about the product

Powder for the preparation of a solution for intravenous and intramuscular administration, externally it is a white powder, white with a yellowish or greenish-yellow tinge of color.
Solvent Water for injection is a colorless, transparent, odorless liquid.

Specifications

Name
Ampicillin+Sulbactam
Dosage form
POWDER FOR SOLUTION PREPARATION FOR INTRAVENOUS AND INTRAMUSCULAR ADMINISTRATION
Nosological classification
Antibacterial drugs of systemic action
INN
AMPICILLIN+SULBACTAM
Dosages
500 mg + 250 mg; 1000 mg + 500 mg; 2000 mg+1000 mg
ATC code
J01CR01
Active substance
amoxicillin + [sulbactam]
Pharmacotherapeutic group
Antibacterial

use

Always use the drug in full accordance with the recommendations of the attending physician. If in doubt, consult your doctor.
Recommended dose
The doctor will determine the dosage regimen for you or your child individually, depending on the severity and location of the infection, and the sensitivity of the pathogen.
Adults
The doses are given in terms of amoxicillin.
The usual daily dose of Amoxicillin + Sulbactam for adult patients (over 18 years of age) It is 1000 mg, the frequency of administration is 2-3 times a day.
For the prevention of postoperative infections during operations lasting less than 1 hour during introductory anesthesia, the drug is administered intravenously (IV) at a dose of 1000 mg.
For longer operations – 1000 mg every 6 hours during the day. If there is a high risk of infection, the administration can be continued for several days.
Use in children and adolescents
The dosage regimen for children from 12 to 18 years does not differ from the dosage regimen for adults.
Children from 6 to 12 years: 500 mg 3 times a day.
Children from 2 to 6 years: 250 mg 3 times a day.
Children under 2 years of age: 40-60 mg/kg/day 2-3 times.
In severe infections, especially those caused by gram-negative pathogens, the daily dose of the drug (in terms of amoxicillin) it can be increased to 100 mg/kg/day.
Patients with impaired renal function
Be sure to tell your doctor if you or your child have serious kidney problems. Your doctor may adjust the dose of the drug.
Route and/or method of administration
The drug is administered intramuscularly (i.m.), intravenously (i.v.) by injection or intravenous infusion (a doctor will determine the appropriate route of administration for you).
When administered intravenously, the prepared solution is injected deep into the muscle.
During intravenous injection, the prepared solution is administered slowly.
With intravenous infusion, the prepared solution is slowly drip-fed for 15-60 minutes.
Duration of therapy
The duration of treatment is determined by the doctor. The doctor will continue treatment with the drug for at least another 2-3 days after the disappearance of the clinical symptoms of the disease, but not more than 14 days. In the treatment of infections caused by beta-hemolytic streptococci, the drug is recommended to be used for at least 10 days.

Help

Package leaflet

The drug Amoxicillin + Sulbactam is indicated for use in adults and children from 0 to 18 years of age for:
• Treatment of infectious and inflammatory diseases caused by strains of microorganisms sensitive to amoxicillin:
− infections of the upper respiratory tract and ENT organs (acute and chronic sinusitis (inflammation of the nasal mucosa), acute and chronic otitis media (inflammation of the ear), pharyngeal abscess (purulent inflammation of the lymph nodes and tissues of the pharyngeal space), tonsillitis (inflammation of the tonsils of the pharynx), pharyngitis (inflammatory disease of the pharynx));> − lower respiratory tract infections (acute bronchitis with bacterial superinfection (repeated infection), chronic bronchitis, pneumonia (pneumonia)); − biliary tract infections (cholecystitis (inflammation of the gallbladder), cholangitis (inflammation of the bile ducts)); − intestinal infections (salmonellosis (intestinal infection caused by the bacterium salmonella)); − infections of the genitourinary system and pelvic organs (pyelonephritis (inflammatory kidney disease), pyelitis (inflammation of the renal pelvis), cystitis (inflammation of the bladder), urethritis (inflammation of the urethra), prostatitis (inflammation of the prostate gland), cervicitis (inflammation of the cervix), salpingitis (inflammation of the fallopian tubes), salpingoophoritis (inflammation of the ovaries and fallopian tubes), tubo-ovarian abscess (acute purulent inflammation of the uterine appendages), endometritis (inflammation of the inner lining of the uterus), bacterial vaginitis (inflammation of the vaginal mucosa), postpartum sepsis (infectious blood poisoning), pelvioperitonitis (severe inflammation in the lower pelvis), gonorrhea (infection of the genitourinary organs, caused by gonococcal bacteria));
− infections of the skin and soft tissues (erysipelas (acute inflammatory infectious skin lesion), impetigo (pustular infectious skin lesion), secondarily infected dermatoses (skin diseases), abscess (purulent inflammation in tissues), phlegmon (acute purulent inflammation in subcutaneous fat), wound infection); − postoperative infections.
• Prevention of infectious and inflammatory diseases in surgery.

