Cefma film-coated tablets 200 mg blister No. 10

Instructions for use Cefma film-coated tablets 200 mg blister No. 10

Composition

active ingredient: cefpodoxime;

1 tablet contains cefpodoxime proxetil, equivalent to 200 mg of cefpodoxime;

excipients: sodium lauryl sulfate, magnesium stearate, hydroxypropyl cellulose, crospovidone, lactose monohydrate, calcium carboxymethylcellulose, titanium dioxide (E 171), talc, hypromellose.

Dosage form

Film-coated tablets.

Main physicochemical properties: oblong tablets, film-coated, with a score on both sides, from white to yellowish in color.

Pharmacotherapeutic group

Antibacterials for systemic use. Other β-lactam antibiotics. Third generation cephalosporins. ATX code J01D D13.

Pharmacological properties

Pharmacodynamics

The mechanism of antibacterial action of cefpodoxime is based on the inhibition of bacterial cell wall synthesis (in the growth phase) by inhibiting penicillin-binding proteins (PBPs), such as transpeptidases. This leads to the interruption of cell wall (peptidoglycan) biosynthesis, which causes lysis and death of bacterial cells.

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); Neisseriameningitidis; Neisseriagonorrhoeae; Escherichia coli; Klebsiella spp. (K. pneumoniae, K. oxytoca); Proteus mirabilis.

Cefpodoxime is moderately sensitive to: methicillin-susceptible staphylococci, penicillinase-producing and non-penicillinase-producing strains (S. aureus and S. epidermidis).

Resistant to cefpodoxime: Enterococci; methicillin-resistant staphylococci (S. aureus and S. epidermidis); Staphylococcussaprophyticus; Pseudomonasaeruginosa and Pseudomonas spp.; Clostridiumdifficile; Bacteroidesfragilis and related species.

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

Pharmacokinetics

Cefpodoxime proxetil is absorbed in the intestine and hydrolyzed to the active metabolite cefpodoxime. When cefpodoxime proxetil is administered orally to fasting patients in tablet form, equivalent to 100 mg of cefpodoxime, 51.1% is absorbed, and absorption increases with food intake. The volume of distribution is 32.3 L, and peak levels of cefpodoxime are observed 2–3 hours after administration. Maximum plasma concentrations are 1.2 mg/L and 2.5 mg/L after 100 mg and 200 mg doses, respectively. After administration of 100 mg and 200 mg twice daily for 14.5 days, the pharmacokinetic parameters of cefpodoxime in plasma remain unchanged. The binding of cefpodoxime to serum proteins, mainly albumin, is 40%. This binding is non-saturable in nature. Concentrations of cefpodoxime exceeding the minimum inhibitory levels (MICs) for common pathogens can be achieved in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate tissue. Studies in healthy volunteers show that mean concentrations of cefpodoxime in total ejaculate 6-12 hours after a single 200 mg dose exceed the MIC90 for N. gonorrhoeae. Since most of the cefpodoxime is excreted in the urine, the concentration is high (concentrations in the 0-4, 4-8, 8-12 hour fractions after a single dose exceed the MIC90 for common urinary pathogens). Good diffusion of cefpodoxime is also observed in renal tissue, with concentrations above the MIC90 for common urinary pathogens 3–12 hours after a single 200 mg dose (1.6–3.1 μg/g). Cefpodoxime concentrations in brain and cerebral cortex tissues are similar. The main route of excretion is renal, with 80% of the dose excreted unchanged in the urine with a half-life of approximately 2.4 hours.

Indication

Treatment of infections caused by pathogens sensitive to the drug:

– ENT infections (including sinusitis, tonsillitis, pharyngitis); for the treatment of tonsillitis and pharyngitis, cefpodoxime should be 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 infections (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 tissue infections (abscesses, cellulitis, infected wounds, boils, folliculitis, paronychia, carbuncles and ulcers);

– uncomplicated gonococcal urethritis.

Contraindication

Hypersensitivity to cefpodoxime, cephalosporin drugs or any of the components of the drug.

History of immediate or severe hypersensitivity reactions to penicillin or any other type of beta-lactam drug.

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

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.

