Universal reference book for medicines
Product name: IBUKLIN ® (IBUCLIN)

Active substance: ibuprofen, paracetamol

Type: Analgesic-antipyretics of combined composition

Manufacturer: DR.
REDDY`S LABORATORIES (India)
Composition, form of production and packaging
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Tablets covered with a film membrane of orange color, capsular, with a risk on one side; for certain tablets marble color is allowed.
1 tab.

ibuprofen 400 mg

paracetamol 325 mg

Auxiliary substances: cellulose microcrystalline - 120 mg, corn starch - 76 mg, glycerol - 3 mg, sodium carboxymethyl starch (type A) - 7 mg, silicon colloidal dioxide - 5 mg, talc - 8 mg, magnesium stearate - 6 mg.

The composition of the membrane: hypromellose 6 cps - 11.32 mg, dye yellow sunset (E110) lacquer aluminum - 1.78 mg, macrogol 6000 - 2.2 mg, talc - 4.06 mg, titanium dioxide 0.16 mg, polysorbate 80 0.16 mg, sorbic acid 0.16 mg mg, dimethicone 0.16 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (20) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Combined drug, the effect of which is due to its constituent components.

Ibuprofen - NSAIDs, has an analgesic, anti-inflammatory, antipyretic effect.
Inhibiting COX-1 and COX-2, disrupts the metabolism of arachidonic acid, reduces the number of prostaglandins (mediators of pain, inflammation and hyperthermic reaction), both in the focus of inflammation and in healthy tissues, suppresses the exudative and proliferative phases of inflammation.
Paracetamol - indiscriminately blocks COX, mainly in the central nervous system, has little effect on water-salt metabolism and gastrointestinal mucosa.
Has analgesic and antipyretic effect. In inflamed tissues, peroxidases neutralize the effect of paracetamol on COX-1 and COX-2, which explains the low anti-inflammatory effect.
The effectiveness of the combination is higher than that of the individual components.
Relieves arthralgia at rest and during movement, reduces morning stiffness and swelling of joints, promotes an increase in the volume of movements.
PHARMACOKINETICS

Ibuprofen

Suction and distribution

Absorption is high, quickly and almost completely absorbed from the digestive tract.
T max after oral administration - about 1-2 hours. Binding to blood plasma proteins - more than 90%. Slowly penetrates into the joint cavity, accumulates in the synovial fluid, creating higher concentrations in it than in the blood plasma.
Metabolism and excretion

After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into an active S-form.
Exposed to metabolism.
T 1/2 - about 2 hours. More than 90% is excreted by the kidneys (unchanged not more than 1%) and, to a lesser extent, with bile in the form of metabolites and their conjugates.

Paracetamol

Suction and distribution

Absorption is high, binding to plasma proteins is less than 10% and slightly increases with an overdose.
Sulfate and glucuronide metabolites do not bind to plasma proteins even at relatively high concentrations. With max 5-20 μg / ml, T max is 0.5-2 h. It is fairly evenly distributed in the liquid media of the body. Penetrates through the BBB. Breast milk penetrates less than 1% of the accepted dose of paracetamol.
Metabolism

About 90-95% of paracetamol is metabolized in the liver with the formation of inactive conjugates with glucuronic acid (60%), taurine (35%) and cysteine ​​(3%), as well as a small amount of hydroxylated and deacetylated metabolites.
A small part of the preparation is hydroxylated by microsomal enzymes with the formation of highly active N-acetyl-n-benzoquinonimine, which binds to the sulfhydryl groups of glutathione. When depletion of glutathione stores in the liver (with an overdose) enzyme systems of hepatocytes can be blocked, leading to the development of their necrosis.
Excretion

Т 1/2 - 2-3 hours. It is excreted by the kidneys, mainly in the form of glucuronide and sulfate conjugates (less than 5% - unchanged).

Pharmacokinetics in special clinical cases

In patients with cirrhosis of the liver, T 1/2 slightly increases.

