Instructions for Cefodox film-coated tablets 100 mg No. 10
Composition
active ingredient: cefpodoxime;
1 tablet contains cefpodoxime (in the form of proxetil) 100 mg or 200 mg;
excipients: silicified microcrystalline cellulose*, croscarmellose sodium, sodium starch glycolate (type A), sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, Opadry OY-L white 28900 (lactose, monohydrate; titanium dioxide (E 171); polyethylene glycol; hydroxypropylmethylcellulose), iron oxide yellow (E 172), polyethylene glycol 6000.
* PROSOLV® SMCC 50; PROSOLV® SMCC 90.
Dosage form
Film-coated tablets.
Main physicochemical properties:
100 mg tablets: oval-shaped tablets with a biconvex surface with a score, coated with a creamy-white film coating, with imprints of “PhI” on one side and “CF” “1” on the other;
200 mg tablets: oval-shaped tablets with a biconvex surface, coated with a creamy-white film coating, with an imprint of “PhI” on one side and a score and imprints of “CF” “2” on the other.
Pharmacotherapeutic group
Antibacterials for systemic use. Other beta-lactam antibiotics. Third generation cephalosporins. ATX code J01D D13.
Pharmacological properties
Pharmacodynamics
Cefodox (cefpodoxime in the form of proxetil) is a third-generation beta-lactam antibiotic for oral use. Its bactericidal effect is due to the inhibition of the synthesis of components of the bacterial wall of microorganisms. The drug is active against many gram-positive, gram-negative, aerobic and anaerobic microorganisms.
The spectrum of action of cefpodoxime covers the following microorganisms:
sensitive gram-positive bacteria – Streptococcus pneumoniae, streptococci of group A (S. pyogenes), group B (S. agalactiae), groups C, F and G, as well as S. mitis, S. Sanguis, S. Salivarius and Corynebacterium diphtheriae;
sensitive gram-negative bacteria – Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis (beta-lactamase producing and non-producing strains), Neisseria meningitidis, Neisseria gonorrhoeae, Escherichia coli, Klebsiella spp. (K. pneumoniae, K. oxytoca), Proteus mirabilis;
moderately sensitive bacteria – methicillin-sensitive staphylococci, strains that produce and do not produce penicillinase (S. aureus and S. epidermidis).
The following bacteria are resistant to cefpodoxime, as well as to other cephalosporins: enterococci,
methicillin-resistant staphylococci (S. aureus and S. epidermidis), Staphylococcus saprophyticus, Pseudomonas aeruginosa and Pseudomonas spp., Clostridium difficile, Bacteroides fragilis.
Pharmacokinetics
The active substance of the drug is absorbed in the small intestine and hydrolyzed to the active metabolite cefpodoxime. The maximum concentration in the blood plasma is reached within 2-4 hours after taking a single dose. Cefpodoxime binds to blood plasma proteins (mainly albumin), the bond is unsaturated. The minimum inhibitory concentration (MIC) of cefpodoxime against most pathogens is observed in the lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate secretion.
It penetrates well into the kidney tissue. Within 12 hours after taking a single dose, MIC90 is achieved against most pathogens of kidney and urinary tract infections. It is excreted mainly in the urine, the half-life is approximately 2.4 hours.
Indication
Infections caused by cefpodoxime-sensitive pathogens:
- ENT organs (including sinusitis, tonsillitis, pharyngitis); for the treatment of tonsillitis and pharyngitis, Cefodox 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 (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 cephalosporins, penicillins or to any of the excipients. History of immediate or severe hypersensitivity reactions to penicillin or any other beta-lactam agent.
Rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Interaction with other medicinal products and other types of interactions
Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or histamine H2-receptor blockers leads to a decrease in the extent of absorption by 27–32%, and Cmax by 24–42%. Oral anticholinesterase agents increase Tmax by 47%, but do not affect the extent of absorption. If necessary, use with ranitidine, the drug should be taken 2–3 hours after taking ranitidine.
Cephalosporins potentially enhance the anticoagulant effect of coumarins and reduce the contraceptive effect of estrogens.
Studies have shown that the bioavailability of Cefodox is reduced by approximately 30% when administered concomitantly with drugs that neutralize gastric pH or inhibit gastric secretion.
The bioavailability of the drug Cefodox increases when taken with food.
When determining glucose in urine by copper reduction methods (using Benedict's or Fehling's solutions), a false-positive result may be observed, however, cefpodoxime does not affect the determination of glucose in urine by enzymatic methods.
