SULTASYN

Active material: Ampicillin, Sulbactam
When ATH: J01CR01
CCF: Antibiotics penicillin with a broad-spectrum beta-lactamase inhibitor
ICD-10 codes (testimony): A02, A03, A38, A39, A40, A41, A46, A54, G00, H66, i33, J01, J03, J15, J20, J32, J35.0, J42, J85, J86, K65.0, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, L30.3, M00, M86, N10, N11, N15.1, N30, N34, N41, N70, N71, N72, N73.0, Z29.2
When CSF: 06.01.02.04.02
Manufacturer: Synthesis of (Russia)

Pharmaceutical form, composition and packaging

Powder for solution for I / O, and the / m white or white with a yellowish tint, hygroscopic.

Vials 10 ml (1) – packs cardboard.
Vials 10 ml (50) – packs cardboard.

Powder for solution for I / O, and the / m white or white with a yellowish tint, hygroscopic.

Vials 10 ml (1) – packs cardboard.
Vials 10 ml (50) – packs cardboard.

Pharmacological action

Bactericidal broad-spectrum antibiotic, is acid. Blocks the synthesis of peptidoglycan cell walls of microorganisms.

Ampicillin - a semisynthetic antibiotic penicillin group of broad-spectrum, which acts bactericidal, inhibiting bacterial cell wall synthesis, destroyed by the β-lactamase, is acid.

Sulbactam – ингибитор b-лактамаз; not having antibacterial activity, inhibit β-lactamase and therefore the ability to operate the drug becomes resistant to (продуцирующие b-лактамазы) strains.

Sultasyn^® It is active against most Gram-positive microorganisms: Staphylococcus spp., Streptococcus spp.; Gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Escherichia coli, Some strains of Klebsiella spp.; Anaerobic bacteria: Bacteroides spp. (incl. Bacteroides fragilis), Clostridium spp., Peptococcus spp., Peptostreptococcus spp.

Activity against non-producing β-lactamase activity pathogens not exceed one ampicillin.

Preparation are not active against метициллин-резистентных штаммов Staphylococcus spp., all strains of Pseudomonas aeruginosa, Most strains of Klebsiella spp., Enterobacter spp.

Pharmacokinetics

Absorption and distribution

After the / m and / in the introduction are achieved high levels of ampicillin and sulbactam levels. Both components are well into tissues and body fluids, pass the placental barrier, excreted in breast milk. When inflammation of the meningeal membranes of the penetration of the two components of the drug in the cerebrospinal fluid increases dramatically.

Metabolism and excretion

Ampicillin and sulbactam hardly undergo metabolic transformations.

T_1/2 ampicillin and sulbactam is about 1 no, derived primarily unchanged in the urine (70-80%), and with bile. In the form of metabolites derived about 25% product.

Testimony

Bacterial infections of various localization, caused by susceptible pathogens:

- Respiratory infections (incl. pneumonia, lung abscess, chronic bronchitis, empyema);

- Infections of upper respiratory tract (incl. sinusitis, tonsillitis, otitis media);

- Infections of the urinary tract and genital organs (incl. pyelonephritis, pyelitis, cystitis, uretrit, prostatitis, endometritis);

- Infections of the biliary tract (incl. cholecystitis, kholangit);

- Infections of the skin and soft tissues (incl. mug, impetigo, secondarily infected dermatitis);

- Infections of the digestive tract (incl. dysentery, salmonellosis, salmonellonositelstvo);

- Bone and joint infections;

- Sepsis;

- Bacterial endocarditis;

- Meningitis;

- Peritonitis;

- Scarlet fever;

- Gonococcal infection.

Prevention of postoperative complications in surgery of the abdomen and pelvis.

Dosage regimen

The drug is administered / m or / (drip at a rate of 60-80 drops / min, spray – slowly, during 3-5 m). In / injected over 5-7 days, then, if necessary, continuation of treatment, go to the / m introduction.

The following are the total doses of ampicillin and sulbactam (in relation to 2:1).

