Benzydamine Hydrochloride

Registered South African indications:

• Symptomatic relief of painful inflammatory conditions of the mouth and throat such as
  - Traumatic conditions: Pharyngitis following the use of nasogastric tube or tonsillectomy
  - Inflammatory conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiotherapy
  - Dentistry: After dental operations

Registered South African contraindications

• Hypersensitivity to the active substance or any of its excipients
• Children below 12 years
• Pregnancy (sol)
• Breastfeeding (sol)

Contraindications registered in other jurisdictions

• Hypersensitivity to the active substance or any of its excipients

• Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Delayed hypersensitivity to methyl parahydroxybenzoate
• Pregnancy (spo) (South African recommendations)
• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (spo) (South African recommendations)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment
• History of asthma
• Avoid contact with eyes
• Alcoholism

Forms avail. in SA and covered in this monograph: mow (sol), spo

South African registered indications and dosages

Symptomatic relief of painful inflammatory conditions of the mouth and throat such as
- Traumatic conditions: Pharyngitis following the use of nasogastric tube or tonsillectomy
- Inflammatory conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiotherapy
- Dentistry: After dental operations

• Oral (sol): Rinse or gargle with 15ml (approx. one tablespoon), every 1.5-3hrs as required for pain relief; Solution should be expelled from mouth after use
• Oral (spo): 5-10 sprays directly onto the painful or inflamed area and swallow gently; Repeat every 1.5-3hrs as necessary

Do not exceed the recommended dose. Contact with the eyes should be avoided

Benzydamine hydrochloride solution should generally be used undiluted, but if "stinging" occurs, the rinse may be diluted with water

Paed. forms avail. in SA and covered in this monograph: mow (sol), spo

South African registered indications and dosages

Symptomatic relief of painful inflammatory conditions of the mouth and throat such as
- Traumatic conditions: Pharyngitis following the use of nasogastric tube or tonsillectomy
- Inflammatory conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiotherapy
- Dentistry: After dental operations

Younger than 12 years

• Contraindicated

12 years and older

• See adult dosage

Pregnancy

South African recommendations

Oral rinse

• Contraindicated
• Benzydamine hydrochloride should not be used during pregnancy

Spray

• Caution
• The safety of benzydamine hydrochloride in pregnancy has not been established

Recommendations in other jurisdictions

• Caution; not recommended
• Benzydamine hydrochloride should not be used during pregnancy

Breastfeeding

South African recommendations

Oral rinse

• Contraindicated
• Benzydamine hydrochloride should not be used during lactation

Spray

• Caution
• The safety of benzydamine hydrochloride in lactation has not been established

Recommendations in other jurisdictions

• Caution; not recommended
• Benzydamine hydrochloride should not be used during breastfeeding unless considered essential

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• There is no evidence of a teratogenic effect in animal studies

• Caution; no dose adjustment recommended

• No dose adjustment recommended

• No dose adjustment recommended

Respiratory  Disorders

• Laryngospasm
• Bronchospasm

Gastrointestinal Disorders

• Oral numbness (hypoesthesia)  
• A stinging feeling in the mouth  
• Oral pain

Skin and Subcutaneous Tissue Disorders

• Hypersensitivity reactions
• Pruritus
• Urticaria
• Photosensitivity reaction
• Rash
• Angioedema

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis

No information available

None routine

An indazole non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic, and anti-oedema properties. Unlike aspirin-like NSAIDs, benzydamine hydrochloride does not inhibit cyclooxygenases (COX) but stabilizes membranes, resulting in local anaesthesia and exerts its effects through inhibition of the synthesis of proinflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and Interleukin-1β (IL-1β). Further mechanisms of action are hypothesised including the inhibition of the oxidative burst of neutrophils as well as membrane stabilisation as demonstrated by the inhibition of granule release from neutrophils and the stabilization of lysosomes. The local anaesthetic activity of the compound has been related to an interaction with cationic channels. 

Oral Rinse (per 15ml) 22.5mg 

• Andolex (iNova) originator
• Throflam (Pharmacare)

Spray (per 15ml) 22.5mg 

• Andolex (iNova) originator
• Throflam (Pharmacare)

Lozenges 3mg

• Andolex (iNova) originator

Also available in the following form: Topical gel and oral gel.

COMBINATION PREPARATIONS

Benzydamine/ Cetylpyridinium

Lozenges 3mg/1.33mg 

• Andolex C Raspberry (iNova Pharma) originator
• Andolex C Eucaluptus Menthol (iNova) originator
• Andolex C Orange (iNova) originator
• Andolex C Honey and Lemon (iNova) originator

Oral Gel (per g) 10mg/1mg 

• Andolex C Oral Gel (iNova) originator

Benzydamine/ Chlorhexidine

Spray (per 15ml) 22.5mg/18mg

• Andolex C (iNova) originator
• Oranix (iNova)
• Throflam Co (Pharmacare)

Oral Rinse (per 15ml) 22.5mg/18mg

• Andolex C (iNova) originator 
• Throflam Co (Pharmacare)