active substance: dexibuprofen;
1 tablet coated liner contains dexibuprofen 200 mg or 300 mg, or 400 mg
cellulose microcrystalline, silica colloidal anhydrous, talc, calcium carmellose, the composition of the shell: hypromellose, titanium dioxide (E 171), talc, dichloromethane, isopropyl alcohol.The
basic physico-chemical properties:
ZOTAC-200:round biconvex tablets, film-coated white color.
Zotech-300 and ZOTEK-400:oblong biconvex tablets coated with a white film shell with a notch for division on one side.The
Nonsteroidal anti-inflammatory drugs. Derivatives of propionic acid. Dexibuprofen. Code ATH M01A E14.The
Dexibuprofen is the pharmacologically active isomer of racemic ibuprofen that relates to non-selective NSAIDs (NSAIDs). The mechanism of its action is associated with the suppression of prostaglandin synthesis. The drug has antipyretic, analgesic and anti-inflammatory properties.
the results of comparative clinical studies in the treatment of osteoarthritis, dysmenorrhea, pain (including toothache) indicate that dexibuprofen dose is 2 times less than ibuprofen has a similar effectiveness.
after oral administration, dexibuprofen is rapidly and completely absorbed in the small intestine. The maximum concentration in the blood is achieved through 2: 00 after oral 200 mg of the drug. The connection with plasma proteins is approximately 99%.
Dexibuprofen is metabolized in the liver (hydroxylation, carboxylation), after which it is excreted as inactive metabolites, mainly (90%) by the kidneys, the rest with bile. The half-life is 1.8-3.5 hours.
Symptomatic therapy of mild and moderate intensity pain of various origins: toothache, back pain, joint pain, muscle pain, rheumatic pain, dysmenorrhea.
hypersensitivity to dexibuprofen, other NSAIDs or other components of the drug use in patients who have substances with a similar mechanism of action, such as acetylsalicylic acid and other NSAIDs, cause bronchial asthma attacks, bronchospasm, acute rhinitis or lead to the development of polyps in the nose, urticaria or angioedema; bleeding or perforation in the digestive tract in history, associated with use of NSAIDs, the active phase of peptic ulcer/bleeding in the digestive tract, peptic ulcer/bleeding in the digestive tract in history (at least two confirmed facts ulcers or bleeding) Crohn's disease or ulcerative colitis in the active phase; cerebrovascular bleeding or other bleeding in the active phase; violation of hematopoiesis or blood clotting severe hepatic insufficiency, severe renal insufficiency, severe heart failure.The
Concomitant use of dexibuprofen with the following drugs is not recommended
blood ThinnersNSAIDs may enhance the effects of anticoagulants, such as warfarin. In case of simultaneous use, it is recommended to monitor coagulation processes and, if necessary, adjust the dose of anticoagulants.
Other NSAIDs, including acetylsalicylic acid (at a dose of 100 mg/day):the simultaneous use of other NSAIDs, including selective COX-2 inhibitors, can increase the risk of ulcers and bleeding in the gastrointestinal tract.
Lithium:NSAIDs can increase the level of lithium in the blood plasma, reducing its renal clearance. In the case of simultaneous use should be carried out frequent monitoring of lithium plasma levels and, if necessary, consider reducing the dose.
Methotrexate when used at a dose of 15 mg/week or more:when using NSAIDs for 24 hours before or after taking methotrexate may increase the level of the latter in plasma due to a decrease in renal clearance and increase the toxic effect.
Concomitant use of dexibuprofen with the following drugs should be carried out with caution
Aminoglycosides, tacrolimus, sirolimus, cyclosporine:while the use of NSAIDs may increase the risk of nephrotoxicity by reducing the synthesis of prostaglandins. In the case of simultaneous use should be carried out constant monitoring of kidney function, especially in elderly patients.
Antihypertensive agents:NSAIDs can reduce the effectiveness of beta-blockers, possibly by suppressing the synthesis of vasodilating prostaglandins.
Concomitant use of NSAIDs with ACE inhibitors and angiotensin factor inhibitors may increase the risk of acute renal failure, especially in patients with pre-existing renal impairment, elderly and dehydrated patients. At the beginning of treatment should be monitored kidney function.
Antiplatelet agents, selective inhibitors of serotonin reuptake:while the use of NSAIDs may increase the risk of gastrointestinal bleeding.
Acetylsalicylic acid (at a dose below 100 mg/day):concomitant use of NSAIDs may impair the ability of low doses of acetylsalicylic acid to inhibit platelet aggregation;
Digoxin:NSAIDs can increase the level of digoxin in blood plasma and increase its toxicity.
Tools that increase the level of potassium in the blood plasma (e.g. potassium-sparing diuretics, ACE inhibitors, antagonists of angiotensin-II, cyclosporine, tacrolimus, trimethoprim, heparin):NSAIDs can increase the level of potassium in the blood plasma. In the case of simultaneous use, it is recommended to monitor the level of potassium in the blood plasma.
