Neosili (Nimesulide) 0,1g/dose 7g Powder - №10 sachets
Non-steroidal
anti-inflammatory agent
Generic name: NIMESULIDE.
ATС Code: M01AX17.
Drug
form: Powder for solution in
sachet - 7g.
Pharmacological group: Non-steroidal
anti-inflammatory agent from sulfonanilides group.
Composition of one sachet:
Active substance: 0,1 g nimesulide.
Aiding substances: sugar, sodium saccharin, citric acid, sodium citrate,
orange emulsion, sodium lauryl sulphate, PEG 400.
Pharmacological operation: Nimesulide is an anti-inflammatory non-steroidal
mean from the Sulfonanilide group. It is characterized with anti-inflammatory,
pain relieving and antipyretic action.
Mechanism of the action is caused by selective competitive inhibition of the
enzyme cyclooxygenase – 2, which suppresses synthesis of prostaglandins – that are mediators of
intumescence, inflammation and pain.
Furthermore, the preparation suppresses synthesis of cartilaginous
tissue’s disbanding enzyme (Colagenesis, Stromelizin, Elastaza), which delays
cartilaginous tissue’s damage and subserves regulation of this system.
Pharmacokinetics: After internal taking, Nimesulide is well absorbed from intestine tract.
Ingest of food reduces absorption speed, though does not influence on absorbing
quality. Nimesulide’s maximal concentration in blood plasma is achieved after
1,5 -2,5 hours from taking, but effect continues approximately 6 hours. 99% of
Nimesulide relates to plasma proteins, actively metabolizes in liver, 80 % of
metabolite is exiled by urine, but 20% - by
fecal mass.
Indication:
· Different etiological pains (headache,
toothache, pain in the postoperative and posttraumatic period and etc);
· At time of joint and muscles diseases
(different genesis osteoarthritis, among them rheumatic gout, osteoarthrosis,
ankylosing spondylitis, bursitis, tendenitis);
· At time of infectious - inflammatory diseases
in otolaryngology;
· Dysmenorrhea (painful menstruation).
· Diseases that occur with fever (in the combined
therapy);
· Inflammatory diseases of the peripheral nervous
system: neuralgia, neuritis, plexitis and etc.
Contra-indication:
· High sensitivity towards the Nimesulide and
other components of the preparation;
· High sensitivity towards acetylsalicylic acid
or other anti-inflammatory nonsteroidal
means;
· Stomach and duodenum ulcerous diseases in an acute
phase;
· Normal or expressed disorders of the liver or
kidney function;
·
Pregnancy and lactation period;
· For children – till 12 age;
· Heart insufficiency.
Administration and dosage rule: The powder should be diluted in a glass of
water.
Dosage rule for adults: 1 sachet (0.1g) twice a day after meal. For children from 12 to 18 year and for
elderly patient dosage correction is not necessary.
In aged people choose and reduce of doses is determined by the doctor
according to the patient’s condition.
For children up to 12 year the preparation is contra-indicated.
Usage of the preparation is recommended for the shortest period, to
avoid appearance of side-effects.
It is not recommended to use the preparation more then 15 days.
Side effects: Neosili is characterized with good endurance,
although there may be developed:
From the side of gastrointestinal tract:
discomfort of epigastrium, nausea and diarrhea;
From the side of central nervous system:
headache, insomnia, nausia.
Alergic reactions: rash on the skin, erythema, hives,
itch;
Rarely there may be developed oliguria with liquid retain and local or
diffuse intumescence of the tissue.
Like other anti-inflammatory nonsteroidal means
Neosili may cause Steven Johnson’s, Layel’s
syndrome, also anaphylactic reactions.
In case of side-effects occurance
shoul get consultation from doctor and stop taking the preparation.
Cautions: Neosili if carefully prescribed for those
patients who have blood coagulation system disorder and intestine system
diseases, also patients who take anticoagulants or antiaggregant.
Patients who have kidney’s functional disorder have to reduce dosage of
Nimesulide with consideration of hanking filtration indicator.
The preparation may keep liquid in the tissues, so Nimesulide should be
given carefully to the patients with heart insufficiency.
The preparation is carefully prescribed to the elderly patients,
especially when age weakness is expressed.
Preparation contains saccharose, which is considerable for the patients
with diabetes.
Overdosage: In case of overdosage following symptoms may be
occurred: nausea, vomiting, insomnia. Treatment is symptomatic, stomach ablution and taking of activated carbon is recommended.
Pregnancy and lactation period: Usage of the preparation is not
recommended.
Influence on ability of management of motor
transport and mechanisms: Caution should be taken because the preparation may cause sleepness
and dizziness.
Interactions with
other drugs: Caution
should be exercised with concomitant administration of Neosili and anticoagulants, diuretics,
antihypertensive drugs, hypoglycemic drugs, digoxin, phenytoin, lithium, other
non-steroidal anti-inflammatory drugs, cyclosporine, methotrexate, as there may
be the case they interact.
Package: 7g powder in a sachet. 10 sachets
are placed in a cardboard box.
Issue: Pharmaceutical product group II, issued with a prescription №3.
Sheif-life:
2 years.
Storage conditions: Store at 15-25ºC temperature in a dark, dry
place and keep away from children.
In case of visual defects and expiry
of validity date, the preparation can not be used.