BAKTOSID 1,5g

INSTRUCTIONS FOR USE OF THE MEDICINE



International nonproprietary name: Ampicillin/ Sulbactam

Ingredients: ampicillin/sulbactam.

Active ingredient: each bottle contains ampicillin sodium/sulbactam sodium in a ratio of 500 mg/250 mg or 1000 mg/500 mg.

Excipient:

Description: white powder and solvent in an ampoule for the preparation of a solution for intramuscular and intravenous injections in a glass bottle, sterile pyrogen preparation.

Pharmacotherapeutic group: Beta-lactamase inhibitor and combination drug of a broad-spectrum penicillin antibiotic.

ATS code: JO1CR01

Pharmacological properties:

Pharmacodynamics:

Semi-synthetic broad-spectrum ampicillin, a derivative of 6-aminopenicillic acid, has a bactericidal effect on gram(+) and gram(-) aerobes, as well as anaerobes. 
Ampicillin has a bactericidal effect due to inhibition of the mucopeptide layer of the microbial cell. Ampicillin is not resistant to the action of β-lactamases, 
therefore it is broken down by some microbes that secrete β-lactamases and loses its effect. Sulbactam does not have a bactericidal effect,
 inhibits the enzyme β-lactamase and enhances the effect of ampicillin on resistant strains.

Ampicillin/sulbactam in vitro β-lactamase-secreting and non-secreting Staphylococcus aureus, Staphylococcus faecalis, Streptococcus pneumoniae, 
Streptococcus pyogenes, Streptococcus viridans, Haemophilus influenzae, Haemophilus parainfluenzae, Neisseria meningitidis, Branhamella catarrhalis,
 Escherichia coli, K lebsiella s. , Neisseria gonorrhoeae, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Morganella morgani, Citobacter spp.
Enterobacter spp., Clostridium spp., non-spore-forming anaerobes, for example, has a high bactericidal effect against microorganisms such as Peptococcus spp.,
 Bacteroides spp., as well as Bacteroides fragilis. Gram-positive bacteria that secrete penicillinase are resistant to ampicillin/sulbactam.

Pharmacokinetics:

Penetrates into most tissues and body fluids; With inflammation, the permeability of the cerebrospinal fluid to the cerebrospinal fluid increases.
 Ampicillin and sulbactam accumulate in the blood in high concentrations after intravenous and intravenous administration. 
28% of ampicillin and 38% of sulbactam are bound to blood proteins. T1/2 is 1 hour. 70-80% is excreted unchanged by the kidneys,
 as well as with bile and breast milk. Sulbactam undergoes almost no metabolic changes, is excreted by the kidneys and only 25% in the form of metabolites.

ndications for use:

- In the treatment of diseases caused by microorganisms sensitive to ampicillin/sulbactam:

- infections of the skin and soft tissues (staphylo-streptoderma);

- infections of the bones and musculoskeletal system;

- Intra-abdominal infections (cholecystitis, pancreatitis, etc.)
 
- gynecological infections (salpingoophoritis, endometritis, inflammatory cysts);

- infections present during pregnancy (amnionitis and chorionitis, turbidity of amniotic fluid);

- Pyelonephritis during pregnancy;

- respiratory tract infections (laryngitis, pharyngitis, tracheitis, pneumonia);

- infections of the urinary system (pyelonephritis, cystitis);

- bacterial sepsisemia;

- gonococcal infections;

- Used to prevent infection of surgical operations, as well as to prevent sepsis after abortion and cesarean section.

Contraindications:

- cases of allergies to ampicillin, sulbactam and other beta-lactam antibiotics;

- Infectious mononucleosis, lymphocytic leukemia;

- Severe renal and liver failure.

Special instructions and precautions:


Hypersensitivity reactions may occur during treatment with ampicillin/sulbactam. If an allergic reaction is observed, the use of the drug 
is stopped, and in such cases antihistamines and corticosteroids are used. Despite the fact that penicillins do not have a toxic effect, during long-term treatment 
it is necessary to monitor the function of vital organs (kidneys, liver, hemolytic system).

interaction with other drugs:

The risk of skin reactions increases when taken together with allopurinol. The combined use of ampicillin with aminoglycosides significantly reduces the effect of both drugs. 
Penicillins enhance the effect of anticoagulants due to their effect on platelet aggregation and hemocoagulation parameters.

When used together with oral contraceptives and estrogen-containing drugs, the effectiveness of these drugs is reduced and can lead to unplanned pregnancy. 
Ampicillin may increase the toxicity of methotrexate by reducing its clearance. Probenecid may reduce the renal clearance of ampicillin and sulbactam, 
increase ampicillin serum concentrations and increase the risk of intoxication.


Use during pregnancy and lactation:

Bactocide is used with caution during pregnancy and lactation. The use of the drug is possible only in cases where it is absolutely necessary.

Impact on the ability to drive a vehicle and other potentially dangerous mechanisms:

Does not affect.

Directions for use and dosage:

Adults: daily dose ranges from 1.5 g (1 g ampicillin/0.5 g sulbactam) to 12 g (8 g ampicillin/4 g sulbactam). The maximum daily dose of Sulbactam is 4 g. 
Depending on the severity of the disease, the drug is administered every 6-8 hours. For moderate infections, the drug is used every 12 hours.

In renal failure, the excretion of ampicillin and sulbactam is altered, but plasma levels remain unchanged. In such cases, the following scheme is used:

After the temperature normalizes, treatment should be continued for 48 hours. Typically, treatment is carried out for 5-14 days, but in case of severe disease, the treatment period is extended.

In order to prevent infection of a surgical operation, 1.5-3 g is administered every 6-8 hours for 24 hours during anesthesia to create a high concentration of the drug in the tissues. 
If used with an aminoglycoside, the two drugs should be prepared separately and administered to different parts of the body.

Children and infants: the daily dose is 150 mg/kg every 6-8 hours; for premature babies and newborns - 150 mg/kg every 12 hours.

After dissolution, the drug is injected into the deep muscle layer; the solution should be used within 1 hour after preparation. Bactoside powder is dissolved in a solution of
 lidocaine hydrochloride for intramuscular injection and in sterile water for intravenous injection.

From the gastrointestinal tract: darkening of the upper surface of the tongue, gastritis, diarrhea, enterocolitis, pseudomembranous colitis, nausea, vomiting;

From the skin and soft tissues: skin rash, itching, erythema multiforme, urticaria;

From the hematopoietic system: agranulocytosis, hematocrit, decrease in the number of erythrocytes, leukocytes or increase in lymphocytes, eosinophils, platelets. 
These changes are transient, and blood counts return to normal after stopping the drug.

According to laboratory indicators: increased activity of ALT and AST, increased LDH, hyperbilirubinemia;

Rarely: convulsions, interstitial nephritis.

If unexpected effects occur, consult your doctor!

Overdose:

Because beta-lactam antibiotics accumulate in high concentrations in the cerebrospinal fluid, neurological reactions, including seizures, may occur.

Release form:

BACTOSID is packaged in a cardboard box with an insert containing 2 ml and 3.5 ml of solvent (0.5% solution of lidocaine hydrochloride) in bottles with powder of 750 and 1000 mg and 1 ampoule, respectively, for the preparation of a solution for intramuscular injection.

Best before date:

3 years

Do not use after expiration date.

Conditions for dispensing from the pharmacy:

Dispensed on the basis of a prescription.

Manufacturer:

Ulaqay ilaç, Türkiye.