Diclofenac

Registered South African indications:

• Pain - mild to moderate
• Inflammation

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy (third trimester)
• Children younger than 14 years
• Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or non-steroidal anti-inflammatory agents

Cautions

• Pregnancy (first and second trimester)
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Use over large areas of skin over a prolonged period
• Asthma
• Gastrointestinal bleeding
• Exposure to sunlight
• Application to skin wounds, open injuries or infected skin
• Application to eyes or mucous membranes
• Use of airtight occlusive dressings
• Smoke or open flames - risk of severe burns

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

Pain and inflammation - musculoskeletal and joint

• Topical (pls): Apply 1 patch, 12hrly to painful area; Max duration: 7 days

Dosage may vary depending on product strength; Consult product information for dosage guidance

Acute pain: If symptoms do not improve by day 7, or worsen within the first 7 days, review by a doctor is recommended

Apply only to intact skin 

Do not allow contact with the eyes or mucous membranes, and should never be taken by mouth 

Not approved for use in South Africa for children

Pregnancy

• First and second trimesters: Caution; not recommended
  Third trimester: Contraindicated
• Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development  
• Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%
• The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality
• In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period
• During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible  
• During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
  - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension)
  - renal dysfunction, which may progress to renal failure with oligohydramnios
• It may expose the mother and the neonate, at the end of pregnancy, to:
  - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses
  - inhibition of uterine contractions resulting in delayed or prolonged labour

Breastfeeding

• Caution; not recommended
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac passes into breast milk in small amounts. Diclofenac should not be administered during breastfeeding in order to avoid undesirable effects in the infant

Fertility 

• There are no data available on the use of topical formulations of diclofenac and its effects on fertility in humans

Renal Impairment

• Caution; no information available 

Hepatic Impairment

• Caution; no information available 

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Respiratory Disorders

• Asthma

Skin and Subcutaneous Tissue Disorders

• Rash pustular
• Erythema  
• Eczema
• Pruritus  
• Dermatitis (including contact)
• Dermatitis bullous  
• Desquamation
• Skin discolouration
• Photosensitivity reaction  
• Urticaria

Immune System Disorders

• Hypersensitivity  
• Angioneurotic oedema  

None known 

None routine

Diclofenac is a potent non-steroidal anti-inflammatory drug (NSAID) with effective analgesic, anti-inflammatory and antipyretic properties. Diclofenac exerts its therapeutic effects primarily through inhibition of prostaglandin synthesis by cyclo-oxygenase 2 (COX-2). This medicine is an anti-inflammatory and analgesic preparation designed for topical application. In inflammation and pain of traumatic or rheumatic origin, it relieves pain and decreases swelling.

Lotion (per 100g) 1g

• Athru-derm Lotion (Sandoz)

Patch 0.13g

• Voltaren Patch (GSK) originator

Also available in the following forms: Tablet, capsule, sachet, drop, injection, eye drop, suppository.