Loxidol
(Meloxicam)




COMPOSITION

One tablet contains:

Active ingredient: meloxicam 15 mg.

Excipients: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc.

Film coating: hydroxypropylmethicellulose, talc, polyethyleneglycol 400, polyethyleneglycol 600, titanium dioxide, quinoline yellow.

THERAPEUTIC INDICATIONS

Symptomatic therapy of the following diseases:

- Rheumatoid arthritis

- Arthropathy deformans of joints

- Ankylosing spondylitis (Bechterew disease).

CONTRAINDICATIONS

- Hypersensitivity to meloxicam (including other NSAIDs) or to any other ingredients of Loxidol.

- Severe stage of gastric or duodenal ulcer and during the following 6 months.

- Non-dialyzed severe renal insufficiency.

- Severe renal failure.

- Children and adolescents under 15 years old.

- Gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding.

- Pregnancy.

- Lactation (breastfeeding).

- Allergic reactions (bronchial asthma, recrudescent nasal polyposis, polyposis of paranasal sinuses, Quincke's edema, urticaria) to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs

- Hypersensitivity to acetylsalicylic acid and to any other non-steroidal anti-inflammatory drugs

ADVERSE EFFECTS

GIT disorders: dyspepsia, nausea, vomiting, abdominal pains, constipation, flatulence, diarrhea, eructation, esophagitis, gastric and duodenal ulceration, gastro-intestinal bleeding, inflammation of mouth cavity.

Hemopoietic system disorders: anemia, leukopenia, thrombocytopenia.

Respiratory system disorders: acute asthmatic attack.

Cardiovascular disorders: peripheral oedema, elevated arterial pressure, heartbeat, flushing.

CNS disorders: headache, dizziness, sonitus, somnolence, disorientation, mental confusions.

Urinoexcretory disorders: abnormal kidney function test.

Visual disorders: conjunctivitis, impaired vision.

Dermatological disorders: itching, rash, urticarial, photosensitization.

DOSAGE AND ADMINISTRATION

For oral administration.

In rheumatoid arthritis: maximum daily dose is 15 mg daily. The dose may be titrated down to 7.5 mg daily in case of sufficient therapeutic outcome.

In osteoarthritis: 7.5mg of Loxidol per day. If needed, the dose may be increased to 15 mg daily.

In ankylosing spondylitis: 15 mg of Loxidol daily.

The initial daily dose for patients with increased risk of adverse effects is 7.5 mg. Maximum daily dose is 15 mg daily.

Daily dose for hemodialysis patients with severe kidney failure shouldn’t exceed 7.5 mg.

Daily dose for patients with mild kidney failure (CC >25 ml/min) does not require down-titrating. Indicated dose is taken once daily at meals, washing down with water.

Overdose.

Symptoms : aggravated adverse effects.

Therapy : consult a doctor.

DRUG INTERACTIONS

Concomitant use of high doses of Loxidol and other NSAIDs (including saliculates) increases the risk of gastro-intestinal ulcers and bleeding.

Concomitant use of Loxidol and indirect anticoagulants, ticlopidine, heparin, thrombolytics increases the risk of bleeding.

Concomitant use of Loxidol and methotrexate potentiates the myelodepressive effect of methotrexate.

Loxidol may decrease the efficacy of intrauterine contraceptives.

Concomitant use of Loxidol with diuretics may increase the risk of acute hepatic failure at patients with dehydration.

A reduced effect of the antihypertensive drugs may be reported in case of concomitant administration with Loxidol.

Administered concomitantly with cyclosporines, cyclosporine nephrotoxicity may be enhanced.

Administered concomitantly with lithium, Loxidol increases the plasma concentration of the latter.

Concomitant administration of Loxidol and cholestyramine leads to a faster elimination of Loxidol.

PREGNANCY AND LACTATION.

Loxidol is contraindicated during pregnancy and lactation (breastfeeding).

MANUFACTURED FORM

Film-coated tablets 15 mg.

10 tablets in the blister.

1 or 2 blisters with leaflet in a carton box.

Musculo-Skeletal system

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