Extensillin: Instructions for use: Description of the drug: Price on EUROLAB

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Manufacturers: Sandoz Inc. (USA), Sandoz GmbH (Austria)

Active ingredients

Benzathine benzylpenicillin

Disease class

Rheumatism, unspecified
Syphilis, unspecified
Inflammatory diseases of the female pelvic organs caused by syphilis (A51.4, A52.7)

Clinical and pharmacological group

Not indicated. See instructions

Pharmacological action

Antibacterial

Pharmacological group

Penicillins

Powder for the preparation of a suspension for intramuscular administration of Extencilline

Instructions for medical use of the drug

Description of pharmacological action

Benzathine benzylpenicillin is a long-acting beta-lactam antibiotic from the group of penicillins type G. It has a bactericidal effect on sensitive microorganisms by suppressing the synthesis of cell membrane mucopeptides. Effective against Streptococcus pyogenes A and Treponema pallidum, which cause syphilis and yaws.

Indications for use

Treatment of infections caused by bacteria sensitive to the drug, including: - prevention of exacerbation of articular rheumatism; - treatment of syphilis and other diseases caused by treponemes (yaws, pinta).

Release form

powder for preparing a suspension for intramuscular administration 600 thousand units; bottle (bottle) 5 ml with solvent, box (box) 50; powder for preparing a suspension for intramuscular administration 2.4 million units; bottle (bottle) 15 ml with solvent, box (box) 50; Composition 1 bottle of lyophilized powder for the preparation of an injection solution contains benzathine benzylpenicillin 600,000 or 2,400,000 units; complete with solvent, 2 and 8 ml respectively, or without solvent, 50 pcs in a cardboard box.

Pharmacodynamics

Pharmacokinetics

Distribution After intramuscular injection of benzathine, benzylpenicillin is very slowly hydrolyzed, releasing benzylpenicillin. Cmax in serum is achieved 12-24 hours after injection. Long T1/2 ensures a stable and long-term concentration of the drug in the blood: on the 14th day after administration of 2.4 million IU of the drug, the concentration in the serum is 0.12 mcg/ml; on the 21st day after administration of 1.2 million IU of the drug, in 89-97.4% of patients its concentration is 0.06 μg/ml (1 IU = 0.6 μg). Diffusion of the drug in liquid is complete, diffusion into tissue is very weak. Communication with plasma proteins is 40-60%. Biotransformation Biotransformation of the drug is insignificant. Excretion Excreted primarily by the kidneys. Extensillin crosses the placental barrier and is excreted in mother's milk.

Use during pregnancy

Extensillin crosses the placental barrier and is excreted in mother's milk. Use during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus. It is recommended to stop breastfeeding if it is necessary to prescribe the drug.

Use for renal impairment

In case of renal failure, doses are reduced in accordance with CC: with CC from 10 to 50 ml/min, 75% of the daily dose of the drug is administered, with CC less than 10 ml/min, 25-50% of the daily dose of the drug is administered.

Contraindications for use

- allergy to beta-lactam antibiotics (penicillins and cephalosporins). The possibility of cross-allergy with cephalosporins should also be kept in mind.

Side effects

Allergic reactions: urticaria, fever, eosinophilia, erythema multiforme, exfoliative dermatitis, Quincke's edema, difficulty breathing, in exceptional cases - anaphylactic shock. From the digestive system: nausea, vomiting, diarrhea, candidiasis. Isolated cases of the development of pseudomembranous colitis have been described when using the drug. Other side effects of an immuno-allergic nature have been reported less frequently: a moderate transient increase in the level of serum transaminases; reversible anemia, leukopenia, thrombocytopenia; acute interstitial nephritis. The use of high doses of beta-lactam antibiotics, especially in cases of renal failure, can cause the development of encephalopathy (impaired consciousness, movement disorders, convulsions). Children may develop local reactions to the administration of the drug.

Directions for use and doses

Prevention of relapses of articular rheumatism: 1 intramuscular injection after 15 days: - adults - 2.4 million ME; - children (depending on age) - 0.6 million ME-1.2 million ME Treatment of syphilis: 1 intramuscular injection after 8 days: - adults - 2.4 million ME. Treatment of yaws and pinta (endemic treponematoses): Single intramuscular injection: - adults - 1.2 - 2.4 million ME; - children (weight up to 45 kg) - 0.6 million ME-1.2 million ME. The drug is administered only deep intramuscularly. The drug cannot be administered intravenously! Under aseptic conditions, prepare a solution by introducing into the vial: - 2 ml of water for injection for 0.6 million IU, - 4 ml of water for injection for 1.2 million IU, - 8 ml of water for injection for 2.4 million IU. Mix thoroughly before use by rolling the bottle between the palms of your hands, trying to avoid the formation of excessive foam. Benzathine benzylpenicillin in the form of a prepared suspension can be stored in the refrigerator for no more than 24 hours.

