- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of sulindac.
Gout - acute
400mg daily in two divided doses.
The use of lower doses may be sufficient.
Treatment should not normally last more than 7 days.
Treatment should be limited to 7 to 10 days.
Patients with Renal Impairment
Renal function should be monitored throughout treatment. Anticipate need to reduce dose to avoid drug accumulation.
The Renal Drug Handbook suggests the following:
GFR 20 to 50ml/minute - Dose as in normal renal function. Avoid if possible.
GFR 10 to 20ml/minute - Give 50 to 100% of normal dose. Avoid if possible.
GFR less than 10ml/minute - Give 50 to 100% of normal dose. Only use if on dialysis.
Children under 18 years
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy
Precautions and Warnings
Females attempting to conceive
Risk factors for cardiovascular disorder
Congestive cardiac failure
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
History of asthma
History of cardiac failure
History of gastrointestinal disorder
Ischaemic heart disease
Peripheral arterial circulatory disorder
Second trimester of pregnancy
NSAIDs may provoke or exacerbate asthma
Advise ability to drive/operate machinery may be affected by side effects
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
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).
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).
Abnormal liver function tests
Bone marrow depression
Congestive cardiac failure
Discolouration of urine
Dry mucous membranes
Exacerbation of colitis
Exacerbation of Crohn's disease
Exacerbation of pre-existing asthma
Gastro-intestinal ulceration and bleeding
Toxic epidermal necrolysis
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 ).
Last Full Review Date: February 2021
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.
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.