about the product
Ampicillin + Sulbactam is a powder for the preparation of a solution for intravenous and intramuscular administration, externally it is a white or almost white crystalline powder.
Solvents:
Solvents:
- Novocaine, solution for injection, 5 mg/ml. Transparent, colorless or slightly colored liquid.
- Water for injection, solvent for preparation of dosage forms for injection. 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
ampicillin + [sulbactam]
Pharmacotherapeutic group
Antibacterial
use
Always use the drug in full accordance with the recommendations of your doctor. If in doubt, consult your doctor.
Recommended dose The total doses of ampicillin and sulbactam are shown below (in a 2:1 ratio).
Adults For the treatment of moderate infections, the recommended dose is 1.5 g every 6 hours. For severe infections, 3 g every 6 hours.
The maximum daily dose of sulbactam should not exceed 4 g, which corresponds to a daily dose of 12 g. Gonorrhea:
For uncomplicated gonorrhea – 1.5 g once.
Prevention of postoperative infections:
For the prevention of postoperative infection – 1.5–3 g during anesthesia, then within 24 hours after surgery at the same dose every 6-8 hours.
Patients with impaired renal function:
The doctor will prescribe the dose of the drug depending on the degree of impairment of your kidney function. The recommended dosage regimen is 1.5–3 g every 6-8 hours, every 12 hours or every 24 hours.
Use in children and adolescents Children over 12 years of age and weighing more than 40 kg:
The dosage regimen for children over 12 years of age and weighing more than 40 kg does not differ from the dosage regimen for adults.
Children over 1 month and under 12 years of age with a body weight of less than 40 kg:
The drug is administered at a dose of 150 mg / kg per day, which is divided into 3-4 injections. In case of severe infection, the dose can be increased to 300 mg/ kg / day.
Children aged from 7 days to 28 days:
The drug is prescribed at a dose of 150 mg / kg per day, divided into 3 intravenous injections.
Premature newborns and infants of the first week of life:
The daily dose of the drug is 75 mg / kg, which is divided into two injections.
Children with renal insufficiency:
In children with renal insufficiency (creatinine clearance less than 30 ml / min), the drug is administered in regular single doses (50-75 mg / kg), increasing the intervals between injections, as indicated in adults.
Route and/or method of administration Intravenously (IV) (jet or drip) and intramuscularly (i / m). The method of administration depends on the severity of the infection and the chosen dose.
Intramuscularly, the drug is injected deep into areas of the body with a pronounced muscle layer, for example, into the buttock.
With intravenous injection, the drug is administered slowly for 3-5 minutes. Intravenous infusion is administered at a rate of 60-80 drops per minute.
Ampicillin + Sulbactam solution can be injected directly into a vein or into an infusion tube if you are receiving infusion therapy.
Recommended dose The total doses of ampicillin and sulbactam are shown below (in a 2:1 ratio).
Adults For the treatment of moderate infections, the recommended dose is 1.5 g every 6 hours. For severe infections, 3 g every 6 hours.
The maximum daily dose of sulbactam should not exceed 4 g, which corresponds to a daily dose of 12 g. Gonorrhea:
For uncomplicated gonorrhea – 1.5 g once.
Prevention of postoperative infections:
For the prevention of postoperative infection – 1.5–3 g during anesthesia, then within 24 hours after surgery at the same dose every 6-8 hours.
Patients with impaired renal function:
The doctor will prescribe the dose of the drug depending on the degree of impairment of your kidney function. The recommended dosage regimen is 1.5–3 g every 6-8 hours, every 12 hours or every 24 hours.
Use in children and adolescents Children over 12 years of age and weighing more than 40 kg:
The dosage regimen for children over 12 years of age and weighing more than 40 kg does not differ from the dosage regimen for adults.
Children over 1 month and under 12 years of age with a body weight of less than 40 kg:
The drug is administered at a dose of 150 mg / kg per day, which is divided into 3-4 injections. In case of severe infection, the dose can be increased to 300 mg/ kg / day.
Children aged from 7 days to 28 days:
The drug is prescribed at a dose of 150 mg / kg per day, divided into 3 intravenous injections.
Premature newborns and infants of the first week of life:
The daily dose of the drug is 75 mg / kg, which is divided into two injections.
Children with renal insufficiency:
In children with renal insufficiency (creatinine clearance less than 30 ml / min), the drug is administered in regular single doses (50-75 mg / kg), increasing the intervals between injections, as indicated in adults.
Route and/or method of administration Intravenously (IV) (jet or drip) and intramuscularly (i / m). The method of administration depends on the severity of the infection and the chosen dose.
Intramuscularly, the drug is injected deep into areas of the body with a pronounced muscle layer, for example, into the buttock.
With intravenous injection, the drug is administered slowly for 3-5 minutes. Intravenous infusion is administered at a rate of 60-80 drops per minute.
Ampicillin + Sulbactam solution can be injected directly into a vein or into an infusion tube if you are receiving infusion therapy.
Help
Package leaflet
Ampicillin is an antibiotic from the penicillin group: it kills bacteria that cause a number of infections. Some bacteria are able to produce special proteins (enzymes) called beta-lactamases that break down ampicillin.
Sulbactam blocks the action of such enzymes (beta-lactamase inhibitor) and thus prevents ampicillin degradation.
