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Musculo-Sceletal System

Naproff (Tablets)
(Naproxen)



CONTENT:
Film coated tablets. Tablet contains naproxen sodium 275 mg/550 mg.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Naproff is a nonsteroidal anti-inflammatory drug. Naproxen sodium, active ingredient of drug, is the derivative of propionic acid. It has pronounced anti-inflammatory, analgesic and antipyretic action. The action mechanism of naproxen is the inhibition of migration of leukocytes, decrease of lysosome activity and inflammatory mediators. The drug is a strong inhibitor of lipoxygenase, blocks the synthesis arachidonic acid. Besides, it inhibits COX-1 and COX-2 activity, what results in the inhibition of synthesis of prostaglandins. It inhibits thrombocytes agregation. Naproxen sodium is not a narcotic analgesic and doesnt influence the CNS. PHARMACOKINETICS. After oral administration naproxen sodium is quickly and practically completely absorbed from gastrointestinal tract. The bioavailability is 95%. Naproxen half life period is 12-17 hours. The meal intake doesnt influence naproxen concentration in blood. Maximal concentration of Naproxen sodium in blood is achieved in 1-2 hours. During administration in therapeutic concentrations 99% of active substance is bound to plasma proteins. Naproxen is metabolized in liver to the 6-?-desmethylnaproxen. Approximately 95% of naproxen is eliminated with urine as unchanged naproxen, 6-?- desmethylnaproxen and their conjugates.
 
THERAPEUTIC INDICATIONS:
- inflammatory and degenerative diseases of joints: rheumatoid, arthritis, rheumatoid spondylitis (Marie-Striinipell disease), osteoarthrosis;
- pain syndrome: myalgia, ossalgia, neuralgia, arthralgia, radiculitis, headache and toothache, tendinitis, during oncological diseases, posttraumatic and postoperative pain syndrome, accompanied by pain syndrome, algodismenorrhea, adnexitis;
- as intermediate agent during infectious-inflammatory diseases of ear, throat, nose with pronounced pain syndrome: pharyngitis, tonsillitis, otitis.
Fever during "catarrhal" and infectious diseases;
- prophylaxis of migraine attacks.
 
CONTRAINDICATIONS:
- hypersensitivity to naproxen;
- bronchial asthma, urticaria, other allergic reactions, associated with administration of acetylsalicylic acid and other NSAIDs;
- severe renal insufficiency (creatinine clearance <30 ml/min);
- pronounced hepatic insufficiency or inactive hepatic disease;
- erosive gastritis and duodenal cancer in active stage.
 
SIDE EFFECTS:
From digestive system: nausea, vomiting, epigastric burning, coprostasis, diarrhea, erosions and cancer of stomach, gastrointestinal hemorrhages.
From nervous system: headache, drowsiness, tinnitus, dizziness, weakness, and decrease in alertness.
From cardiovascular system: heartbeats.
From blood system: leukopenia, thrombocytopenia, anaemia, granulocytopenia.
Allergic reactions: skin rash, urticaria.
 
DOSAGE AND ADMINISTRATION:
Naproff is administered orally, without chewing, washing down with sufficient amount of water.
The treatment should not be discontinued and the dosage shouldnt be changed without preliminary consultation with doctor.
During inflammatory and degenerative diseases of joints the drug is prescribed in dose of 550-1100 mg 2 times a day with interval of 12 hours. Daily dose for supporting treatment is 550 mg.
During pain syndrome the drug is prescribed in dose of 550 mg at the beginning, then in dose of 275 mg every 6-8 hours. Daily dose must not exceed 1375 mg. If necessary, daily dose can be increased up to 1650 mg to patients for some period of time, in case of absence of diseases of gastrointestinal tract.
During gout episodes the initial dose is 825 mg, then continues by 275 mg every 8 hours till the end of attack.
For preventing migraine episodes the drug is prescribed in dose of 550 mg 2 times a day. However, the treatment must be discontinued, if the frequency, intensiveness and duration of migraine episodes are not decreased during 4-6 weeks. At first signs of migraine episodes the dose of 825 mg should be administered, and if necessary - more 275-550 mg should be taken in 30 minutes.
 
PACKAGING:
10 tablets are in blister.
1 or 2 blisters are in carton box together with leaflet.
 
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