ArthroCam - instructions for use, doses, side effects, contraindications

Similar drugsTo uncover

Dosage form: & nbspfilm-coated tablets

Composition:

Active substance: ibuprofen 0.2 g or 0.4 g;

Auxiliary substances of the core: lactose, (sugar milk), potato starch "Extra", magnesium stearate, microcrystalline cellulose, povidone medium molecular weight, croscarmelose sodium.

Shell accessories: talcum, hypromellose, povidone, somemolulcular, titanium dioxide, polysorbate.

Description:Round biconvex tablets, coated with a coat, white, core white or almost white.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

Pharmacodynamics:

Ibuprofen is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to the indiscriminate blockade of cyclooxygenases 1 and 2 and has an inhibitory effect on the synthesis of prostaglandins.

The analgesic effect is most pronounced for inflammatory pains. The analgesic activity of the drug does not apply to the narcotic type. Like all NSAIDs, ibuprofen shows antiaggregant. activity.

Pharmacokinetics:

Absorption: well absorbed from the stomach, maximum concentration (C_max) of ibuprofen in plasma is approximately 30 μg / ml and is reached about 2 hours aftertaking the drug at a dose of 0.4 g.

Distribution: ibuprofen approximately 99% is associated with plasma proteins. It is slowly distributed in the synovial fluid and is withdrawn from it more slowly than from the plasma.

Biotransformation: ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. Metabolites are pharmacologically inactive.

Excretion: has a two-phase kinetics of elimination. The half-life period (T1 / 2) from the plasma is 2-3 hours. Up to 90% of the dose can be detected in the urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in urine and to a lesser extent with bile.

Indications:Rheumatoid arthritis, osteoarthritis, psoriatic arthritis, arthritis with gout, ankylosing spondylitis (Bechterew's disease), neuralgia, myalgia, tendovaginitis, bursitis, sciatica, traumatic inflammation of soft tissues, pain after surgery (including surgical operations in dentistry), toothache , inflammatory processes in the small pelvis, algodismenorea, febrile conditions with influenza and colds.

Contraindications:

- Hypersensitivity to any of the substances that make up the drug. Hypersensitivity to acetylsalicylic acid or other NSAIDs in history, incl. anamnestic data on an attack of bronchial obstruction, rhinitis, hives after taking acetylsalicylic acid or other NSAIDs; complete or incomplete syndrome of acetylsalicylic acid intolerance (rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma).

- Erosive and ulcerative diseases of the gastrointestinal tract in the stage of exacerbation (including peptic ulcer of the stomach and duodenum, Crohn's disease, ulcerative colitis).

- Hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.

- The period after aortocoronary bypass surgery,

- Gastrointestinal bleeding and intracranial hemorrhage.

- Severe hepatic impairment or active liver disease.

- Severe renal failure, confirmed hyperkalemia.

- Progressive kidney disease.

- Lactose intolerance (lactase insufficiency).

- Pregnancy, lactation.

- Children under 12 years.

Carefully:

- Elderly age;

- Heart failure;

- Arterial hypertension;

- Cardiac ischemia;

- Cerebrovascular diseases;

- Dyslipidemia;

- Diabetes;

- Diseases of peripheral arteries;

- Smoking;

- Frequent use of alcohol;

- Cirrhosis of the liver with portal hypertension;

- Hepatic and / or renal failure, nephrotic syndrome,

- Hyperbilirubinemia;

- Peptic ulcer of stomach and duodenum (in the anamnesis), gastritis, enteritis, colitis;

- Diseases of unclear etiology (leukopenia and anemia);

- Severe somatic diseases, simultaneous administration of oral GCS (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (incl. acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline).

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

The dosage regimen is set individually, depending on the indications, the minimum effective dose should be used with the minimum possible short course.

ArthroCam is prescribed for adults and children over 12 years old, usually at an initial dose of 0.2 g 3-4 times a day. To achieve a rapid therapeutic effect, the dose can be increased to 0.4 g 3 times a day. When the therapeutic effect is achieved, the daily dose is reduced to 0.6-0.8 g.

For adults, the maximum single dose is 0.8 g, the maximum daily dose is 1.2 g.

If symptoms persist for 2-3 days after taking the drug, stop treatment and consult a doctor.

The drug should not be used for more than 7 days or at higher doses without consulting a doctor.

