Pecef (cefpodoxime) 200 mg № 10

Description

Pecef storage
active substance: cefpodoxime;
1 film-coated tablet contains cefpodoxime proxetil equivalent to cefpodoxime 100 mg or 200 mg;
Excipients: calcium carboxymethylcellulose, corn starch, crospovidone (type B), lactose monohydrate, sodium lauryl sulfate, hydroxypropylcellulose, magnesium stearate, Opadry White 03H58900 (hypromellose, titanium dioxide (E 171).

Dosage form
Film-coated tablets.

Pharmacological properties
Cefpodoxime proxetil is a beta-lactam antibiotic that belongs to the third generation of oral cephalosporins and is an inactive form of cefpodoxime. After oral administration, it is absorbed in the intestine, where it is rapidly hydrolyzed by nonspecific esterases to cefpodoxime, which is then systemically absorbed.
The mechanism of action of cefpodoxime is based on inhibition of bacterial cell wall synthesis. Cefpodoxime is resistant to most beta-lactamases.
Cefpodoxime has been shown to have bactericidal activity against numerous gram-positive and gram-negative bacteria in vitro.
It is very active against gram-positive microorganisms:

• Streptococcus pneumoniae;
• Group A streptococci (S. pyogenes), B (S. agalactiae), C, F and G
  Other streptococci (S. mitis, S. sanguis and S. salivarius);
• Corynebacterium diphtheriae.

It is very active against gram-negative microorganisms:

• Haemophilus influenzae (strains that produce and do not produce beta-lactamases);
• Haemophilus para-influenzae (strains that produce and do not produce beta-lactamases);
• Branhamella catarrhalis (beta-lactamase producing and non-producing strains);
• Neisseria meningitidis;
• Neisseria gonorrhoeae;
• Escherichia coli;
• Klebsiella Spp. (K. pneumoniae; K. oxytoca);
• Proteus mirabilis.

It is moderately active against methicillin-sensitive staphylococci, strains that produce and do not produce penicillinase (S. aureus and S. epidermidis).
In addition, as with other cephalosporins, the following microorganisms are resistant to cefpodoxime: enterococci, methicillin-resistant staphylococci (S. aureus and S. epidermidis), Staphylococcus saprophyticus, Pseudomonas aeruginosa and Pseudomosium diffe, Spp. related species.
As with other antibiotics, sensitivity should be confirmed by in vitro testing whenever possible.

Indication
Treatment in adults of infections caused by drug-sensitive pathogens, such as:

tonsillitis;

acute sinusitis;

acute bronchitis;

exacerbation of chronic bronchitis;

bacterial pneumonia.

Contraindication
Hypersensitivity to cefpodoxime or other cephalosporin drugs, or to any of the excipients.
Immediate and / or severe hypersensitivity reactions (anaphylaxis) to a history of penicillin or other beta-lactam antibiotics.
Rare hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Children
To date, there is no information on the use of the drug Pecef in children.

Use during pregnancy or breastfeeding
There are no clinical data on the effect of cefpodoxime proxetil on pregnancy. Given the expected benefits, the use of cefpodoxime during pregnancy may be considered despite insufficient clinical and animal data. Caution should be exercised when prescribing to pregnant women in case of urgent need.
Animal studies indicate no direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development.
Cefpodoxime passes into human breast milk, so it is recommended to stop breastfeeding for the duration of treatment.

Method of application and dosage
In adults, the drug Pecef is administered orally 2 times a day with an interval of 12 hours during meals.

• Acute bacterial sinusitis: 2 tablets of 200 mg per day: 1 tablet (200 mg) in the morning and evening. In acute maxillary sinusitis, the drug is effective for 5 days.
• Tonsillitis: 100 mg 2 times a day.
• Acute bronchitis: 200 mg 2 times a day.
• Exacerbation of chronic bronchitis: 200 mg 2 times a day.
• Bacterial pneumonia: 200 mg 2 times a day.

Overdose
In case of cefpodoxime overdose, maintenance and symptomatic therapy is indicated. In case of overdose, in particular in patients with renal insufficiency, reversible encephalopathy may develop. The specific antidote is unknown.

Side effects
Digestive system disorders were mainly observed: diarrhea, nausea, vomiting, abdominal pain. General disorders: asthenia, fatigue, malaise.
Several rare cases of the following adverse reactions have also been reported:

• From the digestive system: as with other broad-spectrum antibiotics, rare cases of enterocolitis with hemorrhagic diarrhea have been reported, as well as rare cases of pseudomembranous colitis, flatulence, and acute pancreatitis.
• From the hepatobiliary system: moderate temporary increase in transaminases, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatases, increased bilirubin, acute hepatitis.
• From the skin: allergic reactions: skin rash, itching, urticaria, Quincke’s edema, anaphylactic shock, various rashes, localized vesicular rash, polymorphic erythema, Stevens-Johnson syndrome and Lyell’s syndrome, erythema.
• From the nervous system: headaches, dizziness, paresthesia.
• From the kidneys and urinary system: a slight increase in blood urea and creatinine, acute renal failure.
• From the circulatory system: thrombocytosis, thrombocytopenia, leukopenia and hypereosinophilia, agranulocytosis, hemolytic anemia, eosinophilia, lymphocytosis, neutropenia, leukocytosis.
• From the organ of hearing and balance: ringing in the ears.

Expiration date
3 years.

Storage conditions
Store Pecef at a temperature below 25 ° C. Keep out of reach of children.