Composition, structure and packing
Solution for i / m administration: a set of injection solutions A and B. Solution for injection A transparent, ranging from colorless to slightly yellowish to.
2 ml of dexamethasone 3.32 mg of lidocaine hydrochloride 4 mg sodium salitsilamid-o-acetate 150 mg fenilbutazon 375 mg (in the form of sodium salt).
Excipients: sodium hydroxide, 49.08 mg, Water d / and 1675.92 mg.
Solution for injection B transparent red.
1 ml cyanocobalamin 2.5 mg of lidocaine hydrochloride 2 mg.
Excipients: Water d / and 996.5 mg. Ampoules double (6) dark glasses containing solution A (2 ml) and solution B (1 ml).
At the ampoule solution A there is a point of white and 2 rings - Zelenova light and dark pink flowers.
At the ampoule solution in a point of white. Solution for i / m administration: a set of injection solutions A and B.
Solution for injection A transparent, from colorless to slightly yellowish.
2 ml of dexamethasone 3.32 mg of lidocaine hydrochloride 4 mg sodium salitsilamid-o-acetate 150 mg fenilbutazon 375 mg.
Excipients: sodium hydroxide, 49.08 mg, Water d / and 1675.92 mg. Solution for injection in a transparent, red.
1 ml cyanocobalamin 2.5 mg of lidocaine hydrochloride 2 mg.
Excipients: Water d / and 996.5 mg.
Clinico-pharmacological group: preparation of anti-inflammatory and analgesic effect.
Pharmacological action
Combination drug whose action caused by properties of the components in its composition. Has anti-inflammatory, analgesic and antipyretic effect, causes urikozurichesky effect. Dexamethasone - glucocorticoid, has a marked anti-inflammatory effect, an index of its relative anti-inflammatory activity of 30, with virtually no mineralocorticoid activity. Fenilbutazon - NSAIDs, pyrazolone derivative, has anti-inflammatory, analgesic and antipyretic effect, causes urikozurichesky effect. Sodium salitsilamid-o-acetate, has analgesic effect, but also contributes to a better solubility of the drug. Cyanocobalamin involved in the synthesis of nucleic acids, activates the exchange of lipids and consequently of importance in the regeneration of cells and the formation of myelin nerve fiber layer, part of the drug in high enough doses to enhance the analgesic effect. Due to the presence of lidocaine hydrochloride injection virtually painless.
The active ingredients that make up Ambion, potentiate the action of each other, thereby reducing the dose of dexamethasone. The activity of the drug persists for a long time (36 months) due to separation of solutions A and B from each other.
Pharmacokinetics
Absorption
After a / m dexamethasone treatment rapidly absorbed into the systemic circulation.
Distribution
Fenilbutazon has a high degree of plasma protein binding. Dexamethasone and fenilbutazon penetrate through the placenta, are excreted with breast milk.
Metabolism
Due to the high plasma protein binding fenilbutazona metabolism is slow, providing a long T1 / 2.
Withdrawal
T1 / 2 of dexamethasone is approximately 3 hours
Statement
Short-term treatment of acute conditions when:
joint syndrome in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout;
neuritis, neuralgia, radiculitis (including degenerative diseases of the spine).
Dosage regimen
The drug is prescribed to 1 injection per day every day or every other day. Produce not more than 3 injections per week. When the need for repeated courses of treatment interval between them must be at least several weeks. Injections of the drug produced deep in the auto, slowly, the patient should be in a horizontal position. Terms of preparing injection solution When using Ambion in the form of a set of 2 vials into the syringe first gaining solution A, then the solution B. In applying the drug in the form of a ready syringe removed from the conical part of the syringe rubber cap, attached sterile needle, removing the protective element, mounted on a cone, slowly move the piston rod with a cork in advance before the first drops of solution. With the right technique to prepare the injection solution B flows through the connecting bridge in the anterior chamber of the syringe and mixed with a solution of A. The agents immediately after mixing the solutions.
The temperature of the prepared solution should be close to the temperature of the patient's body.
Side effect
On the part of the digestive system: ulcerogenic effect, anorexia, stomachalgia, nausea, vomiting, diarrhea, rarely - liver problems, and in some cases - bleeding and perforation of the gastrointestinal tract, hemorrhagic pancreatitis.
