Contraindications : התוויות נגד

4.3   Contraindications

Hypersensitivity to ketorolac or to other non-steroidal anti-inflammatory drugs (NSAIDs) and in patients in whom aspirin and other prostaglandin synthesis inhibitors induce allergic reactions (severe anaphylactic-like reactions have been observed in such patients), or to any of the excipients listed in section 6.1.

Ketorolac is contraindicated in patients with a history of bronchial asthma.
Ketorolac is contraindicated in patients with complete or partial syndrome of nasal polyps, angioedema or bronchospasm.

As with other NSAIDs, ketorolac is contraindicated in patients with severe heart failure, hepatic failure and renal failure (see section 4.4).

Ketorolac is contraindicated in patients with moderate or severe renal impairment (serum creatinine > 160 µmol/l) or in patients at risk of renal failure due to volume depletion or dehydration.

Ketorolac is contraindicated in the patients with active peptic ulcer, with a history of gastrointestinal bleedings, ulceration or perforation, in patients with gastrointestinal bleedings or active perforations related to previous NSAIDs therapy, in patients with a history of peptic ulcer or gastrointestinal haemorrhage, and in patients with active gastrointestinal haemorrhage (two or more episodes of ulceration or bleeding).

Ketorolac inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients who had operations with a high risk of haemorrhage or incomplete haemostasis, and those at high risk of bleeding such as those with haemorrhagic diatheses, including coagulation disorders.

Ketorolac is contraindicated in the patients who receive treatment with oral anticoagulants, including warfarin, and low dose heparin (2500 - 5000 IU twelve hourly).

Ketorolac is contraindicated in patients currently receiving acetylsalicylic acid or other NSAIDs (including cyclooxygenase-2 selective inhibitors).

The combination of ketorolac with oxpentifylline (pentoxifylline), lithium salts, probenecid is contraindicated.

Ketorolac is contraindicated in children and adolescents less than 16 years of age.

Ketorolac is contraindicated during pregnancy, labour, delivery or lactation (see section 4.6).
Ketorolac is contraindicated as prophylactic analgesic before surgery due to inhibition of platelet aggregation, and is contraindicated intra-operatively because of the increased risk of bleeding.

Ketorolac Trometamol Rompharm 30 mg/ml solution for injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.