Sulfasalazine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sulfasalazine.
Drugs List
Therapeutic Indications
Uses
Crohn's disease
Rheumatoid arthritis
Ulcerative colitis: induction of remission
Ulcerative colitis: maintenance of remission
Unlicensed Uses
Juvenile idiopathic arthritis
Dosage
Not all formulations are licensed for all indications.
Gastro-resistant tablets should be used where there is gastro-intestinal intolerance of plain tablets.
The dose should be adjusted according to severity of the disease and the patient's tolerance to the drug.
Adults
Ulcerative colitis and Crohn's disease
Severe attack
1g to 2g four times a day (given in conjunction with steroids if necessary).
Night-time dose interval should not exceed 8 hours.
Moderate attack
1g to 2g four times a day (given in conjunction with steroids if necessary).
Mild attack
1g four times a day (given in conjunction with steroids if necessary).
Maintenance therapy
With induction of remission reduce the dose gradually to 2g daily. This dose should be continued indefinitely.
Rheumatoid arthritis
The patient should start with 500mg daily for one week, increasing the dosage by 500mg a day each week until 500mg four times a day, or 1g three times a day is reached, according to tolerance and response.
Onset of effect is slow and a marked effect may not be seen for six weeks.
Children
The oral suspension may be more suitable for children.
Ulcerative colitis and Crohn's disease
Acute attack or relapse
Children aged 2 to 18 years: 40mg/kg to 60mg/kg daily.
The following alternative dosing schedule may be suitable:
Children aged 12 to 18 years: 1g to 2g four times daily until remission occurs.
Children aged 2 to 12 years: 10mg/kg to 15mg/kg (up to 1g) four to six times daily until remission occurs. If necessary this dose can be increased to a maximum of 60mg/kg daily in divided doses.
Maintenance
Children aged 2 to 18 years: 20mg/kg to 30mg/kg daily.
The following alternative dosing schedule may be suitable:
Children aged 12 to 18 years: 500mg four times daily.
Children aged 2 to 12 years: 5mg/kg to 7.5mg/kg (up to 500mg) four times daily.
Juvenile idiopathic arthritis (unlicensed)
Children aged 12 to 18 years
Initial titration period: 5mg/kg twice daily for 1 week, then 10mg/kg twice daily for 1 week, then 20mg/kg twice daily for 1 week.
Maintenance dose: 20mg/kg to 25mg/kg twice daily.
Maximum dose: 3g daily.
Children aged 2 to 12 years
Initial dose: 5mg/kg twice daily for 1 week, then 10mg/kg twice daily for 1 week, then 20mg/kg twice daily for 1 week.
Maintenance dose: 20mg/kg to 25mg/kg twice daily.
Maximum dose: 2g daily.
Contraindications
Children under 2 years
Acute porphyria
Breastfeeding
Precautions and Warnings
Allergic disposition
Soft contact lenses
Asthma
Folate deficiency
G6PD deficiency
Hepatic impairment
Pregnancy
Renal impairment
Slow acetylator status
Not all formulations are licensed for all uses
Ensure patient has adequate fluid intake
Monitor FBC prior, every two weeks for first 3 months & periodically after
Monitor liver function prior, every 2wks for first 3 months & periodically
Monitor renal function prior,monthly for first 3months & periodically after
Macrocytosis due to folate deficiency: give folic acid or folinic acid
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Pregnancy: Monitor folate levels as supplements are recommended
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Pancytopenia due to folate deficiency: give folic acid or folinic acid
May affect results of some laboratory tests
Discontinue immediately if suspicion of a blood dyscrasia
Male: May cause infertility
May discolour urine orange
May stain extended-wear soft contact lenses
Complete blood counts, including differential white cell count should be performed before starting sulfasalazine, and every two weeks during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated.
Pregnancy and Lactation
Pregnancy
Sulfasalazine should be used with caution during pregnancy.
The manufacturer does not recommend using sulfasalazine during pregnancy unless clearly needed. At the time of writing there is limited published information regarding the use of sulfasalazine during pregnancy. Potential risks cannot be ruled out.
Lactation
Sulfasalazine is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking sulfasalazine. Available data indicates sulfasalazine is expressed in human breast milk at low levels. Bloody stools or diarrhoea have been reported in exposed infants.
Side Effects
Abdominal pain
Acute pancreatitis
Agranulocytosis
Alopecia
Anaphylaxis
Aplastic anaemia
Arthralgia
Aseptic meningitis
Ataxia
Autoantibody positive
Convulsions
Cough
Crystalluria
Cyanosis
Decreased appetite
Depression
Diarrhoea
Discolouration of urine
Dizziness
Drug fever
Dyspnoea
Elevation of liver enzymes
Encephalopathy
Eosinophilia
Epidermal necrolysis
Erythema
Exacerbation of colitis
Exanthema
Exfoliative dermatitis
Eye disorder
Facial oedema
Fibrosing alveolitis
Gastric upset
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Heinz-body anaemia
Hepatitis
Hypoprothrombinaemia
Insomnia
Interstitial lung disease
Interstitial nephritis
Leucopenia
Lichen planus
Lupus erythematosus-like syndrome
Lymphadenopathy
Macrocytosis
Megaloblastic anaemia
Methaemoglobinaemia
Myocarditis
Nausea
Nephrotic syndrome
Neutropenia
Oligospermia (reversible)
Pancreatitis
Pancytopenia
Parotitis
Pericarditis
Periorbital oedema
Peripheral neuropathy
Photosensitivity
Polyarteritis nodosa
Possible staining of soft contact lenses
Proteinuria
Pruritus
Pseudomembranous colitis
Rash
Serum sickness
Smelling disturbances
Stevens-Johnson syndrome
Stomatitis
Taste disturbances
Thrombocytopenia
Tinnitus
Urticaria
Vasculitis
Vertigo
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: November 2019
Reference Sources
Summary of Product Characteristics: Salazopyrin En-Tabs. Pfizer Ltd. Revised October 2019.
Summary of Product Characteristics: Salazopyrin Tablets. Pfizer Ltd. Revised October 2019.
Summary of Product Characteristics: Sulazine EC Tablets. Genesis Pharmaceuticals Limited. Revised August 2019.
Summary of Product Characteristics: Sulfasalazine 250mg/5ml Oral Suspension. Rosemont Pharmaceuticals Limited. Revised September 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 November 2019
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.