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Mobic, Meloxicam
 

Mobic

Brand Names: Mobic, Movalis, Meloxicam, Melox, Recoxa, Mobicox, Metacam, Tenaron
Generic Name:
Meloxicam
Manufacturer:
Boehringer Ingelheim

Composition
1 tablet contains 7.5 mg or 15 mg
4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyI)-2H-1, 2-benzothiazine-3-carboxamide-1,
1-dioxide (= meloxicam)

Properties
MOBIC is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class, which has shown anti- inflammatory, analgesic and antipyretic properties in animals. MOBIC showed potent anti-inflammatory activity in all standard models of inflammation. A common mechanism for the above effects may exist in the ability of MOBIC to inhibit the biosynthesis of prostaglandins, known mediators of inflammation. Comparison of the ulcerogenic dose and the anti-inflammatory effective dose in the rat adjuvant arthritis model confirmed a superior therapeutic margin in animals over standard NSAIDs. In vivo, MOBIC inhibited prostaglandin biosynthesis more potently at the site of inflammation than in the gastric mucosa or the kidney.

These differences are thought to be related to a selective inhibition of COX-2 relative to COX-1 and it is believed that COX-2 inhibition provides the therapeutic effects of NSAIDs whereas inhibition of constitutive COX-1 may be responsible for gastric and renal side effects.
The COX-2 selectivity of MOBIC has been confirmed both in vitro and ex vivo in a number of test systems. In the human whole blood assay, MOBIC has been shown in vitro to inhibit COX-2 selectively. MOBIC
(7.5 and 15 mg) demonstrated a greaterinhibition of COX-2 ex vivo, as demonstrated by a greater inhibition of lipopolysaccharide-stimulated PGE2 production (COX-2) as compared with thromboxane production in clotting blood (COX-1).These effects were dose-dependent. MOBIC has been demonstrated to have no effect on either platelet aggregation at recommended doses ex vivo, while indomethacin, diclofenac, ibuprofen and naproxen significantly inhibited platelet aggregation and prolonged bleeding.
In clinical trials, gastro-intestinal adverse events overall were reported less frequently with MOBIC 7.5 mg and 15 mg than with the NSAIDs with which it has been compared, due predominantly to a lower reporting incidence of events such as dyspepsia, vomiting, nausea and abdominal pain.The incidence of upper gastro­intestinal perforation, ulcers, and bleeds reported in association with MOBIC is low and dose dependent. There is no single study powered adequately to detect statistically differences in the incidence of clinically significant upper gastro-intestinal perforation, obstruction, or bleeds between MOBIC and other NSAIDs.
A pooled analysis has been conducted involving patients treated with MOBIC in 35 clinical trials in the indications osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Exposure to MOBIC in these trials ranged from 3 weeks to one year (most patients were enrolled in one-month studies). Almost all patients participated in trials that permitted enrolment of patients with a prior history of gastro-intestinal perforation, ulcer or bleed.The incidence of clinically significant upper gastro-intestinal perforation, obstruction, or bleed (POB) was assessed retrospectively following independent blinded review of cases. Results are shown in the following table.

Cumulative risk of POBs for MOBIC 7.5 mg and 15 mg from BI clinical trials compared to diclofenac and piroxicam (Kaplan-Meier estimates)


TREATMENT - Interval (days) - Patients at interval midpoint - POBs within interval - Risk (%) - 95% confidence interval


Daily dose

MOBIC
7.5 mg 1 - <30 9636 2 0.02 0.00 - 0.05
30 - <91 551 1 0.05 0.00 - 0.13
15 mg 1 - <30 2785 3 0.12 0.00 - 0.25
30 - <91 1683 5 0.40 0.12 - 0.69
91 - <182 1090 1 0.50 0.16 - 0.83
182 - <365 642 0 0.50


Diclofenac 1 - <30 5110 7 0.14 0.04 - 0.24
100 mg 30 - <91 493 2 0.55 0.00 - 1.13

Piroxicam
1 - <30 5071 10 0.20 0.07 - 0.32
20 mg 30 - <91 532 6 1.11 0.35 - 1.86

Indications
MOBIC is a non-steroidal anti-inflammatory drug indicated for

  • buy ataraxsymptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease)
  • buy ataraxsymptomatic treatment of rheumatoid arthritis
  • buy ataraxsymptomatic treatment of ankylosing spondylitis.

