Meloxicam-BP (inj)

Meloxicam

1 ml of solution for injection contains meloxicam 10 mg. One ampoule of 1.5 ml solution for injection contains meloxicam 15 mg. Excipient with known effect: sodium.

Indication: Short-term symptomatic treatment of acute exacerbations of rheumatoid arthritis and ankylosing spondylitis in adults, in cases where oral administration is not appropriate.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications This medicine is contraindicated in the following situations: − hypersensitivity to meloxicam or to any of the excipients listed in section 6.1 − third trimester of pregnancy (see section 4.6) − children and adolescents under 18 years of age; − hypersensitivity to substances with similar activity, e.g. NSAIDs, aspirin. Meloxicam must not be given to patients with bronchial asthma, nasal polyps, angioneurotic oedema or urticaria precipitated by acetylsalicylic acid or other NSAIDs. − history of gastrointestinal bleeding or perforation associated with NSAID use; − active peptic ulcer/haemorrhage or a history of these conditions (two or more distinct episodes of proven ulceration or bleeding); − severe hepatic impairment; − severe renal impairment in non-dialysed patients; − gastrointestinal bleeding, recent cerebrovascular bleeding, or other haemorrhagic disorders; − haemostatic disorders or concomitant anticoagulant treatment (contraindication related to the route of administration); − severe heart failure.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and the gastrointestinal and cardiovascular risks below). The maximum recommended daily dose must not be exceeded in case of insufficient therapeutic effect, and other NSAIDs must not be added to the treatment regimen, as this may increase toxicity without proven therapeutic benefit. Concomitant use of meloxicam with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Meloxicam is not recommended for the treatment of patients with acute pain. If there is no improvement in symptoms after a few days, the clinical benefit of treatment must be reassessed. Any history of oesophagitis, gastritis and/or ulcer […]