Drugs List

Therapeutic Indications

Uses

Acute musculoskeletal disorders
Chronic rheumatic conditions
Control of pain/inflammation after orthopaedic surgery
Dysmenorrhoea (primary)
Gout
Rheumatoid arthritis

Contraindications

Asthma, urticaria or acute rhinitis associated with NSAIDS
History of gastrointestinal haemorrhage
History of gastrointestinal perforation
History of peptic ulcer
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy

Precautions and Warnings

Children under 18 years
Elderly
Females attempting to conceive
Predisposition to fluid retention
Risk factors for cardiovascular disorder
Sepsis
Systemic infection
Asthma
Breastfeeding
Cardiac failure
Cerebrovascular disorder
Coagulopathy
Connective tissue disorder
Crohn's disease
Diabetes mellitus
Epileptic disorder
First trimester of pregnancy
Galactosaemia
Gastrointestinal diverticula
Glucose-galactose malabsorption syndrome
Haematological disorder
Hepatic impairment
History of asthma
History of gastrointestinal disorder
Hypertension
Hypovolaemia
Ischaemic heart disease
Lactose intolerance
Parkinsonism
Peripheral arterial circulatory disorder
Psychiatric disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis

If renal function impaired, reduce dose to lowest to maintain control
May mask symptoms or signs of infections
May precipitate bronchospasm in patients with asthma or allergy
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Discontinue if signs of gastro-intestinal bleeding occur
During prolonged therapy eye and blood examinations advisable
Elderly: Monitor for gastrointestinal bleeding
May inhibit platelet aggregation - observe for signs of bleeding
Monitor patients on prolonged therapy
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Discontinue if signs of gastro-intestinal ulceration occur
High dose/long term use may increase risk of arterial thrombotic events
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
May affect results of some laboratory tests
Discontinue if patient is attempting to conceive
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
May cause impaired fertility
Advise patient to take after food to reduce gastro-intestinal disturbances

Prostaglandins are important in maintaining renal perfusion. NSAID drugs may precipitate renal failure in patients with renal impairment by reducing prostaglandin formation.

Headache, dizziness and lightheadedness can occur during the initiation of treatment. The symptoms normally disappear when therapy is continued or upon dosing reduction. Discontinue treatment if headache continues despite dosage reduction.

In rheumatoid arthritis patients, eye changes may occur due to the underlying condition or indometacin treatment. Discontinue therapy if eye changes observed.

Pregnancy and Lactation

Pregnancy

Indometacin is contraindicated during the 3rd trimester of pregnancy. Use with caution during the 1st and 2nd trimester.

Use of indometacin during the 3rd trimester of pregnancy is contraindicated by the manufacturer. The manufacturer does not recommend using indometacin during the 1st and 2nd trimester.

Animal studies have shown teratogenic effects. Human data is limited, however the effects of NSAIDs in pregnancy pose a potential risk that cannot be ruled out. The risks include premature closure of the ductus arteriosus and delayed and prolonged labour with increasing risk of bleeding. Congenital abnormalities have been reported.

Lactation

Use indometacin with caution during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking indometacin.

Available data indicates indometacin is present in human breast milk in very low concentrations.

Effects on exposed infants are unknown.

Side Effects

Aggravation of existing asthma
Altered liver function tests
Anaemia
Anaphylaxis
Angioedema
Anorexia
Anxiety
Arrhythmias
Arterial thrombosis
Aseptic meningitis
Asthma
Blood dyscrasias
Blood urea increased
Bone marrow depression
Breast changes
Bronchospasm
Bullous dermatoses
Cerebral oedema
Chest pain
Cholestasis
Coma
Confusion
Congestive cardiac failure
Convulsions
Depersonalisation
Depression
Disorientation
Dizziness
Drowsiness
Dysarthria
Dyspnoea
Ecchymosis
Epistaxis
Erythema multiforme
Erythema nodosum
Exacerbation of Crohn's disease
Exacerbation of epilepsy
Exacerbation of psoriasis
Eye disorder
Fatigue
Fever
Flushing
Gastro-intestinal symptoms
Gastro-intestinal ulceration and bleeding
Glycosuria
Haematuria
Hair loss
Hallucinations
Headache
Hearing disturbances
Hepatitis
Hyperglycaemia
Hyperkalaemia
Hypersensitivity reactions
Hypertension
Hypotension
Ileitis
Increase in serum ALT/AST
Insomnia
Interstitial nephritis
Intravascular coagulation (disseminated)
Involuntary movement disorders
Jaundice
Light-headedness
Listlessness
Malaise
Muscle weakness
Neck stiffness
Nephrotic syndrome
Nervousness
Non-specific allergic reactions
Oedema
Palpitations
Pancreatitis
Paraesthesia
Parkinsonism
Peptic ulceration with perforation and haemorrhage
Peripheral neuropathy
Petechiae
Photosensitivity
Proteinuria
Psychiatric disorders
Pulmonary eosinophilia
Purpura
Renal failure
Renal impairment
Skin disorder
Stevens-Johnson syndrome
Stomatitis
Sweating
Syncope
Tachycardia
Tinnitus
Toxic epidermal necrolysis
Ulcerative colitis
Vaginal bleeding
Vasculitis
Vertigo

Presentation

Oral formulations of indometacin.