On the part of the hemopoietic system: leucopenia, agranulocytosis, thrombocytopenia, pancytopenia, aplastic anemia. Allergic reactions: rash, itching, fever, rarely - Stevens-Johnson syndrome, Lyell's syndrome, volchanochnopodobny syndrome, bronchospasm.
From the side of the central nervous system: dizziness, headache, sleep disturbances, agitation, seldom - vision and hearing disorders, mental disorders. Since the cardiovascular system: rarely - hypotension, orthostatic collapse.
Local reactions: seldom - pain at the injection site, and in some cases - the development of abscesses and necrotic tissue.
Other: rarely - Itsenko syndrome, Cushing's mycosis, renal dysfunction, the manifestation immunodepressive actions (lowering resistance to infection, slow healing of wounds), lymphadenopathy, sialadenitis.
Contraindications
acute gastritis;
ulcer of the stomach and duodenum (including history);
diseases of the circulatory system (including acute myocardial infarction, chronic heart failure in a phase of decompensation, diseases of the myocardium with conduction disturbance, ventricular arrhythmia);
pronounced renal dysfunction;
marked disturbances of liver function;
expressed thyroid;
viral infection (including herpes infection, chickenpox, mumps, polio, with the exception of the bulbar form of the disease);
systemic mycosis;
glaucoma;
myelosuppression;
pronounced myopathy, myasthenia gravis;
Sjogren's syndrome;
systemic lupus erythematosus;
hemorrhagic diathesis;
giant cell (temporal) arteritis, polymyalgia rheumatica;
pancreatitis;
stomatitis;
period of 8 weeks before and 2 weeks after vaccination;
lymphadenitis after BCG vaccination;
surgery;
Pregnancy
lactation (breastfeeding);
Children under 14 years
elderly age;
information in the history of the origin of urticaria, acute rhinitis, bronchospasm to receive aspirin or other NSAIDs;
Hypersensitivity to the drug's components, pyrazolone derivatives, salicylates.
Pregnancy, Lactation
Ambion contraindicated in pregnancy.
If necessary, use Ambion during lactation should decide on the termination of breastfeeding.
Application for violations of liver function
Contraindications disturbancies liver function.
Application for violations of renal function
Contraindications disturbancies renal function.
Cautions
Precautions should be prescribed drug in renal failure, diabetics, patients with tuberculosis, epilepsy, mental illness, asthma, hay fever, chronic nonspecific lung diseases, acute and chronic bacterial infections, amebiasis, with hypertension or hypotension, thromboembolism, marked osteoporosis.
In the above cases Ambion used only with appropriate treatment of the underlying disease or syndrome. Due to the large half-life fenilbutazona for prolonged use at high doses Ambion should consider the possibility of cumulation of the drug, and this is particularly true for patients with impaired liver function.
Before treatment Ambion should conduct a thorough examination of the patient, in particular to avoid gastric ulcer and duodenal ulcer.
To reduce the risk of side effects should be possible to assign the drug in the minimum dose, and this is particularly true for the weak and elderly patients.
To prevent irritation at the site of a / m injection, which is possible with the introduction of highly concentrated solutions of the drug must be injected to produce deep, in different areas. Manipulation is carried out in absolutely sterile conditions. During therapy with patients with food should contain adequate amounts of potassium, protein, vitamins and low in fat, carbohydrates and salt.
If you experience fever, headache, changes in the skin and mucous membranes during the development of leukopenia, agranulocytosis, with staining of stool in a dark color drug overturned. Fenilbutazon affects the results of studies of thyroid function, so the appropriate tests should be conducted not earlier than 2 weeks after cessation of treatment Ambion.
Medicinal preparations containing cyanocobalamin, may contribute to the distortion of clinical and laboratory parameters in patients with funicular myelosis and / or pernicious anemia. Monitoring of laboratory parameters during prolonged therapy Ambion requires systematic monitoring patterns of peripheral blood and kidney function, liver.
In patients receiving simultaneously with Ambion diuretic drugs, requires regular monitoring of potassium level in blood serum.
Patients receiving simultaneously with Ambion anticoagulants, should be systematically analyze the performance of coagulation (prothrombin time).
