Sulbamox Elfa^® (Powder) Instructions for Use

Marketing Authorization Holder

Elfa SPC, JSC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

ATC Code

J01CR02 (Amoxicillin and beta-lactamase inhibitor)

Active Substances

Amoxicillin (Rec.INN registered by WHO)

Sulbactam (Rec.INN registered by WHO)

Dosage Forms

	Sulbamox Elfa®	Powder for solution for intravenous and intramuscular administration 250 mg+125 mg
		Powder for solution for intravenous and intramuscular administration 500 mg+250 mg
		Powder for solution for intravenous and intramuscular administration 1000 mg+500 mg

Dosage Form, Packaging, and Composition

Powder for solution for intravenous and intramuscular administration

375 mg – vials – cardboard packs – Prescription only

Powder for solution for intravenous and intramuscular administration

750 mg – vials – cardboard packs – Prescription only

Powder for solution for intravenous and intramuscular administration

1500 mg – vials – cardboard packs – Prescription only

Clinical-Pharmacological Group

Broad-spectrum penicillin antibiotic with a beta-lactamase inhibitor

Pharmacotherapeutic Group

Systemic antibacterial agents; beta-lactam antibacterial agents, penicillins; combinations of penicillins, including combinations with beta-lactamase inhibitors

Pharmacological Action

A combined agent that includes a broad-spectrum penicillin antibiotic and a beta-lactamase inhibitor. It has a bactericidal effect against microorganisms sensitive to amoxicillin, including strains producing beta-lactamases.

Amoxicillin is a broad-spectrum semi-synthetic penicillin from the aminopenicillin group. It acts bactericidally by inhibiting the synthesis of the cell wall proteins of pathogenic microorganisms. It is active against aerobic gram-positive bacteria (including strains producing beta-lactamases): Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic gram-positive bacteria: Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; aerobic gram-negative bacteria (including strains producing beta-lactamases): Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella spp., Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Yersinia multocida, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Haemophilus influenzae, Haemophilus ducreyi, Campylobacter jejuni, Acinetobacter spp., Helicobacter pylori; anaerobic gram-negative bacteria (including strains producing beta-lactamases) Bacteroides spp., including Bacteroides fragilis.

Sulbactam is an irreversible beta-lactamase inhibitor; it expands the spectrum of activity of amoxicillin against resistant strains whose resistance develops under the influence of beta-lactamases. It does not alter the activity of amoxicillin against sensitive strains; by binding to some penicillin-binding proteins of bacteria, it exhibits synergism when used simultaneously with beta-lactam antibiotics. It has independent antibacterial activity against Neisseria spp. and Acinetobacter spp. and is resistant to the action of most plasmid beta-lactamases.

Pharmacokinetics

Amoxicillin

Plasma protein binding — 20%. Amoxicillin is distributed in most tissues and body fluids, crosses the placental barrier, and is found in breast milk. T_1/2 from plasma – 1 hour. It is excreted mainly by the kidneys (glomerular filtration and tubular secretion) — 70-80% and with bile — 5-10%.

Sulbactam

Plasma protein binding — 40%. T_1/2 is 1 hour. Sulbactam does not affect the pharmacokinetics of amoxicillin. Sulbactam is excreted almost completely unchanged by the kidneys (75-85%). It crosses the placental barrier.

Indications

Infectious and inflammatory diseases caused by amoxicillin-sensitive strains of microorganisms: infections of the upper respiratory tract and ENT organs (acute and chronic sinusitis, tonsillitis, pharyngitis, retropharyngeal abscess, acute and chronic otitis media); infections of the lower respiratory tract (acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia, pleural empyema, lung abscess); infections of the biliary tract (cholangitis, cholecystitis); intestinal infections (dysentery, salmonellosis, salmonella carriage); infections of the genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis); infections of the pelvic organs (cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, postpartum sepsis, pelvioperitonitis); bacterial vaginitis; septic abortion; chancroid; gonorrhea; infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection); osteomyelitis; endocarditis; meningitis; sepsis; peritonitis; postoperative infections; prevention of infectious and inflammatory diseases in surgery.

