Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Symptomatic relief in the treatment of osteoarthritis
Symptomatic relief in the treatment of rheumatoid arthritis

Contraindications

Children under 18 years
Females attempting to conceive
Asthma, urticaria or acute rhinitis associated with NSAIDS
Breastfeeding
Cerebrovascular disorder
Congestive cardiac failure
Galactosaemia
Gastrointestinal haemorrhage
Inflammatory bowel disease
Ischaemic heart disease
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Peripheral arterial circulatory disorder
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe hepatic impairment - Child-Pugh score greater than or equal to 10

Precautions and Warnings

Elderly
Oedema
Risk factors for cardiovascular disorder
Tobacco smoking
Alcoholism
Cardiac impairment
CYP2C9 poor metaboliser genotype
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of cardiac failure
History of gastrointestinal bleeding
History of gastrointestinal disorder
History of gastrointestinal ulceration
Hyperlipidaemia
Hypertension
Hypovolaemia
Lactose intolerance
Reduced left ventricular function
Renal impairment

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
Contains lactose
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

Pregnancy

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 ).

Lactation

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

Side Effects

Accidental injury
Acute labyrinthitis
Acute renal failure
Aggravated allergy
Allergic reaction
Alopecia
Anaemia
Anaphylaxis
Angina
Angioedema
Anosmia
Anxiety
Arrhythmias
Arthralgia
Aseptic meningitis
Ataxia
Blurred vision
Breast tenderness
Bronchopneumonia
Bronchospasm
Cardiac failure
Cerebral infarct
Chest pain
Confusion
Conjunctivitis
Cough
Deep vein thrombosis (DVT)
Depression
Dizziness
Dysphagia
Dysphonia
Dyspnoea
Ecchymosis
Electrolyte disturbances
Erythema multiforme
Exacerbation of epilepsy
Exfoliative dermatitis
Fatigue
Floaters
Flushing
Ganglion
Gastro-intestinal disturbances
Gastro-intestinal perforation
Gastro-intestinal ulceration
Haemorrhage
Hallucinations
Headache
Hearing disturbances
Hepatitis
Hyperkalaemia
Hypertension
Hypertonia
Hyponatraemia
Increase in blood urea nitrogen
Increase in creatinine
Increases in hepatic enzymes
Infections
Inflammatory bowel disease
Influenza-like symptoms
Insomnia
Interstitial nephritis
Jaundice
Leg cramps
Leucopenia
Lipoma
Liver function disturbances
Melaena
Menstrual disturbances
Myocardial infarction
Myositis
Nephrolithiasis
Nocturia
Oedema
Palpitations
Pancreatitis
Pancytopenia
Paraesthesia
Pharyngitis
Photosensitivity
Pneumonitis
Prostatic hyperplasia
Pulmonary embolism
Retinal artery occlusion
Retinal vein occlusion
Rhinitis
Severe hepatic reactions
Sinusitis
Skin disorder
Somnolence
Stevens-Johnson syndrome
Stomatitis
Suppressed female fertility
Tachycardia
Taste disturbances
Thrombocytopenia
Toxic epidermal necrolysis
Vasculitis
Vertebral and long bone fractures
Weight gain

Presentation

Oral formulations of celecoxib.

Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Symptomatic relief in the treatment of osteoarthritis
Symptomatic relief in the treatment of rheumatoid arthritis

Dosage

Adults

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Females attempting to conceive
Asthma, urticaria or acute rhinitis associated with NSAIDS
Breastfeeding
Cerebrovascular disorder
Congestive cardiac failure
Galactosaemia
Gastrointestinal haemorrhage
Inflammatory bowel disease
Ischaemic heart disease
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Peripheral arterial circulatory disorder
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe hepatic impairment - Child-Pugh score greater than or equal to 10

Precautions and Warnings

Elderly
Oedema
Risk factors for cardiovascular disorder
Tobacco smoking
Alcoholism
Cardiac impairment
CYP2C9 poor metaboliser genotype
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of cardiac failure
History of gastrointestinal bleeding
History of gastrointestinal disorder
History of gastrointestinal ulceration
Hyperlipidaemia
Hypertension
Hypovolaemia
Lactose intolerance
Reduced left ventricular function
Renal impairment

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
Contains lactose
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

Pregnancy

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 ).

Lactation

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

Side Effects

Accidental injury
Acute labyrinthitis
Acute renal failure
Aggravated allergy
Allergic reaction
Alopecia
Anaemia
Anaphylaxis
Angina
Angioedema
Anosmia
Anxiety
Arrhythmias
Arthralgia
Aseptic meningitis
Ataxia
Blurred vision
Breast tenderness
Bronchopneumonia
Bronchospasm
Cardiac failure
Cerebral infarct
Chest pain
Confusion
Conjunctivitis
Cough
Deep vein thrombosis (DVT)
Depression
Dizziness
Dysphagia
Dysphonia
Dyspnoea
Ecchymosis
Electrolyte disturbances
Erythema multiforme
Exacerbation of epilepsy
Exfoliative dermatitis
Fatigue
Floaters
Flushing
Ganglion
Gastro-intestinal disturbances
Gastro-intestinal perforation
Gastro-intestinal ulceration
Haemorrhage
Hallucinations
Headache
Hearing disturbances
Hepatitis
Hyperkalaemia
Hypertension
Hypertonia
Hyponatraemia
Increase in blood urea nitrogen
Increase in creatinine
Increases in hepatic enzymes
Infections
Inflammatory bowel disease
Influenza-like symptoms
Insomnia
Interstitial nephritis
Jaundice
Leg cramps
Leucopenia
Lipoma
Liver function disturbances
Melaena
Menstrual disturbances
Myocardial infarction
Myositis
Nephrolithiasis
Nocturia
Oedema
Palpitations
Pancreatitis
Pancytopenia
Paraesthesia
Pharyngitis
Photosensitivity
Pneumonitis
Prostatic hyperplasia
Pulmonary embolism
Retinal artery occlusion
Retinal vein occlusion
Rhinitis
Severe hepatic reactions
Sinusitis
Skin disorder
Somnolence
Stevens-Johnson syndrome
Stomatitis
Suppressed female fertility
Tachycardia
Taste disturbances
Thrombocytopenia
Toxic epidermal necrolysis
Vasculitis
Vertebral and long bone fractures
Weight gain

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: March 2017

Reference Sources

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