Foxero film-coated tablets 100 mg blister No. 10

Instructions for use Foxero film-coated tablets 100 mg blister No. 10

Composition

active ingredient: cefpodoxime;

1 tablet contains cefpodoxime proxetil equivalent to cefpodoxime 100 mg or 200 mg;

excipients: lactose monohydrate; magnesium stearate; carmellose calcium; low-substituted hydroxypropylcellulose; sodium lauryl sulfate; Opadry white 03A28718 (hypromellose (E 464); titanium dioxide (E 171); talc).

Dosage form

Film-coated tablets.

Pharmacotherapeutic group

Antibacterials for systemic use. Other β-lactam antibiotics. Third generation cephalosporins.

ATC code J01D D13.

Indication

Infections caused by cefpodoxime-sensitive pathogens:

– ENT organs (including sinusitis, tonsillitis, pharyngitis); for the treatment of tonsillitis and pharyngitis, cefpodoxime is prescribed in case of chronic or recurrent infection, as well as in cases of known or suspected insensitivity of the pathogen to widely used antibiotics;

– respiratory tract (including acute bronchitis, relapses or exacerbations of chronic bronchitis, bacterial pneumonia);

– uncomplicated upper and lower urinary tract infections (including acute pyelonephritis and cystitis);

– skin and soft tissues (abscesses, cellulitis, infected wounds, boils, folliculitis, paronychia, carbuncles and ulcers);

– uncomplicated gonococcal urethritis.

Contraindication

Hypersensitivity to cefpodoxime, other cephalosporins or to any of the components of the drug.

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Method of administration and doses

For oral use. Tablets should be taken with food for optimal absorption.

Adults with normal renal function.

Sinusitis: 200 mg 2 times a day.

Tonsillitis and pharyngitis: 100 mg 2 times a day.

Acute bronchitis, exacerbation of chronic bronchitis and bacterial pneumonia: 100-200 mg 2 times a day, depending on the severity of the infection.

Uncomplicated lower urinary tract infections: 100 mg 2 times a day.

Uncomplicated upper urinary tract infections: 200 mg 2 times a day.

Skin and soft tissue infections: 200 mg 2 times a day.

Uncomplicated gonococcal urethritis: 200 mg as a single dose.

Elderly patients.

No dose adjustment is required for elderly patients with normal renal function.

Children.

Tablets are prescribed to children aged 12 and over at 100 mg twice a day. Children under 12 years of age are recommended to use Foxero®, powder for oral suspension.

Liver failure.

No dose adjustment is required for patients with hepatic impairment.

Kidney failure.

No dose adjustment is required for patients with renal impairment with a creatinine clearance greater than 40 ml/min/1.73 m2. If the creatinine clearance is below this value, the dose should be adjusted accordingly (see Table).

Table

Note:

1The standard dose is 100 mg or 200 mg, depending on the type of infection.

The duration of treatment depends on the severity of the disease and is determined individually.

Adverse reactions

Adverse reactions are classified by system organ class and frequency of occurrence: very common (> 1/10); common (≥ 1/100 to ≥ 1/1,000 to ≥ 1/10,000 to <

Infections and infestations:

rarely - superinfection caused by some fungi of the genus Candida, insensitive to cefpodoxime;

very rarely - colitis associated with the use of antibiotics.

From the side of the hematopoietic and lymphatic systems:

rarely – eosinophilia;

very rarely - leukopenia, neutropenia, thrombocytopenia, thrombocytosis, agranulocytosis, decreased hemoglobin concentration, hemolytic anemia.

On the part of the immune system:

rarely - hypersensitivity;

very rarely - anaphylactic reactions.

Metabolic disorders:

rarely - dehydration, gout, peripheral edema, weight gain.

From the musculoskeletal system:

rarely - myalgia.

From the nervous system:

infrequently - headache;

rarely - dizziness;

very rarely - vertigo, insomnia, drowsiness, neurosis, irritability, nervousness, unusual dreams, blurred vision, confusion, night terrors, paresthesia.

On the part of the respiratory system:

rarely - asthma, cough, nosebleed, rhinitis, wheezing, bronchitis, shortness of breath, pleural effusion, pneumonia, sinusitis.

From the digestive tract:

often - diarrhea;

infrequently - abdominal pain, nausea;

If severe persistent diarrhea occurs during therapy with the drug or after completion of the course of treatment, the risk of developing pseudomembranous enterocolitis must be borne in mind (see section "Special instructions").

Hepatobiliary disorders:

very rarely - cholestatic liver damage.

