Next Uno Express - instructions for use, dose, side effects, contraindications

Composition of gelatin capsule shell: gelatin, sorbitol noncrystallizing solution, glycerol, methyl parahydroxybenzoate, purified water, red enchanting dye E-129.

Description:

Capsules soft gelatinous oval, with a seam, transparent, red. The contents of the capsules are a clear or colorless or pink shade.

Pharmacotherapeutic group:NSAIDs

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

The mechanism of action of ibuprofen, a derivative of propionic acid from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia. Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), due to even inhibits the synthesis of prostaglandins. Has a quick directional action against pain (analgesic), antipyretic and anti-inflammatory action. Ibuprofen back inhibits the aggregation of platelets.

Pharmacokinetics:

Ibuprofen is absorbed from the digestive tract by approximately 80%. Absorption slightly decreases when taking the drug after a meal. The time to reach the maximum concentration (TC_m_Oh) when taking on an empty stomach - 45 minutes, when taken after meals - 1,5-2 hours, in synovial fluid - 2-3 hours.

Ibuprofen 90% binds to blood proteins, mainly with albumins. Exposed to the systemic and post-systemic metabolism in the liver. After absorption about 60% of pharmacologically inactive Rform of ibuprofen is slowly transformed into an active S-form. In the metabolism of the drug takes part isoenzyme CYP2C9. It has a two-phase kinetics of elimination with a half-life (T_1/2) 2-2.5 hours. It is excreted by the kidneys (in unchanged form not more than 1%) and to a lesser extent - with bile.

Indications:

Applied with headache, migraine, toothache, painful menstruation, neuralgia, back pain, muscle and rheumatic pains; at feverish conditions at a flu and catarrhal diseases.

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

Contraindications:

- Hypersensitivity to ibuprofen and other components of the drug;

- erosive and ulcerative diseases of the gastrointestinal tract (including gastric ulcer and duodenal ulcer in the acute stage, ulcerative colitis, peptic ulcer, Crohn's disease);

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

- disorders of blood clotting (including hemophilia, lengthening bleeding time, propensity to bleed, hemorrhagic diathesis);

- children's age till 12 years;

- pregnancy III trimester, the period of breastfeeding;

- active gastrointestinal bleeding;

- intracranial hemorrhage;

- bleeding or perforation of a gastrointestinal ulcer in an anamnesis, provoked by the use of NSAIDs;

- severe heart failure;

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

- progressive kidney disease;

- severe hepatic impairment or active liver disease;

- condition after aortocoronary bypass surgery;

- confirmed hyperkalemia;

- intolerance to fructose.

Carefully:

Carefully the drug is used for cirrhosis of the liver with portal hypertension, hyperbilirubinemia, peptic ulcer and duodenal ulcer (in the anamnesis), gastritis, enteritis, colitis; hepatic porphyria, hepatic and / or renal insufficiency,nephrotic syndrome; chronic heart failure, arterial hypertension; disorders of blood clotting, blood diseases of unclear etiology (leukopenia and anemia), old age, pregnancy (I-II trimester), ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (CK 30-60 ml / min), infection Helicobacter pylory, prolonged use of NSAIDs, frequent use of alcohol, severe somatic diseases, systemic lupus erythematosus or other autoimmune diseases of connective tissue (increased risk of aseptic meningitis), simultaneous intake of oral GCS (including prednisolone), anticoagulants (in g.ch. warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxegin, sertraline).

Pregnancy and lactation:

In animal studies, there was no adverse effect of ibuprofen on the fetus. In the absence of a sufficient number of well-controlled observations in humans, the drug should be used in the first and second trimesters of pregnancy only in cases of acute necessity,if the potential benefit to the mother exceeds the potential risk to the fetus and the baby.

Ibuprofen inhibits contraction of the uterine muscles. The action of ibuprofen on the fetus may cause premature closure of the botulinum duct, which can lead to the development of pulmonary hypertension in the newborn. Do not use ibuprofen at the end (third trimester) of pregnancy.

Ibuprofen was not detected with maternal milk. However, in view of the limited amount of these studies and the possible adverse effect of inhibition of prostaglandin synthesis in a newborn, it is not recommended to use the drug during breastfeeding.

Dosing and Administration:

Nekst® Uno Express is prescribed for adults and children over 12 years inside after meals, 200 mg (1 capsule) 3-4 times a day. Capsules should be washed down with a glass of water.

To achieve a rapid therapeutic effect, the dose can be increased to 400 mg (2 capsules) 3 times a day. When the therapeutic effect is achieved, the daily dose of the drug is reduced to 600-800 mg.

The maximum daily dose for adults is 1200 mg (do not take more than 6 capsules in 24 hours).

The maximum daily dose for children 12-18 years is 800 mg.

Repeated dose should be taken no earlier than 4 hours later.

If, during the application of the drug for 5 days, the pain syndrome or within 3 days of increased body temperature persists or worsens, you should stop taking the medicine and consult with your doctor.