Overdose
Symptoms: nausea, vomiting, abdominal pain, gastrointestinal bleeding, dizziness, headache, metabolic alkalosis or acidosis, hyperventilation, respiratory distress, fever, hypotension, hepatic and renal failure, bradycardia, edema of the brain and lungs, thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, increased activity of transaminases, cardiac insufficiency, anuria, convulsions, coma.
Treatment: mechanical ventilation and other resuscitation, according to indications - anticonvulsant drugs (eg, in / diazepam), hemodialysis.
Drug Interactions
With simultaneous use of Ambion and other anti-inflammatory drugs and preparations containing ethanol, increases the risk of bleeding from the gastrointestinal tract. When applied simultaneously with oral hypoglycemic Ambion drugs (sulfonylurea derivatives) or insulin can be hyper-or hypoglycemia. The simultaneous use of Ambion and indirect anticoagulants, heparin, dipyridamole, or sulfinpirazon may require adjustment of doses of drugs in relation to the risk of bleeding.
At simultaneous application with Ambion may increase the plasma concentrations of sulphonamides and drugs lithium.
With simultaneous use of Ambion and methotrexate may increase the toxicity of the latter.
With simultaneous use of Ambion with phenytoin may develop symptoms of intoxication last.
With simultaneous use of Ambion with barbiturates may enhance their soporific effect.
With simultaneous use of Ambion with cardiac glycosides may slow or accelerate the digitalization of patients.
With simultaneous use of Ambion and antihypertensive drugs reduces the action of the latter.
With simultaneous use of Ambion and diuretics may decrease in diuresis and natriuresis, as well as the development of hypo-or hyperkalemia.
With simultaneous use of Ambion and hormonal contraceptives may decrease the effectiveness of the latter.
When applied simultaneously with Ambion sulfinpirazon or probenecid may decrease their urikozuricheskogo effect.
The use of prior therapy Ambion drugs - inducers of microsomal liver enzymes (eg, barbiturates, promethazine, rifampicin, hydantoin) reduces the effect of Ambion. With simultaneous use of anabolic steroids and methylphenidate enhance the effect of Ambion.
Terms and Conditions of storage
The drug should be stored in a dark place at temperatures not above 25 ° C. Shelf life - 3 years.
Solution for i / m administration: a set of injection solutions A and B. Solution for injection A transparent, ranging from colorless to slightly yellowish to.
2 ml of dexamethasone 3.32 mg of lidocaine hydrochloride 4 mg sodium salitsilamid-o-acetate 150 mg fenilbutazon 375 mg (in the form of sodium salt).
Excipients: sodium hydroxide, 49.08 mg, Water d / and 1675.92 mg.
Solution for injection B transparent red.
1 ml cyanocobalamin 2.5 mg of lidocaine hydrochloride 2 mg.
Excipients: Water d / and 996.5 mg. Ampoules double (6) dark glasses containing solution A (2 ml) and solution B (1 ml).
At the ampoule solution A there is a point of white and 2 rings - Zelenova light and dark pink flowers.
At the ampoule solution in a point of white. Solution for i / m administration: a set of injection solutions A and B.
Solution for injection A transparent, from colorless to slightly yellowish.
2 ml of dexamethasone 3.32 mg of lidocaine hydrochloride 4 mg sodium salitsilamid-o-acetate 150 mg fenilbutazon 375 mg.
Excipients: sodium hydroxide, 49.08 mg, Water d / and 1675.92 mg. Solution for injection in a transparent, red.
1 ml cyanocobalamin 2.5 mg of lidocaine hydrochloride 2 mg.
Excipients: Water d / and 996.5 mg.
Clinico-pharmacological group: preparation of anti-inflammatory and analgesic effect.
Pharmacological action
Combination drug whose action caused by properties of the components in its composition. Has anti-inflammatory, analgesic and antipyretic effect, causes urikozurichesky effect. Dexamethasone - glucocorticoid, has a marked anti-inflammatory effect, an index of its relative anti-inflammatory activity of 30, with virtually no mineralocorticoid activity. Fenilbutazon - NSAIDs, pyrazolone derivative, has anti-inflammatory, analgesic and antipyretic effect, causes urikozurichesky effect. Sodium salitsilamid-o-acetate, has analgesic effect, but also contributes to a better solubility of the drug. Cyanocobalamin involved in the synthesis of nucleic acids, activates the exchange of lipids and consequently of importance in the regeneration of cells and the formation of myelin nerve fiber layer, part of the drug in high enough doses to enhance the analgesic effect. Due to the presence of lidocaine hydrochloride injection virtually painless.