Concomitant use of the drug with loop diuretics may increase nephrotoxicity. It is recommended to conduct careful monitoring of renal function if the drug Cefodox, tablets, is prescribed simultaneously with drugs that exhibit nephrotoxic effects.
Plasma levels of cefpodoxime are increased when the drug is administered with probenecid.
Application features
Approximately 5–10% of patients with penicillin allergy have a cross-reaction to cephalosporins, therefore, before prescribing cephalosporins, it is necessary to clarify the possible presence of penicillin allergy in the patient and ensure careful medical supervision from the first day of cefpodoxime use. At the first signs of an anaphylactic reaction, the drug should be discontinued.
Cefpodoxime is not recommended for use in patients with known hypersensitivity to cephalosporin antibiotics. Allergic reactions (especially anaphylaxis) observed with beta-lactam antibiotics can be severe and, in rare cases, fatal.
At the first signs of an allergic reaction when using the drug, you should immediately stop taking it and consult a doctor.
In the event of exudative erythema multiforme, Stevens-Johnson syndrome, or Lyell's syndrome, the drug should be discontinued.
Cefpodoxime is not an antibiotic for the treatment of staphylococcal pneumonia, nor should it be used to treat atypical pneumonia caused by Legionella, Mycoplasma, and Chlamydia.
When using the drug, side effects from the digestive tract are possible, including nausea, vomiting, abdominal pain, so cefpodoxime should be prescribed with caution to patients with a history of gastrointestinal diseases, especially colitis. The use of cefpodoxime can cause the development of diarrhea, antibiotic-associated colitis and pseudomembranous colitis. These side effects, which may occur more often in patients who have been treated with high doses of cefpodoxime for a long time, should be considered as potentially severe.
Clostridium difficile testing should be performed. If colitis occurs, cefpodoxime treatment should be discontinued immediately, sigmoidoscopy performed, and appropriate therapy (vancomycin) administered if necessary. Constipating foods should be avoided. Although any antibiotic can cause pseudomembranous colitis, the risk is greater with broad-spectrum antibiotics such as cephalosporins.
When using beta-lactam antibiotics, neutropenia and agranulocytosis may develop, especially during prolonged treatment. If the drug is used for more than 10 days, blood tests should be monitored, and if neutropenia develops, treatment with cefpodoxime should be discontinued.
A positive Coombs test and, very rarely, hemolytic anemia may occur during treatment with cefpodoxime. In these reactions, there is cross-resistance between cephalosporins and penicillins.
Changes in renal function have been observed with concomitant use with aminoglycosides or strong diuretics, in which case monitoring of renal function is necessary.
Prolonged use of cefpodoxime may result in overgrowth of nonsusceptible organisms. If superinfections occur, the patient should be evaluated and appropriate treatment instituted.
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 data on the safety of cefpodoxime during pregnancy. Experimental studies on animals have not revealed any teratogenic or fetotoxic effects of cefpodoxime. During pregnancy, the drug can be used only when the expected benefit to the mother outweighs the potential risk to the fetus, especially in the first months of pregnancy.
Cefpodoxime is excreted in breast milk. Therefore, changes in the intestinal flora, including diarrhea and colonization with yeast-like fungi, may occur in breast-fed infants. The possibility of sensitization should also be considered. If necessary, breast-feeding should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using cefpodoxime, dizziness or a decrease in blood pressure may occur, which may affect the speed of reaction when driving or using other mechanisms.
Method of administration and doses
For adults and children over 12 years of age with normal kidney function, the following doses are recommended:
| Infections | Total daily dose | Reception mode |
ENT infections: sinusitis other infections (including tonsillitis, pharyngitis) | 400 mg 200 mg | 200 mg 2 times a day 100 mg 2 times a day |
Respiratory tract infections (including acute bronchitis, relapses or exacerbations of chronic bronchitis, bacterial pneumonia) | 200–400 mg (depending on the sensitivity of the pathogen) | 100–200 mg 2 times a day |
| Uncomplicated urinary tract infections: | | |
| upper (acute pyelonephritis) | 400 mg | 200 mg 2 times a day |
| lower (cystitis) | 200 mg | 100 mg 2 times a day |
Skin and soft tissue infections (abscesses, cellulitis, infected wounds, boils, folliculitis, paronychia, carbuncles and ulcers) | 400 mg | 200 mg 2 times a day |
| Uncomplicated gonococcal urethritis | 200 mg | one-time |
The duration of treatment depends on the severity of the disease and is determined individually.
