Pensilina - instructions for use, doses, side effects, contraindications

Description:White or white with yellowish tinge capsules in capsule form, covered with a film membrane, with. risk on both sides; On the fracture, a homogeneous mass of white or almost white color.

Pharmacotherapeutic group:Antibiotic - penicillin semisynthetic + beta-lactamase inhibitor

ATX: & nbsp

J.01.C.R. Combinations of penicillins (including those with beta-lactamase inhibitors)

Pharmacodynamics:

The antibacterial component of the drug is ampicillin - an antibiotic from the group of semisynthetic penicillins, which has a bactericidal effect on sensitive microorganisms during the active propagation phase by inhibiting the biosynthesis of the mucopeptide of the cell wall. Sulbactam does not have clinically significant antibacterial activity (except for Neisseriaceae and Acinetobacter), it is an irreversible inhibitor of most of the major beta-lactamases that are produced by microorganisms resistant to beta-lactam antibiotics. Sulbactam also binds to certain penicillin-binding proteins, so some strains are more sensitive to the combination than to a single beta-lactam antibiotic.

Ammiside is active against a wide range of Gram-positive and Gram-negative bacteria, including Staphylococcus aureus and Staphylococcus epidermidis (including penicillin-resistant and some methicillin-resistant strains); Streptococcus pneumoniae, Streptococcus faecalis and other streptococci, Haemophilus influenzae and Haemophilus parainfluenzae (strains producing and not producing beta-lactamases), Branhamella catarrhalis, Escherichia coli, Klebsiella spp., Proteus spp. (indole-positive and indolotric), Morganella morganii, Citrobacter spp. and Enterobacter spp., Neisseria meningitidis and Neisseria gonorrhoeae; anaerobes, including Bacteroides fragilis, Peptococcus spp., Peptostreptococcus spp. and species close to it.

Pharmacokinetics:

Ammiside is well absorbed when taken orally, without deteriorating in the acidic environment of the stomach. Penetrates into most tissues and body fluids. Poorly penetrates the blood-brain barrier. It is excreted mainly by the kidneys, and very high concentrations of the unchanged antibiotic, as well as bile and breast milk, are created in the urine.

Ammiside does not cumulate during repeated administration, which makes it possible to apply it for a long time in large doses.

Indications:

Infectious-inflammatory diseases caused by sensitive microorganisms: infections of the upper, lower respiratory tract and ENT organs (including sinusitis, otitis media and epiglottitis, bacterial pneumonia); infections of the urine of excreting and genital organs (including pyelonephritis, endometritis, cystitis, urethritis); infection of the biliary tract (cholecystitis, cholangitis); infection of the skin, soft tissues; infection of bones and joints; gonococcal infections.

Contraindications:

Hypersensitivity to ampicillin and sulbactam and other beta-lactam antibiotics, infectious mononucleosis, lymphocytic leukemia, severe violations of the liver and kidneys, children under 3 years old.

Pregnancy and lactation:

If it is necessary to use in pregnancy, you should evaluate the expected benefit to the mother and the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Dosing and Administration:

Inside. Adults and children with a body weight of more than 30 kg of the drug prescribed by. 375 - 750 mg per day. Children with body weight less than 30 kg are prescribed 25 - 50 mg per kg body weight of the patient per day (depending on the severity of the infection). The daily dose is given in two divided doses.

The course of treatment is from 5 to 14 days.

In the treatment of uncomplicated gonorrhea, sultamycillin can be given as a single dose of 2,250 mg (6 tablets), (preferably in combination with 1,000 mg probenecid). Children preferably use the drug in the form of a suspension.

Side effects:

Allergic reactions: urticaria, skin hyperemia, angioedema, rhinitis, conjunctivitis, fever, arthralgia, eosinophilia,in rare cases, rashes, itching, rarely - bronchospasm, eosinophilia, serum sickness, anaphylactic shock, very rare: erythema polymorph, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the gastrointestinal tract: nausea, vomiting, decreased appetite, diarrhea, pseudomembranous enterocolitis, impaired liver function (increased activity of "liver" transaminases, cholestatic jaundice).