The active ingredients that make up Ambion, potentiate the action of each other, thereby reducing the dose of dexamethasone. The activity of the drug persists for a long time (36 months) due to separation of solutions A and B from each other.
Pharmacokinetics
Absorption
After a / m dexamethasone treatment rapidly absorbed into the systemic circulation.
Distribution
Fenilbutazon has a high degree of plasma protein binding. Dexamethasone and fenilbutazon penetrate through the placenta, are excreted with breast milk.
Metabolism
Due to the high plasma protein binding fenilbutazona metabolism is slow, providing a long T1 / 2.
Withdrawal
T1 / 2 of dexamethasone is approximately 3 hours
Statement
Short-term treatment of acute conditions when:
joint syndrome in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout;
neuritis, neuralgia, radiculitis (including degenerative diseases of the spine).
Dosage regimen
The drug is prescribed to 1 injection per day every day or every other day. Produce not more than 3 injections per week. When the need for repeated courses of treatment interval between them must be at least several weeks. Injections of the drug produced deep in the auto, slowly, the patient should be in a horizontal position. Terms of preparing injection solution When using Ambion in the form of a set of 2 vials into the syringe first gaining solution A, then the solution B. In applying the drug in the form of a ready syringe removed from the conical part of the syringe rubber cap, attached sterile needle, removing the protective element, mounted on a cone, slowly move the piston rod with a cork in advance before the first drops of solution. With the right technique to prepare the injection solution B flows through the connecting bridge in the anterior chamber of the syringe and mixed with a solution of A. The agents immediately after mixing the solutions.
The temperature of the prepared solution should be close to the temperature of the patient's body.
Side effect
On the part of the digestive system: ulcerogenic effect, anorexia, stomachalgia, nausea, vomiting, diarrhea, rarely - liver problems, and in some cases - bleeding and perforation of the gastrointestinal tract, hemorrhagic pancreatitis.
On the part of the hemopoietic system: leucopenia, agranulocytosis, thrombocytopenia, pancytopenia, aplastic anemia. Allergic reactions: rash, itching, fever, rarely - Stevens-Johnson syndrome, Lyell's syndrome, volchanochnopodobny syndrome, bronchospasm.
From the side of the central nervous system: dizziness, headache, sleep disturbances, agitation, seldom - vision and hearing disorders, mental disorders. Since the cardiovascular system: rarely - hypotension, orthostatic collapse.
Local reactions: seldom - pain at the injection site, and in some cases - the development of abscesses and necrotic tissue.
Other: rarely - Itsenko syndrome, Cushing's mycosis, renal dysfunction, the manifestation immunodepressive actions (lowering resistance to infection, slow healing of wounds), lymphadenopathy, sialadenitis.
Contraindications
acute gastritis;
ulcer of the stomach and duodenum (including history);
diseases of the circulatory system (including acute myocardial infarction, chronic heart failure in a phase of decompensation, diseases of the myocardium with conduction disturbance, ventricular arrhythmia);
pronounced renal dysfunction;
marked disturbances of liver function;
expressed thyroid;
viral infection (including herpes infection, chickenpox, mumps, polio, with the exception of the bulbar form of the disease);
systemic mycosis;
glaucoma;
myelosuppression;
pronounced myopathy, myasthenia gravis;
Sjogren's syndrome;
systemic lupus erythematosus;
hemorrhagic diathesis;
giant cell (temporal) arteritis, polymyalgia rheumatica;
pancreatitis;
stomatitis;
period of 8 weeks before and 2 weeks after vaccination;
lymphadenitis after BCG vaccination;
surgery;
Pregnancy
lactation (breastfeeding);
Children under 14 years
elderly age;
information in the history of the origin of urticaria, acute rhinitis, bronchospasm to receive aspirin or other NSAIDs;
Hypersensitivity to the drug's components, pyrazolone derivatives, salicylates.
Pregnancy, Lactation
Ambion contraindicated in pregnancy.
If necessary, use Ambion during lactation should decide on the termination of breastfeeding.
