Nextt Uno Express capsules 200 mg, 20 pcs.

Composition

1 capsule contains:

Active ingredient: 

ibuprofen – 200,000 mg.

Auxiliary substances: 

alpha-tocopherol acetate-0.372 mg,

povidone 17 PF-30,000 mg,

macrogol 600-414.628 mg.

Composition of the gelatin capsule shell: gelatin, non-crystallizing sorbitol solution, glycerol, methyl parahydroxybenzoate, purified water, red charming dye-129.

Pharmacological action

Pharmacotherapy group:

Nonsteroidal anti-inflammatory drugs.

ATX code: M 01 AE 01

Pharmacological properties

Pharmacodynamics

The mechanism of action of ibuprofen, a propionic acid derivative from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermic reaction.

It selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thereby inhibiting prostaglandin synthesis. It has a rapid directed action against pain (analgesic), antipyretic and anti-inflammatory effect. Ibuprofen reversely inhibits platelet aggregation.

Pharmacokinetics

Ibuprofen is absorbed from the digestive tract by approximately 80%. Absorption decreases slightly when the drug is taken after a meal. Time to reach the maximum concentration (TS_max) when taken on an empty stomach – 45 minutes, when taken after meals – 1.5‑2 hours, in synovial fluid – 2-3 hours

. Ibuprofen is 90% bound to blood proteins, mainly albumins.

It undergoes presystemic and post-systemic metabolism in the liver. After absorption, about 60% of the pharmacologically inactive R-form of ibuprofen is slowly converted to the active S-form. The isoenzyme CYP2C9 is involved in the metabolism of the drug. It has a two-phase elimination kinetics with a half-life (T_1/2) of 2-2.5 hours. It is excreted by the kidneys (no more than 1% unchanged) and to a lesser extent – with bile.

Indications

It is used for headaches, migraines, toothache, painful menstruation, neuralgia, back pain, muscle and rheumatic pains; for feverish conditions with flu and colds.

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

Use during pregnancy and lactation

In animal studies, no adverse effects of ibuprofen on the fetus were found. Due to the lack of a sufficient number of well-controlled human observations, the drug should be used in the first and second trimesters of pregnancy only in cases of acute need, if the potential benefit to the mother exceeds the potential risk to the fetus and child.

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

No ibuprofen excretion in breast milk was detected. However, due to the limited scope of these studies and the possible adverse effect of inhibiting prostaglandin synthesis in the newborn, it is not recommended to use the drug during breastfeeding.

Contraindications

• Hypersensitivity to ibuprofen and other components of the drug;

• erosive and ulcerative diseases of the gastrointestinal tract (including stomach ulcer and duodenal ulcer in acute phase; ulcerative colitis, peptic ulcer, Crohn’s disease);

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

• the blood coagulation disorders (including hemophilia, prolonged bleeding time, a tendency to bleeding, hemorrhagic diathesis);

• children up to age 12 years;

• the III trimester of pregnancy, lactation;

• active gastrointestinal bleeding;

• intracranial hemorrhage;

• bleeding or perforation of the ulcer in the digestive disease, provoked by the use of NSAIDs;

• severe heart failure;

• severe renal insufficiency (CC less than 30 ml/min);

• progressive kidney disease;

• severe hepatic impairment or active liver disease;

• status after conducting coronary artery bypass grafting;

• confirmed hyperkalemia;

• fructose intolerance.

With caution

With caution, the drug is used for cirrhosis of the liver with portal hypertension, hyperbilirubinemia, peptic ulcer of the stomach and duodenum 12 (in the anamnesis), gastritis, enteritis, colitis; hepatic porphyria, hepatic and/or renal failure, nephrotic syndrome; chronic heart failure, arterial hypertension; blood clotting disorders, blood diseases of unknown etiology (leukopenia and anemia), the elderly, pregnancy (I-II trimester), coronary heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial diseases, smoking, chronic renal failure (creatinine clearance 30-60 ml/min), the presence of Helicobacter pylori infection, prolonged use of NSAIDs, frequent alcohol consumption, severe somatic diseases, systemic lupus erythematosus or other autoimmune connective tissue diseases (increased risk of aseptic meningitis), concomitant administration of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Side effects

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

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

– the gastro-intestinal tract (GIT): NSAID-gastropathy (abdominal pain, heartburn, diarrhea, bloating, 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 mouth or pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis, constipation, indigestion, nausea, loss of appetite, vomiting, hepatitis;