Interactions with other drugs

When prescribing benzathine benzylpenicillin simultaneously with NSAIDs (indomethacin, phenylbutazone, salicylates), allopurinol, probenecid, one should keep in mind the possibility of competitive inhibition of drug excretion from the body.

Precautions for use

If any allergic reaction occurs, immediate cessation of treatment is required. IV administration is not acceptable.

Special instructions for use

If any allergic reactions occur, it is necessary to stop administering the drug and prescribe appropriate treatment. Severe and sometimes fatal allergic reactions may occur, including anaphylactic shock. In this regard, when collecting anamnesis, attention should be paid to the tolerability of previous treatment with penicillin. If there is a history of allergy to penicillin, the drug is strictly contraindicated. In 5-10% of cases, allergic reactions to penicillin can be cross-reactions with allergic reactions to cephalosporins. In this regard, if there is a history of allergic reactions to cephalosporins, the prescription of penicillins is contraindicated. In case of renal failure, doses are reduced in accordance with the CC: with a CC of 10 to 50 ml/min, 75% of the daily dose of the drug is administered, with a CC of less than 10 ml/min, 25-50% of the daily dose of the drug is administered. The sodium content per 0.6 million ME of the drug is 5.5 mg or 0.24 mmol, which must be taken into account when carrying out a hyposalt diet.

Storage conditions

List B: In a place protected from light, at a temperature not exceeding 25 °C.

Best before date

48 months

ATX classification:

J Antimicrobials for systemic use

J01 Antimicrobials for systemic use

J01C Beta-lactam antibiotics - penicillins

J01CE Penicillins, sensitive to beta-lactamases

J01CE08 Benzathine benzylpenicillin

Penicillin (Penicillin G, analogue of Extensillin, Infectocillin) 5 million IU 1 vial/pack. — Instructions

Dosage form

Lyophilisate for preparing a suspension for intramuscular administration, 1 bottle per package.

Compound

1 bottle for preparing a suspension for intramuscular administration contains Benzylpenicillin 5 million IU.

Pharmacological properties

Infectocillin active substance Benzathine Benzylpenicillin. This substance is absorbed within 24 hours after injection, which allows you to maintain the level of its content in the blood necessary for effective therapy.

A natural antibiotic obtained from the mold Penicillium chysogenum. It has a bactericidal effect on microbial cells. Characterized by long-lasting action. Suppresses the synthesis of the cell wall of microorganisms. Active against gram-positive pathogens: Staphylococcus spp. (penicillinase-non-forming), Streptococcus spp., incl. Streptococcus pneumoniae, Corynebacterium diphtheriae, anaerobic spore-forming bacilli, Bacillus anthracis, Clostridium spp., Actinomyces israelii; gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, as well as Treponema spp.

Staphylococcus spp. strains that produce penicillinase, which destroys benzylpenicillin, are resistant to the drug. Due to its long-lasting effect, the drug is used in the treatment of infections caused by Streptococcus spp. and Treponema pallidum.

Indications for use

syphilis;
yaws;
pint;
bejel;
infectious diseases caused by streptococcus.

Directions for use and dosage

Dosage depends on the characteristics of the disease and the age of the patient. Infectocillin is used in adults and children (including newborns). The doctor can prescribe both one-time procedures and treatment courses that can be repeated. The drug is administered intramuscularly. For primary syphilis, the recommended treatment regimen is 2.4 million units once a week.

It is administered only intramuscularly; if necessary, 2 injections of Infectocillin are given in different buttocks. When treating congenital syphilis in newborns and young children - 2 injections of 0.6 million units or 1 injection of 1.2 million units of Extensillin.

For primary seronegative syphilis: once 2.4 million units; for primary seropositive and secondary fresh syphilis - 2.4 million units twice with an interval of 7 days; for secondary recurrent and latent early syphilis, the first injection is made in a dose of 4.8 million units (2.4 million units in each buttock), the second and third injections - 2.4 million units each with an interval of 1 week; newborns and young children - 1.2 million units.

If clinical manifestations of the disease resume or if clear positive laboratory parameters persist, treatment should be repeated.

