Sultasin - Instructions For Use Of The Antibiotic, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sultasin

Sultasin: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. In case of impaired renal function
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Sultasin

ATX code: J01CR01

Active ingredient: ampicillin + sulbactam (ampicillin + sulbactam)

Producer: Sintez, JSC (Russia)

Description and photo update: 10.07.2018

Sultasin is an antibacterial drug (semi-synthetic penicillin + β-lactamase inhibitor).

Release form and composition

The dosage form of Sultasin is a powder for the preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration: hygroscopic, white with a yellowish tinge or white (in 10 ml vials; 1 vial in a cardboard box).

Content of active substances in 1 powder bottle:

• ampicillin (in the form of sodium salt) - 0.5 or 1 g;
• sulbactam (in the form of sodium salt) - 0.25 or 0.5 g

Pharmacological properties

Pharmacodynamics

Sultasin is a broad-spectrum bactericidal antibacterial agent. The drug is acid-resistant, blocks the synthesis of peptidoglycan of the cell wall of microorganisms. Its active principle is ampicillin (a semi-synthetic penicillin broad-spectrum antibiotic that destroys β-lactamases).

Sulbactam, the second active substance of the drug, has no antibacterial activity (the exception is Neisseriaceae Hacinetobacter), inhibits β-lactamases, due to which it acts on resistant strains (producing β-lactamases).

The antibiotic Sultasin is active against the following aerobes / anaerobes:

• gram-positive aerobes: Listeria monocytogenes, Streptococcus spp. viridans groups, Streptococcus ruogenes, Streptococcus pneumoniae (including penicillin-resistant strains), Enterococcus faecalis, Staphylococcus saprophyticus (strains producing and non-producing β-lactamases), Staphylococcus β-lactamase producing and non-producing strains β-lactamase, Staphylococcus β-lactamase producing and non-producing β-lactamase strains, Staphylococcus adensitis epidermidis (producing and lactating strains) β-lactamase strains);
• gram-negative aerobes: Neisseria gonorrhoeae (β-lactamase-producing and non-β-lactamase-producing strains); Morganella morganii, Providencia stuartii, Providencia rettgeri, Proteus vulgaris, Proteus mirabilis, Klebsiella spp., Escherichia coli, Moraxella catarrhalis (β-lactamase-producing and non-β-lactamase-producing strains), Haemophilus influenzae (including ampicillin resistant strains);
• anaerobes: Bacteroides spp., including Bacteroides fragilis, Peptostreptococcus spp., Peptococcus spp., Clostridium spp. (the exception is Clostridium difficile).

Resistant to Sultasin are mycoplasmas, Chlamydia spp., Clostridium difficile, Mycobacterium spp., Pseudomonas aeruginosa, Citrobacter spp., Most strains of Enterobacter spp., Methicillin-resistant Staphylococcus spp.

Pharmacokinetics

Characteristics of ampicillin and sulbactam:

• absorption and distribution: after intravenous and intramuscular administration, their high concentrations in the blood are achieved; penetrate into most body fluids and tissues, are excreted in breast milk; the permeability to the cerebrospinal fluid increases sharply against the background of inflammation;
• metabolism and excretion: the half-life (T1 / 2) is 1 hour; 70-80% are excreted through the kidneys and bile, mainly unchanged; Sulbactam hardly undergoes metabolic transformations and is mainly excreted unchanged by the kidneys and about 25% in the form of metabolites.

Indications for use

• infectious and inflammatory pathologies caused by microorganisms sensitive to the drug: sepsis, meningitis, septic endocarditis; joint and bone infections; an abdominal abscess, peritonitis (infections of the gastrointestinal tract); secondarily infected dermatoses, impetigo, erysipelas (infections of the skin and soft tissues); cholangitis, cholecystitis (biliary tract infections); cervicitis, uncomplicated gonorrhea, urethritis, cystitis, pyelitis, pyelonephritis (infections of the urinary tract and genitals); ENT infections, including otitis media, tonsillitis, sinusitis, sore throat; respiratory infections, including chronic bronchitis and pneumonia;
• postoperative complications during operations on the pelvic organs and the abdominal cavity (for prevention).

Contraindications

Absolute:

• Infectious mononucleosis;
• period of breastfeeding;
• individual intolerance to the components contained in the drug.

Relative (diseases / conditions in the presence of which the appointment of Sultasin requires caution):

• pregnancy;
• hepatic and / or renal failure.

Instructions for the use of Sultasin: method and dosage

A solution prepared from a powder is injected intravenously (at a rate of 60–80 drops per minute) or jet (slowly, over 3-5 minutes) or intramuscularly.

During the first 5–7 days, IV administration of Sultasin is recommended, then (if it is necessary to continue therapy), they switch to IV administration.

Immediately before administration, a solution for parenteral administration is prepared from the powder. If intramuscular administration is expected, add 2 or 4 ml of 0.9% sodium chloride solution, 0.5% procaine or water for injection to the contents of the vial. It is permissible to use a solution of lidocaine 0.5% for dilution.

