Nurofen (Pills)

Active material: Ibuprofen
When ATH: M01AE01
CCF: NSAIDs
ICD-10 codes (testimony): G43, J06.9, J10, K08.8, M25.5, M54, M79.1, M79.2, N94.4, N94.5, R50, R51, R52.0, R52.2
When CSF: 05.01.01.06
Manufacturer: RECKITT BENCKISER HEALTHCARE INTERNATIONAL Ltd. (Great Britain)

Pharmaceutical form, composition and packaging

◊ Pills, coated white or nearly white, round, lenticular, labeled black “Nurofen” on one side.

Excipients: sodium croscarmellose, sodium lauryl, sodium citrate, stearic acid, colloidal silicon dioxide, carmellose sodium, talc, acacia gum, sucrose, Titanium dioxide, macrogol 6000, opakod (shellac, iron oxide black, n-butyl alcohol, soy lecithin, denatured alcohol, antipennyj DC component 1510).

6 PC. – blisters (1) – packs cardboard.
6 PC. – blisters (2) – packs cardboard.
12 PC. – blisters (1) – packs cardboard.
12 PC. – blisters (1) – plastic containers.
12 PC. – blisters (2) – packs cardboard.
12 PC. – blisters (3) – packs cardboard.
12 PC. – blisters (8) – packs cardboard.

◊ Effervescent tablets white, round, flat, with a rough surface; the resulting solution is transparent, colorless, opalescent.

Excipients: potassium carbonate, Citric acid anhydrous, sorbitol, sodium saccharin, sucrose monopal′mitat.

10 PC. – polypropylene tubes (1) – packs cardboard.

Pharmacological action

NSAIDs. It is a derivative of phenylpropionic acid. It has analgesic, antipyretic and anti-inflammatory action. The effect of the drug is due to inhibition of prostaglandin synthesis by blocking cyclooxygenase enzyme.

Pharmacokinetics

Absorption and distribution

After intake of ibuprofen rapidly absorbed from the digestive tract. Plasma protein binding is 90%. Slowly into the joint cavity, is delayed in the synovial tissue, creating great concentration, than in plasma.

Metabolism

Biotransformed in the liver. After absorption of about 60% pharmacologically inactive form of R-form slowly transformed into an active S-shape.

Deduction

Ibuprofen is displayed with urine in an unmodified form (no more 1%) and in the form of kongugatov, a small portion of the return to jelchew. T_1/2 is about 2 no.

Testimony

• headache;
• migraine;
• toothache;
• neuralgia;
• myalgia;
• back pain;
• rheumatic pain;
• algomenorrhea;
• fever with flu and colds.

Dosage regimen

To adults and children over 12 years the initial dose is 200 mg 3-4 times / day. To achieve rapid clinical effect may increase the initial dose to 400 mg 3 times / day. The maximum daily dose – 1200 mg.

Children aged 6 to 12 years – by 200 mg not more 4 time / day. It should be taken into account, that the drug can be prescribed only children weighing more than 20 kg. The interval between meals should not be less than pills 6 no.

Should not take more 6 tab. / day. The maximum dose – 1.2 g.

Pills, coated, You should drink water. Fizzy tablets should be dissolved in 200 ml of water (1 glass).

Side effect

When applying Nurofena^® during 2-3 days there are virtually no side effects. In the case of prolonged use may cause the following side effects.

From the digestive system: nausea, vomiting, heartburn, anorexia, epigastric discomfort, diarrhea, flatulence, erosive and ulcerative lesions of the gastrointestinal tract (in some cases, complicated by perforation and bleeding), stomach ache, irritation, dryness and pain in the oral mucosa, izayazvlenie right, thrush, pancreatitis, constipation, hepatitis.

CNS: possible headache, dizziness, insomnia, excitation, drowsiness, depression, confusion, hallucinations; rarely – aseptic meningitis (more frequently in patients with autoimmune diseases).

From the senses: reversible toxic optic neuritis, blurred vision, diplopia, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis, scotoma); hearing loss, ringing or noise in the ears.

Cardio-vascular system: heart failure, increased blood pressure, tachycardia.

From the urinary system: nephrotic syndrome, acute renal failure, jade, polyuria, cystitis.

From the hematopoietic system: anemia (incl. hemolytic, aplastic), thrombocytopenia, trombotsitopenicheskaya purpura, agranulocytosis, leukopenia.

Allergic reactions: skin rash, itch, hives, angioedema, anaphylactoid reactions, anaphylactic shock, fever, erythema multiforme exudative (incl. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eozinofilija, nasal allergy.

The respiratory system: bronchospasm, breathlessness.

Other: increased sweating.

Prolonged use of high doses: ulceration of the gastrointestinal mucosa, bleeding (incl. from the gastrointestinal tract, right, Royal, hemorrhoidal), visual impairment (impaired color vision, scotoma, amblyopia).

