AMBENE (ambene) ampoules 2 ml №10
Active ingredient: sodium phenylbutazone
Essential medicines components:
Ambene ® parenteral vial with 2 ml solution for injection contains 400 mg of phenylbutazone sodium.
Other effective components: lidocaine hydrochloride 1 H20 Propylenglycol, sodium hydroxide, water for injection
Hint. Ampoule contains 1,24 mmol (28,4 mg) of sodium. You should take this into account
Release form and content
Ambene ® parenteral available in their original packaging with an ampoule, 3 ampoules and 10 vials.
Analgesic and anti-inflammatory drug
Manufacturer and Pharmaceutical Representative
Pharmaceutical Representative: Meickle Recordati GmbH, Eberhard-Pinckh-Str. 99.89078 Ulm
Telephone (0731) 7047-0
Fax (about 731) 7047-298
Merckle GmbH, Ludwig-Merckle-Str. 3,89143 Blaubeuren
Symptomatic treatment of pain and inflammation, and when:
joint syndrome in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout
neuritis, neuralgia, radiculitis (t.ch in degenerative diseases of the spine)
Ambene parenteral application is not a priority before taking the oral form and is applied only because the reception is impossible because of a variety of possible side effects.
Application Ambene parenteral principally for use when other therapeutic measures, including other non-steroidal drug had insufficient impact.
ambene parenteral may not apply if:
gastric ulcer and duodenal ulcer (including history);
diseases of the circulatory system (in t.ch acute myocardial infarction, chronic heart failure in a phase of decompensation, myocardial disease with conduction disturbances, ventricular arrhythmias);
marked impairment of renal function;
expressed in human liver;
expressed by the dysfunction of the thyroid gland;
viral infections (including herpes infection, chickenpox, mumps, polio, with the exception of the bulbar form of the disease);
severe myopathy, myasthenia gravis;
systemic lupus erythematosus;
giant cell (temporal) arteritis, polymyalgia rheumatica;
period of 8 weeks before and 2 weeks after vaccination;
lymphadenitis after the introduction of the vaccine BCG;
Children up to age 14 years;
information in the history of the occurrence of urticaria, acute rhinitis, bronchospasm to receive aspirin or other NSAIDs;
hypersensitivity to the drug, a pyrazolone derivative of salicylate
Precautions for use and warnings
Caution must be exercised in the appointment of the drug to patients with impaired renal function, patients with diabetes, 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 Ambene apply only when the appropriate treatment of the underlying disease or syndrome. Due to the large half-life, phenylbutazone in long-term high-dose Ambene should consider the possibility of cumulation of the drug and this is particularly true for patients with impaired liver function. Before starting treatment Ambene should conduct a thorough examination of the patient, in particular, to exclude the gastric ulcer and duodenal ulcer. To reduce the risk of side effects must be assigned to the minimum possible dose, it is particularly true for the weak and elderly patients. To prevent irritation at the site / m injection, which is possible with the introduction of highly concentrated solutions of the drug, it is necessary to produce an injection deep into different areas. Manipulation is carried out in a completely sterile conditions. During therapy with patients with food shall contain sufficient 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, the staining of stool in the dark drug overturned. Phenylbutazone has an impact on the results of studies of thyroid function, so the appropriate tests should be conducted not earlier than 2 weeks after cessation of treatment Ambene. Medicinal preparations containing cyanocobalamin, may contribute to the distortion of clinical and laboratory parameters in patients with funikulyarnym myelosis and / or pernicious anemia.
Monitoring of laboratory parameters
Long-term therapy Ambene the regular control pattern of peripheral blood and kidney function, liver. In patients receiving both with Ambene diuretic drugs, requires regular monitoring of potassium level in blood serum. In patients receiving both with Ambene anticoagulants, should be systematically analyze the performance of blood coagulation (prothrombin time).
Interaction with other drugs
While the application Ambene and other anti-inflammatory drugs and preparations containing ethanol, increases the risk of bleeding from the gastrointestinal tract.
At simultaneous application with oral hypoglycemic Ambene agents (sulfonylureas) or insulin can hyper-or hypoglycemia.
Concomitant use of anticoagulants Ambene and indirect actions of heparin, dipyridamole, or sulfinpyrazone may require dose adjustment of drugs in connection with the risk of bleeding.
While the application Ambene may increase the plasma concentrations of sulfonamides and products of lithium.
While the application Ambene and methotrexate may increase the toxicity of the latter.
While the application Ambene with phenytoin may develop symptoms of intoxication last.
While the application Ambene with barbiturates may increase their soporific effect.
While the application Ambene with cardiac glycosides may slow or accelerate digitalization of patients.
While the application Ambene and antihypertensive drugs reduces the action of the latter.
While the application Ambene and diuretics may decrease urinary output and natriuresis, as well as the development of hypo-or hyperkalemia.
While the application Ambene and hormonal contraceptives may reduce the efficacy of the latter.
While the application ambene with sulfinpyrazone or probenecid may reduce urikozuricheskogo effect.
Application before therapy Ambene medicines - inducers of microsomal liver enzymes (eg barbiturates, promethazine, rifampicin, hydantoin) reduces the effect of Ambene.
With the simultaneous use of anabolic steroids and enhance the effect of methylphenidate Ambene.
Guidelines for dosage form and properties of
In early acute disease rheumatoid arthritis and gout 1 ampoule ambene unique.
The contents of the ampoule should be body temperature.
Injection is deeply and slowly in the upper right quadrant of the buttocks.
Injection should be made in strictly sterile conditions.
Make sure the needle does not lie in a blood vessel, injection is slow to avoid injury and / or stretching of muscle tissue. The needle should not be located in the nerve or the next, otherwise you simply will kill the nerve.
Injection is made exclusively with the patient lying down.
Recommended supervision of a physician within 1 hour after injection Ambene.
Ordinary course consists of 3 vials of the drug, but it produces a doctor appointment.
Repeat the course of the drug shall be appointed not earlier than a few weeks.
From the digestive system: ulcerogenic action, anorexia, stomachodynia, nausea, vomiting, diarrhea, rarely - liver function abnormalities, in some cases - bleeding and perforation of the gastrointestinal tract, hemorrhagic pancreatitis.
From the hemopoietic system: leucopenia, agranulocytosis, thrombocytopenia, pancytopenia, aplastic anemia.
Allergic reactions: rash, itching, fever, rarely - Stevens-Johnson syndrome, Lyell's syndrome, volchanochnopodobny syndrome, bronchospasm.
CNS: dizziness, headache, sleep disturbances, agitation, rarely - vision and hearing disorders, mental disorders.
With the cardiovascular system: rarely - hypotension, orthostatic collapse.
Local reactions: seldom - local pain at the injection site, in some cases - the development of abscesses and tissue necrosis.
Other: rarely - Itsenko-Cushing syndrome, mycosis, impaired renal function, a manifestation of immunosuppressive action (lowering resistance to infection, slow healing of wounds), lymphadenopathy, sialoadenit.
Symptoms of nausea, vomiting, abdominal pain, gastrointestinal bleeding, dizziness, headache, metabolic alkalosis or acidosis, hyperventilation, respiratory depression, fever, hypotension, hepatic and renal failure, bradycardia, brain edema and lung, thrombocytopenia, aplastic anemia, increased transaminase activity, heart failure, anuria, convulsions, coma.
Treatment: mechanical ventilation and other resuscitative measures, according to testimony - anticonvulsants (eg, intravenous diazepam), hemodialysis.
Before using the drug ambene you should consult your doctor.