ICD codes

Dosage Regimen

It is administered intramuscularly or intravenously as injections or infusions.

The dosage regimen is individual, depending on the severity of the course, localization of the infection, and sensitivity of the pathogen.

Treatment should be continued for at least another 2-3 days after the disappearance of clinical symptoms of the disease, but not more than 14 days. When treating infections caused by beta-hemolytic streptococcus, the drug is recommended to be used for at least 10 days.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, dyspepsia, pain in the epigastric region, increased activity of hepatic transaminases, cholestatic jaundice, hepatitis, pseudomembranous colitis.

From the nervous system: hyperactivity, agitation, anxiety, insomnia, confusion, behavioral changes.

From the hematopoietic system: anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis.

Allergic reactions: urticaria, angioedema, respiratory disorders, multiform exudative erythema, anaphylactic shock, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis.

Local reactions: burning and pain at the injection site; in some cases – phlebitis at the site of intravenous administration.

Other: candidomycosis, development of superinfection, interstitial nephritis, reversible increase in prothrombin time.

Contraindications

Infectious mononucleosis (including when a measles-like rash appears); nonspecific ulcerative colitis (including associated with antibiotic use); Crohn’s disease; infection caused by Herpes simplex; simultaneous use of allopurinol (in the presence of skin allergic reactions when using penicillins); history of colitis associated with the use of penicillins.

With caution

In severe hepatic insufficiency, gastrointestinal diseases, chronic renal failure, in elderly patients (due to the possible risk of developing renal failure).

Use in Pregnancy and Lactation

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Should be used with caution in severe hepatic insufficiency.

Use in Renal Impairment

Should be used with caution in chronic renal failure.

Geriatric Use

Should be used with caution in elderly patients (due to the possible risk of developing renal failure).

Special Precautions

Treatment of patients suffering from asthma, eczema or hay fever should be carried out under medical supervision.

With prolonged use, an increase in the activity of hepatic transaminases is possible.

The drug should be discontinued if superinfection caused by Pseudomonas spp. and Candida spp. develops.

Since Amoxicillin reduces the effectiveness of oral contraceptives, women taking progestogenic and estrogenic contraceptive agents are recommended to use alternative or additional methods of contraception.

A false-positive result of reactions when conducting tests for the determination of glucose in urine by a colorimetric method is possible, as well as a reversible increase in prothrombin time.

Amoxicillin can reduce the concentration of total protein in blood plasma.

Amoxicillin in high concentration contributes to a decrease in blood glucose concentration.

With prolonged use of the drug, periodic monitoring of kidney and liver function and a complete blood count are necessary.

Due to the high concentration of amoxicillin in the urine, it can precipitate on the walls of the catheter, so periodic monitoring of catheter patency is necessary.

Effect on ability to drive vehicles and mechanisms

Given the likelihood of developing side effects from the central nervous system, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

When used concomitantly with antacids, glucosamine, laxatives, aminoglycosides, the absorption of this combination is slowed and reduced; ascorbic acid increases absorption.

When used concomitantly with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), a synergistic effect is observed; with bacteriostatic agents (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) – antagonism.

Use of probenecid may cause a decrease in renal tubular secretion, leading to a prolonged increase in the plasma concentration of amoxicillin.

When used concomitantly with methotrexate, the excretion of the latter is slowed.

This combination increases the effectiveness of indirect anticoagulants (monitoring of blood coagulation parameters is necessary); reduces the effectiveness of oral contraceptives, drugs metabolized to form PABA.

When used concomitantly with ethinyl estradiol, the risk of breakthrough bleeding increases.

When used concomitantly with allopurinol, the risk of skin manifestations of allergic reactions increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.