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Avegesic

Composition:
Avegesic Tablet 7.5mg: Meloxicam 7.5 mg/tablet
Avegesic Tablet 15mg: Meloxicam 15 mg/tablet

Product Description
Avegesic Tablet 7.5mg: Light yellow, round, flat tablet, 8mm diameter, cross-scored on one side.
Avegesic Tablet 15mg: Light yellow, round, concave tablet, 10mm diameter, scored on one side.

Pharmacodynamics
Non-steroidal anti-inflammatory agent (M; locomotor system).

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti-inflammatory, analgesic and antipyretic properties.

The anti-inflammatory activity of meloxicam has been proven in classical models of inflammation. As with other NSAIDs, its precise mechanism of action remains unknown. However there is at least one common mode of action shared by all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, known inflammation mediators.

Pharmacokinetics
The bioavailability of meloxicam following oral administration is on the average 89%.

With the doses of 7.5 and 15 mg, plasma concentrations are proportional to dose: 0.4 to 1.0 mg/lt for 7.5 mg and 0.8 to 2.0 mg/It for 15 mg, on average (Cmin and Cmax at steady state).

Meloxicam is very strongly bound to plasma proteins, essentially albumin (99%).

Meloxicam is extensively metabolized, chiefly by oxidation of the methyl radical attached to the thiazolyl ring. Elimination is unchanged form accounts for 3% of the dose. Half of the substance is eliminated in urine and the other half in faeces.

The mean elimination half-life of the order of 20 hours.

Steady state is reached in 5 days.

In terminal renal failure, the volume of distribution is increased and a daily dose of 7.5 mg must not be exceeded.

Plasma clearance is on average 8 ml/min. Clearance is decreased in the elderly. Volume of distribution is low, on average 11 litres. Inter individual variation is the order of 30 - 40%.

Indication
- symptomatic treatment of painful osteoarthritis (- arthrosis, degenerative joint disease).
- symptomatic treatment of rheumatoid arthritis.
- symptomatic treatment of ankylosing spondylitis

Recommended Dose
Meloxicam may be taken without regard to timing of meals.

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

Rheumatoid arthritis: 15 mg/day. According to 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.

The total daily dosage of meloxicam should not exceed 15mg. As a dosage for used in children has yet to established, usage should be restricted to adults. Tablets should be swallowed with water or other fluid in conjunction with food.

Elderly: In elderly patients being treated for rheumatoid arthritis the recommended dose for long term treatment is 7.5 mg a day.

Children (Under 15 years of age): Not recommended After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.

Mode of administration
Oral administration

Contraindication
Hypersensitivity to meloxicam or to one of the excipients. The possibility exists of crossover sensitivity with aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

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 NSAIDs
- Severe hepatic failure.
- Severe heart failure.
- Non-dialyzed severe renal failure.
- Children aged under 15.
- Pregnancy (see Pregnancy and lactation).
- Lactation.
- Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
- History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
- Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders.

Warning and Precaution
WARNING
RISK OF GI ULCERATION, BLEEDING AND
PERFORATION WITH NSAID
Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients  treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms.

Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.

Under the Precautions Section:
Cardiovascular Thrombotic Events Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, principally myocardial infarction, which may increase with dose or duration of use. Patients with cardiovascular disease or cardiovascular risk of an adverse cardiovascular event in patient taking NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.

Hypertension NSAIDs may lead to the onset of new hypertension or worsening the pre-existing hypertension and patients taking antihypertensive with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.

Heart Failure Fluid retention and oedema have been observed in some patients taking NSAIDs, there caution is advised in patients with fluid retention or heart failure.

Gastrointestinal Events All NSAIDs can cause gastrointestinal discomfort and rarely serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation which may increase with dose or duration of use, but can occur at any time without warning. Caution is advised in patients with risk factors for gastrointestinal events e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism. When gastrointestinal bleeding or ulcerations occur in patients receiving NSAIDs, the drug should be withdrawn immediately. Doctors should warn patient about signs and symptoms of serious gastrointestinal toxicity. The concurrent use of aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.

Severe Skin Reactions NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash or any other sign of hypersensitivity.

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