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Bicillin®-1 (Bicillin-1)

The drug is injected only deep intramuscularly into the upper outer quadrant of the buttock. If blood appears in the syringe, indicating that the needle has entered the vessel, you should remove the syringe and inject into another place. If two injections are necessary, the drug should be injected into different buttocks.

The drug cannot be administered intravenously!

For adults

for
preventive treatment of syphilis,
a single dose of 2.4 million units is prescribed;
for primary syphilis
- 1 injection (2.4 million units) intramuscularly with an interval of 7 days (course - 2 injections);
for secondary and early latent syphilis
- 1 injection (2.4 million units) intramuscularly with an interval of 7 days (course - 3 injections).

For the preventive treatment
of a child born to a mother with untreated syphilis,
1 injection (50,000 units/kg body weight) intramuscularly with an interval of 7 days (course of 3 injections), the dose is divided in half and administered into different buttocks.

For preventive treatment
of a child due to insufficient treatment of the mother or seroresistance of syphilis
- 1 injection (50,000 units/kg body weight) intramuscularly with an interval of 7 days (course - 2 injections).

When treating yaws and pinta (endemic treponematoses)
for children
- 1.2 million units once;
adults
- 2.4 million units once.

For acute tonsillitis, scarlet fever, erysipelas, wound infections in the acute phase
for children under 12 years of age -
0.6 million units every 3 days or 1.2 million units every 2-4 weeks, depending on the severity of the infection;
adults
- 1.2-2.4 million units once a week.

To prevent recurrent attacks after acute rheumatic fever,
children weighing <25 kg
- 0.6 million units once every 3 weeks;
children weighing >25 kg
- 1.2 million units once every 3 weeks;
for adolescents and adults
- 2.4 million units once every 3 weeks. The duration of prophylaxis is determined individually.

To prevent recurrence of erysipelas
for children
- 0.6 units once every 2 weeks or 1.2 million units every 3-4 weeks;
adults
with
seasonal relapses
- 2.4 million units once every 4 weeks for 3-4 months annually;
with frequent relapses
- 2.4 million units once every 3-4 weeks for 2-3 years.

For the prevention of postoperative infections
for children
- 0.6 million units or 1.2 million units;
adults
- 2.4 million units every 7-14 days until complete recovery.

For 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 <10 ml/min,
25-50% of the daily dose of the drug is administered.

Rules for preparing the solution

A suspension of the drug is prepared under aseptic conditions immediately before use: 3-5 ml of water for injection or 0.9% sodium chloride solution is added to the bottle. The mixture is stirred until a uniform suspension is obtained, quickly rotating the bottle between the palms for at least 1 minute or gently shaking the bottle in the direction of its longitudinal axis for 30 seconds.

Bicillin-5 powder for the preparation of a suspension for intramuscular administration 1,200,000 units + 300,000 units No. 10

Name

Bicillin-5 por.d/preg.susp.for intramuscular injection.1200t.IU+300t.IU in bottle No.10

Description

The powder for preparing a suspension for intramuscular administration is white or white with a slightly yellowish tint, prone to clumping, forming a stable suspension when water is added.

Main active ingredient

Benzylpenicillin novocaine salt (benzylpenicillin procaine), Benzathine benzylpenicillin

Release form

The powder for preparing a suspension for intramuscular administration is white or white with a slightly yellowish tint, prone to clumping, forming a stable suspension when water is added. 1 fl. benzathine benzylpenicillin 1.2 million units benzylpenicillin novocaine salt (benzylpenicillin procaine) 300 thousand units 10 ml bottles (1) - cardboard packs. 10 ml bottles (5) - cardboard packs. Bottles with a volume of 10 ml (10) - cardboard packs. 10 ml bottles (50) - cardboard boxes (for hospitals).

Dosage

1200 t. units + 300 t. units in flask No. 10

special instructions

It cannot be administered subcutaneously, intravenously, endolumbarally, or into body cavities. With accidental intravascular administration, transient feelings of depression, anxiety and visual disturbances (Wanier syndrome) may occur. In order to avoid accidental intravascular injection 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 syphilis, microscopic and serological studies are necessary before starting therapy and then for 4 months. Due to the development of fungal infections, it is advisable to simultaneously prescribe B vitamins and vitamin C, and, if necessary, antifungal drugs for systemic use. It must be taken into account that the use of insufficient doses or stopping treatment too early often leads to the emergence of resistant strains of pathogens.

pharmachologic effect

A combined bactericidal antibiotic consisting of two long-acting benzylpenicillin salts. Suppresses the synthesis of the cell wall of a microorganism. Active against gram-positive microorganisms: Staphylococcus spp. (non-penicillinase-forming), Streptococcus spp. (including Streptococcus pneumoniae), Corynebacterium diphtheriae, anaerobic spore-forming bacilli, Bacillus anthracis, Clostridium spp., Actinomyces israelii; gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, Treponema spp. Strains of Staphylococcus spp. that produce penicillinase are resistant to the action of the drug.