On the part of the skin and its derivatives:

rarely - rash, itching, urticaria, increased sweating, macular rash, fungal dermatitis, peeling, dry skin, hair loss, vesicular rash, solar erythema, purpura, bullous reactions (including Stevens-Johnson syndrome), toxic epidermal necrolysis, erythema multiforme.

From the kidneys and urinary tract:

rarely - hematuria, urinary tract infections, metrorrhagia, dysuria, frequent urination, proteinuria, vaginal candidiasis.

Changes in renal function have been reported with antibiotics of the same class as cefpodoxime, especially when used concomitantly with aminoglycosides and/or potent diuretics.

From the cardiovascular system:

rarely - congestive heart failure, migraine, palpitations, vasodilation, hematoma, arterial hypertension or hypotension.

From the sensory organs:

rarely - taste disturbance, eye irritation, infrequently - tinnitus.

General disorders and administration site conditions:

rarely - discomfort, malaise, fatigue, asthenia, drug fever, chest pain (pain may radiate to the lower back), fever, generalized pain, candidiasis, abscess, allergic reaction, facial swelling, bacterial infections, parasitic infections.

Laboratory indicators:

rarely - increased liver function tests AST, ALT, alkaline phosphatase, bilirubin, urea and creatinine, pseudopositive Coombs' test.

Overdose

Symptoms: nausea, vomiting, abdominal pain, diarrhea. In cases of overdose, especially in patients with renal insufficiency, encephalopathy may develop. Encephalopathy is usually reversible and disappears with a decrease in the level of cefpodoxime in the plasma.

Treatment: Hemodialysis, peritoneal dialysis. Supportive and symptomatic therapy.

Use during pregnancy or breastfeeding.

Foxero® can be used during pregnancy only if clearly needed.

Cefpodoxime passes into breast milk, so if necessary, breastfeeding should be discontinued.

Children.

Tablets are prescribed for children aged 12 years and over. Children under 12 years of age are recommended to use Foxero®, powder for oral suspension.

Application features

Before prescribing cephalosporins, it is necessary to study the history of penicillin allergy, since cross-allergic reactions to penicillins occur in 5-10% of cases.

Special caution should be exercised in patients with allergic reactions to penicillin.

The possibility of cross-allergic reactions to cefpodoxime should be considered in patients with a history of allergic reactions to other cephalosporins. Patients with a history of immediate-type hypersensitivity reactions to cephalosporins should not be given cefpodoxime.

Allergic reactions (anaphylaxis) to β-lactam antibiotics can be serious, sometimes even fatal.

If any signs of hypersensitivity occur, treatment should be discontinued.

In cases of severe renal insufficiency, a dose reduction may be necessary depending on creatinine clearance.

Possible side effects include gastrointestinal disturbances such as nausea, vomiting, and abdominal pain. Antibiotics should be used with caution in patients with a history of gastrointestinal disease (especially colitis).

Cefpodoxime may cause diarrhea, antibiotic-associated colitis, and pseudomembranous colitis. These adverse effects, which occur more frequently in patients receiving high doses for prolonged periods, should be considered potentially serious.

C. difficile should be tested. If colitis is suspected, treatment should be discontinued immediately. The diagnosis should be confirmed by sigmoidoscopy and, if clinically indicated, another antibiotic (vancomycin) should be prescribed. Drugs that cause fecal impaction should be avoided. There is an increased risk of pseudomembranous colitis with broad-spectrum drugs such as cephalosporins.

As with other β-lactam antibiotics, neutropenia and, less frequently, agranulocytosis may occur, especially with prolonged treatment. If treatment lasts more than 10 days, a blood test should be performed and, if neutropenia occurs, treatment should be discontinued.

Cephalosporins may induce a positive Coombs test and, very rarely, may lead to the development of hemolytic anemia. In this reaction, cross-reactivity with penicillins may occur.

When used concomitantly with potentially nephrotoxic drugs such as aminoglycosides and/or potent diuretics (furosemide), renal function should be monitored.

Prolonged use of cefpodoxime may result in overgrowth of nonsusceptible organisms. Oral antibiotics may alter the normal microbial flora of the colon, leading to overgrowth of Clostridium with subsequent pseudomembranous colitis.

1 tablet of 200 mg contains lactose monohydrate 18 mg.

The ability to influence the reaction speed when driving or working with other mechanisms

Attention should be paid to the risk of dizziness.

Interaction with other medicinal products and other types of interactions

Histamine H2 receptor antagonists and antacids reduce the bioavailability of cefpodoxime. Probenecid reduces the excretion of cephalosporins. Cephalosporins may enhance the anticoagulant effect of coumarins and reduce the contraceptive effect of estrogen.

