Instructions Foxero powder for oral suspension 40 mg/5 ml bottle 100 ml
Composition
active ingredient: cefpodoxime;
5 ml of oral suspension contains cefpodoxime proxetil equivalent to cefpodoxime - 40 mg;
excipients: microcrystalline cellulose and carmellose sodium; colloidal anhydrous silica; corn starch; hydroxypropylcellulose; sodium benzoate
(E 211); citric acid anhydrous; aspartame (E 951); banana flavoring; iron oxide yellow (E 172); sucrose.
Dosage form
Powder for oral suspension.
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 infections (including acute otitis media, sinusitis, tonsillitis, pharyngitis); the drug should be prescribed for the treatment of chronic or recurrent infections, as well as in case of known or suspected insensitivity of the pathogen to widely used antibiotics;
- respiratory tract infections (including pneumonia, acute bronchitis or bronchiolitis complicated by bacterial superinfection);
- uncomplicated infections of the upper and lower urinary tract (including acute pyelonephritis and cystitis);
- skin and soft tissue infections (abscesses, cellulitis, infected wounds, boils, folliculitis, paronychia, carbuncles and ulcers).
Contraindication
Hypersensitivity to cefpodoxime, other cephalosporins or to any of the components of the drug.
Phenylketonuria, as the drug contains aspartame.
Rare hereditary diseases of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Method of administration and doses
The suspension is intended for use in pediatrics.
The drug should be taken orally with food for optimal absorption.
For instructions on reconstitution before use, see section “Preparation of the suspension”.
Warning: - the plastic graduated measuring cup is intended only for measuring the amount of water required to prepare the suspension; - after preparing the suspension, the plastic measuring cup should be thrown away; - a plastic graduated measuring cup cannot be used for administering medication to a child. |
The recommended average dose for children aged 6 months to 12 years is 8 mg/kg body weight per day, which should be divided into two doses with an interval of 12 hours.
Please note that: 5 ml of suspension contains 40 mg of cefpodoxime; 1 ml of suspension contains 8 mg of cefpodoxime.
A graduated dosing syringe is used to measure the individual dose of the drug.
(single dose) depending on the child's body weight (from 5 to 25 kg).
For example: the mark 12 corresponds to the individual single dose prescribed
a child weighing 12 kg.
Two separate doses should be taken per day.
Duration of treatment
The duration of treatment depends on the severity of the disease and is determined individually.
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 creatinine clearance greater than 40 ml/min/1.73 m2. If creatinine clearance is below this value, the dose should be adjusted accordingly (see Table).
Table
| Creatinine clearance (ml/min/1.73 m2) | Recommended dose |
| 39-10 | calculated based on body weight, a single dose every 24 hours |
| calculated based on body weight, a single dose every 48 hours | | |
| patients on hemodialysis | calculated based on body weight, single dose after each dialysis session |
Preparation of suspension.
It is recommended to prepare the suspension in a pharmacy as follows:
1. Shake the bottle vigorously to separate the powder from the bottom of the bottle.
2. Unscrew the cap on the bottle by pressing and turning it at the same time (safety valve).
3. Remove the protective film.
4. Fill a plastic graduated measuring cup with boiled, cooled water to the 27 ml mark.
5. Pour the water from the measuring cup into the bottle and shake vigorously so that no powder remains on the walls.
6. Fill the plastic graduated measuring cup again with water to the 27 ml mark.
7. Pour the water from the measuring cup into the bottle and shake vigorously until a homogeneous suspension is formed.
8. Throw away the plastic graduated measuring cup.
Shake well before each use.
Close the bottle carefully after each use.
The prepared suspension is stored in a refrigerator (2-8 °C) for 10 days.
The suspension is measured using the dosing syringe included in the package.
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, not sensitive to cefpodoxime;
very rarely - colitis associated with the use of antibiotics.
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, dyspnea, pleural effusion, pneumonia, sinusitis.
From the digestive tract:
often - diarrhea;
infrequently - abdominal pain, nausea;
rarely - feeling of thirst, tenesmus, bloating, vomiting, dyspepsia, dry mouth, decreased appetite, constipation, candidal stomatitis, anorexia, belching, gastritis, mouth ulcers, pseudomembranous colitis.
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:
Rare: rash, itching, urticaria, increased sweating, macular rash, fungal dermatitis, desquamation, 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 disturbances, eye irritation, tinnitus.
General disorders:
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.
The drug is used for children.
Children.
The drug is prescribed for children aged 6 months to 12 years.
The drug is contraindicated in children under 6 months of age.
Application features
Before prescribing cephalosporins, it is necessary to take a preliminary 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.
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 proxetil may result in overgrowth of non-susceptible organisms. Oral antibiotics may alter the normal microbial flora of the colon, leading to overgrowth of Clostridium with subsequent pseudomembranous colitis.
The drug contains sucrose 2465 mg/5 ml.
The drug contains aspartame (E 951) 20 mg/5 ml.
The ability to influence the reaction speed when driving or working with other mechanisms
The drug is intended for children.
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.
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); Propionibacterium acnes; 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); Moraxella catarrhalis (strains that produce and do not produce β-lactamase); Neisseria meningitidis; Neisseria gonorrhoeae; Escherichia coli; Klebsiella Spp. (K. Pneumoniae, K. oxytoca); Proteus mirabilis.
Moderately susceptible to cefpodoxime: 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 (negative)); 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 undergoes presystemic deesterification in the small intestine to its active form. Cefpodoxime is not significantly metabolized and is excreted unchanged, primarily in the urine.
Breeding.
Children: Peak plasma concentrations are reached approximately 2-4 hours after administration. In children aged 4 to 12 years, peak plasma concentrations were similar to those in adults given a single 5 mg/kg dose.
In patients under 2 years of age who received repeated doses of 5 mg/kg every 12 hours, mean plasma concentrations 2 hours after dosing ranged from 2.7 mg/L (1-6 months) to 2.0 mg/L (7 months-2 years).
In patients aged 1 month to 12 years who received repeated doses of 5 mg/kg every 12 hours, steady-state plasma trough concentrations ranged from 0.2-0.3 mg/L (1 month to 2 years) to 0.1 mg/L (2 to 12 years).
Pharmaceutical characteristics
Main physicochemical properties:
Powder from almost white to light yellow in color with a characteristic banana odor.
After preparation: suspension from almost white to light yellow in color with a characteristic banana odor.
Expiration date
2 years. Do not use after the expiry date stated on the packaging.
Storage conditions
Store the powder for oral suspension at a temperature not exceeding 25°C.
The prepared suspension is stable for 10 days at a temperature of 2 °C to 8 °C.
Keep out of reach of children.
Packaging
64.8 g of powder for the preparation of 100 ml of oral suspension in a white translucent plastic (HDPE) bottle with a child-resistant closure.
1 bottle, a measuring cup for dosing the water needed to prepare the suspension, a dispenser (plastic syringe) for oral administration in a cardboard box.
Vacation category
According to the recipe.
Producer
ALKALOID AD Skopje/
ALKALOID AD Skopje.
Location of the manufacturer and its business address
Alexander the Great Boulevard, 12, Skopje, 1000, Republic of North Macedonia.
Boulevard Aleksandar Makedonski 12, Skopje, 1000, Republic of North Macedonia.
