Naproff (gel)

(Naproxen)

 

COMPOSITION

1 g of gel contains

Active ingredient: naproxen (as naproxen sodium) 100 mg.

 

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS

A non-steroidal anti-inflammatory preparation for topical use. Produces a marked anti-inflammatory and analgesic effect. 

Its mechanism of action is associated with non-selective inhibition of COX-1 and COX-2, disturbance of arachidonic acid metabolism and inhibition of prostaglandin biosynthesis in the area of inflammation. The drug is a potent lipoxygenase inhibitor blocking arachidonic acid synthesis and inhibiting platelet aggregation. Naproff reduces activity of lysosomes and inflammation mediators, inhibits leukocyte migration. Administration of Naproff in inflammation reduces or eliminates pain syndrome and tissues oedema.

PHARMACOKINETICS

Peak blood concentration after topical use of naproxen is reached within 4 hours. Significant accumulation of the drug is observed in epidermis, derma and muscular tissue. Plasma and synovial fluid concentration is low. 99.9% of naproxen binds to plasma proteins, mainly to albumins. Naproxen and its metabolites are predominantly eliminated in urine. 

 

THERAPEUTIC INDICATIONS 

Symptomatic treatment of painful and inflammatory processes of various geneses, including:

-  rheumatoid arthritis and periarthritis;

-  ankylosing spondylitis (Bekhterev’s disease);

-  psoriatic arthritis;

-  osteoarthrosis of various localization;

-  tendinitis, bursitis;

-  myalgia;

-  neuralgia;

-  radiculitis, lumbago, ischias;

-  traumas of locomotor system (including sport traumas), bruises, strains, ruptures of ligaments and tendons.

 

CONTRADICTIONS

-  hypersensitivity to the components of the drug, acetylsalicylic acid or other NSAIDs;

•   skin integrity damage; - the 3^rd trimester of pregnancy;

-  children under 3 years old.

 

ADVERSE EFFECTS

Naproff gel rarely causes side effects. Reddening, itching and burning sometimes develop in the application area. Individual patients may demonstrate photosensibilization. Hypersensitivity reactions (rash, urticaria, bronchial asthma, angioedema) are very rare. Long-term administration to large skin areas may result in reactions typical of systemic effect of naproxen: constipation, abdominal pain, nausea, headache, somnolence, palpitations, tinnitus, etc.

 

DOSAGE AND ADMINISTRATION 

Naproff gel is administered externally.

In adults and children over 3 years old Naproff gel is administered 2 to 4 times daily. Apply to the skin a strip of gel of up to 4 cm and rub in gently. The amount of the drug depends on the size of painful area.

Wash the hands after application of the drug.

Treatment duration depends on indications and effectiveness of therapy. Do not use the drug for more than 7 successive days in soft tissue injuries and rheumatic diseases, and for more than 4 weeks in rheumatoid arthritis or osteoarthritis deformans (unless the doctor prescribes another treatment regime). In case of absence of positive clinical dynamics within 7 days or deterioration of condition consult the doctor. PACKAGING

Gel 45 g in an aluminum tube. 

1 aluminum tube together with an enclosed leaflet in a carton box.