Drugs List

Therapeutic Indications

Uses

Acute musculoskeletal disorders
Chronic rheumatic conditions
Control of pain/inflammation after orthopaedic surgery
Dysmenorrhoea (primary)
Gout
Rheumatoid arthritis

Dosage

Adults

Children

Contraindications

Asthma, urticaria or acute rhinitis associated with NSAIDS
History of gastrointestinal haemorrhage
History of gastrointestinal perforation
History of peptic ulcer
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy

Precautions and Warnings

Children under 18 years
Elderly
Females attempting to conceive
Predisposition to fluid retention
Risk factors for cardiovascular disorder
Sepsis
Systemic infection
Asthma
Breastfeeding
Cardiac failure
Cerebrovascular disorder
Coagulopathy
Connective tissue disorder
Crohn's disease
Diabetes mellitus
Epileptic disorder
First trimester of pregnancy
Galactosaemia
Gastrointestinal diverticula
Glucose-galactose malabsorption syndrome
Haematological disorder
Hepatic impairment
History of asthma
History of gastrointestinal disorder
Hypertension
Hypovolaemia
Ischaemic heart disease
Lactose intolerance
Parkinsonism
Peripheral arterial circulatory disorder
Psychiatric disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis

If renal function impaired, reduce dose to lowest to maintain control
May mask symptoms or signs of infections
May precipitate bronchospasm in patients with asthma or allergy
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Discontinue if signs of gastro-intestinal bleeding occur
During prolonged therapy eye and blood examinations advisable
Elderly: Monitor for gastrointestinal bleeding
May inhibit platelet aggregation - observe for signs of bleeding
Monitor patients on prolonged therapy
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Discontinue if signs of gastro-intestinal ulceration occur
High dose/long term use may increase risk of arterial thrombotic events
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
May affect results of some laboratory tests
Discontinue if patient is attempting to conceive
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
May cause impaired fertility
Advise patient to take after food to reduce gastro-intestinal disturbances

Prostaglandins are important in maintaining renal perfusion. NSAID drugs may precipitate renal failure in patients with renal impairment by reducing prostaglandin formation.

Headache, dizziness and lightheadedness can occur during the initiation of treatment. The symptoms normally disappear when therapy is continued or upon dosing reduction. Discontinue treatment if headache continues despite dosage reduction.

In rheumatoid arthritis patients, eye changes may occur due to the underlying condition or indometacin treatment. Discontinue therapy if eye changes observed.

Pregnancy and Lactation

Pregnancy

Indometacin is contraindicated during the 3rd trimester of pregnancy. Use with caution during the 1st and 2nd trimester.

Use of indometacin during the 3rd trimester of pregnancy is contraindicated by the manufacturer. The manufacturer does not recommend using indometacin during the 1st and 2nd trimester.

Animal studies have shown teratogenic effects. Human data is limited, however the effects of NSAIDs in pregnancy pose a potential risk that cannot be ruled out. The risks include premature closure of the ductus arteriosus and delayed and prolonged labour with increasing risk of bleeding. Congenital abnormalities have been reported.

Lactation

Use indometacin with caution during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking indometacin.

Available data indicates indometacin is present in human breast milk in very low concentrations.

Effects on exposed infants are unknown.

Side Effects

Aggravation of existing asthma
Altered liver function tests
Anaemia
Anaphylaxis
Angioedema
Anorexia
Anxiety
Arrhythmias
Arterial thrombosis
Aseptic meningitis
Asthma
Blood dyscrasias
Blood urea increased
Bone marrow depression
Breast changes
Bronchospasm
Bullous dermatoses
Cerebral oedema
Chest pain
Cholestasis
Coma
Confusion
Congestive cardiac failure
Convulsions
Depersonalisation
Depression
Disorientation
Dizziness
Drowsiness
Dysarthria
Dyspnoea
Ecchymosis
Epistaxis
Erythema multiforme
Erythema nodosum
Exacerbation of Crohn's disease
Exacerbation of epilepsy
Exacerbation of psoriasis
Eye disorder
Fatigue
Fever
Flushing
Gastro-intestinal symptoms
Gastro-intestinal ulceration and bleeding
Glycosuria
Haematuria
Hair loss
Hallucinations
Headache
Hearing disturbances
Hepatitis
Hyperglycaemia
Hyperkalaemia
Hypersensitivity reactions
Hypertension
Hypotension
Ileitis
Increase in serum ALT/AST
Insomnia
Interstitial nephritis
Intravascular coagulation (disseminated)
Involuntary movement disorders
Jaundice
Light-headedness
Listlessness
Malaise
Muscle weakness
Neck stiffness
Nephrotic syndrome
Nervousness
Non-specific allergic reactions
Oedema
Palpitations
Pancreatitis
Paraesthesia
Parkinsonism
Peptic ulceration with perforation and haemorrhage
Peripheral neuropathy
Petechiae
Photosensitivity
Proteinuria
Psychiatric disorders
Pulmonary eosinophilia
Purpura
Renal failure
Renal impairment
Skin disorder
Stevens-Johnson syndrome
Stomatitis
Sweating
Syncope
Tachycardia
Tinnitus
Toxic epidermal necrolysis
Ulcerative colitis
Vaginal bleeding
Vasculitis
Vertigo

Effects on Laboratory Tests

False-negative results in the dexamethasone suppression test (DST) in patients being treated with indometacin have been reported. The results of this test should be used with caution in these patients.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2021

Reference Sources

Summary of Product Characteristics: Indometacin 25mg capsules. Almus. Revised July 2017
Summary of Product Characteristics: Indometacin 50mg capsules. Almus. Revised July 2017

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 14 October 2021