Studies have shown that bioavailability is reduced by approximately 30% when cefpodoxime is administered concomitantly with drugs that neutralize gastric pH or inhibit acid secretion. Therefore, drugs such as antacids and H₂ blockers that can increase gastric pH should be administered 2–3 hours after cefpodoxime administration.

The bioavailability of the drug increases when taken with food.

Cefpodoxime should not be used concomitantly with bacteriostatic antibiotics (e.g. chloramphenicol, erythromycin, sulfonamides or tetracyclines) as the therapeutic effect of cefpodoxime may be reduced.

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.

Application features

Before initiating therapy, it is necessary to determine whether the patient has had any history of hypersensitivity reactions to cefpodoxime, cephalosporins, penicillins, or other beta-lactam antibiotics.

This medicine is contraindicated in patients who have had a history of immediate or severe hypersensitivity reaction to penicillin or another type of beta-lactam drug. Allergic reactions (anaphylaxis) to beta-lactam antibiotics can be serious and sometimes fatal.

Patients with any other type of allergic reaction (e.g. hay fever or bronchial asthma) should also use cefpodoxime with particular caution, as the risk of serious hypersensitivity reactions is increased in these cases.

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

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

Cefpodoxime is not the antibiotic of first choice for the treatment of staphylococcal pneumonia and should not be used in the treatment of atypical pneumonia caused by microorganisms such as Legionella, Mycoplasma and Chlamydia.

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

Antibiotic-associated diarrhea, colitis, and pseudomembranous colitis may occur with cefpodoxime. These diagnoses should be considered in any patient who develops diarrhea during or shortly after initiation of treatment. Cefpodoxime should be discontinued if severe and/or bloody diarrhea occurs during treatment and appropriate therapy should be initiated. Cefpodoxime should always be used with caution in patients with gastrointestinal disease, especially colitis.

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 all beta-lactam antibiotics, neutropenia and, less frequently, agranulocytosis may occur, especially with prolonged treatment. If treatment is continued for more than 10 days, blood counts should be monitored and treatment discontinued if neutropenia is detected.

Cephalosporins can be absorbed onto the surface of red blood cell membranes and react with antibodies directed against the drug. This can cause a positive Coombs test and very rarely, hemolytic anemia. Cross-reactivity may occur with penicillin for this reaction.

Coombs' test and non-enzymatic methods of measuring sugar in urine may show a false positive result during treatment with cephalosporins.

Changes in renal function have been observed during treatment with cephalosporin antibiotics, especially when potentially nephrotoxic drugs such as aminoglycosides and/or diuretics (furosemide) are administered concomitantly. In such cases, renal function should be monitored.

No dose adjustment is required if creatinine clearance exceeds 40 ml/min. For patients with creatinine clearance less than 40 ml/min and patients on hemodialysis, the interval between doses of cefpodoxime should be increased.

In case of the appearance of exudative erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome, the drug should be discontinued.

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Use during pregnancy or breastfeeding

There are no clinical data on the effects of cefpodoxime on pregnancy. Experimental studies in animals have not revealed any teratogenic or fetotoxic effects of cefpodoxime. However, the safety of cefpodoxime during pregnancy has not been established, so the drug should be used with caution only after careful assessment of the benefit-risk ratio, especially in the first months of pregnancy.

Cefpodoxime is excreted in breast milk in very small amounts. Therefore, changes in the intestinal flora, including diarrhea and colonization with yeast-like fungi, may occur in breast-fed infants, which may necessitate discontinuation of breastfeeding. The possibility of sensitization should also be taken into account. Therefore, cefpodoxime should be used during breastfeeding only after careful benefit-risk assessment.

Ability to influence reaction speed when driving vehicles or other mechanisms

Cefpodoxime has a weak or moderate influence on the reaction rate when driving vehicles or working with other mechanisms.

Dizziness or decreased blood pressure have been reported during treatment with cefpodoxime, which may affect the reaction rate of patients when driving or operating other machinery.

Method of administration and doses

The drug is administered orally. For optimal absorption, the tablet should be taken with food. The 200 mg tablet can be divided into 2 parts.

Adults and adolescents with normal renal function.

Sinusitis: 200 mg 2 times a day.

Tonsillitis and pharyngitis: 100 mg (½ tablet) 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 disease.