In elderly patients, the clearance of the drug decreases and T 1/2 increases.

In children, the ability to form conjugates with glucuronic acid is lower than in adults.

INDICATIONS

- symptomatic therapy of infectious and inflammatory diseases (cold, flu) accompanied by fever, chills, headache, pain in muscles and joints, sore throat;

- myalgia;

- neuralgia;

- back pain;

- joint pain, pain syndrome with inflammatory and degenerative diseases of the musculoskeletal system;

- pain with bruises, sprains, dislocations, fractures;

- post-traumatic and postoperative pain syndrome;

- toothache;

- algodismenorea.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

DOSING MODE

The drug is taken orally (before or 2-3 hours after eating) without chewing, squeezed with enough water.

Adults - 1 tab.
3 times / day. The maximum daily dose is 3 tablets.
Children over 12 years of age (body weight over 40 kg) - 1 tab.
2 times / day.
Duration of treatment is no more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic.
Continuation of treatment with the drug is possible only after consulting a doctor.
SIDE EFFECT

On the part of the digestive system: NSAIDs-gastropathy - nausea, vomiting, heartburn, anorexia, discomfort or epigastric pain, diarrhea, flatulence;
rarely - erosive-ulcerative lesions, bleeding; abnormal liver function, hepatitis, pancreatitis; irritation or dryness in the oral cavity, pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis; constipation.
From the nervous system and sensory organs: headache, dizziness, insomnia, anxiety, nervousness, irritability, agitation, drowsiness, depression, confusion, hallucinations;
rarely - aseptic meningitis (more often in patients with autoimmune diseases); hearing loss, tinnitus, visual disturbances, toxic damage to the optic nerve, blurred vision or dying, scotoma, amblyopia.
From the cardiovascular system: heart failure, increased blood pressure, tachycardia.

From the hemopoiesis: anemia (including hemolytic and aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, and leukopenia.

On the part of the respiratory system: dyspnea, bronchospasm.

From the urinary system: allergic nephritis, acute renal failure, nephrotic syndrome, edema, polyuria, cystitis.

Allergic reactions: skin rash, itching, urticaria, Quincke's edema, bronchospasm, dyspnoea, allergic rhinitis, dry and irritated eyes, conjunctival edema and eyelids, eosinophilia, fever, anaphylactic shock, erythema multiforme exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

Laboratory indicators: decrease in serum glucose concentration, decrease in hematocrit and hemoglobin, increase in bleeding time, increase in serum creatinine concentration, increase in activity of hepatic transaminases.

Other: increased sweating.

With prolonged use in high doses: ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (violation of color vision, scotoma, amblyopia).

CONTRAINDICATIONS

- Stomach ulcer and duodenal ulcer in the phase of exacerbation;

- gastrointestinal bleeding;

- severe renal failure (CC less than 30 ml / min);

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in anamnesis);

- defeat of the optic nerve;

- genetic absence of glucose-6-phosphate dehydrogenase;

- diseases of the blood system;

- period after aortocoronary shunting;

- progressive kidney disease,

severe hepatic insufficiency or active liver disease;

- confirmed hyperkalemia;

- active gastrointestinal hemorrhage;

- Inflammatory bowel disease;

- children's age till 12 years;

- III trimester of pregnancy;

- increased individual sensitivity to the components of the drug (including other NSAIDs).

With caution: CHD, chronic heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, CC less than 60 ml / min, history of gastrointestinal lesions, presence of Helicobacter pylori infection, advanced age, prolonged use of NSAIDs, alcoholism, severe somatic diseases, simultaneous administration of oral GCS (including prednisolone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), selective inhibitors of
(including citalopram, fluoxetine, paroxetine, sertraline), viral hepatitis, hepatic and / or renal failure of mild or moderate severity, benign hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome), hepatic cirrhosis with portal hypertension, nephrotic syndrome.
PREGNANCY AND LACTATION

In the first and second trimesters of pregnancy, use is only possible according to the doctor's prescription in cases where the potential benefit exceeds the possible risk to the mother and the potential risk to the fetus.
The use of the drug in the third trimester of pregnancy is contraindicated.
If you need to use the drug during lactation (breastfeeding), you should stop breastfeeding.

