How Next works
The pharmacological activity of the drug is determined by the medicinal substances it contains. The combined use of paracetamol and ibuprofen gives a more effective and long-lasting result than either alone.
- Paracetamol is a non-steroidal analgesic with pronounced antipyretic properties. In the body, it suppresses the activity of specific receptors in the central nervous system, affecting the functioning of thermoregulation centers and susceptibility to pain.
- Ibuprofen also has an analgesic effect and is more effective as an anti-inflammatory agent.
The complex therapeutic activity of Next ensures the elimination of pain and fever within 15–30 minutes after taking the capsules. The drug shell quickly dissolves in the gastrointestinal tract, analgesics are adsorbed into the bloodstream within a few minutes. The analgesic and antipyretic effect of the drug lasts up to 5–8 hours. Metabolites of the drug are bound by bile acids and are completely excreted from the body by the kidneys within 10–12 hours.
Next Uno Express
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 hepatotoxicity from ibuprofen.
Ibuprofen reduces the antihypertensive effect of antihypertensive drugs (ACE inhibitors, slow calcium channel blockers, etc.), the natriuretic and diuretic effectiveness 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 blood concentration of digoxin, lithium and methotrexate.
Ibuprofen enhances the undesirable effects of estrogens when used together.
Antacids and cholestyramine reduce the absorption of ibuprofen.
Caffeine enhances the analgesic effect of ibuprofen.
When administered simultaneously, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent is possible after starting ibuprofen).
When prescribed with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding simultaneously increases.
When using ibuprofen and cefamandole, cefoperazone, cefotetan together. 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 the synthesis of prostaglandins 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 plasma concentrations of ibuprofen.
Ibuprofen may reduce the effectiveness of mifepristone, so ibuprofen should be started 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 who received concomitant treatment with zidovudine and ibuprofen.
In patients receiving concomitant treatment with ibuprofen and quinolone antibiotics, the risk of seizures may increase.
When is Next shown?
The combination drug copes with severe pain symptoms much better than other NSAIDs. Including:
- with migraine;
- neuralgia;
- muscle pain that develops as a result of injuries, infectious pathologies, inflammatory processes;
- with pain syndrome due to damage, inflammation of ligaments and joints: with sprains, fractures, exacerbations of arthritis, with degenerative processes in the hard tissues of the joints;
- with toothache;
- with lumbago;
- with painful menstruation and PMS pain.
Next improves the condition of patients during the postoperative recovery period. It is recommended for use in acute respiratory and other types of infections accompanied by fever, physical malaise, chills, headaches and other signs of fever.
Contraindications
NSAIDs are potent drugs and require careful use as they interfere with many internal biological processes. For people with chronic health problems, Next may be dangerous. Among the contraindications to its use:
- bronchial asthma with frequent exacerbations;
- intolerance to aspirin or other NSAIDs;
- acute gastric ulcer, erosion of the mucous membranes of the gastrointestinal tract;
- history of internal bleeding, low blood clotting;
- undergone coronary artery bypass surgery;
- chronic polyposis of the nasal sinuses;
- pregnancy in the third trimester;
- lactation.
Next is prohibited for use by children under 12 years of age. In the early stages of pregnancy, its use must be coordinated with a doctor. The drug should be taken with caution in case of diabetes mellitus, disorders of the liver, kidneys, gastritis, hepatitis, heart failure.
NEXT UNO EXPRESS caps. 200 mg No. 10
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 hepatotoxicity from ibuprofen.
Ibuprofen reduces the antihypertensive effect of antihypertensive drugs (ACE inhibitors, slow calcium channel blockers, etc.), the natriuretic and diuretic effectiveness 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 blood concentrations of digoxin, lithium and methotrexate.
Ibuprofen enhances the undesirable effects of estrogens when used together.
Antacids and cholestyramine reduce the absorption of ibuprofen.
Caffeine enhances the analgesic effect of ibuprofen.
When administered simultaneously, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent is possible after starting ibuprofen).
When prescribed with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding simultaneously increases.
When using ibuprofen and cefamandole, cefoperazone, cefotetan together. 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 the synthesis of prostaglandins 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 plasma concentrations of ibuprofen.
Ibuprofen may reduce the effectiveness of mifepristone, so ibuprofen should be started 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 who received concomitant treatment with zidovudine and ibuprofen.
