Cedex - instructions for use, reviews, analogs and forms of release (capsules or tablets 400 mg, powder for the preparation of antibiotic suspension) of the drug for the treatment of otitis, sinusitis, angina in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Tzedek. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Tsedeks in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Tsedeks in the presence of existing structural analogs. Use for the treatment of otitis, sinusitis and sore throat in adults, children, as well as during pregnancy and lactation.Composition of antibiotic.

Tzedek - 3 generation cephalosporin. It is a beta-lactam antibiotic, has a bactericidal effect, the mechanism of which is due to the suppression of bacterial cell wall synthesis. The drug acts on many microorganisms that produce beta-lactamases and are resistant to penicillins and other cephalosporins.

Ceftibuten (an active substance of antibiotic Cedex) is highly resistant to plasmid penicillinases and cephalosporinases. However, it is destroyed by the action of certain chromosomal cephalosporinases, which are produced by such microorganisms as Citrobacter spp., Enterobacter spp. and Bacteroides spp. The drug should not be used for infections caused by bacterial strains, whose resistance to beta-lactam antibiotics is due to common mechanisms, such as changes in permeability or penicillin-binding proteins (PSB) (eg, penicillin-resistant streptococcus Streptococcus pneumoniae). Ceftibuten interacts mainly with PSB-3 Escherichia coli, which leads to the formation of filamentous forms at a concentration of 1 / 4-1 / 2 of the MPC and lysis at a concentration twice that of the IPC. The minimum bactericidal concentration of ceftibutene for strains of Escherichia coli (E. coli), sensitive and resistant to ampicillin, is approximately equal to the MIC.

It is also active in clinical practice for most strains of the following Gram-positive microorganisms: Streptococcus pyogenes (Streptococcus pneumoniae), Streptococcus pneumoniae (excluding penicillin-resistant strains); Gram-negative microorganisms: Haemophilus influenzae (strains producing and not producing beta-lactamases), Haemophilus parainfluenzae (strains producing and not producing beta-lactamases), Moraxella (Branhamella) catarrhalis (most strains produce beta-lactamases), Escherichia coli, Klebsiella spp . (Klebsiella) (including Klebsiella pneumoniae and oxytoca), indole-positive Proteus spp. (including Proteus vulgaris), as well as Providencia spp., Proteus mirabilis, Enterobacter spp. (including Enterobacter cloacae and Enterobacter aerogenes), Salmonella spp. (salmonella), Shigella spp. (shigella).

It is active against most strains of the following microorganisms, however, its clinical efficacy has not been established: gram-positive microorganisms - Streptococcus spp. groups C and G; Gram-negative microorganisms - Brucella spp., Neisserria spp., Aeromonas hydrophilia, Yersinia enterocolitica, Providencia rettgeri, Providencia stuartii Citrobacter spp., Morganella spp. and Serratia spp., which do not produce large amounts of chromosomal cephalosporinases.

Not active against Staphylococcus spp. (staphylococcus), Enterococcus spp. (enterococcus), Streptococcus spp. group B, Acinetobacter spp., Bordetella spp., Listeria spp. (Listeria), Flavobacterium spp., Pseudomonas spp., Campylobacter spp., Yersinia spp., Hafnia spp.

Slightly active against most anaerobes, including most strains of Bacteroides.

Ceftibuten-trans (ceftibutene derivative) does not have microbiological activity in vitro and in vivo for Staphylococcus spp., Enterococcus spp.,Acinetobacter spp., Bordetella spp., Listeria spp., Flavobacterium spp., Pseudomonas spp., Campylobacter spp., Yersinia spp., Hafnia spp.

Composition

Ceftibuten (in the form of dihydrate) + auxiliary substances.

