Ketoprofen mr cap 100mg 150mg 200mg
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Modified release formulations of ketoprofen.
Control of pain/inflammation after orthopaedic surgery
Gout - acute
100mg to 200mg once a day.
Children under 18 years
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of gastrointestinal haemorrhage
History of gastrointestinal haemorrhage secondary to NSAID
History of gastrointestinal perforation
History of gastrointestinal ulceration
History of peptic ulcer
Renal impairment - glomerular filtration rate below 10ml/minute
Severe cardiac failure
Severe hepatic impairment
Third trimester of pregnancy
Precautions and Warnings
Females attempting to conceive
Risk factors for cardiovascular disorder
Connective tissue disorder
First trimester of pregnancy
History of asthma
History of cardiac failure
History of gastrointestinal disorder
Inflammatory bowel disease
Ischaemic heart disease
Mild hepatic impairment
Peripheral arterial circulatory disorder
Renal impairment - glomerular filtration rate 10 - 50ml/minute
Second trimester of pregnancy
Systemic lupus erythematosus
May mask symptoms or signs of infections
NSAIDs may provoke or exacerbate asthma
Advise ability to drive/operate machinery may be affected by side effects
Consider other first line treatment options in the elderly
Not all available brands are licensed for all indications
Preparation contains sucrose
Discontinue if signs of gastro-intestinal bleeding occur
Monitor closely any patient who develops new infection while on treatment
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Discontinue if signs of gastro-intestinal ulceration occur
High dose/long term use may increase risk of arterial thrombotic events
NSAIDs may provoke bronchospasm/urticaria in susceptible patients
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
Discontinue if any kind of visual disturbance occurs
Discontinue if hypersensitivity reactions occur
Discontinue if severe skin reaction occurs
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
May cause impaired fertility
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring within the first month of treatment in the majority of cases. Ketoprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Elderly patients are more susceptible to the adverse reactions of NSAIDs, including gastrointestinal bleeding and perforation. As such, they should be started on and maintained on the lowest possible dose and should be mointored for gastrointestinal bleeding throughout treatment during NSAID therapy. Concomitant gastro-protection (e.g. proton pump inhibitors) should be considered in these patients and those on other drugs, which increase gastrointestinal risk.
Patients with mixed connective tissue disorders such as systemic lupus erythematosus may be especially susceptible to aseptic meningitis.
Pregnancy and Lactation
Ketoprofen is contraindicated in the third trimester of pregnancy.
Use Ketoprofen with caution in the first trimester and second trimesters of pregnancy.
The manufacturer does not recommend this product in pregnancy.
Studies suggest increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
Ketoprofen should not be given in the first and second trimester unless necessary and the dose should be kept as low and duration of treatment as short as possible.
Ketoprofen may have the following effects during the second and third trimesters:
- Pulmonary and cardiac toxicity in the foetus/newborn (pulmonary hypertension with preterm closing of the ductus arteriosus). The risk exists from the beginning of the sixth month and increases if administration is close to full term.
- Functional renal injury in the foetus. From the twelfth week: oligohydramnios (usually reversible after the end of treatment) or anamnios (particularly with prolonged exposure). Following birth, renal failure may persist (especially with late and prolonged exposure).
- Inhibition of uterine contractions with delayed onset and prolongation of labour.
- Increased possibility of bleeding in mother and child.
Use of any NSAID is considered contraindicated during the third trimester of pregnancy.
Use ketoprofen with caution in breastfeeding.
The manufacturer recommends avoiding the use of ketoprofen when breastfeeding.Although the level of excretion of ketoprofen in breast milk is unknown, some sources report adverse effects on breastfed infants such as gastrointestinal and renal effects.
Ibuprofen is considered a preferable choice in breastfeeding (Briggs 2015, Schaefer 2015).
Abnormal liver function
Aggravation of existing asthma
Alterations in renal function tests
Bone marrow aplasia
Exacerbation of colitis
Exacerbation of Crohn's disease
Increase of liver transaminases
Induces asthma attacks
Non-specific allergic reactions
Serum bilirubin increased
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: Feburary 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: Oruvail 100mg capsules. Sanofi-Aventis. Revised November 2020.
Summary of Product Characteristics: Oruvail 200mg capsules. Sanofi-Aventis. Revised November 2020.
Summary of Product Characteristics: Larafen CR capsules 200mg. Ennogen Pharma Ltd. Revised June 2018.
The Renal Drug Handbook. Fifth Edition. (2019) ed. Ashley, C and Dunleavy, A. Radcliffe Publishing Ltd, London.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Ketoprofen. Last revised: 31 October 2018
Last accessed: 25 February 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.