Dosage and Administration

Osteoarthritis:
7.5 mg/day. If necessary, the dose may be increased to 15 mg/day.

Rheumatoid arthritis:
15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day.

Ankylosing spondylitis:
15 mg/day.
In patients with increased risks of adverse reactions: start treatment at the dose of 7.5 mg/day. In dialysis patients with severe renal failure: the dose should not exceed 7.5 mg/day.
Adolescents: The maximum recommended dose for adolescents is 0.25 mg/kg.
As a dosage for use in children has not yet been established, usage should be restricted to adolescents and adults. The maximum recommended daily dose of MOBIC is 15 mg.
Tablets and capsules should be swallowed with water or other fluid in conjunction with food.

Combined administration:
The total daily dosage of MOBIC administered as tablets should not exceed 15 mg.

Contraindications
Known hypersensitivity to MOBIC or any excipient of the product.There is a potential for cross sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).
MOBIC should not be given to patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of acetylsalicylic acid or other NSAIDs.

  • buy ataraxActive peptic ulceration
  • buy ataraxSevere hepatic insufficiency
  • buy ataraxNon-dialysed severe renal insufficiency
  • buy ataraxChildren under 15 years
  • buy ataraxPregnancy or breastfeeding.

Special warnings and precautions
As with other NSAIDs caution should be exercised when treating patients with a history of gastro-intestinal disease and in patients receiving treatment with anticoagulants. Patients with gastro-intestinal symptoms should be monitored. MOBIC should be withdrawn if peptic ulceration or gastro-intestinal bleeding occurs. Gastro-intestinal bleeding, ulceration or perforation can occur at any time during treatment, with or without warning symptoms or a previous history of serious gastro-intestinal events. The consequences of such events are generally more serious in the elderly.
Special attention should be paid in patients reporting mucocutaneous adverse events and consideration given to discontinuing MOBIC.
NSAIDs inhibit the synthesis of renal prostaglandins, which play a supportive role in the maintenance of renal perfusion. In patients whose renal blood flow and blood volume are decreased, administration of an NSAID may precipitate overt renal decompensation which is typically followed by recovery to pre-treatment state upon discontinuation of non-steroidal anti-inflammatory therapy. Patients at greatest risk of such a reaction are dehydrated patients, those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease, those receiving a diuretic or those having undergone major surgical procedures,
which led to hypovolaemia. In such patients the volume of diuresis and the renal function should be carefully monitored at the beginning of therapy.

In rare instances NSAIDs may be the cause of interstitial nephritis, glomerulonephritis, renal medullary necrosis or nephrotic syndrome.
The dose of MOBIC in patients with end-stage renal failure on haemodialysis should not be higher than 7.5 mg. No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients with a creatinine clearance of greater than 25 ml/min).
As with most other NSAIDs, occasional elevations of serum transaminases or other parameters of liver function have been reported. In most cases these have been small and transient increases above the normal range. If the abnormality is significant or persistent, MOBIC should be stopped and follow up tests carried out. No dose reduction is required in patients with clinically stable liver cirrhosis.
Frail or debilitated patients may tolerate side effects less well and such patients should be carefully supervised. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.
Induction of sodium, potassium and water retention and interference with the natriuretic effects of diuretics may occur with NSAIDs. Cardiac failure or hypertension may be precipitated or exacerbated in susceptible patients as a result.
There are no specific studies about effects on the ability to drive vehicles and to use machinery. Patients who experience visual disturbances, drowsiness or other central nervous system disturbances should refrain from these activities.

Drug Interactions

  • buy ataraxOther NSAIDs including salicylates: Concomitant administration of more than one NSAID may increase the risk of gastro-intestinal ulceration and bleeding through synergistic action.
  • buy ataraxOral anticoagulants, ticlopidine, systemically administered heparin, thrombolytics: increased risk of bleeding. If such co-prescribing cannot be avoided, close monitoring of the effects of anticoagulants is required.
  • buy ataraxLithium: NSAIDs have been reported to increase lithium plasma levels. It is recommended that plasma lithium levels be monitored when initiating, adjusting and discontinuing MOBIC.
  • buy ataraxMethotrexate: As other NSAIDs MOBIC may increase the haematologic toxicity of methotrexate. In this situation, strict monitoring of blood cell count is recommended.
  • buy ataraxContraception: NSAIDs have been reported to decrease the efficacy of intrauterine devices.
  • buy ataraxDiuretics: Treatment with NSAIDs is associated with the potential for acute renal insufficiency in patients who are dehydrated. Patients receiving MOBIC and diuretics should be adequately hydrated and be monitored for renal function prior to initiating treatment
  • buy ataraxAntihypertensives (e.g. beta-blockers, ACE-inhibitors, vasodilators, diuretics): A reduced effect of the antihypertensive drug by inhibition of vasodilating prostaglandins has been reported during treatment with NSAIDs.
  • buy ataraxCholestyramine binds MOBIC in the gastro-intestinal tract leading to a faster elimination of MOBIC.
  • buy ataraxNephrotoxicity of cyclosporin may be enhanced by NSAIDs via renal prostaglandin mediated effects. During combined treatment renal function is to be measured.

