UNAZIN table. 375 mg. 12 tablets
UNAZIN table. 375 mg. 12 tablets
Qualitative and quantitative composition:
Active ingredient: Sultamicillin
Unazin is given as containing Sultamicillin tosylate, equivalent to 375 mg Sultamicillin, which is jointly "prodrug" of sulbastam and ampicillin, the decay of which is released sulbastam, equivalent to 147 mg and 220 mg, respectively ampicillin.
Sultamitsilin be used in infections caused by sensitive microorganisms. Typical indications are infections of the upper respiratory tract, including sinusitis, otitis media and tonsillitis, infections of the lower respiratory tract infections, including bacterial pneumonia and bronchitis, urinary tract infections and pyelonephritis, skin and soft tissue infections and gonococcal infections.
Sultamitsilin also applies to patients where therapy is indicated sulbastam / ampicillin after initial treatment with ampicillin / sulbastam IM. / IV
DOSAGE AND ADMINISTRATION:
Sultamitsilin recommended dose for adults (including elderly patients is 375 mg - 750 mg
Children and adults usually lasts 48 hours treatment with the drop in temperature and the disappearance of other abnormal signs. Treatment usually lasts 5-14 days, but may need to be extended.
In the treatment of uncomplicated gonorrhea sultamitsilin can be given as a single dose of 2.25 g (six tablets of 375 mg). Simultaneously, 1.0 g probenecid appointed to maintain plasma concentrations sulbactam and ampicillin longer.
When a suspected syphilis gonorrhea is necessary to make a diagnosis in a dark box before the appointment of sultamitsilin and for at least four months to make monthly serological tests.
Recommended treatment of infections caused by hemolytic streptococci to last at least 10 days and to prevent the development of rheumatic fever and glomerulonephritis.
Use in children and infants
Dosage for most children weighing less than 30 kg, according to the severity of the infection and the doctor's assessment of 25-50 mg/kg/24 hours sultamitsilin, divided into two doses. For children over 30 kg the usual dose recommended for adults. Administration of sultamitsilin in neonates should be borne in mind that renal function is not fully developed.
Use in patients with renal insufficiency
In patients with severe renal impairment the elimination of ampicillin and sulbastam changed in a similar way as the ratio of plasma concentrations remained constant. In these patients dosing interval sultamitsilin to be more in line with the usual practice for ampicillin.
Application of the product is contraindicated in patients with a history of hypersensitivity to any of any of penicillin antibiotics, including sultamitsilin or any of the excipients in the formulation.
Special warnings and precautions for use
In patients on penicillin therapy, including those treated with sultamitsilin observed severe, rarely fatal hypersensitivity (anafilaktsiya). The occurrence of these reactions are more likely in patients with a history of hypersensitivity to penicillins and cephalosporins, and in those patients who experienced hypersensitivity reactions to several allergens. Before initiation of therapy with penicillin antibiotic necessary downloading thorough history of allergic reactions to penicillins and cephalosporins, and other allergens. In the event that an allergic reaction occurs, administration of the product should be discontinued and appropriate therapy instituted.
Serious anaphylactic reactions require emergency treatment with epinephrine. In testimony should be given oxygen, intravenous steroids to maintain free airways, including if necessary the patient should be intubated. As with any antibacterial agent is essential to ensure continuous monitoring of colonization with resistant organisms, including fungi. In case of superinfection application of the product is interrupted and / or Appropriate therapy.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including sultamitsilin, varying in severity from mild to life threatening. It is therefore important to consider this diagnosis in mind in patients where there is diarrhea after administration of antibacterial agents. Treatment with antibacterial agents alter the normal flora in the colon and may permit excessive multiplication of clostridia. Studies show that the toxin produced by Clostridium difficile is a primary cause of "antibiotic associated colitis." Mild cases of pseudomembranous colitis usually respond favorably only by discontinuation of the respective antibiotic. In moderate to severe cases should come into consideration use of rehydration and electrolyte and protein-containing solutions and treatment with an antibacterial drug clinically effective against a C. Difficile.
Since infectious mononucleosis is a viral in origin, its treatment should not be included ampicillin. A high percentage of patients with infectious mononucleosis, in which was administered ampicillin develop skin rashes.
During prolonged therapy is recommended periodic monitoring of impaired function of the systemic organs, including kidney, liver function and hematopoiesis.
Interactions with other drugs
Allopurinol - Concomitant administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs concomitantly, compared to patients receiving ampicillin alone.
Anticoagulants - Penicillins may impair platelet aggregation and interfere with coagulation assays. The combination with anticoagulants may occur additive effect.