In patients receiving concomitant treatment with ibuprofen and quinolone antibiotics, the risk of seizures may increase.
Side effects
When using the product, undesirable reactions of the body are possible:
- dry mouth, nausea, heartburn, heaviness in the epigastrium, intestinal upset;
- tachycardia;
- changes in laboratory blood parameters, increase in leukocytes, liver tests;
- dizziness, insomnia, muscle weakness, tinnitus;
- decreased amount of urine;
- blurred vision.
Possible signs of an intolerance reaction: itching, redness, rash, conjunctivitis, swelling of the mucous membranes.
How to use Next: instructions
Capsules of the drug can be taken occasionally: when sudden pain develops. If the unpleasant symptom goes away quickly, there is no need to continue drinking Next. In other cases, it is recommended to take 1 capsule 2-3 times a day:
- The pills must be swallowed whole with plain water;
- Desirable time: 1 hour after eating;
- maximum course of daily use: no more than 5 days.
For adults, the maximum daily dose of the drug is 3 capsules. Adolescents 12–17 years old whose body weight does not exceed 50 kg are allowed to take no more than 2 capsules per day. During the treatment period, people with chronic health problems should monitor their physical condition and take a biochemical blood test.
Next cannot be combined with other NSAIDs, including drugs that contain ibuprofen or paracetamol. Simultaneous therapy with anticoagulants, glucocorticoids, and barbiturates is also undesirable. The product should not be taken while intoxicated or hangover; ethanol greatly increases the risk of intoxication.
After taking Next, you should stop driving and using other equipment, since the speed of motor reactions under the influence of NSAIDs may decrease.
Next
Registration number:
LP-001389
Trade name of the drug:
Next
International nonproprietary or generic name:
Ibuprofen+Paracetamol
Dosage form:
film-coated tablets.
Composition per tablet:
Active ingredients:
ibuprofen – 400 mg, paracetamol – 200 mg.
Excipients: core:
calcium hydrogen phosphate - 80.0 mg, microcrystalline cellulose - 64.5 mg, croscarmellose sodium - 24.3 mg, hyprolose (hydroxypropylcellulose) - 19.3 mg, talc - 12.1 mg, magnesium stearate – 7.3 mg, colloidal silicon dioxide (aerosil) – 2.5 mg;
shell:
OPADRY 20А250004 RED [hypromellose (hydroxypropyl methylcellulose) – 13.1 mg, hyprolose (hydroxypropyl cellulose) – 8.1 mg, talc – 6.4 mg, titanium dioxide – 2.5 mg, crimson dye [Ponceau 4R] (E 124) – 0.9 mg, sunset yellow dye (E 110) – 0.5 mg] – 31.5 mg, OPADRY II 85F19250 TRANSPARENT (OPADRY II 85F19250 CLEAR) [macrogol (polyethylene glycol) – 0.3 mg, polyvinyl alcohol – 1.0 mg, polysorbate 80 – 0.1 mg, talc – 0.6 mg] – 2.0 mg.
Description:
Oval biconvex tablets, film-coated, red, scored; on cross-section, the core is white or almost white.
Pharmacotherapeutic group:
combined analgesic agent (NSAID + analgesic non-narcotic drug)
ATC code: M01AE51
Pharmacological properties: Pharmacodynamics:
Combined drug, has an analgesic, anti-inflammatory and antipyretic effect. Paracetamol is a non-narcotic analgesic, has an antipyretic and analgesic effect due to the blockade of cyclooxygenase in the central nervous system and its effect on the centers of pain and thermoregulation. Ibuprofen is a non-steroidal anti-inflammatory drug that has analgesic, anti-inflammatory and antipyretic effects associated with non-selective suppression of the activity of cyclooxygenase, which regulates the synthesis of prostaglandins. The components of the drug affect both the central and peripheral mechanisms of pain syndrome formation. The targeted, complementary action of the two components has a rapid therapeutic effect and a pronounced analgesic effect.