Side effects:

When using the drug "Next" Uno Express for 2-3 days, side effects are almost not observed.

In the case of prolonged use, the following side effects may occur:

- from the gastrointestinal tract (GIT): NSAIDs-gastropathy (abdominal pain, heartburn, diarrhea, flatulence, pain and discomfort in the epigastric region), ulceration of the mucous membrane of the gastrointestinal tract (in some cases complicated by perforation and bleeding); irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, constipation, indigestion, nausea, loss of appetite, vomiting, hepatitis;

- from the respiratory system: shortness of breath, bronchospasm, exacerbation of bronchial asthma;

- Hearing impairment: hearing loss, ringing or tinnitus;

- from the central and peripheral nervous system: insomnia, anxiety, nervousness and irritability, psychomotor agitation, depression, confusion, hallucinations, rarely aseptic meningitis (more often in patients with autoimmune diseases), headache, dizziness, drowsiness;

- from the cardiovascular system: development or aggravation of heart failure, tachycardia, increased blood pressure;

- from the urinary system: acute renal insufficiency, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis;

- from the hematopoiesis: hemolytic anemia, aplastic anemia, thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia, pancytopenia;

- from the side of the organs of vision: reversible toxic amblyopia, blurred vision or dilation, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis). scotoma. violation of color vision;

- allergic reactions: skin rash (usually erythematous, urticaria), itchy skin, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever,multi-form exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis;

- other: increased sweating.

The risk of ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision, scotoma, amblyopia) increases with prolonged use in large doses.

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

Laboratory indicators:

- bleeding time (may increase);

- serum glucose concentration (may decrease);

- clearance of creatinine (may decrease);

- hematocrit or hemoglobin (may decrease);

- serum creatinine concentration (may increase);

- activity of "liver" transaminases (may increase).

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:

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of ibuprofen, increasing the risk of developing severe hepatotoxic reactions.

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

Ibuprofen reduces the antihypertensive effect of antihypertensive drugs (ACE inhibitors, blockers of "slow" calcium channels, etc.), natriuretic and diuretic efficacy of furosemide and hydrochlorothiazide; reduces the effectiveness of uricosuric drugs, enhances the ulcerogenic effect of glucocorticosteroids, colchicine, ethanol; enhances the effect of oral hypoglycemic agents and insulin; increases the concentration in the blood of digoxin, lithium and methotrexate.

Ibuprofen increases the undesirable effect of estrogens when combined.

Antacids and colestramine reduce the absorption of ibuprofen.

Caffeine increases the analgesic effect of ibuprofen.

With simultaneous appointment ibuprofen reduces inflammatory and antiplatelet effect of acetylsalicylic acid (may increase the incidence of acute coronary insufficiency in patients receiving as antiplatelet agents acetylsalicylic acid, low dose, after initiation of ibuprofen).

When administered with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time.

With the joint use of ibuprofen and cefamandole, cefoperazone, cefotetana. Valproic acid increases the frequency of hypoprothrombinemia.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.

Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.

Ibuprofen may reduce the effectiveness of mifepristone, therefore, ibuprofen should be taken no earlier than 8-12 days after taking mifepristone.

With the simultaneous administration of ibuprofen and tacrolimus, an increased risk of nephrotoxicity may occur.

The simultaneous use of ibuprofen and zidovudine may lead to an increase in hematological toxicity.

There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.

Patients receiving co-treatment with ibuprofen and quinolone antibiotics may increase the risk of seizures.

Special instructions:

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

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.

To prevent the development of NSAIDs, gastropathy is recommended to be combined with preparations of prostaglandin E (misoprostol).

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

Before starting therapy for patients with a history of arterial hypertension and / or heart failure, care should be taken and consulted with a specialist, since such patients were noted for fluid retention, hypertension, and edema associated with NSAID use.

Long-term use may increase the risk of acute coronary disease or stroke.

In patients with bronchial asthma or allergic diseases in the history of the drug can cause the development of an attack or bronchospasm.

During the period of treatment, ethanol is not recommended.

Ibuprofen has an antiaggregant effect (weaker in comparison with acetylsalicylic acid), which requires caution in the case of appointment to patients with blood coagulation disorder, and also taking anticoagulants.

It is recommended to take the drug as short a course and in the minimum effective dose necessary to eliminate symptoms.

The agents that inhibit cyclooxygenase and the synthesis of prostaglandins can affect ovulation,violating the female reproductive function (reversible after the withdrawal of treatment).

Effect on the ability to drive transp. cf. and fur:During the treatment period, it is necessary to refrain from those activities where increased attention and speed of mental and motor reaction are required.

Form release / dosage:

Capsules, 200 mg.

Packaging:

10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

For 1 or 2 contour squares, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003898

Date of registration:11.10.2016

Expiration Date:11.10.2021

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

MINSKINTERKAPS, UP Republic of Belarus

Information update date: & nbsp27.10.2016

Illustrated instructions

Instructions

Next-Uno Express (Next® Uno Express)