BRANDS / TRADE NAMES OF MELOXICAM IN KENYA
Benacam, Benmed Pharmaceuticals Ltd
M-Cam, Unichem Laboratories Ltd
Melgesic, Delorbis Pharmaceuticals Limited
Mel OD, Cadila Healthcare Limited
Melonac, Zest Pharma
Melorto, Crest Remedies LLP
Meloxee, PSM Pharmaceuticals Ltd
Meloz, Zawadi Healthcare Ltd
Mexic, Galaxy Pharmaceutical Ltd
Mobic, Boehringer Ingelheim international GmbH
Mofic, Oceanic Healthcare Limited
Muvera, Sun Pharmaceutical Industries Limited
Neoxicam, Neopharma L.L.C.
Uxim, Universal Corporation Limited
MODE OF ACTION
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in models. The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclooxygenase) inhibition
Short-Term Symptomatic Treatment of Exacerbations of Osteoarthritis. Long Term Symptomatic Treatment of Rheumatoid Arthritis or Ankylosing Spondylitis.
DOSAGE AND ADMINISTRATION
Exacerbations of Osteoarthritis: 7.5 mg/day ; if necessary, in the absence of improvement, the dose may be increased to 15 mg/day.
Rheumatoid arthritis, Ankylosing Spondylitis: 15 mg/day .
According to the therapeutic response, the dose may be reduced to 7.5 mg/day .
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms . The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
This medicinal product is contra-indicated in the following situations:
- Third trimester of pregnancy
- Children and adolescents aged under 16 years;
- Hypersensitivity to meloxicam or to one of the excipients or hypersensitivity to substances with a similar action, e.g. NSAIDs, aspirin. Meloxicam should not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other NSAIDs;
- History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;
- Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);
- Active intestinal inflammatory disease (Crohn´s disease, ulcerative colitis);
- Severely impaired liver function;
- Non-dialysed severe renal failure;
- Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders;
- Severe heart failure;
- Meloxicam is contraindicated in treatment of perioperative pain after coronary artery bypass surgery (CABG).
Other non steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid:
combination with other non steroidal anti-inflammatory drugs, including acetylsalicylic acid given at anti-inflammatory doses ( ≥ 1g as single intake or ≥ 3g as total daily amount) is not recommended.
Corticosteroids (e.g. Glucocorticoids):
The concomitant use with corticosteroids requests caution because of an increased risk of bleeding or gastrointestinal ulceration.
Anticoagulant or heparin administered in geriatrics or at curative doses:
Considerably increased risk of bleeding, via inhibition of platelet function and damage to the gastroduodenal mucosa. NSAIDs may enhance the effects of anticoagulants, such as warfarin . The concomitant use of NSAIDs and anticoagulants or heparin administered in geriatrics or at curative dose is not recommended .
In remaining cases of heparin use caution is necessary due to an increased bleeding risk.
Careful monitoring of the INR is required if it proves impossible to avoid such combination.
Thrombolytics and antiplatelet drugs:
Increased risk of bleeding, via inhibition of platelet function and damage to the gastroduodenal mucosa.
Selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding.
Diuretics, ACE inhibitors and Angiotensin-II Antagonists:
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin-II antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Other antihypertensive drugs (e.g. Beta-blockers):
As for the latter, a decrease of the antihypertensive effect of beta-blockers (due to inhibition of prostaglandins with vasodilatory effect) can occur.
Calcineurin inhibitors (e.g. cyclosporin, tacrolimus)::
Nephrotoxicity of calcineurin inhibitors may be enhanced by NSAIDs via renal prostaglandin mediated effects. During combined treatment renal function is to be measured. A careful monitoring of the renal function is recommended, especially in the elderly.
NSAIDs have been reported to decrease the efficacy of intrauterine devices.
A decrease of the efficacy of intrauterine devices by NSAIDs has been previously reported but needs further confirmation.
Pharmacokinetic Interactions (Effect of meloxicam on the pharmacokinetics of other drugs)
NSAIDs have been reported to increase blood lithium levels (via decreased renal excretion of lithium), which may reach toxic values. The concomitant use of lithium and NSAIDs is not recommended. If this combination appears necessary, lithium plasma concentrations should be monitored carefully during the initiation, adjustment and withdrawal of meloxicam treatment.
NSAIDs can reduce the tubular secretion of methotrexate thereby increasing the plasma concentrations of methotrexate. For this reason, for patients on high dosages of methotrexate (more than 15 mg/week) the concomitant use of NSAIDs is not recommended.
The risk of an interaction between NSAID preparations and methotrexate, should be considered also in patients on low dosage of methotrexate, especially in patients with impaired renal function. In case combination treatment is necessary blood cell count and the renal function should be monitored. Caution should be taken in case both NSAID and methotrexate are given within 3 days, in which case the plasma level of methotrexate may increase and cause increased toxicity.
Although the pharmacokinetics of methotrexate (15mg/week) were not relevantly affected by concomitant meloxicam treatment, it should be considered that the haematological toxicity of methotrexate can be amplified by treatment with NSAID drugs (see above).
Pharmacokinetic Interactions (Effect of other drugs on the pharmacokinetics of meloxicam)
Cholestyramine accelerates the elimination of meloxicam by interrupting the enterohepatic circulation so that clearance for meloxicam increases by 50% and the half-life decreases to 13+3 hrs. This interaction is of clinical significance.
No clinically relevant pharmacokinetic drug-drug interactions were detected with respect to the concomitant administration of antacids, cimetidine and digoxin.
Common side effects (affects 1 to 10 users in 100 ):
indigestion, feeling or being sick, abdominal pain, constipation, flatulence, diarrhoea; skin rashes or itching;
swelling of ankles and legs;
Uncommon side effects (affects 1 to 10 users in 1,000):
nettle rash or hives;
dizziness, tinnitus, drowsiness;
irregular heart beat, increased blood pressure, hot flushes;
abnormal white blood cell or platelet numbers;
changes to liver function;
salt and water retention, excessive potassium, changes to kidney function.
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, firstname.lastname@example.org or clicking below button:
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Clinical | Pharmacokinetic data
Pregnancy Category: C
Routes of Administration: By mouth, IV
Protein Binding: 99.4%
Metabolosim: Liver (CYP2C9 and 3A4-mediated)
Onset of Action: Not Available
Elimination Half life: 20 hours
Excretion: Urine and faeces equally
Legal Status | Dosage forms & Strengths
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
Tablets, Capsules : 7.5mg & 15mg
|CompTox Dashboard (EPA)|
- PPB Drugs Retention Register
- Noble, Stuart, and Julia Balfour. “Meloxicam.” Drugs 51.3 (1996): 424-430.
- Davies, Neal M., and Neil M. Skjodt. “Clinical pharmacokinetics of meloxicam.” Clinical pharmacokinetics 36.2 (1999): 115-126.
- Distel, M., et al. “Safety of meloxicam: a global analysis of clinical trials.” Rheumatology 35.suppl_1 (1996): 68-77.