Application for violations of liver function
Contraindications disturbancies liver function.
Application for violations of renal function
Contraindications disturbancies renal function.
Cautions
Precautions should be prescribed drug in renal failure, diabetics, patients with tuberculosis, epilepsy, mental illness, asthma, hay fever, chronic nonspecific lung diseases, acute and chronic bacterial infections, amebiasis, with hypertension or hypotension, thromboembolism, marked osteoporosis.
In the above cases Ambion used only with appropriate treatment of the underlying disease or syndrome. Due to the large half-life fenilbutazona for prolonged use at high doses Ambion should consider the possibility of cumulation of the drug, and this is particularly true for patients with impaired liver function.
Before treatment Ambion should conduct a thorough examination of the patient, in particular to avoid gastric ulcer and duodenal ulcer.
To reduce the risk of side effects should be possible to assign the drug in the minimum dose, and this is particularly true for the weak and elderly patients.
To prevent irritation at the site of a / m injection, which is possible with the introduction of highly concentrated solutions of the drug must be injected to produce deep, in different areas. Manipulation is carried out in absolutely sterile conditions. During therapy with patients with food should contain adequate amounts of potassium, protein, vitamins and low in fat, carbohydrates and salt.
If you experience fever, headache, changes in the skin and mucous membranes during the development of leukopenia, agranulocytosis, with staining of stool in a dark color drug overturned. Fenilbutazon affects the results of studies of thyroid function, so the appropriate tests should be conducted not earlier than 2 weeks after cessation of treatment Ambion.
Medicinal preparations containing cyanocobalamin, may contribute to the distortion of clinical and laboratory parameters in patients with funicular myelosis and / or pernicious anemia. Monitoring of laboratory parameters during prolonged therapy Ambion requires systematic monitoring patterns of peripheral blood and kidney function, liver.
In patients receiving simultaneously with Ambion diuretic drugs, requires regular monitoring of potassium level in blood serum.
Patients receiving simultaneously with Ambion anticoagulants, should be systematically analyze the performance of coagulation (prothrombin time).
Overdose
Symptoms: nausea, vomiting, abdominal pain, gastrointestinal bleeding, dizziness, headache, metabolic alkalosis or acidosis, hyperventilation, respiratory distress, fever, hypotension, hepatic and renal failure, bradycardia, edema of the brain and lungs, thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, increased activity of transaminases, cardiac insufficiency, anuria, convulsions, coma.
Treatment: mechanical ventilation and other resuscitation, according to indications - anticonvulsant drugs (eg, in / diazepam), hemodialysis.
Drug Interactions
With simultaneous use of Ambion and other anti-inflammatory drugs and preparations containing ethanol, increases the risk of bleeding from the gastrointestinal tract. When applied simultaneously with oral hypoglycemic Ambion drugs (sulfonylurea derivatives) or insulin can be hyper-or hypoglycemia. The simultaneous use of Ambion and indirect anticoagulants, heparin, dipyridamole, or sulfinpirazon may require adjustment of doses of drugs in relation to the risk of bleeding.
At simultaneous application with Ambion may increase the plasma concentrations of sulphonamides and drugs lithium.
With simultaneous use of Ambion and methotrexate may increase the toxicity of the latter.
With simultaneous use of Ambion with phenytoin may develop symptoms of intoxication last.
With simultaneous use of Ambion with barbiturates may enhance their soporific effect.
With simultaneous use of Ambion with cardiac glycosides may slow or accelerate the digitalization of patients.
With simultaneous use of Ambion and antihypertensive drugs reduces the action of the latter.
With simultaneous use of Ambion and diuretics may decrease in diuresis and natriuresis, as well as the development of hypo-or hyperkalemia.
With simultaneous use of Ambion and hormonal contraceptives may decrease the effectiveness of the latter.
When applied simultaneously with Ambion sulfinpirazon or probenecid may decrease their urikozuricheskogo effect.
The use of prior therapy Ambion drugs - inducers of microsomal liver enzymes (eg, barbiturates, promethazine, rifampicin, hydantoin) reduces the effect of Ambion. With simultaneous use of anabolic steroids and methylphenidate enhance the effect of Ambion.
Terms and Conditions of storage
The drug should be stored in a dark place at temperatures not above 25 ° C. Shelf life - 3 years.
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