Loxidol
(Meloxicam)




COMPOSITION

Each film coated tablet contains meloxicam 15 mg.

THERAPEUTIC INDICATIONS

- Rheumatoid arthritis;
- Degenerative joint disease;
- Spondylitis (Bechterew disease).

CONTRAINDICATIONS

- Hypersensitivity to meloxicam (including other nonsteroidal anti-inflammatory agents) or other drug compounds;
- Gastric ulcer or duodenal ulcer in phase of exacerbation and during not less than 6 month after it;
- Chronic renal impairment in patients not underwent by hemodialysis;
- Severe liver impairment;
- Infancy and adolescence under 15;
- Bleedings (including bleedings from GIT), apoplexy;
- Pregnancy;
- Lactation (breast feeding);
- Allergic reactions (bronchial asthma, recurrent nasal and paranasal sinuses polyposis, Quincke's edema, urticaria) on acetylsalicylic acid other nonsteroidal anti-inflammatory agents;
- Hypersensitivity to acetylsalicylic acid other nonsteroidal anti-inflammatory agents.

ADVERSE EFFECTS

Effects from digestive system: dyspepsia, nausea, vomiting, abdominal pains, constipation, meteorism, diarrhea, eructation, esophagitis, ulceration of stomach and duodenum, bleedings from GIT, transient changes of indices of liver function (increase in transminases activity or bilirubin plasma level), inflammation of oral cavity.
Effects from hematosis system: anemia, leukopenia, thrombocytopenia.
Effects from respiratory system: acute attack of asthma.
Effects from cardiovascular system: peripheral edemas, increase in blood pressure, palpitation, flushes.
Effects from CNS: headache and vertigo, tinnitus and somnolence, confusion of thoughts.
Effects from urinary organs: changes of indices of renal function (increase in creatinine level or/and blood urine).
Effects from vision organs: conjunctivitis, disorder of acuity of vision.
Dermatological reactions: itching, skin rash, urticaria, photosensitivity.

DOSAGE AND ADMINISTRATION

For oral administration.
Rheumatoid arthritis: 15 mg/day. The dosage may be reduced up to 7.5 mg/day if therapeutical effect is apparent enough. Osteoarthritis: the recommended dose is 7.5 mg/day. If necessary the dosage may be increased up to 15 mg/day. Rheumatoid spondylitis: 15 mg/day. For patients with increased risk of development of side effects the initial dose is 7.5 mg/day. The maximum daily dose is 15 mg. For patients with severe renal impairment on a hemodialysis the daily dose should not exceed 7.5 mg. For patients with moderate renal impairment with CC>25 ml/min the dosage reduction is not necessary. Administer the prescribed dose once a day with water.

PREGNANCY AND LACTATION

Loxidol is contraindicated in pregnancy and lactation (breast-feeding).

MANUFACTURED FORM

10 film coated tablets in blister. 1 or 2 blisters with a leaflet in a carton box.

Musculo-Skeletal system

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