Isolated cases of positive Coombs test have been reported (see section "Special warnings and precautions for use").

Concomitant use of cefpodoxime with drugs that neutralize gastric pH or inhibit gastric acid secretion reduces bioavailability by approximately

30%. Therefore, drugs such as mineral-type antacids and H2 blockers such as ranitidine, which can lead to an increase in gastric pH, should be taken 2-3 hours after taking cefpodoxime.

Bioavailability increases when the drug is taken with food.

A false-positive reaction for glucose in urine may be detected using Benedict/Fehling's solutions or copper sulfate, but such a reaction has not been detected using tests based on enzymatic glucose oxidase reactions.

Pharmacological properties

Pharmacodynamics

Cefpodoxime proxetil is a β-lactam antibiotic of the third generation of cephalosporins for oral administration, a prodrug of cefpodoxime.

The mechanism of action of cefpodoxime is due to the inhibition of bacterial cell wall synthesis in microorganisms. It is resistant to numerous β-lactamases.

In vitro, cefpodoxime has bactericidal activity against numerous gram-positive and gram-negative bacteria.

Cefpodoxime is highly active against gram-positive microorganisms: Streptococcus pneumoniae; Streptococci groups A (S. pyogenes), B (S. agalactiae), C, F and G; other streptococci (S. mitis, S. sanguis and S. salivarius); Corynebacterium diphtheriae.

Cefpodoxime is highly active against gram-negative microorganisms: Haemophilus influenzae (strains that produce and do not produce β-lactamase); Haemophilus para-influenzae (strains that produce and do not produce β-lactamase); Branhamella catarrhalis (strains that produce and do not produce β-lactamase); Neisseria meningitidis; Neisseria gonorrhoeae; Escherichia coli; Klebsiella Spp. (K. Pneumoniae, K. oxytoca); Proteus mirabilis.

Cefpodoxime is moderately sensitive to: methicillin-susceptible staphylococci, strains producing and not producing penicillinase (S. aureus and S. epidermidis).

Resistant to cefpodoxime: Enterococci; methicillin-resistant staphylococci (S. aureus and S. epidermidis); Staphylococcus saprophyticus; Pseudomonas aeruginosa and Pseudomonas spp.; Clostridium difficile; Bacteroides fragilis and related species.

If possible, susceptibility should be determined by in vitro testing.

Pharmacokinetics

Absorption. Cefpodoxime proxetil is absorbed in the intestine and hydrolyzed to its active metabolite cefpodoxime. When cefpodoxime proxetil (tablet containing 100 mg of cefpodoxime) is taken orally on an empty stomach, the absorption of the drug is 51.1%. Food intake increases the absorption period.

Distribution. The volume of distribution is 32.3 L. The maximum level of cefpodoxime is reached within 2-3 hours after administration. The maximum plasma concentration is 1.2 mg/L after administration at a dose of 100 mg and 2.5 mg/L after administration at a dose of 200 mg. After administration at doses of 100 mg and 200 mg 2 times a day for 14.5 days, the pharmacokinetic parameters of cefpodoxime in plasma did not change.

Serum protein binding is 40%, mainly to albumin. Protein binding is unsaturated.

Cefpodoxime penetrates into the lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid, and prostate tissue. Good diffusion of cefpodoxime has also been observed in renal tissue.

It is excreted mainly in the urine, where high concentrations are formed.

Metabolism. Cefpodoxime proxetil is a prodrug of cefpodoxime. Essentially all of the absorbed drug is de-esterified presystemically in the small intestine and converted to its active form. Cefpodoxime is not significantly metabolized and is excreted unchanged, primarily in the urine.

Excretion. The main route of excretion of the drug is the kidneys, 80% is excreted unchanged in the urine. The half-life is about 2.4 hours.

Pharmaceutical characteristics

Main physicochemical properties:

100 mg tablets:

round, biconvex, film-coated tablets, white to off-white in colour, debossed with "100" on one side and plain on the other;

200 mg tablets:

round, biconvex, film-coated tablets, white to off-white in colour, debossed with "200" on one side and plain on the other.

Expiration date

2 years. Do not use after the expiry date stated on the packaging.

Storage conditions

Store at a temperature not exceeding 25 ºС.

Keep out of reach of children.

Packaging

10 film-coated tablets in an aluminum foil blister.

1 or 2 blisters in a cardboard box.

Vacation category

According to the recipe.

Producer

ALKALOID AD Skopje/

ALKALOID AD Skopje.

Alexander the Great Boulevard, 12, Skopje, 1000, Republic of North Macedonia.

Boulevard Aleksandar Makedonski 12, Skopje, 1000, Republic of North Macedonia.