Pharmacokinetics

Bicillin®-5 is a long-acting drug; a high concentration of the antibiotic in the blood lasts up to 4 weeks. Benzathine benzylpenicillin Following intramuscular injection of benzathine, benzylpenicillin hydrolyzes very slowly, releasing benzylpenicillin. The maximum concentration of the drug in the blood serum is achieved 12-24 hours after injection. The long half-life ensures a stable and long-term concentration of the drug in the blood: on the 14th day after elimination of 2,400,000 IU of the drug, the serum concentration is 0.12 mcg/ml; on the 21st day after administration of 1,200,000 IU of the drug - 0.06 mcg/ml (1 IU = 0.6 mcg). Diffusion of the drug in liquid is complete, diffusion into tissue is very weak. Communication with plasma proteins is 40-60%. Benzathine benzylpenicillin passes in small quantities through the placental barrier and also penetrates into mother's breast milk. Biotransformation of the drug is insignificant. It is excreted mainly by the kidneys unchanged. Over 8 days, up to 33% of the administered dose is released. Benzylpenicillin The maximum concentration in blood plasma after intramuscular administration is achieved after 20-30 minutes. The half-life of the drug is 30-60 minutes, in case of renal failure 4-10 hours or more. Communication with plasma proteins - 60%. Penetrates into organs, tissues and biological fluids, except for cerebrospinal fluid, eye tissue and prostate gland. During inflammation of the meningeal membranes, it penetrates the blood-brain barrier. Passes through the placenta and enters breast milk. Excreted unchanged by the kidneys.

Indications for use

Infectious and inflammatory diseases caused by sensitive pathogens: - long-term (year-round) prevention of relapses of rheumatism; - syphilis, yaws; - streptococcal infections (excluding infections caused by group B streptococci) - acute tonsillitis, scarlet fever, wound infections, erysipelas.

Directions for use and doses

Intramuscularly. Adults: 1.2 million units + 300 thousand units once every 4 weeks. For preschool children - 480 thousand units + 120 thousand units once every 3 weeks, for children over 8 years old - 960 thousand units + 240 thousand units once every 4 weeks. To prepare the suspension, use sterile water for injection, isotonic sodium chloride solution or 0.25-0.5% solution of procaine (novocaine). The Bicillin®-5 suspension is prepared aseptically, immediately before use (ex tempore): 5-6 ml of solvent is slowly introduced into the bottle with the drug under pressure (at a rate of 5 ml in 20-25 seconds). The contents of the bottle are mixed and shaken along the longitudinal axis of the bottle until a homogeneous suspension is formed. The presence of bubbles on the surface of the suspension near the walls of the bottle is allowed. Immediately after preparation, the Bicillin®-5 suspension is injected deeply intramuscularly into the upper outer quadrant of the gluteal muscle. Rubbing the gluteal muscle after injection is not recommended. Delaying administration immediately after preparation alters the physical and colloidal properties of the suspension, which may impede its movement through the syringe needle.

Use during pregnancy and lactation

Bicillin®-5 in small quantities penetrates the placental barrier and into 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.

Precautionary measures

With caution in case of renal failure. Use in children Use according to indications

Interaction with other drugs

Bactericidal antibiotics (including cephalosporins, vancomycin, rifampicin, aminoglycosides) have a synergistic effect; bacteriostatic (including macrolides, chloramphenicol, lincosamides, tetracyclines) - antagonistic. Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the prothrombin index); reduces the effectiveness of oral contraceptives, drugs whose metabolism produces para-aminobenzoic acid, ethinyl estradiol - the risk of breakthrough bleeding. Diuretics, allopurinol, tubular secretion blockers, phenylbutazone, NSAIDs, by reducing tubular secretion, increase the concentration of benzylpenicillin in the blood and tissues. Allopurinol increases the risk of allergic reactions (skin rash).

