Benzydamine


Full Generic Medicine Info
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
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.

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.

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.
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.
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.
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.
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.
Disclaimer: This information is independently developed by CIMS based on benzydamine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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