Drugs List

Therapeutic Indications

Uses

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

Contraindications

Children under 18 years
Breastfeeding
Gastric mucosa lesion
Gastrointestinal haemorrhage
History of gastrointestinal perforation
History of peptic ulcer
History of proctitis
History of rectal bleeding
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Third trimester of pregnancy

Precautions and Warnings

Elderly
Females attempting to conceive
Infection
Predisposition to fluid retention
Sepsis
Asthma
Cardiac failure
Coagulopathy
Crohn's disease
Diabetes mellitus
Epileptic disorder
First trimester of pregnancy
Gastrointestinal diverticula
Hepatic impairment
History of asthma
History of gastrointestinal disorder
Hypertension
Hypovolaemia
Parkinsonism
Psychiatric disorder
Renal impairment
Second trimester of pregnancy
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
May inhibit platelet aggregation - observe for signs of bleeding
Monitor for gastrointestinal toxicity
Monitor patients on prolonged therapy
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Severe gastro-intestinal side effects may occur without warning
May affect results of some laboratory tests
Discontinue if patient is attempting to conceive
Maintain treatment at the lowest effective dose
Female: May cause infertility

Headache can occur in early treatment. Start therapy with a low dosage and gradually increase it to minimise the occurrence of headache. Symptoms will frequently disappear as the therapy progresses or during the reduction of dosage. Withdraw indometacin if headache persists despite dosage reduction.

Renal prostaglandins are important in maintaining renal perfusion in patients with reduced renal blood flow therefore non-steroidal anti-inflammatory drugs may precipitate overt renal decompensation on administration.

Eye changes may occur in patients with rheumatoid arthritis which may be related to the underlying condition or due to indometacin therapy. The manufacturer recommends regular ophthalmological examinations and discontinue therapy if eye changes detected.

Pregnancy and Lactation

Pregnancy

Indometacin is contraindicated during the 3rd trimester of pregnancy but may be used with caution during the 1st and 2nd trimester.

The manufacturer advises that indometacin should not be given unless clearly necessary during the 1st and 2nd trimester of pregnancy. The dose should be kept as low and duration of treatment as short as possible. Use of indometacin during the 3rd trimester of pregnancy is contraindicated by the manufacturer.

Animal studies have shown reproductive toxicity.

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.

Lactation

Indometacin is contraindicated during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking indometacin.

Indometacin is present in human breast milk.

Effects on exposed infants are unknown.

Side Effects

Aggravation of existing asthma
Altered liver function tests
Anaemia
Anaphylaxis
Angioedema
Anorexia
Anxiety
Arrhythmias
Asthma
Blood dyscrasias
Blood urea increased
Bone marrow depression
Breast changes
Bronchospasm
Chest pain
Coma
Confusion
Congestive cardiac failure
Convulsions
Depersonalisation
Depression
Dizziness
Drowsiness
Dysarthria
Dyspnoea
Ecchymosis
Epistaxis
Erythema multiforme
Erythema nodosum
Exacerbation of epilepsy
Eye disorder
Fatigue
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
Inhibition of ovulation (reversible)
Insomnia
Interstitial nephritis
Intravascular coagulation (disseminated)
Involuntary movement disorders
Jaundice
Light-headedness
Malaise
Muscle weakness
Nephrotic syndrome
Non-specific allergic reactions
Oedema
Palpitations
Pancreatitis
Paraesthesia
Parkinsonism
Peripheral neuropathy
Petechiae
Photosensitivity
Proteinuria
Psychiatric disorders
Purpura
Rectal disorders
Renal failure
Renal impairment
Skin disorder
Stevens-Johnson syndrome
Stomatitis
Sweating
Syncope
Tachycardia
Toxic epidermal necrolysis
Ulcerative colitis
Vaginal bleeding
Vertigo

Presentation

Rectal formulation 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

The dosage should be carefully adjusted according to the needs of the individual patient.

Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration.

Adults

Contraindications

Children under 18 years
Breastfeeding
Gastric mucosa lesion
Gastrointestinal haemorrhage
History of gastrointestinal perforation
History of peptic ulcer
History of proctitis
History of rectal bleeding
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Third trimester of pregnancy

Precautions and Warnings

Elderly
Females attempting to conceive
Infection
Predisposition to fluid retention
Sepsis
Asthma
Cardiac failure
Coagulopathy
Crohn's disease
Diabetes mellitus
Epileptic disorder
First trimester of pregnancy
Gastrointestinal diverticula
Hepatic impairment
History of asthma
History of gastrointestinal disorder
Hypertension
Hypovolaemia
Parkinsonism
Psychiatric disorder
Renal impairment
Second trimester of pregnancy
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
May inhibit platelet aggregation - observe for signs of bleeding
Monitor for gastrointestinal toxicity
Monitor patients on prolonged therapy
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Severe gastro-intestinal side effects may occur without warning
May affect results of some laboratory tests
Discontinue if patient is attempting to conceive
Maintain treatment at the lowest effective dose
Female: May cause infertility

Headache can occur in early treatment. Start therapy with a low dosage and gradually increase it to minimise the occurrence of headache. Symptoms will frequently disappear as the therapy progresses or during the reduction of dosage. Withdraw indometacin if headache persists despite dosage reduction.

Renal prostaglandins are important in maintaining renal perfusion in patients with reduced renal blood flow therefore non-steroidal anti-inflammatory drugs may precipitate overt renal decompensation on administration.

Eye changes may occur in patients with rheumatoid arthritis which may be related to the underlying condition or due to indometacin therapy. The manufacturer recommends regular ophthalmological examinations and discontinue therapy if eye changes detected.

Pregnancy and Lactation

Pregnancy

Indometacin is contraindicated during the 3rd trimester of pregnancy but may be used with caution during the 1st and 2nd trimester.

The manufacturer advises that indometacin should not be given unless clearly necessary during the 1st and 2nd trimester of pregnancy. The dose should be kept as low and duration of treatment as short as possible. Use of indometacin during the 3rd trimester of pregnancy is contraindicated by the manufacturer.

Animal studies have shown reproductive toxicity.

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.

Lactation

Indometacin is contraindicated during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking indometacin.

Indometacin is present in human breast milk.

Effects on exposed infants are unknown.

Side Effects

Aggravation of existing asthma
Altered liver function tests
Anaemia
Anaphylaxis
Angioedema
Anorexia
Anxiety
Arrhythmias
Asthma
Blood dyscrasias
Blood urea increased
Bone marrow depression
Breast changes
Bronchospasm
Chest pain
Coma
Confusion
Congestive cardiac failure
Convulsions
Depersonalisation
Depression
Dizziness
Drowsiness
Dysarthria
Dyspnoea
Ecchymosis
Epistaxis
Erythema multiforme
Erythema nodosum
Exacerbation of epilepsy
Eye disorder
Fatigue
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
Inhibition of ovulation (reversible)
Insomnia
Interstitial nephritis
Intravascular coagulation (disseminated)
Involuntary movement disorders
Jaundice
Light-headedness
Malaise
Muscle weakness
Nephrotic syndrome
Non-specific allergic reactions
Oedema
Palpitations
Pancreatitis
Paraesthesia
Parkinsonism
Peripheral neuropathy
Petechiae
Photosensitivity
Proteinuria
Psychiatric disorders
Purpura
Rectal disorders
Renal failure
Renal impairment
Skin disorder
Stevens-Johnson syndrome
Stomatitis
Sweating
Syncope
Tachycardia
Toxic epidermal necrolysis
Ulcerative colitis
Vaginal bleeding
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: Indocid Suppositories 100mg. Aspen. Revised December 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 October 2021