When treating tertiary syphilis - 1-2 injections of 2.4 million units weekly for 3-5 weeks.

When treating yaws, children are prescribed 0.6-1.2 million units; adults - 1-2 injections of 1.2 million units. Persons who have had contact with patients or patients with a latent form of infection are prescribed 1/2 dose.

When treating acute tonsillitis, scarlet fever, erysipelas, wound infections in the acute phase with Extensillin, therapy begins with benzylpenicillin, and treatment with benzathine benzylpenicillin is continued, prescribing 0.6 million units to children under 12 years of age, depending on the severity of the infection, daily or every 3 days; it is possible to prescribe 1.2 million units every 2-4 weeks. Adults - 1-2 injections of 1.2 million units once a week.

To prevent attacks of acute articular rheumatism, it is administered intramuscularly once every 15 days at a dose of 2.4 million units for adults and 0.6-1.2 million units for children (depending on age).

To prevent scarlet fever with Extensillin, children who have had contact with patients are administered 0.6-1.2 million units once a week; adults - 2.4 million units.

To prevent exacerbation of erysipelas, children are prescribed 0.6 million units every 2 weeks or 1.2 million units every 3-4 weeks; adults - 2.4 million units; to prevent infections after “minor” surgical interventions, similar doses are prescribed in combination with benzylpenicillin every 7-14 days until complete recovery.

Side effects

Allergic reactions: anaphylactic shock, anaphylactoid reactions, urticaria, fever, arthralgia, angioedema, exudative erythema multiforme, exfoliative dermatitis; headache, stomatitis, glossitis; anemia, thrombocytopenia, leukopenia, hypocoagulation; local reactions (in children).

With long-term therapy with Extensillin, superinfection with resistant microorganisms and fungi occurs.

Contraindications

hypersensitivity to benzylpenicillin and other beta-lactam antibiotics;
patients with allergies to penicillin and cephalosporins;
bronchial asthma
during lactation.

Pregnancy and breastfeeding

The decision on the advisability of using Infectocillin for patients during pregnancy is made by the doctor after comparing the benefits for the mother and possible harm to the fetus.

Children

When treating children, the likelihood of local reactions occurring after injection must be taken into account. Patients receiving a low-salt diet should be aware that the drug contains sodium.

Interaction with other drugs

Bactericidal antibiotics (including cephalosporins, cycloserine, vancomycin, rifampicin, aminoglycosides) have a synergistic effect; bacteriostatic (including macrolides, chloramphenicol, lincosamides, tetracyclines) - antagonistic.

The use of Infectocillin increases the effectiveness of indirect anticoagulants (by suppressing intestinal microflora, reducing the prothrombin index); reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which PABA is formed, ethinyl estradiol - the risk of developing breakthrough bleeding.

Diuretics, allopurinol, tubular secretion blockers, phenylbutazone, NSAIDs, reducing tubular secretion, increase the concentration of penicillins.

special instructions

If any allergic reaction occurs, immediate cessation of treatment with Infectocillin is required.

It cannot be administered subcutaneously, intravenously, endolumbarally, or into the body cavity.

With accidental intravascular administration, transient feelings of depression, anxiety and visual disturbances (Wanier syndrome) may occur. In order to avoid accidental intravascular administration of the drug, it is recommended to perform aspiration before performing an intramuscular injection in order to detect possible needle entry into the vessel.

When treating sexually transmitted diseases, if syphilis is suspected, microscopic and serological studies are necessary before starting therapy and then for 4 months.

Due to the possibility of developing fungal infections, it is advisable to prescribe B vitamins and vitamin C when treating with benzylpenicillin, and, if necessary, nystatin and levorin.

It must be taken into account that the use of Infectocillin in insufficient doses or stopping treatment too early often leads to the emergence of resistant strains of pathogens.

Storage conditions

At a temperature not higher than 25 C.

Vacation category

On prescription.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Extensillin, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Extencillin is provided for informational purposes only and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

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Retarpen®

Before starting therapy, a thorough history should be taken to determine possible sensitization to penicillins and/or other beta-lactam antibiotics. When treated with the drug, severe (up to the development of anaphylactic shock) and sometimes fatal allergic reactions may occur. The patient should be informed about possible allergy symptoms and the need to immediately inform the doctor about their occurrence. If allergic reactions occur, treatment with the drug should be stopped immediately and, if necessary, symptomatic therapy should be prescribed.

In 5-10% of cases, allergic reactions to penicillin can be cross-reactions with allergic reactions to cephalosporins. In this regard, if there is a history of allergic reactions to cephalosporins, the use of penicillins is contraindicated.