Symptoms of overdose
Disorders of the gastrointestinal tract (nausea, vomiting, diarrhea) and impaired sodium, calcium, potassium, and body fluids (impaired water and electrolyte balance).
There are cases of sudden onset of severe renal dysfunction, including with a decrease in urination volume (interstitial nephritis with oliguric renal insufficiency) due to an overdose of amoxicillin. Such drug-induced kidney damage is reversible: kidney function is restored after discontinuation of the drug.
Overdose treatment
Symptomatic. In case of overdose, the doctor will stop the administration of the drug. Amoxicillin and sulbactam can be eliminated from the body by dialysis (a method of purifying blood from toxins).
If you have any questions about the use of the drug, contact your doctor, pharmacy employee, or nurse.

Like all medications, Amoxicillin + Sulbactam can cause undesirable reactions, but they do not occur in everyone.
It is important that you inform your doctor about any adverse reactions that you or your child may have, so that he can take appropriate measures (for example, temporarily suspend or cancel treatment, change the dose and duration of treatment with the drug, and prescribe additional therapy).
Some adverse reactions can be serious and life-threatening.
Tell your doctor immediately if you or your child experience any of the following adverse reactions when using Amoxicillin + Sulbactam: • Severe allergic reactions such as angioedema, respiratory disorders, anaphylactic shock, serum sickness and allergic vasculitis (inflammation of blood vessels due to allergies), the main symptoms of which may be: difficulty breathing, a feeling of lack of air, a feeling of pressure in the chest, rash, itching, swelling of the lips, tongue, face, sudden weakness or other signs of a sharp deterioration in well-being.
• Konis syndrome is the simultaneous appearance of allergic reactions and signs of an acute heart attack: compression or pain in the chest, which can spread to the left arm, lower jaw, under the left shoulder blade; lack of air, dizziness.
• Allergic reactions, mainly leading to severe skin lesions (erythema multiforme exudative, bullous and exfoliative dermatitis, malignant erythema exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (OGEP)). The main symptoms of these diseases are skin rashes all over the body and mucous membranes membranes, soreness, swelling and severe itching, increased body temperature.
Convulsions, the manifestations of which are involuntary twitching of individual parts of the body, tingling, darkening of the eyes, and short-term loss of consciousness is also possible.
• Vomiting and loose stools (diarrhea), as they can lead to dehydration of the body.
• Pseudomembranous colitis, the signs of which are diarrhea, frequent watery stools with mucus and blood, fever, general ill health – weakness, weakness, nausea, vomiting, abdominal pain, which increases before defecation, there may be false urges.

For more information about all possible adverse reactions and the frequency of their occurrence, see the instructions in the leaflet.

Do not use Amoxicillin + Sulbactam if you or your child have:

  • allergy to amoxicillin, sulbactam and penicillins
  • severe allergic reactions (e.g., anaphylaxis) to other beta-lactam antibiotics (e.g., cephalosporins, carbapenems, monobactams)
  • infectious mononucleosis (acute viral infection involving the oropharynx, lymph nodes, spleen, and liver), including the appearance of a crust-like rash (manifested as reddish spots that tend to merge, often occurring on the extremities and places of greatest pressure)
  • ulcerative colitis (chronic inflammation of the colon mucosa)
  • Crohn's disease (a chronic inflammatory disease of the gastrointestinal tract characterized by alternating periods of well-being and acute conditions)
  • herpesvirus infection
  • simultaneous administration of allopurinol (a drug for the treatment of gout) in the presence of skin allergic reactions when using penicillins
  • history of colitis (inflammation of the colon) associated with penicillin use

Tell your doctor if you or your child are taking, have recently taken, or may start taking any other medications.
Your doctor needs to know about the medications you are taking in order to take into account possible adverse reactions that may develop due to the interaction of various medications with Amoxicillin + Sulbactam, and possibly adjust the doses of the medications you are taking.
In particular, tell your doctor if you or your child are using any of the following medications:

  • Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), since when used simultaneously with the drug Amoxicillin + Sulbactam, they enhance each other's effect (synergistic effect).
  • Bacteriostatic antibiotics (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides), since when used simultaneously with the drug Amoxicillin + Sulbactam, they weaken the effect of each other (antagonistic effect).
  • Probenecid (a drug for the treatment of gout), as its use can lead to a prolonged increase in the concentration of amoxicillin in blood plasma.
  • Allopurinol (a drug for the treatment of gout), since the combined use of Amoxicillin + Sulbactam with allopurinol increases the risk of allergic skin reactions.
  • Methotrexate (antitumor drug)Because the drug Amoxicillin + Sulbactam slows down the elimination of methotrexate.
  • Indirect anticoagulants (drugs to reduce blood clotting), since the simultaneous use of the drug Amoxicillin + Sulbactam increases the effectiveness of indirect anticoagulants (monitoring of blood clotting parameters is necessary).
  • Oral contraceptives (drugs to prevent unwanted pregnancy), as the drug Amoxicillin + Sulbactam reduces their effectiveness.

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

The drug should be stored at a temperature not exceeding 25 ° C. Store in the original packaging (pack/box) to protect from light. Store the solvent kit with Water for injection at a temperature not exceeding 25 °C. Store in the original packaging (pack) to protect from light. Do not freeze.

There is no data on the negative effect of the drug Amoxicillin + Sulbactam in recommended doses on the ability to drive a vehicle or work with mechanisms. However, given the likelihood of adverse reactions from the central nervous system, exercise caution when engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.