Pharmacokinetics

After taking the medication, Cedex is almost completely absorbed from the digestive tract (90%). The speed and degree of absorption of ceftibutene when taking Zedex in the form of a suspension change with simultaneous intake with food. Simultaneous food intake does not affect the effectiveness of Cedex in the form of capsules. The binding of ceftibutene to plasma proteins is 62-64%. Easily penetrates into liquid media and body tissues. Ceftibuten penetrates into the middle ear fluid in children with acute otitis media, where its concentration is approximately equal to or greater than plasma level. Concentrations of ceftibutene in lung tissue are approximately 40% of plasma concentrations. In the nasal, tracheal and bronchial secretion, bronchoalveolar lavage fluid and its cellular suspension, ceftibutene concentrations are approximately 46, 20, 24, 6 and 81% of the plasma concentrations, respectively. Adequate data on the concentration of ceftibutene in the cerebrospinal fluid are not present, however, when other cephalosporins are ingested, their content in the cerebrospinal fluid usually does not reach the therapeutic level.It is excreted mostly unchanged in the urine. With renal insufficiency of mild severity, the pharmacokinetics of Cedex do not change significantly.

Indications

Treatment of infectious-inflammatory diseases caused by sensitive microorganisms:

• infections of the upper respiratory tract (including angina, pharyngitis, tonsillitis and scarlet fever in adults and children, acute sinusitis or sinusitis in adults);
• otitis media in children;
• infections of the lower respiratory tract in adults (including acute bronchitis, exacerbation of chronic bronchitis and acute pneumonia) in those cases when it is possible to take the drug inside;
• urinary tract infections in adults and children (including complicated and uncomplicated) (cystitis, urethritis and others);
• enteritis and gastroenteritis in children caused by Salmonella spp., Shigella spp. and Escherichia coli.

Forms of release

Capsules 400 mg (sometimes mistakenly called pills).

Powder for the preparation of a suspension for oral administration for children (sometimes mistakenly referred to as syrup or solution).

Instructions for use and dosage

Is taken internally.

The duration of treatment is on average 5 to 10 days. In the treatment of infections caused by Streptococcus pyogenes, Cedex in a therapeutic dose should be used for at least 10 days.

Adults

The recommended dose is 400 mg per day.Cedex in capsules can be taken regardless of food intake. With acute bacterial sinusitis, acute bronchitis, exacerbation of chronic bronchitis and complicated and uncomplicated urinary tract infections, the drug can be used at a dose of 400 mg once a day.

With community-acquired pneumonia and the possibility of taking the drug inside, the recommended dose of Cedex is 200 mg every 12 hours. The duration of therapy is 5-10 days, depending on the severity and type of the disease.

Patients receiving hemodialysis treatment 2 or 3 times a week, Cedex can be prescribed 400 mg at the end of each hemodialysis session.

Children

The recommended dose of the drug in the form of a suspension is 9 mg / kg per day. The maximum dose is 400 mg per day. With pharyngitis (including tonsillitis), acute purulent otitis media and urinary tract infections (including complicated ones), the drug can be applied once a day.

In acute bacterial enteritis in children, the daily dose can be divided into 2 divided doses (4.5 mg / kg every 12 hours).

Children with a body weight of more than 45 kg or at the age of more than 10 years, the drug can be prescribed in the recommended adult dose.

The safety and effectiveness of Tsedeks in children under the age of 6 months are not established.

A suspension of Zedex can be taken about 1-2 hours before or after a meal.Before taking the drug, the vial with the prepared suspension should be vigorously shaken.

Rules for the preparation of oral suspension

Measure the necessary amount of water (28 ml) by pouring water into a measuring cup (included in the delivery) to the label "28 ml". Pour approximately half of the measured water into the vial of powder and shake to moisten the powder well, then add the remaining amount of water to the vial and shake it again - until the powder is completely dissolved and 33 ml of a homogeneous suspension is obtained. For a more accurate dosing of the prepared suspension, it is recommended to use the measuring spoon included in the kit and having a calibration of 1.25 ml, 2.5 ml, 3.75 ml and 5 ml suspension.

Side effect

• nausea, vomiting;
• diarrhea;
• dyspepsia;
• gastritis;
• stomach ache;
• change in taste;
• increased activity of AST, ALT and LDH;
• growth of Clostridium difficile, combined with moderate or severe diarrhea;
• headache;
• dizziness;
• drowsiness;
• convulsions;
• decrease in hemoglobin level;
• leukopenia, eosinophilia, thrombocytosis;
• anaphylaxis;
• bronchospasm;
• dyspnea;
• rash;
• hives;
• itching;
• angioedema;
• Stevens-Johnson syndrome;
• erythema multiforme;
• toxic epidermal necrolysis;
• renal dysfunction;
• toxic nephropathy;
• a positive Coombs reaction;
• superinfection;
• photosensitization.