Particular caution should be exercised in the following patient groups:

- patients with bronchial asthma, allergic skin rashes have an increased risk of hypersensitivity reactions. Such patients should remain under medical supervision for at least 30 minutes after injection. If allergic reactions occur, the drug should be discontinued; if necessary, symptomatic and/or anti-shock therapy is indicated;

- patients with renal and/or liver failure (see also section “Method of administration and dosage”);

- patients with concomitant dermatomycosis (possible development of paraallergic reactions).

During the treatment of syphilis, due to massive lysis of bacteria and the release of endotoxins, the Jarisch-Herxheimer reaction (fever, chills, and other general and local symptoms) may develop. The patient should be informed about the possibility of this reaction, and if it occurs, appropriate symptomatic therapy should be administered.

In patients with diabetes mellitus, due to impaired peripheral circulation, the absorption of the drug into the systemic circulation may slow down.

The drug Retarpen® should not be administered into tissues with impaired perfusion. It cannot be administered subcutaneously, intravenously, endolumbarally, or into body cavities.

Renal function and peripheral blood patterns should be periodically monitored.

In case of accidental subcutaneous injection, a painful lump may occur at the injection site. The pain may be relieved by applying ice to the injection site.

With accidental intravascular administration of the drug, a transient feeling of anxiety and visual disturbances (Hoyne's syndrome) may occur. Symptoms usually go away within an hour. If symptoms are severe, sedatives may be required.

With the use of the drug, the development of Nicolau syndrome, acute drug-induced embolism of skin vessels, is possible. Nicolau syndrome is a rare complication that occurs during intramuscular administration of drugs, the manifestations of which include necrosis of the skin and/or underlying tissues of varying severity. With accidental intra-arterial administration of the drug, especially in children, serious complications may occur, such as arterial thrombosis and tissue necrosis (gangrene). The initial manifestations of these complications may be pale “spots” on the skin of the buttock area. As a result of high pressure at the injection site, retrograde reflux of the drug into the common iliac artery, aorta or spinal arteries may occur.

In children and adolescents, the peripheral area of the outer upper quadrant of the buttock should be used to administer the drug only in exceptional cases (for example, with widespread burns) to avoid damage to the sciatic nerve.

In order to avoid accidental intravascular injection of the drug, it is recommended to perform aspiration before performing an intramuscular injection in order to identify a possible needle entry into the vessel.

Rubbing the buttock after the injection is not recommended.

When treating sexually transmitted diseases, if syphilis is suspected, dark-field microscopy should be performed before starting therapy and then serological tests should be performed within 4 months. In cases of congenital syphilis, cerebrospinal fluid (CSF) should also be examined. If central nervous system involvement (neurosyphilis) cannot be excluded, other penicillin preparations that penetrate better into the CSF should be used.

In severe purulent-inflammatory diseases (severe pneumonia, empyema, sepsis, meningitis, peritonitis), drugs are required that create a higher concentration of benzylnenicillin in the blood plasma. Water-soluble salts of the drug should be used.

If severe, persistent diarrhea occurs, pseudomembranous colitis should be suspected (possible symptoms include watery stools with blood/mucus, tenesmus, diffuse cramping abdominal pain, fever). This condition can be life-threatening; therapy with Retarpen® should be immediately discontinued, and appropriate therapy should be prescribed based on the sensitivity of the identified pathogen (for example, vancomycin 250 mg orally, 4 times a day). Drugs that inhibit intestinal motility are contraindicated.

Due to the possibility of the development of fungal infections, it is advisable to use B vitamins and vitamin C when treating with benzylpenicillin. If a fungal infection is suspected, the use of antifungal drugs, for example, nystatin or levorin, is indicated, according to the current instructions for the use of these drugs.

The sodium content per 1,200,000 IU of the drug is 11.0 mg or 0.48 mmol, per 2,400,000 IU - 22.0 mg or 0.96 mmol, which must be taken into account when carrying out a hyposalt diet.

It must be taken into account that using the drug in insufficient doses or stopping treatment too early often leads to the emergence of resistant strains of pathogens.

The possibility of the emergence of resistant strains of pathogens should be taken into account during long-term treatment. In case of secondary infections (superinfections), appropriate measures should be taken.

We cannot exclude (in very rare cases) the possibility of accumulation of povidone (an excipient in the drug) in the reticuloendothelial system, with the subsequent development of granuloma, from which tumors can subsequently develop.