiting.
Immune system disorders: Hypersensitivity reactions. Rarely, angioedema.
Metabolism and nutrition disorders: Thirst.
Nervous system disorders: Headache, drowsiness.
Respiratory, thoracic and mediastinal disorders: Rarely, laryngospasm.
Skin and subcutaneous tissue disorders: Photosensitivity reaction, rash, pruritus, erythema, papular eruption.
Potentially Fatal: Anaphylactic reaction. |
Overdosage
Symptoms: Nausea, vomiting, abdominal pain, oesophageal irritation, dizziness, anxiety, agitation, irritability, and hallucinations. Rarely, sweating, ataxia, excitation, tremor, and convulsions in children. Management: Symptomatic and supportive treatment. May perform gastric lavage or induce vomiting. Maintain adequate hydration.
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Action
Benzydamine is an indole NSAID with moderate local anaesthetic activity. It inhibits the production of proinflammatory cytokines including tumour necrosis factor-α (TNF-α) and interleukin-1-β (IL-1β) without significantly affecting other proinflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist). Compared with aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is a weak base and a weak prostaglandin synthesis inhibitor.
Absorption: Absorbed through oropharyngeal mucosa; well absorbed through the skin. Time to peak plasma concentration: 2-4 hours (oral). Distribution: Slowly and completely distributed into tissues. Concentrated at the site of inflammation. Volume of distribution: 100 L. Plasma-protein binding: 10-15% (oral). Metabolism: Metabolised in the liver primarily via oxidation, conjugation, and dealkylation. Excretion: Mainly via urine (approx 50% as unchanged drug). Elimination half-life Approx 10-13 hours. |
Storage
Mouth/Throat: Store between 15-30°C. Do not freeze. Protect from light. Oral: Store below 30°C. Protect from moisture. Topical/Cutaneous: Store between 5-30°C. Do not freeze.
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ATC Classification
R02AX03 - benzydamine ; Belongs to the class of other throat preparations.
M01AX07 - benzydamine ; Belongs to the class of other non-steroidal antiinflammatory and antirheumatic products. A01AD02 - benzydamine ; Belongs to the class of other agents for local oral treatment. G02CC03 - benzydamine ; Belongs to the class of antiinflammatory products for vaginal administration used in the treatment and prevention of inflammation. M02AA05 - benzydamine ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains. |