In patients with impaired renal, hepatic or cardiac function, the dose should be reduced.

Side effects:

-Gal-intestinal tract (GIT)

NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation, rarely - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis.

-Gepatobiliary system

Hepatitis.

-Respiratory system

Shortness of breath, bronchospasm.

-Organ of the senses

Hearing impairment: hearing loss, ringing or tinnitus.

-Objects of sight

Toxic lesion of the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).

-Central and peripheral nervous system

Headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).

-The cardiovascular system

Heart failure, tachycardia, increased blood pressure.

-Urinary system

Acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

-Allergic reactions

Skin rash (usually erythematous or urticaria), itchy skin, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnoea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

-Options of hemopoiesis

Anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.

The risk of ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision, scotoma, optic nerve damage) increases with prolonged use of the drug in large doses.

Laboratory indicators:

- bleeding time (may increase)

-concentration of glucose in serum (may decrease)

-Creativity of the creatinine (May diminish)

-hematocrit or hemoglobin (may decrease)

- serum creatinine concentration (may increase)

-activity of "liver" transaminases (may increase)

If side effects occur, stop taking the medication and consult a doctor.

Overdose:

Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering of blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy.

Interaction:

- It is not recommended simultaneous reception of Ibuprofen with acetylsalicylic acid and other NSAIDs. With simultaneous appointment ibuprofen reduces the anti-inflammatory effect and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after taking ibuprofen).

- In appointments with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urcinase), the risk of bleeding increases at the same time.

- With simultaneous administration with serotonin reuptake inhibitors (cyhalopram, fluoxetine, paroxetine, sertraline) increases the risk of developing gastrointestinal bleeding.

- Ibuprofen can reduce the effectiveness of antihypertensive drugs.

- In the literature, single cases of increased plasma concentrations of digoxin, phenytoin and lithium with simultaneous administration of ibuprofen have been described.

- Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia. Cyclosporin and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandin in the kidneys, which is manifested by increased nephrotoxicity.

Ibuprofen may increase the concentration of cyclosporine in the plasma. Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen! Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, fenidbutazon, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication.

Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic effects. Reduces the hypotensive activity of vasodilators, natriuretic in furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, increases the effect of indirect anticoagulants, antiaggregants, fibrinolytics. Increases the side effects of mineralocorticoids, glucocorticoids, estrogens, ethanol. Antacids and colestramine reduce absorption. Caffeine strengthens the analgesic effect.

Combined treatment with zidovudine and ibuprofen may increase the risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia.

Ibuprofen enhances the effect of oral hypoglycemic agents and insulin derivatives of sulfonylureas; it may be necessary to adjust the dose.

Special instructions:

If there are signs of gastrointestinal bleeding Artokam should be canceled (see section Contraindications).

If there are signs of liver damage (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of the urine, increasing the level of "liver" transaminases), stop taking the drug and consult your doctor.

Ibuprofen may mask objective and subjective signs of infection, so ibuprofen therapy in patients with infection should be administered with caution.

During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood is shown.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction. During the period of treatment, ethanol is not recommended.

The use of ibuprofen May adversely affect female fertility and is not recommended for women planning a pregnancy.

Effect on the ability to drive transp. cf. and fur:Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction.

Form release / dosage:

Tablets, film-coated, 0.2 g and 0.4 g.

Packaging:For 10 tablets in a contour mesh box made of polyvinyl chloride film and aluminum foil, 50 or 100 tablets in a can of polymer or a polymer bottle. For 50 or 100 tablets in a jar of glass with a screw neck type OS, ukuporennuyu cover screwed. For 2, 5 or 10 contour mesh packages, a jar or bottle together with a medical instruction is placed in a cardboard pack.

Storage conditions:Store in a dry place at a temperature not exceeding 30 ° C.Keep out of the reach of children.

Shelf life:

2 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-007064/09

Date of registration:07.09.2009 / 18.05.2012

Expiration Date:Unlimited

The owner of the registration certificate:CAMELIA NPP, LLC CAMELIA NPP, LLC Russia

Manufacturer: & nbsp

CAMELIA NPP, LLC Russia

Representation: & nbspCAMELIA NPP LLC CAMELIA NPP LLC Russia

Information update date: & nbsp14.09.2017

Illustrated instructions

Instructions

ArthroCam (ArtroCam)