On the part of the organs of hematopoiesis and the system of hemostasis: anemia, hemolytic anemia, leukopenia, neutropenia, lymphopenia, thrombocytopenia and eosinophilia.

From the nervous system: drowsiness, malaise, headache, very rarely reported the appearance of seizures.

Laboratory indicators: transient increase in activity of alanine aminotransferase (ALT) and aspartic aminotransferase (ACT), Hyperbilirubinemia, azotemia, increased urea concentration, hypercreatininaemia.

Other: Very rarely reported cases of interstitial nephritis, with long-term treatment - superinfection caused by drug-resistant microorganisms (candidiasis).

Overdose:

Symptoms caused by an overdose of the drug are significantly different from its side effects. It should be borne in mind that high concentrations of beta-lactam antibiotics in the cerebrospinal fluid can cause disruption of the central nervous system, including convulsions. how ampicillin, and sulbactam are removed from the circulatory system by hemodialysis.

Treatment: gastric lavage, symptomatic therapy, hemodialysis (especially in patients with impaired renal function).

Interaction:

Anticoagulants: penicillin can alter platelet aggregation and indicators of hemocoagulation (increase the effect of anticoagulants).

Preparations with bacteriostatic action (chloramphenicol, erythromycin, sulfonamide preparations and tetracyclines): antagonistic action.

Bactericidal antibiotics: (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect.

Antacids, glucosamine, laxative drugs, food, aminoglycosides (with enteral administration) slow down and reduce absorption; ascorbic acid increases absorption.

Oral contraceptives containing estrogen: reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which produces paraaminobenzoic acid, and ethinyl estradiol (risk of bleeding "breakthrough").

Methotrexate: co-administration of penicillins led to a decrease in the clearance of methotrexate and an increase in its toxicity. Such patients should be carefully observed.

Probenecid, diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that reduce tubular secretion, increase the concentration of ampicillin and sulbactam in the plasma, lead to their longer preservation in the blood, prolong the half-life and increase the risk of toxicity.

Influence on laboratory indicators: non-enzymatic methods for determining sugar in urine, using Benedict, Felling or Klinist's reagents can give a false positive result. It was noted that the use of ampicillin in pregnant women led to a transient decrease in plasma levels of total bound estriol, estriol-glucoronide, and also bound estrone and estradiol.

Allopurinol: increases the risk of skin rash.

Special instructions:

In the treatment of penicillins, serious and sometimes fatal allergic (anaphylactic) reactions are described. In case of an allergic reaction, it is necessary to cancel the drug and prescribe the appropriate treatment. If necessary, prescribe adrenaline, oxygen, glucocorticosteroid hormones intravenously and take measures to improve airway patency, including intubation.

In the treatment of patients with sepsis, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

As with any antibiotic, constant monitoring is important to identify signs of excess growth in insensitive microorganisms, including fungi. When superinfection occurs, the drug should be discontinued and / or an adequate therapy should be prescribed.

During prolonged therapy with the drug, it is recommended to periodically monitor the performance of internal organs, including kidneys, liver and hematopoiesis. This is especially important for newborns (especially premature babies) and young children.

Form release / dosage:

Tablets coated with a film coating, 375 mg.

Packaging:10 tablets in a bottle of orange glass type III, screwed with an aluminum or plastic cover. The bottle is placed with a plastic cylindrical container, with a desiccant (silica gel) in size, different from the tablets, or a container with a dehumidifier is built in the lid of the vial (it is part of the sealant).

1 bottle in a cardboard box with instructions for use.

200 bottles (2000 tablets) in a cardboard box (for hospitals) with an equal number of instructions for use.

Storage conditions:At a temperature of no higher than 25 ° C, in a dry, dark place. Keep out of the reach of children.

Shelf life:

2 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014013 / 03

Date of registration:21.07.2008 / 07.04.2017

Expiration Date:Unlimited

The owner of the registration certificate:Mustafa Nevzat Ilach Sanai A.Sh.Mustafa Nevzat Ilach Sanai A.Sh. Turkey

Manufacturer: & nbsp

MUSTAFA NEVZAT ILAC SANAYII, A.S. Turkey

Information update date: & nbsp21.08.2017

Illustrated instructions

Instructions

Pensilina (Pensilina)