In experimental studies , embryotoxic, teratogenic and mutagenic effects of the components of the drug Ibuklin ® have not been established.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe renal failure (QC less than 30 ml / min), progressive kidney disease.

Caution should be applied to the drug with renal failure of mild or moderate degree, nephrotic syndrome.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe hepatic insufficiency or active liver disease.

Caution should be used in cases of viral hepatitis, mild to moderate hepatic insufficiency, benign hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome), liver cirrhosis with portal hypertension.

APPLICATION FOR CHILDREN

Contraindicated in children under 12 years.

APPLICATION IN ELDERLY PATIENTS

With caution should take the drug in the elderly.

SPECIAL INSTRUCTIONS

It is necessary to avoid simultaneous application of the drug with other drugs containing paracetamol and / or NSAIDs.
When using the drug for more than 5-7 days according to the doctor's prescription, the parameters of peripheral blood and the functional state of the liver should be monitored.
At simultaneous application of anticoagulants of indirect action it is necessary to supervise parameters of a coagulating system of blood.

It should be avoided sharing the drug Ibuklin ® with other NSAIDs.

To avoid possible damaging effects on the liver during the intake of the drug should not drink alcohol.

The drug may distort the results of laboratory tests for the quantitative determination of uric acid glucose in blood serum, 17-ketosteroids (48 hours prior to the study should be discontinued).

Impact on the ability to drive vehicles and manage mechanisms

During treatment, the patient should refrain from engaging in potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: gastrointestinal disorders (diarrhea, nausea, vomiting, anorexia, pain in the epigastric region), increased prothrombin time, bleeding after 12-48 h, inhibition, drowsiness, depression, headache, tinnitus, impaired consciousness, cardiac arrhythmias rhythm, lowering blood pressure, manifestations of hepato- and nephrotoxicity, convulsions, possibly the development of hepatonecrosis.

Treatment: When overdosing on an overdose, the patient should immediately seek medical help.
Recommended gastric lavage for the first 4 hours; alkaline drink, forced diuresis; Activated charcoal inside, introduction of SH-group donors and glutathione-methionine synthesis precursors 8-9 hours after an overdose and N-acetylcysteine ​​inside or / in - after 12 hours, antacid preparations; hemodialysis; symptomatic therapy. The need for additional therapeutic measures (further introduction of methionine, intravenous injection of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.
DRUG INTERACTION

With the simultaneous use of the drug Ibuklin ® with drugs, it is possible to develop various interaction effects.

At simultaneous reception with acetylsalicylic acid, ibuprofen reduces its anti-inflammatory and antiaggregant effect (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as antiplatelet agent after the start of admission).

The combination with ethanol, GCS corticotropin increases the risk of erosive and ulcerative lesions of the gastrointestinal tract.

Ibuprofen enhances the action of direct (heparin) and indirect (coumarin and indanedione derivatives) anticoagulants, thrombolytic agents (alteplase, anestreplase, streptokinase, urokinase), antiaggregants, colchicine - increases the risk of hemorrhagic complications.

Strengthens the hypoglycemic effect of insulin and oral hypoglycemic drugs.

Weaken the effects of antihypertensive drugs and diuretics (by inhibiting the synthesis of renal prostaglandins).

Increases the concentration in the blood of digoxin, lithium and methotrexate.

Caffeine increases the analgesic effect of ibuprofen.

Cyclosporine and gold preparations increase nephrotoxicity.

Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.

Antacids and colestyramine reduce the absorption of the drug.

Myelotoxic drugs promote the manifestation of hematotoxicity of the drug.

TERMS OF RELEASE FROM PHARMACY

The drug is dispensed without a prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 5 years. Do not use after the expiration date printed on the package.
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