Ampicillin + Sulbactam is used to treat infectious and inflammatory diseases caused by microorganisms sensitive to the drug in adults and children, starting from the newborn period.:
• infections of the ear, throat and nose (including inflammation of the paranasal sinuses, tonsillitis (inflammation of the tonsils), inflammation of the middle ear or otitis media);
• respiratory infections (including bronchitis (inflammation of the bronchi), pneumonia (pneumonia), lung abscess (purulent-inflammatory disease) and pleural empyema (accumulation of pus in the pleural cavity of the lungs));
• infectious endocarditis (a special inflammatory heart disease);
• meningitis (inflammation of the membranes of the brain or spinal cord);
• sepsis (a severe infectious disease that develops when infectious agents or their toxins enter the bloodstream);
• cholecystitis (inflammation of the gallbladder), cholangitis (inflammation of the bile ducts), peritonitis (inflammation of the abdominal cavity), abdominal abscess (purulent inflammation) and other intra-abdominal infections;
• urinary tract infections (pyelonephritis (inflammatory kidney disease), pyelitis (infectious and inflammatory disease of the renal pelvis));
• infectious and inflammatory diseases of the pelvic organs, including salpingitis (inflammation of the fallopian tubes), salpingo-oophoritis (inflammatory process of the uterine appendages localized in the ovaries and tubes), tubo-ovarian abscess (melting of the ovary and fallopian tube with the formation of a single cavity filled with purulent contents), endometritis (inflammation of the uterine mucosa), pelvioperitonitis (pelvic peritoneum inflammation) and other genital tract infections;
• infections of the skin and soft tissues (erysipelas (an infectious skin disease), abscess (limited purulent inflammation of tissues), phlegmon (unlimited purulent inflammation), wound and postoperative infection);
• infections of bones and joints.
The drug can also be used before, during and after surgical procedures for
prevention of infectious complications.
Symptoms of overdose: neurological disorders up to seizures (especially if you have impaired kidney function), nausea, vomiting, diarrhea (diarrhea), a violation of the ratio of salts and fluids in the body (water-electrolyte balance).
Like all medications, Ampicillin+ Sulbactam can cause undesirable reactions, but they do not occur in everyone. Some adverse reactions can be serious and life-threatening.
Discontinue use of Ampicillin + Sulbactam and seek immediate medical attention if one of the following serious adverse reactions occurs:
• swelling of the face and oral mucosa, may spread to the larynx, causing difficulty breathing, hoarseness of voice and barking cough (Quincke's edema);
• shortness of breath, wheezing or difficulty breathing, swelling of the lips, tongue and throat or body, rash, itching, fainting or difficulty swallowing, which may be symptoms of a severe allergic reaction to the drug (anaphylactic shock);
• fever and malaise, followed by a widespread rash on the skin and mucous membranes in the form of spots, blisters, crusts; detachment of skin areas (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• diarrhea (loose stools 3 or more times a day, possible admixture of blood and mucus), abdominal pain
by type of cramps, fever (pseudomembranous colitis).
(For more information about all possible adverse reactions, see the leaflet)
Do not use Ampicillin + Sulbactam:
- if you are allergic to ampicillin and sulbactam, other beta-lactam antibiotics (other penicillins, cephalosporins, carbapenems);
- if you have a viral disease, infectious mononucleosis (including if you have a measles-like rash);
- if you have a malignant blood disease (lymphocytic leukemia);
- if you have the last stage of chronic renal failure; if you are allergic to procaine (novocaine), lidocaine, used as a solvent preparation. Before injecting Ampicillin + Sulbactam into a muscle using lidocaine or procaine, your doctor should rule out any contraindications to these drugs.
Tell your doctor that you are using, have recently used, or may start using any other medications. In particular, tell your doctor if you are receiving any of the medications listed below.:
-
drugs that prevent blood clotting (indirect anticoagulants). Ampicillin + Sulbactam enhance the effect of these drugs;
- oral contraceptives (for oral administration). Ampicillin + Sulbactam reduce the effectiveness of oral contraceptives; medicinal products that produce paraaminobenzoic acid during metabolism (for example, benzocaine, procaine, procainamide). Ampicillin + Sulbactam reduce the effectiveness of such drugs, as well as increase the risk of bleeding (the so-called "breakthrough bleeding");
- other antibiotics, some of them may enhance the therapeutic effect of Ampicillin + Sulbactam, while others weaken; medications for the treatment of gout (for example, probenecid, allopurinol). The simultaneous use of ampicillin and allopurinol increases the risk of skin rash; painkillers and antipyretics are nonsteroidal anti–inflammatory drugs (for example, phenylbutazone). They slow down the elimination of ampicillin and sulbactam from the body, which may lead to the development of adverse reactions (see "Possible adverse reactions"); Diuretics (diuretics) – reduce the rate of penicillin excretion.
Registration certificate holder
JSC Biochemist, Russian Federation
430030, Republic of Mordovia, Saransk, Vasenko str., 15A
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
Organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., 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
Store at a temperature not exceeding 25 ° C. Store in the original packaging (pack/box).
When using Ampicillin + Sulbactam, undesirable reactions from the central nervous system are possible, so be careful when driving vehicles and when engaging in other potentially dangerous activities that require increased concentration and responsiveness.
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