Many molecules have nonsteroidal anti-inflammatory effects (NSAIDs).
Action mechanism :
Blocks the production of inflammatory substances.
Depends on the analgesic and anti-inflammatory activity of NSAIDs and the extent of the manifestations of intolerance to which the drug gives rise. “Light” NSAIDs are used as analgesics with few adverse effects such as ibuprofen, and “stronger” NSAIDs whose indications are more extensive for taking more frequent and sometimes more severe adverse effects such as Ketoprofen for example are used in certain chronic inflammatory diseases.
– Beyond the fifth month of pregnancy. (not recommended during breastfeeding because passes into milk).
– Hypersensitivity to this molecule or to any of the product’s excipients.
– History of allergic reactions to NSAIDs, acetylsalicylic acid (Aspirin).
– History of haemorrhage or digestive perforation during previous treatment with NSAIDs.
– Evolving hemorrhage.
– Active gastric ulcer, history of gastric ulcer or recurrent bleeding (2 or more distinct episodes).
– Severe liver failure.
– Severe kidney failure.
– Severe heart failure.
– Systemic lupus erythematosus.
– Specific contraindications to excipients (Wheat allergy for Ketoprofen for example)
Warnings and precautions for use:
– The concomitant use of two NSAIDs simultaneously is strongly discouraged.
– The occurrence of adverse effects is reduced by using the lowest possible dose and the shortest treatment necessary.
– Patients with asthma with chronic rhinitis or sinusitis and/or nasal polyposis have an increased risk of allergy.
– The elderly present an increased risk of adverse effects from NSAIDs.
– Gastrointestinal haemorrhage, ulceration or perforation, sometimes fatal, has been reported with all NSAIDs. These risks increase with dose. Mucosal protective therapy (proton pump inhibitor) should be considered for these patients.
– Beware of associated treatments, which may increase the risk of ulceration or bleeding, such as:
* oral anticoagulants,
* Certain antidepressants
* antiplatelet agents such as aspirin.
– In the event of onset of haemorrhage or ulceration occurring in a patient receiving NSAIDs, treatment should be discontinued.
– Beware of the risk of aggravation of chronic inflammatory intestinal pathologies (ulcerative colitis, Crohn’s disease).
– Serious skin reactions are rare but possible. An NSAID should be discontinued as soon as a skin rash or mucosal lesions appear.
– NSAIDs are likely to cause renal failure and/or water and sodium retention.
– Risk of impaired female fertility.
– The treatment can mask a serious infection.
– Risk of photosensitivity.
– Hepatitis and jaundice are possible but rare
– In case of visual disturbances stop treatment.
– Excipients may cause unusual side effects in patients with enzyme or genetic abnormalities.
In case of route refer to the instructions for use of the laboratory.
Certain drugs or therapeutic classes promote hyperkalemia. To know the risks and levels of constraint specific to hyperkalaemic drugs, it is advisable to refer to the interactions specific to each substance.
– Other NSAIDs (including high dose aspirin).
– Oral anticoagulants
– Unfractionated heparins, low molecular weight heparins and related
– Lithium: increased lithium
– Methotrexate, used at doses > 20 mg per week: increased haematological toxicity of methotrexate.
Requiring precautions for use:
– Diuretics, ACE inhibitors, angiotensin II receptor antagonists.
– Methotrexate, used at low doses ≤ 20 mg per week: increased haematological toxicity of methotrexate.
– Ciclosporin, tacrolimus: risk of additive nephrotoxic effects, especially in the elderly. Monitor renal function at the start of treatment with NSAIDs.
To consider :
Increased risk of gastrointestinal bleeding with:
– Acetylsalicylic acid in anti-aggregation doses (from 50 mg to 375 mg per day in one or more doses)
– Glucocorticoids (except hydrocortisone in replacement therapy):
– Antiplatelet agents
– Selective serotonin reuptake inhibitors (SSRIs).
– Unfractionated heparins, low molecular weight heparins (preventive doses).
Beta-blockers (except esmolol): reduction of the antihypertensive effect (inhibition of vasodilator prostaglandins by NSAIDs, water and sodium retention).
Side effects :
– Common: dyspepsia, nausea, abdominal pain, gastric pain, vomiting.
– Uncommon: diarrhoea, constipation, flatulence, gastritis.
– Rare: stomatitis, ulcer, colitis.
– Not known: exacerbation of colitis and Crohn’s disease, gastrointestinal bleeding and perforation.
Immune System Disorders:
– Not known: angioedema, anaphylactic reactions (including anaphylactic shock).
Skin and Subcutaneous Tissue Disorders:
– Uncommon: Rash, rash, pruritus.
– Not known: urticaria, aggravation of chronic urticaria, photosensitivity, alopecia and bullous dermatoses (Stevens-Johnson syndrome and Lyell syndrome).
Respiratory, Thoracic and Mediastinal Conditions:
– Rare: asthma attack.
– Not known: bronchospasm, especially in subjects allergic to aspirin and other NSAIDs, rhinitis.
Nervous System Disorders:
– Uncommon: headache, dizziness, somnolence.
– Rare: paresthesia.
– Not known: convulsions, taste disturbances.
– Frequency not known: mood disturbances.
– Rare: visual blurring.
Ear and Labyrinth Disorders:
Kidney and Urinary Tract Disorders:
– Not known: water and sodium retention, hyperkalaemia.
– Functional acute renal failure (ARF) in patients with risk factors.
– Organic renal damage that can result in an ARF: isolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.
– Renal function abnormalities.
Blood and Lymphatic System Disorders:
– Rare: anemia due to haemorrhage, leucopenia.
– Not known: agranulocytosis, thrombocytopenia, bone marrow failure.
– Rare: increased transaminases, hepatitis, increased bilirubin related to liver problems.
Cardiac and vascular conditions:
– Uncommon: oedema.
– Not known: heart failure.
– Not known: Hypertension, vasodilation.
General conditions and administration site conditions:
– Uncommon: fatigue.
– Rare: Weight gain.
Pregnancy and breast feeding :
– In the first stage of pregnancy, increased risk of miscarriage, heart defect and aparoschisis.
– Unless clearly necessary, the use of NSAIDs should be avoided during the 1st trimester and 2nd trimester of pregnancy. During the 3rd trimester, all prostaglandin synthesis inhibitors may expose to:
– Kidney damage: during and after pregnancy.
– A risk of cardiopulmonary damage. This effect exists even for a one-time shot.
– A risk of prolonged bleeding time for the mother and child
– Inhibition of uterine contractions which may delay or prolong labour.
– Up to 12 weeks of amenorrhea: the use of NSAIDs should only be considered if necessary.
– Between 12 and 24 weeks of amenorrhea prolonged intake is strongly discouraged.
– Beyond 24 weeks of amenorrhea (5 months completed): any intake, even punctual, is contraindicated.
Feeding with milk :
As NSAIDs pass into breast milk, as a precaution, they should not be administered to breastfeeding women.
In adults, the main signs of overdose are:
– abdominal or epigastric pain.
In cases of severe poisoning, hypotension, respiratory depression and gastrointestinal haemorrhage have been observed.
There is no specific antidote.
The patient must be transferred immediately to a specialized hospital where symptomatic treatment will be instituted to compensate for dehydration, monitor renal function and correct any acidosis.
If kidney failure occurs, hemodialysis may be used to remove the drug.
Gastric lavage or the administration of activated charcoal can be practiced in order to limit the absorption of NSAIDs.