MOBIC is eliminated almost entirely by hepatic metabolism, of which approximately two thirds are mediated by cytochrome (CYP) P450 enzymes (CYP 2C9 major pathway and CYP 3A4 minorOathway) and one-third by other pathways, such as peroxidase oxidation. The potential for a pharmacokinetic interaction should be taken into account when MOBIC and drugs known to inhibit, or to be metabolised by, CYP 2C9 and/or CYP 3A4 are administered concurrently.
No relevant pharmacokinetic drug-drug interactions were detected with respect to the concomitant administration of antacids, cimetidine, digoxin and furosemide.
Interactions with oral antidiabetics cannot be excluded.

Pregnancy and lactation

Although no teratogenic effects were seen in preclinical testing, MOBIC should not be used during pregnancy and breastfeeding.

Side effects

The following adverse events, which may be causally related to the administration of MOBIC, have been reported.The frequencies given below are based on corresponding occurrences in clinical trials, regardless of ally causal relationship.The information is based on clinical trials involving 3750 patients who have been treated with daily oral doses of 7.5 or 15 mg MOBIC tablets or capsules over a period of up to 18 months (mean duration of treatment 127 days).

Adverse events which may be causally related to the administration of MOBIC that have come to light as a result of reports received in relation to administration of the marketed product are followed by a reference number.The incidence of these rare events is difficult to quantify. All are assumed to occur with a frequency of less than 0.1%.

Gastro-intestinal:

more frequent than 1%: dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhoea
between 0.1 and 10/0: transitory abnormalities of liver function parameters (e.g. raised transaminases or bilirubin), eructation, oesophagitis, gastroduodenal ulcer, occult or macroscopic gastro-intestinal bleeding
less frequent than 0.1%: gastro-intestinal perforation, colitis, hepatitis, gastritis.

Haematological:

more frequent than 1%: anaemia
between 0.1 and 1%: disturbances of blood count, including differential white cell count, leukopenia and thrombocytopenia. Concomitant administration of a potentially myelotoxic drug, in particular methotrexate, appears to be a predisposing factor to the onset of a cytopenia.


Dermatological:

more frequent than 1%:  pruritus, skin rash
between 0.1 and 10/0:  stomatitis, urticaria
less frequent than 0.1%: photosensitisation. On rare occasions balloon reactions, erythema multiforme, Stevens Johnson Syndrome, toxic epidermal necrolysis may develop

Respiratory:
less frequent than 0.1%: onset of acute asthma has been reported in certain individuals following the administration of aspirin or other NSAIDs, incl. MOBIC.

Central nervous system:
more frequent than 1%: light-headedness, headache
between 0.1 and 1%: vertigo, tinnitus, drowsiness,
less frequent than 0.1%: confusion and disorientation, alteration of mood.

Cardiovascular
more frequent than 1%: oedema

between 0.1 and 1%: increase of blood pressure, palpitations, flushes

Genitourinary
between 0.1 and 1%: abnormal renal function parameters (increased serum creatinine and/or serum urea),
less frequent than 0.1%: acute renal failure

Vision disorders:
less frequent than 0.1%: conjunctivitis, visual disturbances including blurred vision.

Hypersensitivitv reactions:

less frequent than 0,1%: angio-oedema and immediate hypersensitivity reactions, including anphylac-toid / anaphylactic reations

Overdose
In case of overdose the standard measures of gestric evacuation and general supportive should be used, as there is no known antidote. It has been shown in a clinical trial that cholestyramine accelerats the elimination of MOBIC.

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More info on Meloxicam and Mobic

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News Update

May 17, 2018:

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