Loxidol
(Meloxicam)




COMPOSITION

One suppository contains:

Active substances:

makrogolglitserol hydroxystearate (Cremophor RH 40), solid fat (Suppocire AM).

THERAPEUTIC INDICATIONS

Symptomatic treatment of pain syndrome

- in osteoarthritis (arthrosis, degenerative diseases of the joints)

- rheumatoid arthritis, ankylosing spondylitis

CONTRAINDICATIONS

- Known hypersensitivity to meloxicam or any component of the formulation. There is a possibility of cross-sensitivity to acetylsalicylic acid and other NSAIDs. The drug should not be prescribed to patients who have previously after taking acetylsalicylic acid or other NSAIDs reported symptoms of asthma, nasal polyps, angioneurotic edema or urticarial

- a history of gastrointestinal bleeding or perforation associated with NSAID.

- peptic ulcer and duodenal ulcer exacerbation

- severe hepatic insufficiency

Non-dialysed severe renal insufficiency.

- gastrointestinal bleeding, recent cerebrovascular bleeding or other bleeding

- severe heart failure

- presence history of proctitis or rectal bleeding

- Children under 15 years old

- Pregnancy and lactation

-

ADVERSE EFFECTS

- digestive system: dyspepsia, nausea, vomiting, abdominal pains, constipation, meteorism, diarhea;

Rarely:

- Gastro-intestinal bleeding, ulceration of perforation, severe, especially to elder patients;

- Anemia, leukopenia, thrombocytopenia, agranulocytosis, particularly in the case of simultaneous treatment with methotrexate;

- itching, rash

Uncommon:

- photosensitivity, urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis, angioedema, dermatitis, erythema multiform-like vesicular dermatitis.

- anaphylactic / anaphylactoid reactions

- meloxicam can cause an asthma attack, especially in persons allergic to (более научно) aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)

- feeling drunk, headache, dizziness, ringing in the ears, drowsiness, confusion, disorientation

- edema: increased blood pressure, palpitations, hot flashes

- abnormal liver function test (increased level of blood creatine and/ or blood urea) and rarely acute renal failure

- a temporary increase in transaminases or bilirubin

Rarely:

- hepatitis

- blurred vision

DOSAGE AND ADMINISTRATION

For rectal use

1 suppository of Loxidol is administered once daily (15mg meloxicam per day), because the risk of side effects depends on the dose and duration of treatment. The medication should be used for the shortest possible duration. Maximum recommended dosage is 15 mg. per day.

DRUG INTERACTIONS

Other NSAIDs including salicylates (acetyl salicylic acid): concomitant administration of more than one NSAID increases the risk of gastrointestinal ulcers, and gastro-intestinal bleeding via a synergistic effect. The combined use of meloxicam and other NSAIDs is not recommended.

Anticoagulants, antiaggregants, heparin for systemic use, thrombolytic drugs: increase risk of bleeding. If it is impossible to avoid the concomitant administration of these drugs, monitoring of their effects on coagulation is required.

Lithium: NSAIDs increase the concentration of lithium in the plasma due to the decrease in renal excretion of lithium. The combined use of lithium and NSAIDs is not recommendedIf this combination appears necessary, lithium plasma concentrations should be monitored carefully during the initiation, adjustment and withdrawal of meloxicam treatment.

Methotrexate: NSAIDs can reduce the tubular secretion of methotrexate thereby increasing the plasma concentrations of methotrexate. 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 this case the plasma level of methotrexate may increase and cause increased toxicity.

Cyclosporine: NSAIDs, exerting effects on renal prostaglandins, may increase cyclosporine nephrotoxicity. In the case of combination therapy renal function should be monitored.

Intrauterine devices: NSAIDs have been reported to decrease the efficacy of intrauterine devices.

Diuretics: The use of NSAIDs increases the risk of acute renal failure in patients with dehydration. Patients receiving meloxicam concomitantly with diuretics should be adequately hydrated and be monitored for renal function prior to initiating treatment.

Antihypertensive agents (e.g., beta-blockers, angiotensin-converting fermeta (ACE) inhibitors, vasodilators, diuretics) NSAIDs reduce the effect of antihypertensive agents due to inhibition of vasodilating prostaglandin.

Cholestyramine binds Meloxicam in the gastrointestinal tract leading to a faster elimination of Meloxicam.

MANUFACTURED FORM

3 suppositories in the blister of PVC film and aluminum foil.

2 blisters with a leaflet ​ in a carton box.

Musculo-Skeletal system

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