- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of celecoxib.
Symptomatic relief in the treatment of osteoarthritis
Symptomatic relief in the treatment of rheumatoid arthritis
Use for the shortest duration possible and lowest effective dose.
200 mg once daily or 100mg twice daily. Increase dose to 200 mg twice daily if needed to achieve symptom relief. If no additional therapeutic benefit seen after 2 weeks then consider other therapeutic options. Maximum daily dose: 400mg daily.
100mg twice daily. Increase dose to 200 mg twice daily if needed to achieve symptom relief. If no additional therapeutic benefit seen after 2 weeks then consider other therapeutic options. Maximum daily dose: 400mg daily.
200 mg once daily or 100mg twice daily. Increase dose to 400mg once daily or 200 mg twice daily if needed to achieve symptom relief. If no additional therapeutic benefit seen after 2 weeks then consider other therapeutic options. Maximum daily dose: 400mg daily.
Patients with Hepatic Impairment
Moderate liver impairment (serum albumin 25 to 35g/L): Treatment should be initiated with caution at half the recommended dose.
CYP2C9 poor metabolisers: consider reducing dose by 50%.
Children under 18 years
Females attempting to conceive
Asthma, urticaria or acute rhinitis associated with NSAIDS
Congestive cardiac failure
Inflammatory bowel disease
Ischaemic heart disease
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peripheral arterial circulatory disorder
Renal impairment - creatinine clearance below 30 ml/minute
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Precautions and Warnings
Risk factors for cardiovascular disorder
CYP2C9 poor metaboliser genotype
Glucose-galactose malabsorption syndrome
History of cardiac failure
History of gastrointestinal bleeding
History of gastrointestinal disorder
History of gastrointestinal ulceration
Reduced left ventricular function
Do not use as a substitute for acetylsalicylic acid for CV prophylaxis
May mask fever
May mask signs of inflammation
Advise ability to drive/operate machinery may be affected by side effects
Ensure hypertension is controlled prior to treatment
Some formulations contain propylene glycol
Advise patients of risks/benefits & review need for treatment regularly
Monitor blood pressure regularly
Monitor for signs of fluid retention
Monitor patients for signs of adverse cardiovascular effects
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if hepatic function deteriorates
Discontinue if renal function deteriorates
If no increase in efficacy following dose increase consider alternative
Pregnancy confirmed: Discontinue this medication
Maintain treatment at the lowest effective dose
Maintain treatment for the shortest possible duration
Female: Ensure adequate contraception during treatment
Pregnancy and Lactation
Celecoxib is contraindicated in pregnancy.
At the time of writing there is limited published information regarding the use of celecoxib during pregnancy.
The manufacturer states that animal studies in rats and rabbits have shown reproductive toxicity, to include malformations. The inhibition of prostaglandin synthesis might affect pregnancy in a negative way. Existing data from epidemiological research suggest an increase risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. Celecoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.
During the second and third trimester celecoxib may cause foetal renal impairment which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. These effects may occur shortly after beginning treatment and are usually reversible.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Celecoxib is contraindicated in breastfeeding.
The manufacturer states that celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma. Celecoxib is excreted into human breast milk in a very low transfer.
Hale (2014) suggests that breastfeeding would not be a threat to the infant due to the low dose of celecoxib that infants are exposed to via milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Acute renal failure
Deep vein thrombosis (DVT)
Exacerbation of epilepsy
Increase in blood urea nitrogen
Increase in creatinine
Increases in hepatic enzymes
Inflammatory bowel disease
Liver function disturbances
Retinal artery occlusion
Retinal vein occlusion
Severe hepatic reactions
Suppressed female fertility
Toxic epidermal necrolysis
Vertebral and long bone fractures
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: March 2017
Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.
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.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Celecoxib 100 mg capsules, hard. Actavis UK Limited. Revised January 2014.
Summary of Product Characteristics: Celecoxib 200 mg capsules, hard. Actavis UK Limited. Revised January 2014.
Summary of Product Characteristics: Celebrex 100 mg capsule. Pfizer Limited. Revised September 2017.
Summary of Product Characteristics: Celebrex 200 mg capsule. Pfizer Limited. Revised September 2017.
Summary of Product Characteristics: Celecoxib 100 mg capsules, hard. Teva UK Limited. Revised November 2015.
Summary of Product Characteristics: Celecoxib 200 mg capsules, hard. Teva UK Limited. Revised November 2015.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Celebrex. Last revised: 26 April 2016
Last accessed: 07 March 2017
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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.