Trifamox IBL^® DUO (Tablets) Instructions for Use

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Laboratorios Bagó, S.A. (Argentina)

ATC Code

J01CR02 (Amoxicillin and beta-lactamase inhibitor)

Active Substances

Amoxicillin (Rec.INN registered by WHO)

Sulbactam (Rec.INN registered by WHO)

Dosage Form

Trifamox IBL® DUO

Film-coated tablets, 875 mg+125 mg: 14 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, oblong, biconvex, with a score line and engraving “IBL DUO” on both sides.

Excipients : croscarmellose sodium – 48 mg, colloidal silicon dioxide – 5 mg, magnesium stearate – 14 mg, microcrystalline cellulose – up to 1600 mg.

Coating composition Opadry white II YS-30-18056 – 62.4 mg (lactose monohydrate 40%, hypromellose 40%, titanium dioxide 10%, triacetin 10%).

7 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Broad-spectrum penicillin antibiotic with a beta-lactamase inhibitor

Pharmacotherapeutic Group

Antibiotic, semi-synthetic penicillin + beta-lactamase inhibitor

Pharmacological Action

A combined agent including 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

Absorption

After oral administration, both active components of the drug are rapidly absorbed from the gastrointestinal tract. Food intake does not affect the absorption of the drug. The bioavailability of amoxicillin after oral administration is 80%. Time to reach C_max is 1-2 hours.

Sulbactam pivoxil is hydrolyzed in the gastrointestinal tract, which improves the absorption of sulbactam. Time to reach C_max is 1-2 hours.

Distribution

Amoxicillin is distributed in most tissues and biological fluids of the body. Amoxicillin crosses the placental barrier and is found in breast milk.

Plasma protein binding of amoxicillin is 20%, and of sulbactam is 40%.

Elimination

The T_1/2 of amoxicillin and sulbactam is 1 hour.

Amoxicillin is excreted mainly by the kidneys (glomerular filtration and tubular secretion) – 70-80% and with bile – 5-10%. Sulbactam is almost completely excreted by the kidneys (75-85%) unchanged.

Sulbactam does not affect the pharmacokinetics of amoxicillin.

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); postoperative infections.

ICD codes

Dosage Regimen

Take orally, regardless of meals.

Swallow the tablet whole with a sufficient amount of water.

The dosage regimen is individual, set by a physician based on the severity and location of the infection, and the sensitivity of the pathogen.

For adults and children weighing 40 kg or more, the usual dose is one tablet (875 mg amoxicillin / 125 mg sulbactam) every 12 hours.

For severe infections, lower respiratory tract infections, or infections caused by less sensitive organisms, take one tablet every 8 hours.

For children under 40 kg, use the appropriate pediatric suspension formulation; this tablet is not suitable.

The standard course of treatment is 5 to 14 days.

Continue treatment for at least 48-72 hours after symptoms disappear or until evidence of bacterial eradication is obtained.

In infections caused by beta-hemolytic streptococci, maintain therapy for at least 10 days to prevent rheumatic fever or glomerulonephritis.

In cases of impaired renal function, dosage adjustment is necessary based on creatinine clearance values.

If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and continue the regular schedule.

Do not double the dose to make up for a forgotten one.

Complete the entire prescribed course of therapy, even if feeling better, to prevent recurrence of infection and development of bacterial resistance.

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, behavior change.

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.

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; children under 2 years of age (for tablets); hypersensitivity to the components of the drug; hypersensitivity to other beta-lactam antibiotics.

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 use is necessary 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.

Pediatric Use

For children under 2 years of age, the drug is prescribed in the form of a suspension.

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.

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, a reversible increase in prothrombin time is possible.

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 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 CNS side effects, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with antacids, glucosamine, laxatives, aminoglycosides the absorption of this combination is slowed down and reduced; ascorbic acid increases absorption.

With simultaneous use 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.

With simultaneous use with methotrexate, the excretion of the latter is slowed down.

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

With simultaneous use with ethinyl estradiol, the risk of breakthrough bleeding increases.

With simultaneous use 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.