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Meloxicam oral

Updated 2 Feb 2023 | NSAIDs

Presentation

Oral formulations of meloxicam

Drugs List

  • meloxicam 15mg orodispersible tablets sugar-free
  • meloxicam 15mg tablets
  • meloxicam 7.5mg orodispersible tablets sugar-free
  • meloxicam 7.5mg tablets
  • Therapeutic Indications

    Uses

    Ankylosing spondylitis
    Long term symptomatic treatment of rheumatoid arthritis
    Short term symptomatic treatment of acute exacerbations of osteoarthritis

    Dosage

    Adults

    Osteoarthritis
    7.5mg daily. Increase to 15mg daily if necessary.

    Rheumatoid arthritis
    15mg daily. Reduce to 7.5mg daily if necessary.

    Ankylosing spondylitis
    15mg daily. Reduce to 7.5mg daily if necessary.

    Elderly

    Rheumatoid arthritis and ankylosing spondylitis
    7.5mg daily.

    NSAIDs should always be prescribed with caution in the elderly in whom there is an increased risk of serious side effects and fatalities.

    Children

    Children aged 16 to 18 years
    (See Dosage; Adult)

    The following alternative dosing schedule may be suitable:

    Relief of pain and inflammation in juvenile idiopathic arthritis and other musculoskeletal disorders in adolescents intolerant to other NSAIDs (unlicensed)
    Children aged 12 to 18 years weighing 50kg and above: 15mg once daily.
    Children aged 12 to 18 years weighing under 50kg: 7.5mg once daily.

    Patients with Renal Impairment

    In dialysis patients with severe renal failure
    The dose should not exceed 7.5mg daily.

    Additional Dosage Information

    Dose of 15mg daily should not be exceeded.

    Patients with increased risk for adverse reactions should start treatment with 7.5mg daily.

    Start treatment at the lowest recommended dose for the shortest time possible. Reassess treatment in the absence of any improvement after several days.

    Contraindications

    Children under 12 years
    Suspected cerebrovascular haemorrhage
    Breastfeeding
    Cerebrovascular haemorrhage
    Coagulopathy
    Gastrointestinal haemorrhage
    Gastrointestinal perforation
    Non-dialysed severe renal failure
    Peptic ulcer
    Recurrent peptic ulcer
    Severe congestive cardiac failure
    Severe hepatic impairment
    Third trimester of pregnancy

    Precautions and Warnings

    Children aged 12 to 16 years
    Elderly
    Predisposition to hypovolaemia
    Risk factors for cardiovascular disorder
    Cerebrovascular disorder
    Congestive cardiac failure
    Connective tissue disorder
    First trimester of pregnancy
    Galactosaemia
    Gastritis
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of gastrointestinal bleeding
    History of gastrointestinal perforation
    History of peptic ulcer
    Hyperkalaemia
    Hypertension
    Inflammatory bowel disease
    Ischaemic heart disease
    Lactose intolerance
    Nephrotic syndrome
    Oesophagitis
    Peripheral arterial circulatory disorder
    Renal impairment
    Second trimester of pregnancy

    May mask fever
    May mask signs of inflammation
    May precipitate bronchospasm in patients with asthma or allergy
    Not suitable for acute pain relief
    Reduce dose in patients with hepatic impairment
    Reduce dose in patients with renal impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Consider other first line treatment options in the elderly
    Some formulations contain lactose
    Discontinue if signs of gastro-intestinal bleeding occur
    Monitor for signs of fluid retention
    Monitor patients with GI symptoms or history of GI disease
    Monitor patients with history of peptic ulceration
    Monitor urine output & renal function in patients at risk of renal failure
    Advise patient to report abdominal pain or tenderness, fever or diarrhoea
    Advise patients to report signs or symptoms of gastro-intestinal ulcer
    Discontinue if signs of gastro-intestinal ulceration occur
    Severe gastro-intestinal side effects may occur without warning
    Discontinue if drug-related rash or other hypersensitivity reactions occur
    Discontinue if significant/persistent hepatic function abnormalities occur
    Maintain treatment at the lowest effective dose
    Reduce dose in elderly
    Start treatment at lowest recommended dose
    Female: Reduced fertility (reversible) possible with long term use

    Data suggest that NSAID use (especially high doses for prolonged periods) may be associated with a small increased risk of arterial thrombotic events e.g. myocardial infarction or stroke. Patients who may be predisposed to thrombotic events should only be prescribed meloxicam after careful consideration.