Zidovudine:while the use of NSAIDs and zidovudine increases the risk of hemarthrosis and hematoma in patients with hemophilia.
potassium-Sparing, loop and thiazide diuretics:while the use of NSAIDs may increase the risk of renal failure due to lower renal blood flow.
Corticosteroids:while the use of NSAIDs may increase the risk of gastrointestinal bleeding and ulcers.
Methotrexate at a dose less than 15 mg/week:dexibuprofen may increase the level of methotrexate in plasma. In the case of simultaneous use of dexibuprofen and low doses of methotrexate (less than 15 mg/week) should monitor the patient's blood counts, especially at the beginning of treatment. The combination is used with caution in patients with impaired renal function (even moderate), including elderly patients, and to carry out continuous monitoring of kidney function.
Pemetrexed:high doses of NSAIDs can raise the level of pemetrexed in blood plasma. Patients with impaired kidney function should avoid use of NSAIDs during the 2 days before and 2 days after receiving pemetrexed.
Oral antidiabetic agents:simultaneous use of NSAIDs with sulfonylureas may lead to fluctuations in the level of glucose in the blood plasma. You may need to monitor glucose levels in the blood plasma.
of Thrombolytics, antiplatelet agents:dexibuprofen increases antithrombotic effect by inhibiting platelet aggregation.
Phenytoin:some NSAIDs may increase the level of phenytoin in blood plasma and increase its toxicity. In the case of simultaneous use should monitor the level of phenytoin in blood plasma and, if necessary, adjust the dose.
Phenytoin, phenobarbital, rifampicin:with simultaneous use may reduce the effectiveness of dexibuprofen.
Alcohol:excessive alcohol consumption during NSAID use may increase the risk of side-effects from the digestive tract.
features of the application.
Adverse reactions that occur when using dexibuprofen can be reduced by applying the minimum effective dose necessary to treat symptoms for a short period of time.
With prolonged use of dexibuprofen patients should regularly monitor kidney function, liver and hematological functions.
the Constant use of analgesics, especially combinations of various analgesic agents can lead to severe renal damage with renal failure (analgesic nephropathy).
you Should avoid the simultaneous application of dexibuprofen with other NSAIDs, including selective COX-2 inhibitors.
effect on the digestive tract.
cases of gastrointestinal bleeding, perforation, ulcers, sometimes lethal, have been Reported to have occurred at any stage of the treatment of NSAIDs, regardless of a history of preventative symptoms or severe disorders of the digestive tract.
elderly patients there is increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
the risk of gastrointestinal bleeding, perforation, ulcer increases with increased doses of NSAIDs in patients with a history of ulcer, especially if it is complicated by bleeding or perforation in alcoholism patients and elderly patients. These patients should start treatment with the minimum dose.
NSAIDs should be used with caution by patients with chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.
NSAIDs should be used with caution in patients receiving concomitant agents that increase the risk of ulceration or bleeding such as oral corticosteroids, anticoagulants (e.g. warfarin), selective inhibitors of serotonin reuptake or antiplatelet agents (e.g. acetylsalicylic acid). For these patients, as well as for patients with a history of ulcer, especially if it is complicated by bleeding or perforation, alcoholism patients and elderly patients, the doctor should consider the feasibility of combination therapy with misoprostol or proton pump inhibitors.
Patients with existing gastrointestinal disorders in history, especially elderly patients, should report any unusual symptoms from the gastrointestinal tract (primarily bleeding), especially gastro-intestinal bleeding at the beginning of treatment.
in case of gastrointestinal bleeding or ulcers, do not use dexibuprofen immediately.
effects on the cardiovascular system.
patients with hypertension and/or heart failure (mild to moderate) in the history should proceed with caution treatment (doctor's consultation is needed), as in the treatment of NSAIDs reported cases of fluid retention and edema.
Data from clinical trials and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400 mg daily) and long-term treatment may be associated with a slightly increased risk of arterial thrombotic complications (e.g., myocardial infarction or stroke). In General data from epidemiological studies do not suggest that low dose ibuprofen (e.g. ? 1200 mg daily) may lead to increased risk of myocardial infarction. There is not enough data to eliminate this risk when using dexibuprofen.
for patients with uncontrolled hypertension, congestive heart failure, diagnosed ischemic heart disease, peripheral artery disease and/or cerebrovascular disease, long-term treatment may be prescribed by a physician only after a thorough analysis.
patients with pronounced risk factors for cardiovascular complications (e.g. hypertension, hyperlipidemia, diabetes mellitus, Smoking) should be prescribed long-term treatment of NSAIDs only after careful consideration.
the effect on the blood system.
