COMPOSITION: Each sachet contains: Nimesulide 100 mg with Beta-cyclodextrin.

PROPERTIES: NILSID is a non steroidal anti-inflammatory drug (NSAID) that exerts antipyretic and analgesic effects. It is generally well tolerated.

Beta-cyclodextrin: Cyclodextrins are cyclic oligosaccharides (sugars) that have a hydrophilic outer surface and a hydrophobic inner surface, with the center capable of having a steroid molecule stuck inside it. The hydrophilic outer surface makes the Cyclodextrin soluble in water, and when it is combined with a steroid, it can make the poorly water-soluble steroid soluble as well. In addition to making steroids soluble, Cyclodextrins have other important properties that make them ideal for use. Cyclodextrins are known to enhance steroid delivery through biological membranes. The large CDs themselves are very bad at permeating biological membranes, but they deliver the steroid to the membrane. where it partitions into the membrane, leaving the CD on the outside of the membrane. Another advantage is. once administered. the steroid is rapidly absorbed.

MODE OF ACTION

Nimesulide, the active ingredient in NILSID, has a preferential inhibitory effect on Cyclooxygenase enzyme (COX) involved in the biosynthesis of prostaglandins thus it has a preferential action on COX-2 rather than COX-1. This selectively results in effective relief of inflammation, pain and fever with the least unwanted gastrointestinal, renal and other side effects which commonly occur following the inhibition of COX-1 by the non-selective NSAIDs.

NILSID also affects other inflammatory mediators and exerts other properties such as:

• Inhibition of histamine release, inflammatory cytokines release.
• Inhibition of free radicals generation (super-oxide anions).
• Prevention of cartilage matrix damage through inhibition of metalloprotease synthesis.
• Inhibition of protein kinase C through inhibition of  phosphodiestrase.

INDCATIONS

All types of pain, fever and inflammation when rapid action is needed.

Painful inflammatory conditions, e.g. bursitis, tendinitis and thrombophlebitis.

Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and acute gout .

Painful musculoskeletal conditions, e.g. low back pain.

Post-traumatic pain and sports injury.

Post-operative pain.

Toothache and after orodental procedures.

Primary dysrnenorrhea and other gynecological disorders.

Conditions associated with fever.

DOSAGE

The content of one sachet is added to half glass of water and taken once or twice daily. or as directed by the physician.

SIDE EFFECTS

Nimesulide is a NSAID, however, the incidence of side effects is lower than with other non-selective NSAIDs. Mild gastrointestinal disturbance and skin rashes may rarely occur.

CONTRAINDICATIONS

Nimesulide is contraindicated in cases of hypersensitivity to nimesulide, active peptic ulcer, or in sever hepatic or renal impairment.

DRUG INTERACTIONS

• Concomitant use of NSAIDs with oral anticoagulants, ticlopidine and heparin Increases the risk of hemorrhage, thus prothrombin and bleeding times should be monitored.
• Lithium and methotrexate elimination is reduced.
• The risk of acute renal insufficiency is increased with diuretics in dehydrated patients.
• The effect of antihypertensive drugs as ACEIs and beta-blockers may be reduced.

PRECAUTIONS

It should not be given for infants below 24 months unless prescribed.

As with other NSAIDs. NILSID is to be administered with caution in cases of:

• patients with coagulation defects or on anticoagulation therapy.
• Patients with mild to moderate hepatic or renal insufficiency.
• Patients with history of peptic ulcer, ulcerative colitis or Crhon’s disease.

USE IN PREGNANCY AND LACTATION

No enough available data on the safety of nimesulide for use during pregnancy or lactation.

PRODUCED BY PHARAONIA PHARMACEUTICALS: New Borg El-Arab City Alexandria, A. R. E.( PHARO PHARMA).

Storage

• Store at controlled temperature not exceeding 30 C .
• Keep in a dry place .
• keep all medications out of reach of children.

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