– the respiratory system: dyspnea, bronchospasm, exacerbation of asthma;

– hearing loss: hearing loss, ringing or roaring in the ears;

of the Central and peripheral nervous system: insomnia, anxiety, nervousness and irritability, psychomotor agitation, depression, confusion, hallucinations, rarely – aseptic meningitis (usually in patients with autoimmune diseases), headache, dizziness, drowsiness;

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

– from the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis

– the bodies of the blood: hemolytic anemia, aplastic anemia, thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia, pancytopenia;

– on the part of the organs of vision: reversible toxic amblyopia, blurred vision or double vision, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic Genesis), scotoma, colour vision defects;

allergic reactions: skin rash (usually erythematous, urticaria), itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), eosinophilia, allergic rhinitis;

other: increased sweating.

The risk of developing ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual disturbances (color vision disorders, scotoma, amblyopia) increases with prolonged use in large doses.

If side effects occur, you should stop taking the drug and consult a doctor.

Laboratory parameters.

– bleeding time (may increase);

– serum glucose concentration (may decrease);

– creatinine clearance (may decrease);

– hematocrit or hemoglobin (may decrease);

– serum creatinine concentration (may increase);

– activity of “hepatic” transaminases (may increase).

Interaction

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

Microsomal oxidation inhibitors reduce the risk of hepatotoxic effects of ibuprofen.

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

Ibuprofen increases the undesirable effect of estrogens when used together.

Antacids and colestyramine reduce the absorption of ibuprofen.

Caffeine enhances the analgesic effect of ibuprofen.

When administered concomitantly, ibuprofen reduces the anti-inflammatory and antiplatelet effects 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 starting ibuprofen).

When prescribed with anticoagulant and thrombolytic drugs (alteplase, streptokinase. urokinase) simultaneously increases the risk of bleeding.

With the combined use of ibuprofen and cefamandol, cefoperazone, cefotetane. valproic acid increases the incidence of hypoprothrombinemia.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

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

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

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

Ibuprofen may reduce the effectiveness of mifepristone, so you should start taking ibuprofen no earlier than 8-12 days after taking mifepristone.

Concomitant administration of ibuprofen and tacrolimus may increase the risk of nephrotoxicity.

Concomitant use of ibuprofen and zidovudine may lead to increased hematological toxicity.

There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia treated with zidovudine and ibuprofen.

Patients receiving co-treatment with ibuprofen and quinolone antibiotics may have an increased risk of seizures.

How to take, course of administration and dosage

Next® Uno Express is prescribed for adults and children over 12 years of age 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 aged 12-18 years is 800 mg.

Repeat the dose no earlier than 4 hours later.

If the use of the drug for 5 days of pain or for 3 days of elevated body temperature persists or increases, you should stop taking it and consult your doctor.

Overdose

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

Treatment: gastric lavage (only within an hour after ingestion), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy.

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 is indicated, including esophagogastroduodenoscopy, a blood test with the determination of hemoglobin, hematocrit, and a fecal occult blood test.

To prevent the development of NSAID gastropathy, it is recommended to combine with prostaglandin E preparations (misoprostol).

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

Before starting therapy, patients with a history of hypertension and/or heart failure should exercise caution and consult a specialist, as these patients have been noted: fluid retention, hypertension and edema associated with NSAID use.

Prolonged use may increase the risk of acute coronary disease or stroke.

In patients with a history of asthma or allergic diseases, the drug may cause the development of an attack or bronchospasm.

During the treatment period, it is not recommended to take ethanol.

Ibuprofen has an antiplatelet effect (weaker than acetylsalicylic acid), which requires caution in the case of prescribing to patients with blood clotting disorders, as well as taking anticoagulants.

It is recommended to take the drug as short as possible and in the minimum effective dose necessary to eliminate symptoms. Drugs that inhibit cyclooxygenase and prostaglandin synthesis can affect ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).

Storage conditions

Keep out of the reach of children in a dark place, at a temperature not exceeding 25 °C.

Shelf

life is 2 years.

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

Active ingredient

Ibuprofen

Dosage form

Tablets

Purpose

For adults, Children over 12 years of age, Pregnant women in the first and second trimester as prescribed by a doctor

Indications

Flu, Migraines, Osteoarthritis, Myositis, Swelling after injuries and operations, Sciatica, Rheumatoid Arthritis, Osteoarthritis, Colds, Neuritis, Lumbago, Bruises, Sprains and Sprains, Periarthritis, Arthritis

Weight

Weight: 35 gr.