As with other NSAIDs, dexibuprofen may reversibly inhibit platelet aggregation and prolong bleeding time. Use with caution in patients with hemorrhagic diathesis, other coagulation disorders and with simultaneous use of dexibuprofen with oral anticoagulants.
data from experimental studies indicate that with simultaneous use ibuprofen can suppress the effect of acetylsalicylic acid in low doses on platelet aggregation. However, the limited availability of these data and uncertainty about the extrapolation ofex vivodata to the clinical situation do not allow us to make definitive conclusions about the regular use of ibuprofen; if ibuprofen is not used Systematically, the effects are considered unlikely.
effects on the urinary system.
Like other inhibitors of prostaglandin synthesis, dexibuprofen can affect kidney function, which can lead to glomerular or interstitial nephritis, renal papillary necrosis, nephrotic syndrome, and acute renal failure.
As with other NSAIDs, dexibuprofen can increase plasma concentration of blood urea nitrogen and creatinine.
patients with impaired renal function should use dexibuprofen with caution at the most effective dose, should take into account the risk of fluid retention, swelling and deterioration of kidney function and perform regular monitoring of kidney function.
Effect on the hepatobiliary system.
As with other NSAIDs, there may be a slight increase in some functional parameters of the liver, as well as a significant increase in AST and ALT. In case of increasing ALT and AST levels, dexibuprofen should be discontinued.
in patients with impaired liver function, dexibuprofen should be used with caution at the most effective dose and regular monitoring of liver function.
effect on the skin and subcutaneous tissue.
Very rarely in patients receiving NSAIDs can occur severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The highest risk of such reactions is observed in the early stages of therapy, in most cases, the beginning of such reactions occurs within the first month of treatment. Dexibuprofen should be abolished at the first signs of skin rashes, pathological changes in the mucous membranes or any other signs of hypersensitivity.
effects on fertility in women.
there is limited evidence that drugs that inhibit the synthesis of cyclooxygenase/prostaglandin may affect fertility and are not recommended for women who are trying to get pregnant. Women who have problems with the onset of pregnancy or are examined for infertility, dexibuprofen should be abolished.
effect on the immune system.
as with other NSAIDs, it is possible to develop allergic reactions, including anaphylactic/anaphylactoid reactions. In patients with bronchial asthma, a history of NSAIDs can cause bronchospasm.
with caution, dexibuprofen should be used in patients with systemic lupus erythematosus and mixed connective tissue diseases for an increased risk of adverse reactions from the nervous system and kidneys, including aseptic meningitis.
As with other NSAIDs, dexibuprofen can mask the symptoms of infectious diseases.
chicken pox can rarely cause severe infectious complications to the skin and soft tissues. Currently, the role of NSAIDs in worsening the severity of these infections cannot be ruled out. As a result, it is recommended to avoid the use of dexibuprofen in patients with varicella.
use during pregnancy or lactation.
the Period of pregnancy.
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetus development. These epidemiological studies indicate an increased risk of miscarriage, congenital heart disease and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular disease increased from less than 1% to about 1.5%. It is believed that the risk increases with increasing dose and duration of therapy. In animal studies, prostaglandin synthesis inhibitors led to an increase in pre - and post-implantation mortality and lethality of the embryo and fetus. There is also increased incidence of various malformations, including cardiovascular. During the third trimester of pregnancy with the use of all inhibitors of prostaglandin synthesis, the possible effects on the fetus as cardiopulmonary toxicity (premature closure of the ductus arteriosus of the fetus with pulmonary hypertension) and renal impairment which may progress to renal failure with the manifestation of oligohydramnion; as mothers: oppression contractile function of the uterus, which can lead to an increase in the duration of labor with a possible increase in bleeding time in mother and child, even when applying very low doses.
do not use dexibuprofen during I and II trimesters of pregnancy unless the potential benefit to the patient exceeds the potential risk to the fetus. If used during the I or II trimester of pregnancy, a minimum effective dose should be used for as short a period as possible. Since the beginning of the 6th month of pregnancy, the use of dexibuprofen is contraindicated.
the breast-feeding Period.
Dexibuprofen passes into breast milk in very low concentrations. Use during breastfeeding is possible only in low doses for a short period of time.
the use of NSAIDs can be woven into fertility and is not recommended for women who are trying to get pregnant (see "specific application"section).
Ability to influence the reaction rate when driving motor transport or operating other mechanisms.
subject to implementation of recommendations regarding dosing and duration of treatment the drug does not affect the reaction rate when driving motor transport or operating other mechanisms. However, in the case of dizziness, fatigue, drowsiness, disorientation or impaired vision, should refrain from driving vehicles or other mechanisms.
dosing Regimen is set by the doctor individually, taking into account the intensity of the pain syndrome. Adults are usually prescribed 1-2 tablets (200-400 mg dexibuprofen) 3 times a day after meals. The recommended starting dose is 200 mg of dexibuprofen. The recommended daily dose is 600-900 mg of dexibuprofen, divided into 3 doses. The maximum daily dose-1200 mg, the highest single dose-400 mg.
