Benzydamine/ Chlorhexidine

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Mouth and throat infections and inflammation

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Benzydamine
Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Do not use in eye, auditory canal, or near meninges, spinal cord or brain

Cautions

• Breastfeeding
• Renal impairment
• Hepatic imapirment
• Elderly
• Preterm infants

Chlorhexidine 
Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product

Cautions

• Breastfeeding
• Avoid contact with eyes

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

Relief of minor infections and inflammation in the mouth and throat

Benzydamine/ Chlorhexidine
22.5/18 (mg/15ml)

• Oral (sol): 15ml, 1.5-3hrly, gargle for 30secs, then expel from mouth; Max treatment duration: 7 days
• Oral (spo): 5-10 actuations, 1.5-3hrly, spray directly onto affected area, then gently swallow

Paed. forms avail. in SA and covered in this monograph: sol

Relief of minor infections and inflammation in the mouth and throat

Benzydamine/ Chlorhexidine
22.5/18 (mg/15ml)

• Younger than 6 years: Not established for use 
• Between 6-12 years: Oral (sol): 5-15ml, 3hrly, gargle for 30secs then expel from mouth; Max treatment duration: 7 days
• Older than 12 years: See adult dosage

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy 

• Caution; not recommended (Benzydamine)
• Safety in pregnant women has not been established

Breastfeeding

• Caution; no information available
• Safety in breastfeeding has not been established
• It is not known if the components of this product is excreted in breast milk
• This product should not be used during breastfeeding unless considered essential by the physician

Renal Impairment

• Caution; no dose adjustment recommended (Benzydamine)

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Drugs in Sport

• Permitted - No warning

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Benzydamine
Central Nervous System Disorders

• Aguesia
• Dysguesia
• Glossodynia
• Oral paraesthesia
• Hypoasthesia

Gastrointestinal Disorders

• Tongue coated
• Dry mouth
• Discolouration of teeth and tongue
• Irritation of mouth
• Desquamation of oral mucosa
• Parotid gland swelling

Skin and Subcutaneous Tissue Disorders

• Allergic skin reactions
• Chemical burns in neonates

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylaxis

Chlorhexidine
Respiratory  Disorders

• Laryngospasm
• Bronchospasm

Gastrointestinal Disorders

• Oral numbness 
• A stinging feeling in the mouth

Skin and Subcutaneous Tissue Disorders

• Hypersensitivity reactions
• Angioedema

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis 

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Benzydamine

• Anionic agents
• Tannins
• Organic matter

Chlorhexidine

• No information available

None routine

Benzydamine
An indazole non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic, and anti-oedema properties. Unlike other NSAIDs, benzydamine hydrochloride does not inhibit cyclooxygenases (COX) but stabilizes membranes, resulting in local anaesthesia and inhibits the production of pro-inflammatory cytokines

Chlorhexidine
Chlorhexidine is an antimicrobial whose affect is attributed to the attraction between chlorhexidine, a cation, and negatively charged bacterial cells. After chlorhexidine is absorpted onto the organism’s cell wall, it disrupts the integrity of the cell membrane and causes the leakage of intracellular components of the organisms

COMBINATION PREPARATIONS

Benzydamine/ Chlorhexidine

Spray (per 15ml) 22.5mg/18mg

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

Oral rinse (per 15ml) 22.5mg/18mg

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