Pharmacotherapeutic group

Antibacterial agents for systemic use. Other beta-lactam antibiotics.

Directions for use

Cefpodoxime is used to treat infections of mild to moderate severity caused by susceptible strains of bacteria.

Upper respiratory tract infections caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, including sinusitis (including maxilla), tonsillitis and pharyngitis.
Acute community-acquired pneumonia.
Exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (only strains that do not produce beta-lactamase) or Moraxella catarrhalis.
Uncomplicated skin and soft tissue infections caused by Staphylococcus aureus or Streptococcus pyogenes.
Acute uncomplicated urethral and cervical gonorrhea caused by Neisseria gonorrhoeae.
Uncomplicated acute anorectal infections in women caused by Neisseria gonorrhoeae.
Uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Staphylococcus saprophyticus.
Local official guidelines for the proper use of antibacterial agents should be followed.

Dosage and administration

Inside.

The tablets are taken with food for optimal absorption.

Assign to adults and children over 12 years old in doses:

Upper respiratory tract infections, including: sinusitis (including maxilla), tonsillitis and pharyngitis - 200 mg every 12 hours - 10 days;
Acute community-acquired pneumonia - 400 mg - 200 mg every 12 hours - 14 days;
exacerbation of chronic bronchitis - 400 mg - 200 mg every 12 hours - 10 days;
Uncomplicated skin and soft tissue infections - 800 mg - 400 mg every 12 hours - 7 to 14 days;

Elderly patients: No dose adjustment is necessary in elderly patients with normal renal function.

Patients with hepatic impairment: no dose adjustment is necessary in patients with hepatic impairment.

Patients with renal impairment: use with caution in patients with renal impairment. The dose of cefpodoxime does not require correction if the creatinine clearance exceeds 40 ml / min / 1.73 m2. Below this value, according to pharmacokinetic studies, the elimination half-life from plasma increases.

If you miss the time to take the next dose of medicine, take it as soon as possible. Do not double the dose instead of the missed dose. Subsequent doses of the drug should be taken in accordance with these instructions or the doctor's instructions.

Cons-indications

Hypersensitivity to cefpodoxime and to the auxiliary components of the drug Hypersensitivity to cephalosporins.

An acute and / or severe hypersensitivity reaction (anaphylaxis) to a history of penicillin or other beta-lactam antibiotics.

Children under 12.

Safety precautions

Cepodoxime, like other cephalosporins, should be used with caution in patients receiving concurrent therapy with potent diuretics.

Changes in kidney function have been detected with cephalosporin antibiotics, especially when used in combination with potentially nephrotoxic drugs such as aminoglycosides and / or potent diuretics. In such cases, kidney function should be monitored.

As with other antibiotics, prolonged use of cefpodoxime may cause excessive growth of insensitive microorganisms (including fungi and Clostridium difficile), which may require discontinuation of treatment. The reassessment of the patient's condition is important. If secondary infection occurs during treatment, appropriate measures should be taken.

Cefpodoxime is not a preferred antibiotic for the treatment of staphylococcal pneumonia and should not be used to treat SARS caused by microorganisms such as Legionella, Mycoplasma and Chlamydia. Cepodoxime should always be prescribed with caution in patients with gastrointestinal illness, especially a history of colitis.

As with all beta-lactam antibiotics, neutropenia and more rarely agranulocytosis can develop, especially with prolonged therapy. In cases where treatment lasts more than 10 days, blood tests should be monitored and treatment discontinued in case of neutropenia.

Cephalosporins can be absorbed on the surface of the membranes of red blood cells and react with antibodies to the drug. This can lead to positive Coombs tests and, very rarely, hemolytic anemia. Cross-reactivity with penicillin may occur for this reaction.

Before starting treatment with cefpodoxime proxetil, the patient should be carefully asked about past hypersensitivity reactions to cefpodoxime, other cephalosporins, penicillins, or other medicines.

It is recommended that cefpodoxime be used with caution in patients with allergic conditions (e.g. hay fever or bronchial asthma), as in these cases the risk of severe hypersensitivity reactions is increased, as well as in patients with mild hypersensitivity to penicillins, as there are cases of cross hypersensitivity between beta-lactams. antibiotics. Antibiotic and pseudomembranous colitis has been reported with almost all antibacterial agents, including cefpodoxime; the severity of the forms of the disease can range from mild to life-threatening. Therefore, the correct diagnosis is required in patients with diarrhea after taking antibacterial agents.

The composition of 1 Vantin tablet contains less than 1 mmol (23 mg) of sodium - this means that the tablets are practically "sodium-free".

Interaction with other medicinal products, other forms of interaction

Antacids: the simultaneous administration of large doses of antacids (sodium bicarbonate, aluminum hydroxide) or H2 blockers can reduce plasma levels and the degree of absorption of cefpodoxime proxetil.

Histamine H2 receptor blockers and antacids decrease the bioavailability of cefpodoxime. Studies have shown that bioavailability decreases by approximately 30% when cefpodoxime is administered with drugs that neutralize the pH in the stomach or inhibit acid secretion. Therefore, medicines such as mineral antacids and H2 blockers, such as ranitidine, which can cause the pH in the stomach to increase, should be taken 2-3 hours after taking cefpodoxime.