In dysmenorrhea the highest single dose of 300 mg, daily - 900 mg., Preferably taken with food.
the Preparation is intended for symptomatic relief of pain syndrome, but if symptoms diseases persist for more than 3 days, accompanied by high fever, headache or other phenomena, the necessary diagnosis and additional correction of the treatment regimen.
patients with impaired liver and kidney function.
patients with moderate hepatic and renal impairment should start using the drug with reduced doses. Dexibuprofen is contraindicated to use in patients with severe impaired liver or kidneys.
elderly Patients are advised to start therapy with low doses. The dose can be increased to the recommended daily dose only after a good tolerance of the drug has been established.
the Drug is not used in pediatric practice.
Dexibuprofen is characterized by low acute toxicity. In most cases, overdoses are asymptomatic. The risk of symptoms appears when using more than 80-100 mg/kg of ibuprofen (equivalent to 40-50 mg/kg of dexibuprofen).
Symptoms:abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, nystagmus, tinnitus, and ataxia in rare cases, gastrointestinal hemorrhage, hypotension, hypothermia, metabolic acidosis, seizures, impaired renal function, coma, adult respiratory distress syndrome in adults, transient attacks of apnea.
Treatment:symptomatic therapy, no specific antidote. In case of overdose one should take activated charcoal to carry out gastric lavage (only within an hour after the poisoning). Forced diuresis, hemodialysis, hemoperfusion are ineffective due to the high degree of binding of dexibuprofen with blood proteins.
Infections and infestations:exacerbation of inflammatory infectious processes (necrotizing fasciitis).
from the immune system:angioedema, anaphylactic reactions, rhinitis, generalized hypersensitivity reactions, including bronchospasm, bronchial asthma, tachycardia, arterial hypotension, shock, fever with rashes, abdominal pain, headache, nausea, vomiting. Most cases of aseptic meningitis were observed in patients with risk factors, such as various forms of autoimmune diseases.
on the part of the blood system and lymphatic system: elongation of blood clotting time, thrombocytopenia, leukopenia, granulocytopenia, pancytopenia, agranulocytosis, aplastic anemia, hemolytic anemia.
on the mental side:anxiety, psychotic reactions, depression,irritability, hallucinations.
from the nervous system:drowsiness, headache, vertigo, dizziness, insomnia, anxiety, disorientation, confusion, excitement, aseptic meningitis.
by the organ of vision:visual impairment (including double vision), negotiable toxic amblyopia.
by hearing organs:tinnitus, hearing impairment.
from the digestive tract:dyspepsia, abdominal pain, diarrhea, nausea, vomiting, gastrointestinal ulcers and bleeding, gastritis, ulcerative stomatitis, melena, gastrointestinal perforations, flatulence, constipation, esophagitis, esophageal strictures, exacerbation of diverticulitis, non-specific haemorrhagic colitis, ulcerative colitis, Crohn's disease.
In the case of development of gastrointestinal bleeding may develop anemia and hematemesis.
on the part of the urinary system:interstitial nephritis, nephrotic syndrome, renal failure can not be excluded, given the experience of NSAIDs.
from the digestive system:impaired liver function, hepatitis, jaundice.
on the part of the skin and subcutaneous tissue:rash, urticaria, pruritus, purpura (including allergic purpura), erythema multiforme, epidermal necrolysis, systemic lupus erythematosus and other collagen diseases, alopecia, photosensitivity, Stevens-Johnson syndrome, Lyell's syndrome, allergic vasculitis .
General disorders:increased fatigue, increased sweating.
the use of NSAIDs has also been reported edema, heart failure, high blood pressure, fluid retention, especially in patients with arterial hypertension or renal insufficiency.
Data from clinical trials and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400 mg daily) and long-term treatment may be associated with a slightly increased risk of arterial thrombotic complications (e.g., myocardial infarction or stroke) (see "peculiarities of use").The
Store in its original packaging at a temperature not exceeding 25 ° C. keep out of reach of children.The
there are 10 tablets in blister, 1 or 10 blisters in a carton box.The
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the Drug Soligran is used to treat migraine. Possessing analgesic and vasoconstrictor effects, it effectively eliminates the onset of the disease and prevent re-appearance. The tool is usually used as part of a complex treatment, however, the selection of a combination of drugs should produce only the attending physician.
the perception of the body Samigina not depend on the availability of food in the digestive tract of the patient, so you can take it as a on an empty and on a full stomach. A one-time and daily rate of the drug is determined by the attending physician, depending on the stage of the disease and the characteristics of its course. The total daily dose Samigina for an adult should not exceed 15 mg.