Contraindications

• erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, incl. gastric ulcer and duodenal ulcer, yazvennыy colitis, pepticheskaya ulcer, Crohn's disease;
• severe heart failure;
• severe course of hypertension;
• “Aspirin” bronchial asthma, hives, rhinitis, provoked by taking acetylsalicylic acid (salicylates) or other NSAIDs;
• diseases of the optic nerve, impaired color vision, amblyopia, scotoma;
• deficiency of glucose-6-fosfatdegidrogenazы;
• hemophilia, state hypocoagulation;
• leukopenia;
• hemorrhagic diathesis;
• expressed human liver and / or kidney;
• hearing loss, pathology of the vestibular apparatus;
• III trimester of pregnancy;
• lactation (breast-feeding);
• Children up to age 6 years;
• hypersensitivity to ibuprofen or to the drug.

FROM caution appoint guidance in history on ulcer disease of the stomach and duodenum, gastritis, enteritis, kolity, bleeding from the gastrointestinal tract, When concomitant diseases of the liver and/or kidney (incl. liver cirrhosis with portal hypertension, nephrotic syndrome), chronic heart failure, hypertension, blood diseases of unknown etiology, asthma, autoimmune diseases (incl. systemic lupus erythematosus), giperʙiliruʙinemii, pregnancy (I and II trimesters), in the period of lactation, children under the age of 12 years.

Pregnancy and lactation

Nurofen^® is contraindicated for use in the third trimester of pregnancy.

Use of the drug in the first and second trimesters of pregnancy is possible only in case, when the intended benefits to the mother outweighs the potential risk to the fetus or infant.

If necessary, the appointment during lactation should decide the issue of termination of breastfeeding.

Cautions

When side effects, discontinue use of the drug and consult your doctor.

If you are receiving medication for 2-3 days symptoms persist, drug should be lifted and clarify diagnosis.

If you want to determine the 17-ketosteroids drug should be discontinued for 48 h before the test.

During the period of treatment is not recommended to use ethanol.

When receiving effervescent tablets patients, located on the gipokalievoj diet, We should take into account, what 1 tablet contains 1530 mg of potassium carbonate; diabetics should take into account, what 1 tablet contains 40 sodium saharinata mg; patients with fructose intolerance should take into account, what 1 Tablet contains about 376 mg sorbitol.

Monitoring of laboratory parameters

During prolonged use of the drug needed to be monitored picture peripheral blood and functional status of the liver and kidney. When symptoms of gastropathy shows careful monitoring, comprising carrying out esophagogastroduodenoscopy, General blood analysis (hemoglobin determination), occult blood feces analysis.

Effects on ability to drive vehicles and management mechanisms

Patients should refrain from all activities, requiring attention, psychomotor speed reactions.

Overdose

Symptoms: stomach ache, nausea, vomiting, lethargy, drowsiness, depression, headache, noise in ears, metabolic acidosis, coma, acute renal failure, decrease in blood pressure, bradycardia, tachycardia, Atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only during 1 h after administration), administration of activated charcoal, alkaline water, diurez, simptomaticheskaya therapy.

Drug Interactions

Not recommended simultaneous reception of Nurofen^® with acetylsalicylic acid and other NSAIDS.

When concomitant administration of ibuprofen reduces inflammatory and antiplatelet effect of aspirin (may increase the incidence of acute coronary insufficiency after you start taking ibuprofen in patients, receiving antiplatelet agents as low-dose acetylsalicylic acid).

Together with the use of antikoagulântnami and trombolitičeskimi drugs (incl. alteplase, streptokinase, urokinase) increased risk of bleeding.

When combined with ibuprofen tsefamandol, cefoperazone, cefotetan, valproic acid, plicamycin increase the frequency of gipoprotrombinemii.

When the joint application of Cyclosporine and preparations of ibuprofen reinforce gold on the synthesis of prostaglandins in the kidneys, that leads to increased nephrotoxic effect.

Ibuprofen increases the plasma concentration of cyclosporin and the probability of its hepatotoxic effects.

Drugs, block tubular secretion, while the application of reduced excretion and increase plasma concentrations of ibuprofen.

In a joint application inducers of microsomal oxidation (incl. phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic reactions.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action of ibuprofen.

In a joint application ibuprofen reduces the hypotensive activity of vasodilators, natriuretic effect of furosemide and hydrochlorothiazide.

Ibuprofen reduces the effectiveness of drugs urikozuricheskih, It increases the effect of indirect anticoagulants, antiplatelet agents and fibrinolytic.

Strengthens side effects of mineralocorticoid, GCS, estrogen, ethanol.

In a joint application raises gipoglikemiceski effect oral protivodiabeticakih funds (sulfonylureas) and insulin.

At the same time taking antacids and cholestyramine reduce the absorption of ibuprofen.

In a joint application ibuprofen increases blood concentration of digoxin, lithium preparations, methotrexate.

Caffeine increases the analgesic effect of ibuprofen.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored in a dry, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year.