Interactions

Active ingredient Acemetacin interacts in the following cases:

Alcohol, central nervous system drugs

Caution in administration of acemetacin with alcohol or central nervous system drugs.

Corticosteroids

Co-administration of acemetacin and corticosteroids is associated with increased risk of gastrointestinal ulceration or bleeding.

Bleeding

Acemetacin should be used with caution in patients with bleeding. Inhibition of platelet aggregation may occur.

Impaired renal function

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients.

Impaired liver function

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients.

Anti-coagulants

NSAIDs may enhance the effects of anti-coagulants, such as warfarin.

Anticoagulants (warfarin), sulphonylureas, hydantoins or sulfonamides

Use caution when acemetacin administered concurrently, particularly in large doses, with coumarin-derivative anticoagulants (warfarin), sulphonylureas, hydantoins or sulfonamides.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs)

Co-administration of acemetacin and anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs) is associated with increased risk of gastro-intestinal bleeding.

Potassium-sparing diuretics

Hyperkalaemia has been reported with use of indomethacin and this should be considered when administration with potassium-sparing diuretics is proposed.

Penicillin

Acemetacin decreases elimination of penicillin.

Quinolones

Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Acetylsalicylic acid

Acetylsalicylic acid reduces the concentration of acemetacin.

Ciclosporin

Co-administration of acemetacin and ciclosporin is associated with increased risk of nephrotoxicity.

Cardiac lycoside

NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Furosemide

Furosemide accelerates the elimination of acemetacin.

Lithium

Acemetacin decreases the elimination of lithium.

Methotrexate

Acemetacin decreases the elimination of methotrexate.

Probenecid

Probenecid decreases the elimination of acemetacin.

Tacrolimus

Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine

Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Bronchial asthma

Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Systemic lupus erythematosus

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis after the administration of acemetacin.

Psychiatric disorders, epilepsy, parkinsonism

Aggravation of psychiatric disorders, epilepsy or parkinsonism may occur after the administration of acemetacin.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acemetacin should not be given unless clearly necessary. If acemetacin is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

  • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
  • renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

  • possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
  • inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, acemetacin is contraindicated during the third trimester of pregnancy.

Nursing Mothers

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

Carcinogenesis, Mutagenesis and Fertility

Fertility

The use of acemetacin may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Emflex should be considered.

Effects on Ability to Drive and Use Machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery. These effects will be enhanced in combination with alcohol.