For intravenous administration, a single dose of Sultasin powder is dissolved in 10-200 ml of a solution of 5% dextrose or 0.9% sodium chloride.

Recommended dosing regimen (total doses of ampicillin and sulbactam in a 2: 1 ratio):

• mild infection: 1.5–3 g per day, divided into 2 injections;
• moderate course of infection: 3-6 g per day, divided into 3-4 injections;
• severe course of infection: 12 g per day, divided into 3-4 injections;
• uncomplicated gonorrhea: single administration of 1.5 g;
• prevention of surgical infections: during anesthesia, 1.5–3 g of the agent is injected, then, within 24 hours after the operation, the same dose is administered every 6–8 hours.

The dose of Sultasin for children is determined on the basis of 0.15 g per 1 kg of body weight (0.1 g of ampicillin and 0.05 g of sulbactam per 1 kg of body weight). The frequency of administration of the agent is 3-4 times a day. In cases of severe infections in children aged 1 month to 12 years (or weighing up to 40 kg), the dose is increased to 0.3 g per 1 kg of body weight per day.

Newborns under the age of 7 days and premature babies are usually prescribed 0.075 g of the drug per 1 kg of body weight per day every 12 hours (0.05 g of ampicillin and 0.025 g of sulbactam per 1 kg of body weight).

The duration of therapy varies from 5 to 14 days and can be extended if necessary. The introduction of Sultasin after the normalization of body temperature and the disappearance of other pathological symptoms continues for another 48 hours.

Side effects

• nervous system: headache, malaise, drowsiness;
• digestive system: pseudomembranous colitis, increased activity of hepatic transaminases, diarrhea, decreased appetite, vomiting, nausea;
• hematopoietic organs and hemostatic system: thrombocytopenia, leukopenia, anemia;
• laboratory parameters: hypercreatininemia, increased urea concentration, azotemia;
• allergic reactions: anaphylactic shock, eosinophilia, arthralgia, fever, conjunctivitis, rhinitis, angioedema, skin hyperemia, urticaria;
• local reactions: with intravenous administration - phlebitis; with i / m - soreness at the injection site;
• others: with long-term therapy - caused by drug-resistant microorganisms, superinfection (candidiasis).

Overdose

The main symptoms: diarrhea, vomiting, nausea, imbalance in water and electrolyte balance (as a result of diarrhea and vomiting), manifestation of toxic effects on the central nervous system (especially against the background of renal failure).

Therapy: symptomatic treatment; excreted by hemodialysis.

special instructions

With hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibacterial agents may develop.

Monitoring the state of the kidney, liver and hematopoietic organs is required in cases of course therapy with Sultasin.

One should take into account the likelihood of developing superinfection due to the growth of microflora insensitive to the drug, which requires a corresponding change in antibacterial treatment.

In patients with bacteremia during the period of application of Sultasin, bacteriolysis reactions (Jarisch-Herxheimer reaction) may develop.

Application during pregnancy and lactation

Sultasin is contraindicated during lactation; during pregnancy, it is prescribed with caution.

With impaired renal function

The drug is prescribed with caution in renal failure. In cases of impaired renal function and a decrease in creatinine clearance below 30 ml per 1 minute, it is advisable to increase the interval between Sultasin injections to 12-24 hours.

For violations of liver function

The antibiotic Sultasin is prescribed with caution to patients with hepatic insufficiency.

Drug interactions

According to the instructions, Sultasin is pharmaceutically incompatible with aminoglycosides, protein hydrolysates or blood products. If it is prescribed in combination with aminoglycosides, the drugs are injected into different areas and the interval between injections is observed to be 1 hour (at least).

Bacteriostatic antibiotics, including tetracyclines, lincosamides, chloramphenicol and macrolides, when combined with the drug, have an antagonistic effect; aminoglycosides, bactericidal antibiotics (including rifampicin, vancomycin, cycloserine, cephalosporins) - synergistic.

The effect of Sultasin on drugs / substances in combination therapy:

• indirect anticoagulants: increases their effectiveness (increases prothrombin time, reduces vitamin K synthesis, suppresses intestinal microflora);
• oral contraceptives, drugs, in the process of metabolism of which para-aminobenzoic acid and ethinyl estradiol are formed: reduces their effectiveness and increases the risk of breakthrough bleeding.

The effect of drugs / substances on penicillins in combined use:

• diuretics: reduce their clearance;
• probenecid, nonsteroidal anti-inflammatory drugs, phenylbutazone, allopurinol: by reducing tubular secretion, their concentration in blood plasma is increased.

With the simultaneous treatment of Sultasin with allopurinol, the risk of developing allergic reactions (skin rash) increases.

Analogs

Sultasin's analogues are Pensilina, Libakcil, Ampicillin + Sulbactam.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 20 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sultasin

According to reviews, Sultasin is an affordable and effective broad-spectrum drug.

The price of Sultasin in pharmacies

The approximate price of Sultasin powder for preparing a solution for intravenous and intramuscular administration (1.5 g in a package) is 42 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!