    Induction of sodium, potassium and water retention and interference with the natriuretic effects of diuretics and consequent exacerbation of oedema, cardiac failure or hypertension may occur. Patients should be monitored as soon as therapy is started. A decrease of the antihypertensive effect can occur. Hyperkalaemia may be more likely in diabetic patients. Regular monitoring of potassium values should be performed in patients predisposed to hyperkalaemia.


    Pregnancy and Lactation

    Pregnancy

    During the first and second trimester of pregnancy, the dose of meloxicam should be kept as low and duration of treatment as short as possible.

    Meloxicam is contraindicated in the third trimester.

    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 oligohydramnios.
    The mother and the neonate, at the end of pregnancy, may be exposed 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.

    If treatment during the third trimester is unavoidable, foetal circulation should be monitored with Doppler sonography and therapy discontinued at the first signs of ductal constriction.
    Meloxicam should not be used during the first and second trimesters unless potential benefit outweighs the potential risk to the foetus. If short term use of an NSAID is required then ibuprofen at the recommended therapeutic doses would be the preferred choice. If an NSAID has been taken in early pregnancy Schaefer (2007) concludes that this does not require a termination of pregnancy or additional invasive diagnostic procedures.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Meloxicam is contraindicated in breastfeeding.

    No reports of the use of meloxicam during breastfeeding have be located at the time of writing. The molecular weight (about 351) is low enough that excretion into breast milk should be expected (Briggs, 2011).

    NSAIDs are known to pass into mother's milk. If an NSAID is considered essential ibuprofen is considered the drug of choice. Levels of ibuprofen in breast milk are negligible.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Abdominal pain
    Abnormal kidney function tests
    Acute tubular necrosis
    Agranulocytosis
    Altered liver function tests
    Anaemia
    Anaphylactic reaction
    Anaphylactoid reaction
    Angioedema
    Arterial thrombosis
    Blood disorders
    Blurred vision
    Bullous dermatoses
    Cardiac failure
    Colitis
    Confusion
    Conjunctivitis
    Constipation
    Diarrhoea
    Disorientation
    Dizziness
    Dyspepsia
    Eructation
    Erythema multiforme
    Exacerbation of inflammatory bowel disease
    Flatulence
    Flushing
    Gastritis
    Gastro-intestinal perforation
    Gastro-intestinal symptoms
    Gastro-intestinal ulceration and bleeding
    Haematemesis
    Haematuria
    Headache
    Hepatitis
    Hyperkalaemia
    Hypersensitivity reactions
    Increased blood pressure
    Induces asthma attacks
    Interstitial nephritis
    Leucopenia
    Lower limb oedema
    Melaena
    Mood changes
    Myocardial infarction
    Nausea
    Nephrotic syndrome
    Nightmares
    Oedema
    Oesophagitis
    Palpitations
    Papillary necrosis
    Photosensitivity
    Pruritus
    Rash
    Renal failure
    Renal medullary necrosis
    Sodium/water retention
    Stevens-Johnson syndrome
    Stroke
    Suppressed female fertility
    Thrombocytopenia
    Tinnitus
    Toxic epidermal necrolysis
    Urticaria
    Vertigo
    Visual disturbances
    Vomiting

    Overdosage

    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 ).

    Further Information

    Last full review: September 2013

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Meloxicam 7.5mg orodispersible tablets. Fontus Health Ltd. Revised April 2011.
    Summary of Product Characteristics: Meloxicam 15mg orodispersible tablets. Fontus Health Ltd. Revised April 2011.

    Summary of Product Characteristics: Meloxicam 7.5mg tablets. Teva UK Ltd. Revised July 2012.
    Summary of Product Characteristics: Meloxicam 15mg tablets. Teva UK Ltd. Revised July 2012.

    The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 September 2017

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Meloxicam Last revised: September 07, 2013
    Last accessed: September 20, 2013

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