SULTANID [Ampicillin + Sulbactam] 500 +250 mg Powder for solution for I\M administration

instructions for the medical use of the medicinal product

SULTANID

Tradename

Sultanid, Султанид

International non-proprietary name or generic name

Ampicillin + Sulbactam, Ампициллин + Сульбактам

Composition

Sultanid 750 mg

Each vial contains: ampicillin sodium equiv. ampicillin 500 mg,

sulbactam sodium equiv. sulbactam 250 mg.

The solvent ampoule contains: lidocaine hydrochloride 1% 5 ml.

Sultanid 1500 mg

Each vial contains: ampicillin sodium equiv. ampicillin 1000 mg,

sulbactam sodium equiv. sulbactam 500 mg.

The solvent ampoule contains: lidocaine hydrochloride 1% 5 ml.

Dosage form

Powder for solution for intramuscular injection.

Pharmacotherapeutic group

Antibiotic, penicillin semi-synthetic + beta-lactamase inhibitor.

Pharmacological properties

Combined broad-spectrum antibacterial agent.

Pharmacodynamics

Ampicillin is an antibiotic from the group of semi-synthetic penicillins, the bactericidal effect of which is associated with inhibition of the synthesis of proteins in the cell wall of microorganisms.

Sulbactam is an irreversible beta-lactamase inhibitor. Expands the spectrum of activity of ampicillin against resistant strains, the resistance of which develops under the influence of beta-lactamase. Does not change the activity of ampicillin against susceptible strains. By binding to some penicillin-binding proteins of bacteria, it shows synergism when used simultaneously with beta-lactam antibiotics. It is stable in aqueous solution, has independent antibacterial activity against the Neisseriaceae and Acinetobacter spp. families, and is resistant to most plasmid beta-lactamases.

The combination of ampicillin+sulbacts is active in relation to aerobic gram-positive bacteria-Staphylococcus aureus (stamps that produce and non-disclosure beta-lactamase), staphylococcus epidermidis (strains producing and non-converting beta-lactamase), Stap Hylococcus saprophyticus , Streptococcus pyogenes, Streptococcus pneumoniae (including strains resistant to penicillin), Streptococcus spp. groups viridans, Enterococcus faecalis, Listeria monocytogenes; aerobic gram-negative bacteria - Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella spp., Neisseria gonorrhoeae (beta-lactamase producing and non-producing strains), Moraxella catarrhalis (beta-lactamase producing and non-producing strains), Morganella morganii, Haemophilus influenzae (in including strains resistant to ampicillin), Providencia rettgeri, Providencia stuartii; anaerobic microorganisms - Bacteroides spp., including Bacteroides fragilis, Clostridium spp. (except Clostridium difficile), Peptococcus spp., Peptostreptococcus spp.

Resistant: methicillin-resistant Staphylococcus spp., Citrobacter spp., most strains of Enterobacter spp., Pseudomonas aeruginosa, Mycobacterium spp., Clostridium difficile, Chlamydia pneumoniae, Mycoplasma pneumoniae.

Pharmacokinetics

Penetrates into most tissues and body fluids. With inflammation, the permeability to the cerebrospinal fluid increases dramatically.

After i / m administration, high concentrations of ampicillin and sulbactam in the blood are achieved.

T1 / 2 - 1 h (for ampicillin and sulbactam). Excreted by the kidneys - 70-80%, mainly unchanged, as well as with bile and breast milk.

Sulbactam almost does not undergo metabolic transformations and is excreted by the kidneys, mainly in an unchanged state and only about 25% - in the form of metabolites.

Indications for use

Treatment of infectious and inflammatory diseases caused by susceptible pathogens: respiratory infections (including pneumonia, lung abscess, chronic bronchitis, pleural empyema); infections of ENT organs (including sinusitis, tonsillitis, otitis media); infections of the urinary tract and genital organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, endometritis); biliary tract infections (cholecystitis, cholangitis); infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatitis); gastrointestinal infections (dysentery, salmonellosis, salmonellosis); bone and joint infections; septic endocarditis; meningitis; sepsis; peritonitis; scarlet fever; gonococcal infection.

Prevention of postoperative complications during operations on the organs of the abdominal cavity and small pelvis.

Contraindications

Hypersensitivity to any of the components of the drug and other beta-lactam antibiotics; infectious mononucleosis (including with the appearance of a measles-like rash), lymphocytic leukemia.

When using lidocaine as a solvent - hypersensitivity to local anesthetics of the amide type, severe shock, blockade of intracardiac conduction, severe heart failure.

Method of administration and dosage

Sultanide is administered intramuscularly.

Standard dosing regimen

Adults: with a mild course of infection -1.5-3 g / day in 2 injections; with a moderate course of infection - 3-6 g / day in 3-4 injections; in severe infections - 12 g / day in 3-4 injections.

Children: at the rate of 150 mg/kg of body weight per day (corresponding to 100 mg/kg/day of ampicillin and 50 mg/kg/day of sulbactam); frequency of administration - 3-4 times a day.

Newborns under the age of 1 week and premature babies - at the rate of 75 mg / kg of body weight per day with an interval of 12 hours.

Children weighing 40 kg or more should be dosed as recommended for adults, and the total dose of sulbactam should not exceed 4 g per day.

