Indomethacin

Registered South African indications:

• Pain - mild to moderate
• Inflammation

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy >30 weeks  
• End-stage renal impairment (eGFR ≤10ml/min/1.73 m²)
• Severe hepatic impairment with hepatic encephalopathy
• Severe hepatic impairment clinical jaundice
• Elderly (with abnormal coagulation, renal impairment or concomitant antiplatelet or anticoagulant therapy)

Cautions

• Pregnancy <30 weeks
• Breastfeeding
• Severe renal impairment (eGFR ≥11-29ml/min/1.73m²)
• Hepatic impairment
• Elderly
• Avoid contact with open wounds, mucous membranes or eyes

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

Pain and inflammation - musculoskeletal and joint

• Topical (gel): Apply to the affected area, 3-4 times a day
• Topical (spo): Spray 2ml (approx. 25 sprays) to the affected area, 3-5 times a day; Max: 25ml/24hrs (equiv. to 200mg indomethacin)

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If other indomethacin preparations are used simultaneously, the total daily dose of indomethacin should not exceed 200mg; Do not exceed maximum dose of gel or spray 

Not established for use in children

Pregnancy

• <30 weeks: Caution
• >30 weeks: Contraindicated; positive evidence of risk
• Although the systemic exposure using topical preparations like gel and spray is low, the teratogenic effect cannot be eliminated
• <30 weeks: Use of indomethacin should only be considered when necessary as short-term therapy (24-48hrs). Association between exposure to NSAIDs in early pregnancy and spontaneous abortions was reported
• >30 weeks: Risk of congenital malformations (mainly cardiac) cannot be eliminated

Breastfeeding

• Caution; not recommended
• Indomethacin is excreted in breast milk following systemic exposure. The extent of systemic absorption of topical indomethacin is unknown therefore, caution should be exercised. When considered essential, short-term use, i.e 24-48hrs is recommended

Fertility

• Indomethacin may have a reversible inhibitory effect on women's ovulation. The use of indomethacin may impair female fertility and is not recommended in women attempting to conceive
• In women who have difficulties conceiving or who are undergoing an investigation of infertility, withdrawal of indomethacin should be considered

Renal Impairment

• eGFR ≥30-89ml/min/1.73 m²: No dose adjustment recommended
• eGFR ≥11-29ml/min/1.73 m²: Caution; dose adjustment recommended
  Topical (spo, gel): Apply to the affected area, 1-2 times a day
  Limit use for the shortest period of time
• eGFR ≤10ml/min/1.73 m²/ESRD: Contraindicated 

Hepatic Impairment

• Mild to severe (Child-Pugh class A, B and C): Caution; dose adjustment recommended
  Topical (spo, gel): Apply to the affected area, 1-2 times a day
  Limit use for the shortest period of time
• Severe (Child-Pugh class C with hepatic encephalopathy or clinical jaundice): Contraindicated

Elderly

• Low-risk: Caution; no dose adjustment recommended
• High-risk (Co-morbidities: Abnormal coagulation, renal impairment or concomitant antiplatelet or anticoagulant therapy): Contraindicated

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headaches
• Dizziness
• Light-headedness
• Depression
• Vertigo
• Fatigue 
• Mental confusion
• Anxiety
• Syncope
• Drowsiness
• Convulsions
• Coma
• Peripheral neuropathy
• Muscle weakness
• Involuntary muscle movements
• Insomnia
• Psychiatric disturbances 
• Depersonalisation
• Paraesthesia
• Dysarthria
• Aggravation of epilepsy
• Parkinsonism

Cardiovascular Disorders

• Oedema
• Increased blood pressure
• Tachycardia
• Chest pain
• Arrhythmia
• Palpitation
• Hypotension
• Congestive heart failure
• Blood urea elevation
• Rapid fall in blood pressure resembling a shock-like state

Respiratory Disorders

• Acute respiratory distress
• Asthma 
• Pulmonary oedema
• Bronchospasm

Gastrointestinal Disorders

• Nausea and vomiting
• Anorexia
• Epigastric distress
• Abdominal pain
• Constipation
• Diarrhoea
• Ulceration, perforation and haemorrhage 
• Abdominal pain
• Stomatitis
• Gastritis
• Flatulence
• Bleeding from the sigmoid colon 
• Intestinal strictures
• Intestinal ulceration followed by stenosis and obstruction
• Ulcerative stomatitis

Hepatobiliary Disorders

• Hepatitis
• Jaundice

Genitourinary Disorders

• Haematuria
• Proteinuria
• Nephrotic syndrome
• Interstitial nephritis
• Renal insufficiency 
• Vaginal bleeding

Endocrine and Metabolic Disorders

• Hyperglycaemia
• Glycosuria
• Hyperkalaemia
• Flushing
• Sweating
• Breast changes
• Gynaecomastia

Skin and Subcutaneous Tissue Disorders

• Puritus
• Urticaria
• Angioneurotic oedema
• Angiitis
• Erythema nodosum
• Skin rash and photosensitivity
• Exfoliative dermatitis
• Stevens-Johnson syndrome
• Erythema multiforme
• Toxic epidermal necrolysis
• Loss of hair
• Pruritus
• Redness
• Rash
• Local dryness

Immune, Blood and Lymphatic System Disorders

• Blood dyscrasias
• Purpura
• Aplastic anaemia
• Haemolytic anaemia
• Agranulocytosis
• Bone-marrow depression
• Disseminated intravascular coagulation
• Thrombocytopenia
• Acute anaphylaxis

Sensory Disorders

• Blurred vision
• Diplopia
• Orbital and peri-orbital pain
• Corneal deposits
• Retinal disturbances
• Tinnitus
• Hearing disturbances
• Deafness

Others

• Epistaxis

• Aspirin
• Diflunisal
• Non-steroidal anti-inflammatory agents
• Anticoagulants
• Probenecid
• Methotrexate
• Cyclosporin
• Lithium
• Diuretics
• Triamterene
• Cardiac glycosides
• Digoxin
• Alpha blockers
• Angiotension-converting enzyme inhibitors
• Beta blockers
• Diuretics
• Hydralazine
• Losartan  
• Phenylpropanolamine
• Corticosteroids
• Mifepristone
• Quinolone antibiotics

None routine. Specific cases may require

• Ophthalmological examinations

Non-selective cyclooxygenase (COX) inhibitor and inhibits the activity of both COX-1 and COX-2.

Spray (per g) 10mg

• Elmetacin (Litha Pharma)

Gel (per g) 10mg 

• Adco-indogel (Adcock)

Also available in the following forms: Suppository and capsule.