Pharmacokinetics:
Paracetamol Absorption - high, maximum concentration (Cmax) is 5 - 20 mcg / ml, time to reach maximum concentration (Tmax) - 0.5 - 2 hours;
connection with plasma proteins – 15%. Penetrates the blood-brain barrier. Metabolized in the liver by glucuronidation, sulfation and hydroxylation, with the formation of both active and inactive metabolites. The isoenzyme of the cytochrome P450 system CYP2E1 takes part in the metabolism of paracetamol. Half-life (T 1/2) – 1 – 4 hours. It is predominantly excreted by the kidneys in the form of metabolites - glucuronides and sulfates, 3% - unchanged. Ibuprofen is well absorbed from the gastrointestinal tract. Time to reach maximum concentration (Tmax) when taken on an empty stomach - 45 minutes, when taken after a meal - 1.5 - 2.5 hours. Communication with plasma proteins - 90%. The concentration of the drug in the synovial fluid exceeds the content in plasma. Subject to presystemic and postsystemic metabolism in the liver. The cytochrome P450 isoenzyme CYP2C9 is involved in the metabolism of ibuprofen. It has two-phase excretion kinetics, T1/2 is equal to 2 – 2.5 hours. It is excreted by the kidneys (no more than 1%) unchanged and, to a lesser extent, with bile. Indications for use:
- headache (including migraine);
- toothache;
- algodismenorrhea (painful menstruation);
- neuralgia;
- myalgia;
- back pain;
- joint pain, pain syndrome in inflammatory and degenerative diseases of the musculoskeletal system;
- pain from bruises, sprains, dislocations, fractures;
- post-traumatic and postoperative pain syndrome;
- febrile conditions (including flu and colds).
The drug is used as a means of symptomatic treatment of febrile conditions, headaches, muscle pain in acute respiratory diseases and influenza.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease. Contraindications:
- hypersensitivity to the components of the drug, including other non-steroidal anti-inflammatory drugs (NSAIDs);
- erosive and ulcerative diseases of the gastrointestinal tract (in the acute phase), gastrointestinal bleeding;
- progressive kidney disease;
- severe renal failure (creatinine clearance (CC) less than 30 ml/min.);
- severe liver failure or active liver disease;
- bleeding disorders (hemophilia, prolongation of bleeding time, bleeding tendency, hemorrhagic diathesis);
- cerebrovascular or other bleeding;
- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, incl. in the anamnesis;
- chronic heart failure (functional class III-IV according to the NYHA classification)
- condition after coronary artery bypass surgery;
- confirmed hyperkalemia;
- deficiency of glucose-6-phosphate dehydrogenase;
- pregnancy (III trimester);
- breastfeeding period;
- children under 18 years of age.
Carefully:
Chronic heart failure; viral hepatitis, alcoholic liver damage, liver and/or kidney failure of moderate and mild severity, benign hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome), liver cirrhosis with portal hypertension, nephrotic syndrome; diabetes mellitus, peripheral arterial disease, peptic ulcer of the stomach and duodenum (history); gastritis, enteritis, colitis; bronchial asthma, bronchospasm; elderly age; pregnancy (I and II trimesters - use is possible only as prescribed by a doctor in cases where the potential benefit outweighs the possible risk).
Use during pregnancy and breastfeeding:
If it is necessary to use the drug in the 1st and 2nd trimester of pregnancy, caution should be exercised - use is only possible as prescribed by a doctor in cases where the potential benefit outweighs the possible risk. The use of the drug in the 3rd trimester of pregnancy is contraindicated. During breastfeeding, if it is necessary to use the drug, you should stop breastfeeding.
Directions for use and dosage:
Inside, after eating. 1 tablet 3 times a day. The maximum daily dose is 3 tablets. The duration of treatment is no more than 3 days as an antipyretic and no more than 5 days as an analgesic. Continuation of treatment with the drug is possible only after consultation with a doctor.
Side effect:
Side effects are listed with frequency of occurrence according to the WHO classification: very common (with a frequency of more than 1/10), often (with a frequency of at least 1/100 but less than 1/10), infrequently (with a frequency of at least 1/1000 , but less than 1/100), rare (with a frequency of at least 1/10000, but less than 1/1000), very rare (with a frequency of less than 1/10000, including isolated reports), frequency unknown (cannot be determined from available data ).
