Diclofenac Potassium

Registered South African indications:

• Acute gout attack
  - Emergency treatment
• Pain of inflammatory origin - mild to moderate
• Fever

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other NSAIDs, including aspirin
• Gastric or intestinal ulcer
• History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs, including diclofenac potassium
• Active or history of recurrent ulcer / haemorrhage / perforations
• Asthmatic patients in whom asthma attacks, acute rhinitis or urticaria are precipitated by acetylsalicylic acid (aspirin) or by other medicines which inhibit prostaglandin synthetase (NSAIDs)
• Pregnancy
• Breastfeeding
• Porphyria
• Renal failure
• Hepatic failure
• Heart failure, established ischaemic heart disease and/or cerebrovascular disease (stroke) and peripheral arterial disease

• Renal impairment
• Hepatic impairment
• Elderly 
• High doses
• Ulcerative colitis
• Crohn's disease
• Volume depletion 
• Systemic lupus erythematosus
• Mixed connective tissue disorders
• Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities
• Asthma
• Seasonal allergic rhinitis
• Swelling of the nasal mucosa
• Hypertension
• Chronic obstructive pulmonary diseases 
• Chronic infections of the respiratory tract 
• Mild to moderate congestive heart failure
• Ischaemic heart disease
• Peripheral arterial disease
• Cerebrovascular disease 
• Risk factors for cardiovascular events
• Fluid retention and oedema
• Prolonged therapy
• Women attempting to conceive
• Coadministration with oral corticosteroids, anticoagulants, selective serotonin-reuptake inhibitors or anti-platelet agents

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

South African registered indications and dosages

Acute gout attack
- Emergency treatment

• Oral (tab): 100-150mg, dly, in 2-3 divided doses; Max: 150mg/24hrs; Max duration: 3 days

Fever
Pain of inflammatory origin - mild to moderate

• Oral (tab): 75mg, dly; Max duration: 5 days

Use the lowest effective dose for the shortest possible duration of treatment

No information available

Pregnancy

South African recommendations

• Contraindicated
• Diclofenac potassium should not be used during pregnancy, as safety and efficacy in pregnancy and lactation has not been established
• Use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased
• Use of NSAIDs, such as diclofenac potassium, around 20 weeks gestation or later in pregnancy may cause a rare but serious foetal renal dysfunction leading to oligohyramnios and, in some cases, neonatal renal impairment. Complications of prolonged oligohydramnios include limb contractures and delayed lung maturation, which may require invasive procedures such as exchange transfusion or dialysis, in some cases

Breastfeeding

South African recommendations

• Contraindicated
• A small amount of diclofenac potassium passes into the breast milk. Therefore, in order to avoid undesirable effects in the infant diclofenac potassium should not be used during lactation

Fertility

South African recommendations

• Administration of diclofenac potassium is not recommended in women attempting to conceive, as it may impair female fertility. Withdrawal of diclofenac potassium should be considered in women experiencing difficulties conceiving or who are undergoing investigation of infertility

South African recommendations

• Caution; no dose adjustment recommended
  Patients suffering from renal impairment should be carefully monitored because of the role of prostaglandins in maintaining renal blood flow
  In such cases, monitoring of kidney function is recommended as a precautionary measure when using diclofenac potassium. Recovery to the pre-treatment state usually follows discontinuation of treatment
• Renal failure: Contraindicated

South African recommendations

• Caution; no dose adjustment recommended
  There may be an increase in the values of one or more liver enzymes. Regular monitoring of liver function is required as a precautionary measure during prolonged treatment with diclofenac potassium. If abnormal hepatic function tests continue and symptoms of hepatic disease develop, or if other manifestations such as rash or eosinophilia occur, discontinue treatment. Hepatitis may develop with the use of diclofenac potassium in the absence of prodromal symptoms
• Hepatic failure: Contraindicated

South African recommendations

• Caution; dose adjustment recommended
  Caution is required in elderly patients on basic medical grounds. A reduction in dosage may be required in the elderly, especially in the very frail or those with a low body mass

Central Nervous System Disorders

• Headache
• Dizziness
• Somnolence
• Tiredness
• Paraesthesia
• Memory impairment
• Convulsion
• Anxiety
• Tremor
• Aseptic meningitis
• Cerebrovascular accident
• Confusion
• Hallucinations
• Disturbances of sensation
• Disorientation
• Depression
• Insomnia
• Nightmare
• Irritability
• Psychotic disorder

Cardiovascular Disorders

• Palpitations
• Chest pain
• Cardiac failure
• Myocardial infarction
• Hypertension
• Hypotension
• Vasculitis

Respiratory Disorders

• Asthma
• Pneumonitis

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Dyspepsia
• Abdominal pain
• Flatulence
• Anorexia
• Gastritis
• Gastrointestinal haemorrhage
• Haematemesis
• Melaena
• Gastrointestinal ulcer with or without bleeding or perforation 
• Colitis 
• Constipation
• Stomatitis
• Glossitis
• Oesophageal disorder
• Diaphragm-like intestinal strictures
• Pancreatitis
• Ischaemic colitis

Hepatobiliary Disorders

• Increased transaminases
• Hepatitis
• Jaundice
• Fulminant hepatitis
• Hepatic necrosis
• Hepatic failure

Genitourinary Disorder

• Acute renal failure
• Haematuria
• Proteinuria
• Nephrotic syndrome
• Interstitial nephritis
• Renal papillary necrosis
• Impotence

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Bullous eruptions
• Eczema
• Erythema
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Dermatitis exfoliative
• Loss of hair
• Photosensitivity reaction
• Purpura
• Allergic purpura
• Pruritus

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Leucopoenia
• Anaemia
• Agranulocytosis
• Neutropenia
• Hypersensitivity, anaphylactic and anaphylactoid reactions 
• Fluid retention and oedema
• Angioneurotic oedema 

Sensory Disorders

• Visual disturbance
• Vision blurred
• Diplopia
• Optic neuritis
• Taste disturbances
• Vertigo
• Tinnitus
• Hearing impaired

• Non-steroidal anti-inflammatory drugs 
• Corticosteroids
• Diuretics 
• Antihypertensive agents
• Lithium
• Methotrexate
• Ciclosporin
• Mifepristone
• Anticoagulant agents
• Antiplatelet agents
• Digoxin (cardiac glycosides)
• Selective serotonin reuptake inhibitors
• Tacrolimus
• Quinolone antibacterials
• Phenytoin
• Colestipol
• Cholestyramine
• Zidovudine
• Antidiabetic agents
• Drugs known to increase serum potassium
• CYP2C9 inhibitors

None routine. Specific cases may require

• Renal function
• Hepatic function
• Full blood count

Diclofenac is a non-steroidal anti-inflammatory compound (NSAID) with analgesic, antipyretic and anti-inflammatory activities. It causes decreased formation of prostaglandins and thromboxanes through inhibition of the activity of the enzyme cyclo-oxygenase. Prostaglandins play a major role in the aetiology of inflammation, pain and fever and the inhibition of prostaglandin synthesis may have an important bearing on diclofenac’s mechanism of action. Diclofenac inhibits platelet aggregation in vitro.

Tablet 50mg

• Dynak (Pharma Dynamics)
• K-Fenak Anti-Inflammatory (Cipla Medpro)
• K-Fenak (Cipla Medpro)