Uncomplicated lower urinary tract infections: 100 mg (½ tablet) 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 necessary for elderly patients with normal renal function.

Hepatic impairment: No dose adjustment is required for patients with hepatic impairment.

Renal impairment: Appropriate dose adjustment is required for patients with renal impairment (creatinine clearance < 40 ml/min).

1) Single dose - 100 mg or 200 mg depending on the type of infection, as indicated above.

The duration of therapy depends on the patient, the indication and the pathogen. The usual duration of treatment is 5–10 days. In the treatment of infections caused by Streptococcus pyogenes, therapy should last 10 days.

Children

Tablets should be prescribed to children aged 12 and over at 100 mg (½ tablet) 2 times a day.

Overdose

Symptoms: nausea, vomiting, abdominal pain, diarrhea. In patients with renal insufficiency, overdose may lead to the development of encephalopathy, which is usually reversible after a decrease in cefpodoxime plasma levels.

Treatment: in case of overdose, prescribe supportive and symptomatic therapy. Hemodialysis, peritoneal dialysis.

Adverse reactions

To determine the frequency of adverse reactions, the following classification was used: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000, including isolated cases).

On the part of the digestive tract: often - anorexia, intragastric pressure, gastrointestinal discomfort, nausea, vomiting, abdominal pain, flatulence, diarrhea. Bloody diarrhea may be a symptom of enterocolitis; rarely - thirst, tenesmus, dyspepsia, dry mouth, decreased appetite, constipation, candidal stomatitis, eructation, gastritis, mouth ulcers, acute pancreatitis, pseudomembranous colitis.

Metabolism and nutrition: often - loss of appetite; rarely - dehydration, gout, peripheral edema, weight gain.

Immune system disorders: uncommon - hypersensitivity; rare - anaphylactic reactions, bronchospasm and angioedema; life-threatening shock.

From the hepatobiliary system: infrequently - cholestatic liver damage; rarely - acute hepatitis.

Laboratory indicators: infrequently - transient increase in the activity of liver transaminases (alanine and aspartate aminotransferase), alkaline phosphatase, and/or bilirubin, urea and creatinine, pseudo-positive Coombs' test.

From the respiratory system: rarely - asthma, cough, nosebleeds, rhinitis, wheezing, bronchitis, shortness of breath, pleural effusion, pneumonia, sinusitis.

Musculoskeletal system: rarely - myalgia.

Skin: infrequently - rash, itching, urticaria, exanthema, increased sweating, maculopapular rashes, fungal dermatitis, peeling, dry skin, hair loss, vesicular rashes, solar erythema, purpura, bullous reactions (including Stevens-Johnson syndrome), toxic epidermal necrolysis, exudative erythema multiforme, Lyell's syndrome.

On the part of the urinary system: rarely - hematuria, urinary tract infections, metrorrhagia, dysuria, frequent urination, proteinuria, vaginal candidiasis, acute renal failure, slight increases in blood urea and creatinine levels.

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.

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

From the nervous system: infrequently - headache, paresthesia, dizziness; very rarely - vertigo, insomnia, drowsiness, neurosis, irritability, nervousness, unusual dreams, blurred vision, confusion, night terrors.

From the sensory organs: rarely - taste disturbance, eye irritation; infrequently - tinnitus.

Infections and infestations: common - superinfection caused by some fungi of the genus Candida, not sensitive to cefpodoxime; very rare - colitis associated with the use of antibiotics.

General disorders: uncommon - fatigue, asthenia or malaise; rare - discomfort, drug fever, chest pain (pain may radiate to the lower back), fever, generalized pain, candidiasis, abscess, allergic reaction, facial swelling, bacterial infections, parasitic infections.

In case of side effects or adverse reactions, you should immediately inform your doctor.

Expiration date

3 years.

Storage conditions

No special storage conditions are required.

Store in original packaging. Keep out of reach of children.

Incompatibility.

Data is missing.

Packaging

10 tablets in a blister. 1 (10×1) or 2 (10×2) blisters in a cardboard box.

Vacation category

According to the recipe.

Producer

Sandoz GmbH - Production site Anti-infectives and Chemical Operations Kundl (AIHO Kundl).

Location of the manufacturer and address of its place of business

Biochemiststrasse 10, 6250 Kundl,