BURANA

Active material: Ibuprofen
When ATH: M01AE01
CCF: NSAIDs
When CSF: 05.01.01.06
Manufacturer: ORION CORPORATION ORION PHARMA (Finland)

Pharmaceutical form, composition and packaging

◊ Pills, covered film-coated white or nearly white, round, convex, with the dividing mark on both sides.

Excipients: microcrystalline cellulose, pre-gelatinized starch, dekstratы, Croscarmellose sodium, silicon dioxide, magnesium stearate.

The composition of the shell: gipromelloza, sucrose, Titanium dioxide, polysorbate 80, glycerol 85%, magnesium stearate.

10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.
100 PC. – HDPE bottles (1) – packs cardboard.

◊ Pills, Film-coated white or nearly white, kapsulovidnye, with the dividing mark on both sides.

Excipients: microcrystalline cellulose, pre-gelatinized starch, dekstratы, Croscarmellose sodium, silicon dioxide, magnesium stearate.

The composition of the shell: gipromelloza, sucrose, Titanium dioxide, polysorbate 80, glycerol 85%, magnesium stearate.

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.
100 PC. – HDPE bottles (1) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

NSAIDs, phenylpropionic acid derivative. Anti-inflammatory, analgesic and antipyretic effect.

The mechanism of action is associated with inhibition of COX – primary enzyme metabolism of arachidonic acid, is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. Analgesic effect is due to both peripheral (indirectly, through inhibition of prostaglandin synthesis), and a central mechanism (mediated inhibition of prostaglandin synthesis in the central and peripheral nervous system). Inhibits platelet aggregation.

For external use anti-inflammatory and analgesic effect. Reduces morning stiffness, increases range of motion in the joints.

Pharmacokinetics

When administered ibuprofen almost completely absorbed from the gastrointestinal tract. Simultaneous food intake slows the rate of absorption. It is metabolized in the liver (90%). T_1/2 is 2-3 no.

80% the dose is excreted in the urine mainly as metabolites (70%), 10% – in unchanged form; 20% is output through the intestine as metabolites.

Testimony

Inflammatory and degenerative diseases of joints and spine (incl. rheumatic and rheumatoid arthritis, ankiloziruyushtiy spondylitis, osteoarthritis), articular syndrome in exacerbation of gout, psoriaticheskiy arthritis, ankiloziruyushtiy spondylitis, Tendinitis, ʙursit, radiculitis, traumatic inflammation of soft tissue and musculoskeletal system. Neurology, mialgii, pain in infectious and inflammatory diseases of upper respiratory tract, adnexa, algomenorrhea, headache and toothache. Fever in infectious and inflammatory diseases.

Dosage regimen

Establish individually, depending on the nosology of the disease, clinical manifestations. When administered rectally or adult single dose of 200-800 mg, frequency of administration – 3-4 times / day; for children – 20-40 mg / kg / day in divided doses.

External used for 2-3 weeks.

The maximum dose: Adult ingestion or rectally – 2.4 g.

Side effect

From the digestive system: often – nausea, anorexia, vomiting, epigastric discomfort, diarrhea; may develop erosive and ulcerative lesions of the gastrointestinal tract; rarely – bleeding from the gastrointestinal tract; long-term use are possible liver dysfunction.

From the central and peripheral nervous system: often – headache, dizziness, sleep disorders, excitation, visual impairment.

From the hematopoietic system: long-term use may be anemia, thrombocytopenia, agranulocytosis.

From the urinary system: long-term use are possible renal dysfunction.

Allergic reactions: often – skin rash, angioedema; rarely – aseptic meningitis (more frequently in patients with autoimmune diseases), bronhospastichesky syndrome.

Local reactions: when applied topically can dermahemia, tingling or burning sensation.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, diseases of the optic nerve, “aspirinovaâ triad”, violation of hematopoiesis, expressed by the human kidney and / or liver; Hypersensitivity to ibuprofen.

Pregnancy and lactation

Do not use ibuprofen in the III trimester of pregnancy. Application in I and II trimesters of pregnancy is justified only in cases, the expected benefit to the mother outweighs the potential harm to the fetus.

Ibuprofen in small amounts excreted in breast milk. Use during lactation for pain and fever may. If necessary, long application or application at higher doses (more 800 mg / day) should decide the issue of termination of breastfeeding.

Cautions

To use caution during concomitant liver and kidney diseases, chronic heart failure, when dyspeptic symptoms before treatment, immediately after surgery, When specifying a history of bleeding from the gastrointestinal tract and gastrointestinal diseases, allergic reactions, associated with taking NSAIDs.

During treatment requires systematic monitoring of the liver and kidneys, peripheral blood.

Do not apply topically to the affected areas of the skin.

Drug Interactions

With simultaneous use of ibuprofen reduces the effect of antihypertensive drugs (ACE inhibitors, beta-blockers), diuretics (furosemida, gipotiazida).

While the use of anticoagulants may increase their activities.

While the use of corticosteroids increases the risk of side effects from the gastrointestinal tract.

With simultaneous use of ibuprofen may displace from the compounds to plasma proteins indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), oral hypoglycemic drugs sulfonylureas.

In an application with amlodipine may be a small reduction in the antihypertensive action of amlodipine; acetylsalicylic acid – decreasing the concentration of ibuprofen in the blood plasma; with baclofen – It described the event the toxic effect of baclofen.

In an application with warfarin may increase bleeding time, also observed microhematuria, hematoma; hydrochlorothiazide – perhaps a slight decrease antihypertensive effect of hydrochlorothiazide; captopril – may reduce the antihypertensive effect of captopril; with kolestiraminom – moderately pronounced decrease absorption of ibuprofen.

In an application with lithium carbonate, lithium increases the concentration in the blood plasma.

While the use of magnesium hydroxide increases the initial absorption of ibuprofen; with methotrexate – increases the toxicity of methotrexate.