Contraindications

- hypersensitivity to the drug, benzylpenicillin and other beta-lactam antibiotics; - lactation period. With caution: pregnancy, renal failure, severe allergy history, bronchial asthma, pseudomembranous colitis

Compound

benzathine benzylpenicillin 1.2 million units benzylpenicillin novocaine salt (benzylpenicillin procaine) 300 thousand units

Side effect

Allergic reactions: anaphylactic shock, anaphylactoid reactions, urticaria, fever, arthralgia, angioedema, exudative erythema multiforme, exfoliative dermatitis. Laboratory indicators: anemia, thrombocytopenia, leukopenia, hypocoagulation. Other: stomatitis, glossitis.

Storage conditions

List B. In a dry place at a temperature not exceeding 20°C. Keep out of the reach of children.

Bicillin-5 por. d/susp. i.m. 1.5 million units 10 ml No. 1

Benzathine benzylpenicillin* + Benzylpenicillin procaine (Benzathini benzylpenicillinum + Benzylpenicillinum-Procainum)

Penicillins in combinations

Pharmacological action - bactericidal, antibacterial.
Inhibits the synthesis of peptidoglycan in the cell wall of microorganisms.

Active against gram-positive microorganisms, incl. Staphylococcus spp. (except for strains that produce penicillinase), Streptococcus spp. (including Streptococcus pneumoniae), Corynebacterium diphtheriae, anaerobic spore-forming bacilli Bacillus anthracis, some gram-negative microorganisms (including Neisseria gonorrhoeae, Neisseria meningitidis), Actinomyces israelii, as well as Treponema spp. Not effective against viruses (causative agents of influenza, polio, smallpox, etc.), mycobacterium tuberculosis, protozoa, rickettsia, fungi, as well as most gram-negative microorganisms.

When administered intramuscularly, bicillin-1 is slowly absorbed, hydrolyzed to release benzylpenicillin, and enters the bloodstream over a long period of time. Cmax is reached within 12–24 hours, therapeutic concentration is achieved within 3–6 hours.

Bicillin-3 after intramuscular administration is slowly hydrolyzed to release benzylpenicillin. With a single injection, the therapeutic concentration in the blood is maintained for 6–7 days, Cmax is achieved 12–24 hours after injection. On the 14th day after administration at a dose of 2.4 million units, the serum concentration is 0.12 mcg/ml, on the 21st day after administration of 1.2 million units - 0.06 mcg/ml (1 unit = 0. 6 mcg). Binding to blood proteins is 40–60%. Penetration into liquids is high, into tissues low. Passes through the placental barrier and enters breast milk. It is biotransformed to a small extent and is excreted mainly by the kidneys.

With the intramuscular administration of Bicillin-5, high concentrations in the blood are created already in the first hours after the injection. After administration of 1.2–1.5 million units in most patients (adults and children), the therapeutic concentration in plasma (0.3 units/ml) persists for 28 days or more.

From the cardiovascular system and blood (hematopoiesis, hemostasis):

anemia, thrombocytopenia, leukopenia, hypocoagulation.

Allergic reactions:

rash on the skin and mucous membranes, urticaria, eosinophilia, joint pain, erythema multiforme, exfoliative dermatitis, Quincke's edema, anaphylactic shock.

Other:

headache, fever, arthralgia, stomatitis, glossitis, pain at the injection site; with long-term therapy - superinfection caused by drug-resistant microorganisms and fungi.

Bactericidal antibiotics (including cephalosporins, cycloserine, vancomycin, rifampicin, aminoglycosides) have a synergistic effect, bacteriostatic (including macrolides, chloramphenicol, lincosamides, tetracyclines) have an antagonistic effect. Reduces the effectiveness of oral contraceptives and ethinyl estradiol (risk of breakthrough bleeding). Diuretics, allopurinol, phenylbutazone, NSAIDs reduce tubular secretion and increase concentration. Allopurinol increases the risk of allergic reactions (skin rash).

If blood appears in the syringe during an intramuscular injection (indicating that the needle has entered a blood vessel), the syringe should be removed and injected elsewhere. At the end of the injection, the injection site is pressed with a cotton swab, which prevents the drug from entering the muscle tissue into the subcutaneous tissue (rubbing the buttock after the injection is not recommended).

If an allergic reaction develops, treatment is stopped immediately. When the first signs of anaphylactic shock appear, it is necessary to take urgent measures to remove the patient from this state: administration of norepinephrine, glucocorticoids, etc., and, if necessary, mechanical ventilation.

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, and, if necessary, nystatin and levorin. 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.

IV administration of the drug should not be allowed (possible development of Wanier syndrome - the development of a feeling of depression, anxiety and visual impairment).