Elderly patients
There is no need to change the dose in elderly patients with normal renal function.
Liver dysfunction
There is no need to change the dose for patients with hepatic insufficiency.
Kidney dysfunction
There is no need to change the dose of Cefodox if creatinine clearance is > 40 ml/min.
Pharmacokinetic studies indicate an increase in half-life and maximum plasma concentration if creatinine clearance is below 40 ml/min, so the dose of the drug should be adjusted.
| Creatinine clearance (ml/min) | |
| 39–10 | Single dose1) to be administered every 24 hours (i.e. ½ the usual adult dose) |
| < 10 | A single dose1) should be administered every 48 hours (i.e. ¼ of the usual adult dose) |
| Patients on hemodialysis | Single dose1) to be administered after each dialysis session |
1) Single dose – 100 mg or 200 mg depending on the type of infection.
Children
The drug Cefodox, tablets, is prescribed for children over 12 years of age.
Children under 12 years of age are recommended to use Cefodox, powder for oral suspension.
Overdose
Symptoms: nausea, vomiting, abdominal pain, diarrhea. In patients with renal insufficiency, encephalopathy may occur in case of overdose. Cases of encephalopathy are usually reversible at low plasma levels of cefpodoxime.
Treatment: hemodialysis, peritoneal dialysis. Symptomatic therapy.
Adverse reactions
General disorders: fungal infections, malaise, fatigue, asthenia, fever, chest pain (pain may radiate to the lower back), back pain, chills, generalized pain, abscess, allergic reactions, facial swelling, bacterial infections, localized swelling, localized pain, growth of non-susceptible microorganisms.
Cardiovascular system: congestive heart failure, migraine, palpitations, vasodilation, hematomas, arterial hypertension or hypotension.
On the part of the digestive tract: diarrhea, abdominal pain, feeling of fullness in the stomach, nausea, tenesmus, bloating, vomiting, dyspepsia, decreased appetite, constipation, anorexia, candidal stomatitis, toothache, belching, gastritis, dry mouth, feeling of thirst, mouth ulcers, pseudomembranous colitis.
Diarrhea with blood may be a symptom of enterocolitis. In case of severe or persistent diarrhea occurring during or after treatment, the development of pseudomembranous colitis should be suspected (see section "Special instructions").
From the hepatobiliary system: cholestatic liver damage.
From the blood system: hemolytic anemia, decreased hemoglobin level, decreased hematocrit, eosinophilia, leukocytosis, leukopenia, lymphocytosis, lymphopenia, agranulocytosis, thrombocytosis, neutropenia, thrombocytopenia, prolonged thrombin and prothrombin time.
Metabolic disorders: dehydration, gout, peripheral edema, weight gain.
Musculoskeletal system: myalgia.
From the nervous system: cephalalgia, vertigo, dizziness, unsteadiness of gait, headache, hemorrhages, anxiety, nervousness, neurosis, insomnia, sleep disorders, changes in dreams (unusual dreams, nightmares), paresthesias, confusion.
Respiratory system: bronchial asthma, cough, nosebleeds, rhinitis, wheezing, sneezing, bronchospasm, dyspnea, pleural effusion, pneumonia.
Skin: rash, skin hyperemia, urticaria, itching, increased sweating, maculopapular and vesicular-bullous rashes, fungal dermatitis, epithelial desquamation, dry skin, hair loss, sunburn, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
From the sensory organs: change or loss of taste, eye irritation, ringing/noise in the ears.
From the genitourinary system: hematuria, urinary tract infections, metrorrhagia, vaginal candidiasis, dysuria, frequent urination, proteinuria, increased urea and creatinine in the urine; in isolated cases, renal dysfunction has been observed, especially with the simultaneous use of cefpodoxime with aminoglycosides and/or strong diuretics.
Laboratory indicators: increased liver function tests of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, bilirubin, urea and creatinine, pseudopositive Coombs test.
Biochemical tests: hyper- or hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, hyponatremia.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
Pharma International Company.
Location of the manufacturer and address of its place of business
Al Qastal Area, Airport Road, A.S. 334 Jubailah 11941, Amman – Jordan.
Applicant
Pharma International Company.
Applicant's location
A.S. 334 Al-Jubayha 11941 Amman, Jordan.