From the nervous system: infrequently - headache, dizziness, sleep disturbances, anxiety, hallucinations, confusion, rarely - aseptic meningitis, very rarely - depression. From the cardiovascular system: often - peripheral edema, very rarely - tachycardia, increased blood pressure, heart failure. From the respiratory system: very rarely - shortness of breath, bronchospasm. From the gastrointestinal tract: often - abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, erosive and ulcerative lesions of the gastrointestinal tract; uncommon – constipation, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis, gastrointestinal bleeding. Sense organs: very rarely - hearing impairment, ringing or noise in the ears, visual impairment, blurred vision or diplopia, frequency unknown - dryness and irritation of the eyes. From the urinary system: very rarely - acute renal failure, nephrotic syndrome, cystitis; frequency unknown - polyuria. Allergic reactions: uncommon - skin rash, itching, allergic rhinitis, angioedema; very rarely - exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). From the hematopoietic organs: very rarely - anemia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, eosinophilia. From the skin and subcutaneous tissues: often – hyperhidrosis. With long-term use in large doses - hepatotoxic and nephrotoxic effects (hepatitis, interstitial nephritis and papillary necrosis); hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia. If side effects occur, you should consult a doctor.
Overdose:
Symptoms: abdominal pain, nausea, vomiting, agitation or lethargy, drowsiness, confusion, tachycardia, arrhythmia, acute renal failure, metabolic acidosis, frequent urination, pyrexia, headache, tremor or muscle twitching; increased activity of “liver” transaminases, increased prothrombin time. If you suspect an overdose, you should immediately seek medical help. Treatment: gastric lavage, followed by the administration of activated charcoal; alkaline drinking, forced diuresis, symptomatic therapy, administration of sulfhydryl group donors (acetylcysteine) and precursors for glutathione synthesis (methionine).
Interaction with other drugs:
Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication in case of overdose. Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxicity. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. Cyclosporine and gold preparations increase the nephrotoxicity of the drug. The combination of ibuprofen with ethanol and glucocorticosteroids increases the risk of erosive and ulcerative lesions of the gastrointestinal tract. Concomitant use of paracetamol with ethanol increases the risk of acute pancreatitis. Paracetamol and ibuprofen enhance the effect of indirect anticoagulants and reduce the effectiveness of uricosuric drugs. Long-term use of barbiturates reduces the effectiveness of paracetamol. Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity. Ibuprofen reduces the hypotensive activity of vasodilators, natriuretic and diuretic - furosemide and hydrochlorothiazide. Antacids and cholestyramine reduce the absorption of ibuprofen. Caffeine increases the analgesic effect of ibuprofen. Ibuprofen enhances the effect of oral hypoglycemic agents and insulin. Ibuprofen increases the blood concentration of digoxin, lithium and methotrexate. When administered simultaneously with acetylsalicylic acid, ibuprofen reduces its anti-inflammatory and antiplatelet effect. Cefamandole, cefaperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia.
Special instructions:
The simultaneous use of the drug with other drugs containing paracetamol and/or non-steroidal anti-inflammatory drugs should be avoided. When used simultaneously with indirect anticoagulants, monitoring of hemostasis is necessary. When using the drug for more than 5 - 7 days, peripheral blood counts and the functional state of the liver should be monitored. Paracetamol distorts the results of laboratory tests of glucose and uric acid in blood plasma. If symptoms of NSAID gastropathy appear (nausea, vomiting, abdominal pain, heartburn, loss of appetite, flatulence, epigastric discomfort), careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin and hematocrit, and a stool test for occult blood. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, drinking alcohol-containing drinks is not recommended.
Impact on the ability to drive vehicles and machinery:
While taking the drug, patients should refrain from all activities that require increased attention, rapid mental and motor reactions.
Release form:
Film-coated tablets 400 mg + 200 mg. 2, 6, 10 or 12 tablets in a blister pack. 1 or 2 blister packs with instructions for use in a cardboard pack.
Storage conditions:
At a temperature not higher than 25 °C. Keep out of the reach of children.
Best before date:
2 years. Do not use after the expiration date stated on the packaging.
Vacation conditions:
Available without a prescription.
Marketing authorization holder/organization receiving consumer complaints:
- OTCPharm JSC, Russia,
- 123112, Moscow, st. Testovskaya, 10
- floor 12, room II, room 29
- Tel.
- Fax
- www.otcpharm.ru
- www.nextpainkiller.ru
305022, Russia, Kursk, st. 2nd Aggregatnaya, 1a/18, tel./fax: (4712) 34-03-13 www.pharmstd.ru
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