Basteriostatichni antibiotics - they may impair bactericidal effects of penicillin, it is best to avoid concomitant administration.
Estrogen - containing oral contraceptives - There are rare reports of reduced effectiveness of oral contraceptives in women taking ampicillin, resulting in unwanted pregnancy occurs. Although a causal link is weak, patients should choose an alternative or should use an additional method of contraception during treatment with ampicillin and sultamitsilin respectively.
Methotrexate - Concomitant administration of penicillin may reduce the clearance of methotrexate, leading to a corresponding increase in the toxicity of the latter. Patients should be monitored carefully. It may be necessary to increase the dose of leucovorin and continuous administration.
Probenecid - It inhibits the tubular secretion of ampicillin and sulbaktama, for use with them. As a result, achieve higher concentrations of ampicillin and sulbactam, which are maintained in the longer serum half-life and increased risk of toxicity.
PREGNANCY and BREAST-FEEDING:
Use during pregnancy - Animal reproduction studies have revealed no evidence of violation of fertility and the risk to the fetus due to use of sultamitsilin. Sulbactam crosses the placental barrier. At the same time, it is determined how safe drug administration to pregnant women.
Use during lactation:
Sultamitsilin should be used with caution in nursing women. Ampicillin and sulbactam are excreted in low concentrations in human milk. It should be borne in mind, because of the possibility of exposing the infant, especially because renal function in these children have not fully developed.
Sultamitsilin usually well tolerated. Most side effects were mild or moderate in severity and usually tolerated by patients with continued therapy.
Body as a whole - anaphylactoid reactions and anaphylactic shock.
Central and peripheral nervous system - headache, drowsiness, rarely epiliptichni seizures, they are often seen in the form of parenteral antibiotic administration since it reached higher concentrations in the CNS.
Gastrointestenalni - nausea, vomiting, diarrhea and pseudomembranous colitis.
Haematopoietic and lymphatic system - anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and leukopenia have been reported during treatment with natrium sultamitsilin / ampicillin natrium. These reactions undergo regression after discontinuation of therapy and are believed to be hypersensitivity reactions.
Liver and gall - a transient increase of ALT (SGPT) and AST (SGOT), transaminases, bilirubinemia, abnormal liver function and jaundice.
Skin and skin structure - rash, itching and other skin reactions in rare cases, Stevens-Johnson syndrome, epidermal necrolysis and erythema multiforme.
Renal - rarely interstitial nephritis, acute renal failure.
There is limited information on the acute toxicity of sultamitsilina in humans. Overdose of the drug would lead to effects generally similar to the above side effects. We take into account the fact that high concentrations of ß-lactam antibiotics in cerebrospinal fluid can lead to neurological manifestations, including seizures and. Since ampicillin and sulbactam are otstratyavat from the circulation by hemodialysis, this procedure can accelerate the elimination of the drug from the body in patients with impaired renal function in case of overdose. The rest of the treatment of overdosage is symptomatic and supportive.
Sultamitsilin a double ester in which ampicillin and the beta-lactamase inhibitor sulbactam are associated with methylene groups.
Biochemical studies of bacterial cell-free systems have shown that sulbactam is an irreversible inhibitor of the most important beta-lactamases produced by penicillin - restistentni microorganisms. It exhibits significant antibacterial activity against only Neisseriaceae, Acinetobacer calcoaceticus, Bacteroides spp, Branhamella catarrhalis, and Pseudomonas ceracia. The ability of sulbactam to prevent the destruction of penicillins and cephalosporins rezistintni microorganisms was confirmed in studies in cell systems using rezistintni strains in which sulbactam demonstrated marked synergistic effects in combination with penicillins and cephalosporins. Since sulbactam also associated with some penicillin-binding protein sensitive strains are more sensitive to the combination than to beta-lactam antibiotics alone.
Bactericidal component of this combination penicillin aminopenitsilin you like benzylpenicillin has its effect on actively proliferating susceptible microorganisms by inhibiting the biosynthesis of the cell wall mukopeptida.
The most important incompatibilities
Sulbastam sodium / ampicillin sodium IM / IV and aminoglycosides are incompatible and must be dissolved and applied separately as aminoglycosides are inactivated in vitro by all aminopenitsilini.
Sulbastam sodium is compatible with most intravenous solutions, but ampicillin sodium and hence Sulbastam sodium / ampicillin sodium IM / IV is less stable in solutions containing dextrose or other carbohydrates and should not be mixed with blood products or protein hydrolysates. Ampicillin and hence Sulbastam sodium / ampicillin sodium IM / IV incompatible with aminoglycosides and should not be mixed in the same container.