Benzydamine

Registered South African indications: 

• Short-term treatment for the symptomatic relief of painful inflammatory conditions of the musculoskeletal system
  - Acute inflammatory conditions such as myalgia and bursitis
• Traumatic conditions
  - Such as sprains, strains, contusions and the after-effects of fractures

Contraindications

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding

Cautions

• Renal impairment
• Hepatic impairment
• Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Delayed hypersensitivity to methyl parahydroxybenzoate
• History of asthma
• Avoid contact with eyes and mucous membranes
• Smoking or exposure to naked flames - risk of severe burns

Forms avail. in SA and covered in this monograph: gel

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Short-term treatment for the symptomatic relief of painful inflammatory conditions of the musculoskeletal system
- Acute inflammatory conditions such as myalgia and bursitis
Traumatic conditions
- Such as sprains, strains, contusions and the after-effects of fractures

• Topical (gel): Apply 1-2.5g (35-85mm) to the affected area, 3 times daily, up to 6 times daily in more severe conditions; Treatment duration: Should not exceed 10 days without review of treatment

The gel should be massaged lightly into the area

No information available

Pregnancy

South African recommendations

• Contraindicated
• Safety in pregnancy has not been established

Breastfeeding

South African recommendations

• Contraindicated
• Safety in lactation has not been established

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings 

Skin and Subcutaneous Tissue Disorders

• Photosensitivity reaction
• Erythema
• Papular eruption

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Allergic reactions (possibly delayed)

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. 

Gel (per 100g) 5g

• Norflex Gel Forte (iNova Pharmaceuticals) originator

Also available in the following forms: Oral rinse, gel, spray and lozenge.