Benzydamine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Painful and inflammatory conditions of oropharynx As loz: Dissolve 1 loz slowly in the mouth tid. Alternatively, suck 1 loz 1-2 hourly or as needed (Max: 12 loz/day). Dosing may vary between countries, refer to detailed product guideline for specific dosing information. Max treatment duration: 7 days. Mouth/Throat Painful and inflammatory conditions of oropharynx As 0.15% w/v spray: 4-8 sprays 1.5-3 hourly. As 0.30% w/v spray: 2-4 sprays 1.5-3 hourly. 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. Topical Pain and inflammation associated with musculoskeletal and joint disorders As 3% cream: Apply 35-85 mm (1-2 g) onto the affected area tid, or for up to 6 times/day at the prescriber’s discretion in severe conditions. Max treatment duration: 10 days.
Dosage Details
Mouth/Throat
Inflammation, oropharyngeal, 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.

Oral
Inflammation, oropharyngeal, 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.

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.
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.
Patient Counseling Information
Cream: Avoid smoking or going near naked flames due to risk of burns.
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
Description: 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.
Pharmacokinetics:
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.
Chemical Structure

Chemical Structure Image
Benzydamine

Source: National Center for Biotechnology Information. PubChem Database. Benzydamine, CID=12555, https://pubchem.ncbi.nlm.nih.gov/compound/Benzydamine (accessed on Jan. 21, 2020)

Storage
Loz: Store below 30°C. Protect from moisture. Spray/mouthwash/rinse: Store between 15-30°C. Do not freeze. Protect from light. Cream: Store between 5-30°C. Do not freeze.
ATC Classification
R02AX03 - benzydamine ; Belongs to the class of other throat preparations.
M02AA05 - benzydamine ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
A01AD02 - benzydamine ; Belongs to the class of other agents for local oral treatment.
M01AX07 - benzydamine ; Belongs to the class of other non-steroidal antiinflammatory and antirheumatic products.
References
Anon. Benzydamine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/07/2020.

B Gargle Solution 0.15% w/v (Malaysian Pharmaceutical Industries Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 14/08/2020.

Benzydamine Hydrochloride 0.30% w/v Oromucosal Spray (Abdi Farma, Unip. Lda.). MHRA. https://products.mhra.gov.uk/. Accessed 09/07/2020.

Buckingham R (ed). Benzydamine hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/07/2020.

Difflam 0.15% w/v Oral Rinse (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk/. Accessed 09/07/2020.

Difflam 0.15% w/v Spray (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk/. Accessed 09/07/2020.

Difflam 3 mg Lozenges, Eucalyptus Flavour (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk/. Accessed 09/07/2020.

Difflam Anti-Inflammatory Lozenge Sugar-Free (iNova Pharmaceuticals Pte Ltd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 14/08/2020.

Difflam Anti-inflammatory Lozenges Sugar Free (Bausch & Lomb [Thailand] Ltd). MIMS Thailand. http://www.mims.com/thailand. Accessed 09/07/2020.

Difflam Cream or Difflam 3% P Cream (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk/. Accessed 09/07/2020.

Difflam Forte Anti-Inflammatory Throat Spray 0.3% w/v (iNova Pharmaceuticals Pte Ltd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 14/08/2020.

Difflam Solution (iNova Pharmaceuticals Pte Ltd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 14/08/2020.

Easiflam Mouthwash (Hovid Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 14/08/2020.

Joint Formulary Committee. Benzydamine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/07/2020.

Oroeze 0.15% w/v Mouthwash (Focus Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 09/07/2020.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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