Nimiko

Active material: Nimesulide
When ATH: M01AX17
CCF: NSAIDs. Of selective COX-2 inhibitor
When CSF: 05.01.01.08.01
Manufacturer: IPCA LABORATORIES Ltd. (India)

Pharmaceutical form, composition and packaging

Excipients: starch, microcrystalline cellulose, colloidal silicon dioxide (aэrosyl-200), pregelatinized starch, citric acid monohydrate, Talcum cleared, sodium starch glycolate, Aspartame, magnesium stearate, fruity flavor DC130, Purified water.

10 PC. – блистеры (2) – пачки картонные.

Excipients: starch, microcrystalline cellulose, colloidal silicon dioxide (aэrosyl-200), pregelatinized starch, citric acid monohydrate, Talcum cleared, sodium starch glycolate, Aspartame, magnesium stearate, Banana flavor dry DC104, Purified water.

10 PC. – блистеры (2) – пачки картонные.

Pharmacological action

Non-steroidal anti-inflammatory drug. Niemiec is a non-steroidal anti-inflammatory agent (NSAIDs) from the class sulfonanilides. Anti-inflammatory, analgesic and antipyretic effect.

Nimisulid belongs to a new generation of NSAIDs, mechanism of action is associated with selective inhibition of cyclooxygenase II and the impact of a number of other factors: platelet activating factor inhibition, tumor necrosis factor alpha, suppression of histamine and proteases.

Pharmacokinetics

If ingestion is well absorbed from the gastrointestinal tract. The maximum concentration of active substance in plasma is achieved by 1,5 – 2,5 hours after ingestion. Use of the drug simultaneously with food reduces the rate of absorption, but without affecting the level of its. Plasma protein binding is 99%, volume of distribution - 0,19-0,35 l / kg. Nimesulide is extensively metabolised in the liver with the formation of several metabolites, emissions mainly in the urine (70%) and feces (30%).

In patients with renal insufficiency (creatinine clearance 30-80 ml / min), as well as children and the elderly pharmacokinetic profile of nimesulide has not changed significantly.

Testimony

• symptoms of fever, associated with upper respiratory tract infections ( viral or bacterial origin)
• to relieve pain of various origins in the postoperative period,
• in injuries of the musculoskeletal system,
• when soft tissue injuries.

Dosage regimen

Adults:

Typically prescribed oral dose 100 mg (2 for tablets 50 mg) 2 times after eating.

Children:

Inside, dose 1,5 mg / kg body weight 2-3 once a day.

The maximum dose for children should not exceed 5 mg / kg / day, razdelennaya of 2 or 3 admission.

Tablets to be dissolved before use in 5 ml (1 tea spoon) water.

Side effect

Usually the drug Niemiec does not cause side effects.

In rare cases there may be ulceration of the gastrointestinal mucosa, fluid retention, nausea, vomiting, stomach ache, diarrhea, dizziness, drowsiness, itch, allergic reactions (skin rash, anaphylactic shock); thrombocytopenia, leukopenia, anemia, agranulocytosis; increased activity of "liver transaminases"; prolonged bleeding; hematuria.

If you notice any side effects, stop taking the drug and consult a doctor

Contraindications

• Hypersensitivity to the components of the drug nimesulide and,
• aspirin or other NSAIDs,
• «Aspirinovaya» asthma,
• gastric ulcer and duodenal ulcer in the acute phase,
• bleeding from the gastrointestinal tract,
• expressed human liver and kidneys;
• Pregnancy and breast-feeding,
• Children under 12 years.

Pregnancy and lactation

The drug is contraindicated.

Cautions

Because, that the use of the drug may cause such side effects, as dizziness and somnolence, Caution should be exercised when administered to patients, engaged in potentially hazardous activities, require high concentration and rapid mental and motor responses.

Overdose

Cases of overdose have not been described. There is no specific antidote

Drug Interactions

Caution must be exercised with concomitant use of nimesulide:

• digoksinom, phenytoin, and lithium preparations; nimesulide at therapeutic doses in a short time does not alter the profile of serum digoxin in patients with mild heart failure,increases in plasma levels of lithium.
• diuretics and antihypertensives; Nimesulide may reduce the bioavailability of furosemide and replace furosemide plasma proteins, not recommended intake of nimesulide with diuretics, have a damaging effect on renal hemodynamics.
• other NSAIDs;
• anticoagulants- enhances the effect of anticoagulants;
• cyclosporine;
• metotreksatom; may reduce the effect metotreksanta.
• oral antidiabetic agents.

Nimesulide increases drug concentration, competing for protein binding.(fenofibrate, salicylic acid, tolbutamid).

Conditions and terms

Store in a dry, dark place at a temperature below 250C.

Keep out of the reach of children.

Shelf life 2 year

Do not use medication after the expiration date, on the package.