Use in patients with impaired renal function (creatinine clearance equal to or less than 30 ml / min)

The maximum daily dose is 12 g. The course of treatment is 5-14 days (with severe processes, the treatment period can be extended). After the temperature normalizes and other pathological symptoms disappear, treatment is continued for another 48 hours.

Dosing in special cases

Uncomplicated gonorrhea – 1,5 g once.

Prevention of postoperative infections – 1,5-3 g, depending on the degree of infectious risk, during anesthesia; then within 24 hours after surgery - at the same dose every 6-8 hours.

Preparation of solutions

To the contents of the 750 mg or 1500 mg vial, add 2 ml or 4 ml of a 1% lidocaine hydrochloride solution, respectively.

When treating children under the age of 1 year, do not dissolve the drug in a solution of lidocaine hydrochloride. Water for injection can be used as a solvent.

The drug diluted with lidocaine hydrochloride should not be administered intravenously.

Special instructions and precautions

Before using the drug, consult a doctor.

In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.

Perhaps the development of superinfection due to the growth of microflora insensitive to the drug, which requires a corresponding change in antibiotic therapy.

In the treatment of patients with sepsis, the development of a bacteriolysis reaction (the Jarisch-Herxheimer reaction) is possible.

With prolonged use of the drug, it is necessary to periodically monitor the functions of the kidneys, liver and complete blood count.

Before starting therapy, a thorough history should be taken for previous allergic reactions to beta-lactam antibiotics. With the development of an allergic reaction, the drug should be immediately discontinued.

When using the drug, both against the background of taking it and 2-3 weeks after stopping treatment, diarrhea caused by Clostridium difficile (pseudomembranous colitis) may develop. In mild cases, it is sufficient to cancel treatment and use ion-exchange resins (colestyramine, colestipol), in severe cases, compensation for the loss of fluid, electrolytes and protein, the appointment of vancomycin or metronidazole is indicated. Do not use drugs that inhibit intestinal motility.

When using ampicillin + sulbactam (as well as other antibiotics), superinfection may develop, which requires discontinuation of the drug and the appointment of appropriate treatment.

It is possible to detect a false positive Coombs test, a false positive test for glucose in the urine (using the Benedict or Fehling method).

In the treatment of patients with sepsis, the development of a bacteriolysis reaction (Yarish Herxheimer reaction) is possible.

Prescribe with caution: bronchial asthma, pollinosis and other allergic diseases, liver failure, chronic diseases of the gastrointestinal tract in history, previously transferred colitis associated with the use of antibacterial drugs, impaired renal function, old age.

Influence on the ability to drive vehicles and mechanisms

Given the likelihood of side effects from the central nervous system, care should be taken when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Use during pregnancy or lactation

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

Use during lactation (breastfeeding) is contraindicated.

Interaction with other medicinal products

When used simultaneously with indirect anticoagulants, ampicillin + sulbactam potentiates their action; reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which para-aminobenzoic acid and ethinyl estradiol are formed (risk of "breakthrough" bleeding).

With simultaneous use with aminoglycosides, a pronounced synergism of bactericidal action against gram-positive and gram-negative bacteria is observed.

Pharmaceutically incompatible with blood products or protein hydrolysates, aminoglycosides. With simultaneous use of the drug with aminoglycosides, drugs should not be mixed in one syringe or one infusion system; when administered intramuscularly, inject into different parts of the body.

Probenecid, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs reduce the tubular secretion of ampicillin and sulbactam and increase their half-life.

Diuretics reduce the clearance of penicillins.

Bactericidal antibiotics (including cephalosporins, cycloserine, vancomycin, rifampicin, aminoglycosides) have a synergistic effect; bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines) - antagonistic.

The simultaneous use of ampicillin and allopurinol increases the risk of skin rash.

Side effect

From the digestive system: nausea, vomiting, loss of appetite, diarrhea, increased activity of "liver" transaminases, pseudomembranous enterocolitis.

On the part of the hematopoietic organs: hemolytic anemia, decreased hemoglobin, thrombocytopenia, eosinophilia, leukopenia, neutropenia, lymphopenia, lymphocytosis, thrombocytosis, monocytosis, false positive Coombs test.

From the nervous system: drowsiness, malaise, headache.

Laboratory indicators: azotemia, increased plasma urea concentration, hypercreatininemia, decreased serum protein content, leukocyturia, cylindruria.

Allergic reactions: urticaria, skin flushing, pruritus, angioedema, rhinitis, conjunctivitis, fever, arthralgia, anaphylactic shock, Stevens-Johnson syndrome, erythema multiforme exudative.

Local reactions: with I/M administration - soreness at the injection site.

Other: malaise, chest pain, sore throat, dysuria, edema, bleeding, with long-term treatment - candidiasis, the development of superinfection.

If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: nausea, vomiting, diarrhea, fluid and electrolyte imbalance (as a result of vomiting and diarrhea), neurological disorders up to seizures (especially in patients with impaired renal function).

Treatment: symptomatic therapy, in severe cases - hemodialysis.

Storage conditions

Store at a temperature not exceeding 30°C.

Keep out of the reach of children!

Shelf life

3 years. Do not use after the expiry date stated on the packaging.

Vacation conditions

Dispensed by prescription.

Release form

Sultanid 750 mg

1 bottle with powder for solution preparation and 1 ampoule with solvent together with instructions for use in a cardboard box.

Sultanid 1500 mg

1 bottle with powder for solution preparation and 1 ampoule with solvent together with instructions for use in a cardboard box.