Contraindications

• children age up to 6 months for powder and suspension;
• Children under 10 years of age for capsules (due to the inability to adequately dose Cedex in the form of capsules in young children);
• hypersensitivity to the components of the drug and to other cephalosporins.

Application in pregnancy and lactation

Adequate and strictly controlled studies of the safety and efficacy of the drug during pregnancy and during labor were not conducted. If you need to use the drug Tsedeks during pregnancy, you should evaluate the estimated benefit to the mother and the potential risk to the fetus.

Ceftibuten is not detected in breast milk in nursing women. Caution should be used during breastfeeding.

In experimental animal studies, no damaging effect of ceftibutene on the course of pregnancy or childbirth, on embryonic or postnatal development was detected.

Use in children

Contraindicated in childhood up to 6 months for powder and suspension, in children under 10 years for capsules (due to the inability to adequately dose the drug Cedex in the form of capsules in young children).

special instructions

Approximately 5% of patients with penicillin allergy have cross-reactivity to cephalosporins. In patients who received both penicillins and cephalosporins, serious acute hypersensitivity reactions (anaphylaxis) were recorded; There are cases of cross-reactivity with the development of anaphylaxis. When serious anaphylactic reactions occur, emergency therapy is indicated (eg, epinephrine, GCS, intravenous fluid administration, airway patency, oxygen administration, antihistamines, and dynamic observation).

In the treatment of broad-spectrum antibiotics (including Tzedeks), intestinal microflora disorders can lead to diarrhea, including pseudomembranous colitis associated with the production of Clostridium difficile toxin. The severity of diarrhea, accompanied or not accompanied by dehydration, can range from moderate to severe or life threatening.Diarrhea may occur during or after treatment with an antibiotic. This diagnosis should be discussed in all cases when persistent diarrhea appears against the background of taking any broad-spectrum antibiotic of the Tsedeks type.

The effects of Cedex on the results of chemical or laboratory tests have not been revealed. When using other cephalosporins, a false positive direct Coombs test was sometimes recorded. However, the results of studies using erythrocytes in healthy people did not confirm the ability of Cedex to induce a positive Coombs test, even at concentrations up to 40 μg / ml.

Drug Interactions

In special studies, the interaction of the Cedex drug with the following drugs was studied: antacids containing aluminum and magnesium hydroxide in high doses, Ranitidine and theophylline (single intravenous administration). Signs of significant interaction are not revealed. The effect of Cedex on the concentration in the blood plasma or the pharmacokinetics of theophylline when ingested is not known. Data on the interaction with other drugs have not been received to date.

Cephalosporins, including Cedex, in rare cases can reduce prothrombin activity, leading to an increase in prothrombin time, especially in patients who have been stabilized on oral coagulant therapy. Patients at risk should be monitored regularly for prothrombin time or MNO and, if necessary, to use vitamin K.

Analogues of the drug Cedex

Zedex does not have a structural analogue for the active substance. The drug is unique in the composition of its constituent components.

Analogues on the pharmacological group (antibiotics of cephalosporins):

• Azaran;
• Aksetin;
• Axon;
• Anceph;
• Biotrakson;
• Boncefin;
• Witsef;
• Dardum;
• Duracif;
• Zefter;
• Zinatsef;
• Zinnat;
• Intrazoline;
• Iphietz;
• Ketoceph;
• Kefadim;
• Kefzol;
• Claforan;
• Clafotaxime;
• Lendacin;
• Lysolin;
• Liphoran;
• Longacef;
• Maksitsef;
• Megion;
• Medaxone;
• Medotsef;
• Nacef;
• Opexin;
• Panzef;
• Rocefin;
• Sulperazone;
• Sulceph;
• Supraks;
• Supraks Solutab;
• Tertsef;
• Totatsef;
• Felaxin;
• Forcef;
• Zeclor;
• Cefabol;
• Cefazolin;
• Cephalexin;
• Cefepime;
• Cefoxytin;
• Cefoperazone;
• Ceforal Solutab;
• Cefotaxime;
• Ceftazidime;
• Ceftriabal;
• Ceftriaxone;
• Cefurabol;
• Cefuroxime;
• Cef;
• Ecocephron;
• Etipim.

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