Simultaneous oral administration of anticholinergics slows the time it takes to reach maximum concentration (Tmax), but does not affect the degree of absorption (AUC) of cefpodoxime proxetil.

Probenecid: Probenecid slows the renal excretion of cefododime proxetil, reduces the excretion of cephalosporins, as well as other beta-lactam antibiotics, which results in increased AUC and drug spikes in plasma. Nephrotoxic drugs: although nephrotoxicity has not been established as monotherapy with cefpodoxime proxetil, careful monitoring of renal function when taking cefpodoxime proxetil with other drugs with known nephrotoxic potential is required.

Interaction with laboratory tests:

A false positive urine glucose test can occur with Feling or Benedict solutions or copper sulfate tablets, but not with tests based on enzymatic reactions to glucose oxidase.

Cephalosporins increase the anticoagulant effect of coumarins and reduce the contraceptive effect of estrogens.

Oral anticoagulants:

Co-administration of cefpodoxime and warfarin may increase its anticoagulant effect. There are many reports of increased activity of oral anticoagulants in patients receiving antibacterial agents, including cephalosporins. The risk may vary depending on the type of infection, the age and the general condition of the patient, so that the contribution of cephalosporins to an increase in the INR (International Standard Report) is difficult to assess.

It is often recommended to monitor the INR during and immediately after co-administration of cefpodoxime with oral anticoagulants.

Pregnancy and breast feeding

The safety of the drug during pregnancy and lactation has not been established. Sefpotok can only be used in pregnant women if it is absolutely necessary. Cefpodoxime is excreted in breast milk. If it is necessary to use Vantin, the mother should decide to stop breastfeeding.

Impact on ability to drive vehicles and other mechanisms

During treatment with cefpodoxime, dizziness may occur, which may affect the ability to drive vehicles and other mechanisms.

Side effects

Adverse effects characteristic of the cephalosporin class: renal dysfunction, toxic nephropathy, impaired liver function, including cholestasis, aplastic anemia, bleeding, agranulocytosis and pancytopenia, seizures (especially in patients with renal failure without adjustment dosage).

Allergic reactions: anaphylactic reactions, bronchospasm, angioedema. From the central nervous system, the peripheral nervous system and the sensory organs: anxiety, nervousness, altered attention concentration, increased fatigue, confusion, sleep disturbances, drowsiness, insomnia, dizziness, headache, changes or loss of taste, eye irritation, ringing in the ears, paraesthesia cerebral infarction.

From the genitourinary system: acute renal failure, hematuria, metrorrhagia, dysuria, nocturia, proteinuria, frequent urination, urinary tract infections, vaginal pain, menstrual irregularities.

Liver: impaired liver function. From the digestive system: dry mouth, thirst, belching, nausea, vomiting, abdominal pain, flatulence, stool retention, persistent diarrhea, dysbiosis (growth of Clostridium difficile), decreased appetite, gastritis, ulcerative colitis, mouth ulcers , troubles with side of rectum, pain in teeth, tenesmus.

In terms of metabolism and nutrition: dehydration, weight gain, gout, peripheral edema, hyperkalemia, hyponatraemia.

From the respiratory system: cough, shortness of breath, asthma, bronchitis, pleurisy, pneumonia, rhinitis, sinusitis, nosebleeds.

On the side of the cardiovascular system: hypertension, decrease in blood pressure, congestive heart failure, migraine, palpitations, vasodilation. From the hemopoietic system: thrombocytosis, thrombocytopenia, leukocytosis, leukopenia, lymphocytosis, granulocytosis, basophilia, monocytosis, neutropenia, lymphocytopenia, eosinophilia, anemia, hemolytic anemia, reduced hematocrit.

Skin and subcutaneous tissue: dry skin, scaling, itching, rash, hives, fungal dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Infections and infestations: excessive growth of insensitive microflora and development of infections (fungal, bacterial and parasitic infections), vulvovaginal infections, oral candidiasis.

Other: myalgia, asthenia, fever, chills, weakness, fainting, dehydration, chest pain, back pain, other local pain, bruising, hair loss. Laboratory indicators: increased activity of liver transaminases, hyperbilirubinemia, increased concentrations of LDH, GGT, urea, creatinine in blood serum, hyper- or hypoglycemia, hypoproteinemia and hypoalbuminemia, decrease in Hb, positive Coombs reaction , increased prothrombin time.

If these reactions occur, as well as a reaction not specified in the instructions, you should consult a doctor.

Overdose

Toxic symptoms of an overdose of beta-lactam antibiotics can include nausea, vomiting, upset stomach, diarrhea.

In case of overdose, especially in patients with renal impairment, encephalopathy may occur. Encephalopathy is usually reversible with a decrease in the plasma concentration of cefpodoxime.

In the event of an overdose of cefpodoxime, supportive and symptomatic drug therapy is performed.

In the event of an overdose and the development of a severe toxic reaction, hemodialysis or peritoneal dialysis is prescribed to eliminate cefpodoxime from the body, especially in patients with renal insufficiency.

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