Adults at less severe infections appointed 1.5-3 g / day 2 introduction; at to moderate – 3-6 g / day 3-4 introduction; at heavy current – 12 g / day 4 introduction.

At uncomplicated gonorrhea – 1.5 g once.

To prevention of surgical site infections – 1.5-3 g at ​​induction of anesthesia; then for 24 hours after surgery – at the same dose every 6-8 no.

Babies drug administered in a daily dose rate 150 mg / kg body weight (100 mg / kg of ampicillin and 50 mg / kg of sulbactam); multiplicity – 3-4 times / day.

Infants under the age of 1 weeks and premature babies every drug prescribed 12 no.

A course of treatment – 5-14 days (if necessary, it may be extended). After normalization of the temperature and the disappearance of symptoms continue treatment for another 48 no.

At chronic renal failure (CC<30 ml / min) necessary to increase the intervals between doses of the drug.

Terms of preparation of the solution

The solution for parenteral administration is prepared immediately before use.

For the / m of the contents of the vial 0.75 g was added 2 ml, a vial 1.5 g – 4 ml water for injection, or 0.5% procaine solution (novocaine), or isotonic sodium chloride solution. For the / m is acceptable dilution 0.5% lidocaine.

For / in the single dose dissolved in isotonic sodium chloride solution or 5% dextrose (Glucose) in a volume of 10 ml (for / in bolus) to 100-200 ml (for / in the drip).

Side effect

From the digestive system: nausea, vomiting, anorexia, increase in liver transaminases; rarely - pseudomembranous colitis.

CNS: drowsiness, malaise, headache.

From the side of hematopoiesis: anemia, leukopenia, thrombocytopenia.

Allergic reactions: hives, flushing of the skin, angioedema, rhinitis, conjunctivitis, fever, arthralgia, eozinofilija; rarely – anaphylactic shock.

From the laboratory parameters: azotemia, increase of urea, giperkreatininemiя.

Local reactions: when i / m administration – tenderness at the injection site; at / in – phlebitis.

Other: long-term treatment – superimposed infection, caused by resistant microorganisms,, candidiasis.

Contraindications

- Hypersensitivity to the drug and other antibiotics of the penicillin group;

- Infectious mononucleosis;

- Lactation (breast-feeding).

FROM caution should be prescribed with hepatic and / or renal insufficiency, pregnancy.

Pregnancy and lactation

Precautions should be prescribed Sultasin^® Pregnancy. If necessary, the appointment during lactation should decide the issue of termination of breastfeeding.

Cautions

Patients, with hypersensitivity to penicillins, possible cross-allergic reaction cephalosporin antibiotic.

In exchange treatment is necessary to control the state functions of blood, liver and kidneys.

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

When treating patients with sepsis may develop reactions bacteriolysis (Jarisch-Herxheimer).

Overdose

With the introduction of Sultasina^® in very high doses may develop cerebral (epileptic) seizures.

Drug Interactions

Bactericidal antibiotics (incl. aminoglikozidy, cephalosporins, cycloserine, vancomycin, rifampicin) while the use of Sultasinom^® show synergy; bacteriostatic drugs (makrolidы, chloramphenicol, lincosamides, tetracikliny, sulfonamides) – antagonizm.

Sultasyn^® It increases the efficiency of indirect anticoagulants (suppressing the intestinal microflora, It reduces the synthesis of vitamin K and prothrombin index); reduces the effectiveness of oral contraceptives, preparations, during metabolism which is formed PABA, ethinyl estradiol (the risk of breakthrough bleeding).

Diuretic, allopurinol, phenylbutazone, NSAID drugs, reduce tubular secretion, increase the concentration of the components Sultasina^®.

Allopurinol increases the risk of skin rashes.

Pharmaceutical interaction

Sultasyn^® pharmaceutically incompatible with aminoglycoside antibiotics, blood products or protein hydrolysates.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 20 ° C. Shelf life – 2 year.