Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Gout - acute
Musculo-skeletal conditions
Osteoarthritis
Rheumatoid arthritis

Contraindications

Children under 18 years
Galactosaemia
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy

Precautions and Warnings

Elderly
Females attempting to conceive
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Coagulopathy
Congestive cardiac failure
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of cardiac failure
History of gastrointestinal disorder
Hypertension
Ischaemic heart disease
Lactose intolerance
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy

NSAIDs may provoke or exacerbate asthma
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Discontinue if signs of gastro-intestinal bleeding occur
Elderly: Monitor for gastrointestinal bleeding
Monitor closely patient with a history of congestive cardiac failure
Monitor patients with pre-existing hypertension
Monitor renal function
Advise patients to report signs or symptoms of gastro-intestinal ulcer
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
Discontinue if severe skin reaction occurs
Maintain treatment at the lowest effective dose
Advise patient not to take NSAIDs unless advised by clinician
Female: May cause infertility
Advise patients to report skin rash

Treatment with NSAIDs may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. At higher risk are patients with impaired renal function, cardiac impairment, liver dysfunction, elderly and those taking diuretics. In theses patients renal function should be monitored.

Patients with connective tissue disorders such as systemic lupus erythematosus may be at increased risk of aseptic meningitis.

Any degree of worsening of asthma may be related to the ingestion of NSAIDs, either prescribed or (in the case of ibuprofen and others) purchased over the counter.

Patients appear to be at highest risk for serious skin reactions early in the course of the treatment, the onset of the reaction occurring in the majority of cases within the first month. Sulindac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for patients with a history of ulcer and in the elderly. Also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk.

Pregnancy and Lactation

Pregnancy

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

The manufacturer does not recommend the use of sulindac in the last trimester of pregnancy and indicates that should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the mother outweighs the potential risk to the foetus.

When an NSAID is considered essential, a more established drug such as ibuprofen may be considered (Schaefer, 2015).

NSAIDs can affect the foetal cardiovascular system (risk of closure of the ductus arteriosus). The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother an child.

NSAIDs have been associated with spontaneous abortions and congenital malformations (Briggs, 2015).

Lactation

Use sulindac with caution during breastfeeding.

When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice although occasional use of diclofenac is permissible (Briggs, 2015).

At the time of writing limited information is available on the use of sulindac during breastfeeding, its relatively long-half life and glucuronide metabolite, other agents may be preferred, especially while nursing a newborn or preterm infant (Lactmed, 2018).

Side Effects

Abnormal liver function tests
Agranulocytosis
Alopecia
Anaphylaxis
Angioedema
Angioneurotic oedema
Anorexia
Aplastic anaemia
Arrhythmias
Arterial thrombosis
Aseptic meningitis
Asthenia
Blurred vision
Bone marrow depression
Bronchospasm
Cardiac failure
Cholestasis
Confusion
Congestive cardiac failure
Constipation
Convulsions
Crystalluria
Depression
Diarrhoea
Discolouration of urine
Dizziness
Drowsiness
Dry mucous membranes
Dyspepsia
Dyspnoea
Dysuria
Ecchymosis
Epistaxis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exacerbation of pre-existing asthma
Exfoliative dermatitis
Fatigue
Flatulence
Gastro-intestinal pain
Gastro-intestinal perforation
Gastro-intestinal ulceration and bleeding
Gastrointestinal spasm
Glossitis
Gynaecomastia
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatic failure
Hepatitis
Hyperglycaemia
Hyperkalaemia
Hypersensitivity syndrome
Hypertension
Insomnia
Interstitial nephritis
Intestinal stricture
Jaundice
Leucopenia
Malaise
Melaena
Muscle weakness
Nausea
Necrotising fasciitis
Nephrotic syndrome
Nervousness
Neuritis
Neutropenia
Oedema
Palpitations
Pancreatitis
Paraesthesia
Peptic ulceration
Photosensitivity
Proteinuria
Pruritus
Psychosis
Purpura
Rash
Renal failure
Renal impairment
Retinal disturbances
Somnolence
Stevens-Johnson syndrome
Stomatitis
Sweating
Syncope
Taste disturbances
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Vaginal bleeding
Vasculitis (allergic)
Vertigo
Visual disturbances
Vomiting

Presentation

Oral formulations of sulindac.

Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Gout - acute
Musculo-skeletal conditions
Osteoarthritis
Rheumatoid arthritis

Dosage

Adults

Patients with Renal Impairment

Contraindications

Children under 18 years
Galactosaemia
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy

Precautions and Warnings

Elderly
Females attempting to conceive
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Coagulopathy
Congestive cardiac failure
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of cardiac failure
History of gastrointestinal disorder
Hypertension
Ischaemic heart disease
Lactose intolerance
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy

NSAIDs may provoke or exacerbate asthma
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Discontinue if signs of gastro-intestinal bleeding occur
Elderly: Monitor for gastrointestinal bleeding
Monitor closely patient with a history of congestive cardiac failure
Monitor patients with pre-existing hypertension
Monitor renal function
Advise patients to report signs or symptoms of gastro-intestinal ulcer
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
Discontinue if severe skin reaction occurs
Maintain treatment at the lowest effective dose
Advise patient not to take NSAIDs unless advised by clinician
Female: May cause infertility
Advise patients to report skin rash

Treatment with NSAIDs may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. At higher risk are patients with impaired renal function, cardiac impairment, liver dysfunction, elderly and those taking diuretics. In theses patients renal function should be monitored.

Patients with connective tissue disorders such as systemic lupus erythematosus may be at increased risk of aseptic meningitis.

Any degree of worsening of asthma may be related to the ingestion of NSAIDs, either prescribed or (in the case of ibuprofen and others) purchased over the counter.

Patients appear to be at highest risk for serious skin reactions early in the course of the treatment, the onset of the reaction occurring in the majority of cases within the first month. Sulindac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for patients with a history of ulcer and in the elderly. Also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk.

Pregnancy and Lactation

Pregnancy

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

The manufacturer does not recommend the use of sulindac in the last trimester of pregnancy and indicates that should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the mother outweighs the potential risk to the foetus.

When an NSAID is considered essential, a more established drug such as ibuprofen may be considered (Schaefer, 2015).

NSAIDs can affect the foetal cardiovascular system (risk of closure of the ductus arteriosus). The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother an child.

NSAIDs have been associated with spontaneous abortions and congenital malformations (Briggs, 2015).

Lactation

Use sulindac with caution during breastfeeding.

When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice although occasional use of diclofenac is permissible (Briggs, 2015).

At the time of writing limited information is available on the use of sulindac during breastfeeding, its relatively long-half life and glucuronide metabolite, other agents may be preferred, especially while nursing a newborn or preterm infant (Lactmed, 2018).

Side Effects

Abnormal liver function tests
Agranulocytosis
Alopecia
Anaphylaxis
Angioedema
Angioneurotic oedema
Anorexia
Aplastic anaemia
Arrhythmias
Arterial thrombosis
Aseptic meningitis
Asthenia
Blurred vision
Bone marrow depression
Bronchospasm
Cardiac failure
Cholestasis
Confusion
Congestive cardiac failure
Constipation
Convulsions
Crystalluria
Depression
Diarrhoea
Discolouration of urine
Dizziness
Drowsiness
Dry mucous membranes
Dyspepsia
Dyspnoea
Dysuria
Ecchymosis
Epistaxis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exacerbation of pre-existing asthma
Exfoliative dermatitis
Fatigue
Flatulence
Gastro-intestinal pain
Gastro-intestinal perforation
Gastro-intestinal ulceration and bleeding
Gastrointestinal spasm
Glossitis
Gynaecomastia
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatic failure
Hepatitis
Hyperglycaemia
Hyperkalaemia
Hypersensitivity syndrome
Hypertension
Insomnia
Interstitial nephritis
Intestinal stricture
Jaundice
Leucopenia
Malaise
Melaena
Muscle weakness
Nausea
Necrotising fasciitis
Nephrotic syndrome
Nervousness
Neuritis
Neutropenia
Oedema
Palpitations
Pancreatitis
Paraesthesia
Peptic ulceration
Photosensitivity
Proteinuria
Pruritus
Psychosis
Purpura
Rash
Renal failure
Renal impairment
Retinal disturbances
Somnolence
Stevens-Johnson syndrome
Stomatitis
Sweating
Syncope
Taste disturbances
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Vaginal bleeding
Vasculitis (allergic)
Vertigo
Visual disturbances
Vomiting

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: February 2021

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. wolters kluwer health, Philadelphia.

Summary of Product Characteristics: Sulindac 100 mg Tablets. Generics UK Ltd. Revised September 2014.
Summary of Product Characteristics: Sulindac 200 mg Tablets. Generics UK Ltd. Revised September 2014.

The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 March 2021.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Sulindac Last revised:31 October 2018.
Last accessed: 08 March 2021.