Tsedeks

Цедекс Drug photo

The description is actual on 30.01.2015

  • Latin name: Cedax
  • ATH code: J01DD14
  • Active ingredient: Tseftibuten (Ceftibuten)
  • Producer: MSD FARMASYuTIKALS (Russia), S.I.F.I. (Italy)

Structure

  • One capsule of drug of Tsedeks contains 400 mg of a dihydrate of a tseftibuten. Additional substances: sodium carboxymethylstarch, cellulose microcrystallic, magnesium stearate. Structure of a cover: titanium dioxide, gelatin, sodium lauryl sulfate, polysorbate, water, pharmaceutical glaze, simetikon, black iron oxide, ethylene glycol monoethoxide, lecithin, alcohol.
  • 1 gram of powder for preparation of suspension includes 144 mg of a dihydrate of a tseftibuten, and 1 ml of ready suspension includes 36 mg of a dihydrate of a tseftibuten. Additional substances: xanthane gum, polysorbate, titanium dioxide, simetikon, silicon dioxide, cherry fragrance, sodium benzoate, sucrose.

Release form

  • Solid gelatinous white capsules with a text of "400 mg" on the body; inside powder light (the yellow shade is possible) colors contains. 1 capsule in an aluminum bag; five such bags in a pack from a cardboard.
  • Yellow powder for production of suspension with a cherry smell; ready suspension has light yellow color and a cherry smell. 8,3 grams of powder in a bottle of 30 ml; one bottle (with a measured spoon and a glass) in a pack from a cardboard.

Pharmacological action

Antibacterial (bactericidal) action.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Antibiotic of a tsefalosporinovy row 3 generations (beta laktamnogo type). Has bactericidal action which is caused by braking of synthesis of a wall of cells of microorganisms. Affects many bacteria producing β-lactamelements and resistant to penicillin and other cephalosporins.

Vysokoustoychiv to penicillinases and tsefalosporinaza of plazmidny type, but collapses under the influence of a row chromosomal tsefalosporinaz, the developed Enterobacter spp., Citrobacter spp. and Bacteroides spp.

It is active concerning the following gram-positive microorganisms: Shigella spp., Salmonella spp., Enterobacter spp., Proteus mirabilis, Providencia spp., Proteus spp., Klebsiella spp., Escherichia coli, Streptococcus pyogenes, Streptococcus pneumoniae, Moraxella catarrhalis, Haemophilus parainfluenzae, Haemophilus influenzae.

It is active concerning the following microorganisms, but clinical performance is not established:

  • gram-positive microorganismsStreptococcus spp. (C and G);
  • gram-negative microorganisms – strains of the sort Neisserria, Brucella, Aeromonas hydrophilia, Providencia rettgeri, Yersinia enterocolitica, Providencia stuartii, strains of the sort Morganella, Citrobacter and Serratia.

It is not effective concerning strains of the sort Hafnia, Yersinia, Campylobacter, Pseudomonas, Flavobacterium, Listeria, Bordetella, Streptococcus B, Acinetobacter, Enterococcus, Staphylococcus.

It is ineffective concerning many anaerobe bacterias.

Derivative active ingredient – Tseftibuten-trans does not possess activity concerning Yersinia spp., Campylobacter spp., Pseudomonas spp., Flavobacterium spp., Listeria spp., Staphylococcus spp., Acinetobacter spp., Enterococcus spp., Bordetella spp., Hafnia spp.

Pharmacokinetics

Tseftibuten is absorbed from intestines for 90%. The greatest concentration in plasma is registered in 2,5 hours. Bioavailability – 75%-94%. Linkng with blood proteins averages 63%. Easily gets into body tissues and its fluid mediums.

The main metabolite a tseftibuten-trance. Time of semi-removal averages 2.5 hours and does not depend schemes of use. The antibiotic is removed in an original form by kidneys.

Indications to use

  • Average otitis at persons of children's age.
  • Infections of respiratory ways (tonsillitis, pharyngitis and scarlet fever at persons of all age; an acute bronchitis, pneumonia and acute sinusitis at adults).
  • Infections of urinary tract at persons of all age.
  • The enteritis or gastroenteritis at persons of children's age caused by activity of Escherichia coli or strains of the sort Shigella and Salmonella.

Contraindications

  • Age less than 6 months for suspension.
  • Age less than 10 years for capsules.
  • Sensitization to components of drug and antibiotics of a tsefalosporinovy row.

It is recommended to appoint with care Tsedeks to persons with an allergy to penicillin, dekompensirovanny diseases of a digestive tract, severe forms of a renal failure and being on a hemodialysis.

Side effects

  • Reactions from nervous activity: drowsiness, headache, dizziness, spasms.
  • Reactions from digestion: vomiting, nausea, diarrhea, dyspepsia, gastritis, change of taste, an abdominal pain, growth of Clostridium difficile in combination with diarrhea, increase in maintenance of ALT, nuclear heating plant and LDG, colitis, increase in content of bilirubin.
  • Reactions from a hemopoiesis: anemia, eosinophilia, leukopenia, pancytopenia, thrombocytosis, neutropenia and agranulocytosis.
  • Reactions from secretory system: damage of kidneys.
  • Reactions from system of coagulation: lengthening of a prothrombin time and increase in MHO, internal bleeding.
  • Allergic reactions: Quincke's edema, bronchospasm, anaphylaxis, asthma, Stephens-Johnson's syndrome, small tortoiseshell, rash, itch, mnogoformny erythema.
  • Laboratory indicators: glucosuria, ketonuria.
  • Others: photosensitization, superinfection.

Application instruction (Way and dosage)

The instruction to Tsedeks orders to accept drug inside. Duration of treatment averages 5-10 days. At therapy of the infections connected with Streptococcus pyogenes strain, reception is carried out not less than 10 days.

Adult

At an acute bronchitis, acute sinusitis and infections of urinogenital ways appoint 400 mg of Tsedeks a day.

At extra hospital pneumonia appoint 200 mg of drug each 12 hours. Duration of reception makes till 10 days.

The patient passing a hemodialysis twice or three times a week appoint 400 mg every time at the end of a hemodialysis session.

Application instruction of Tsedeks to children

Suspension for children usually is accepted at the rate of 9 mg on kilogram of weight a day. The greatest dose for children makes 400 mg a day.

At pharyngitis, purulent otitis of a middle ear and infections of urinogenital ways drug is appointed in the dose recommended above once a day.

At acute enteritis the daily dose is divided into 2 receptions.

To children weighing more than 45 kg or 10 years means are more senior appoint according to the adult scheme of treatment. Suspension is accepted for an hour to or after reception of food. Before the use the bottle with ready suspension should be stirred up.

Preparation of peroral suspension

To measure an original glass 28 ml of water, to pour about a half of this liquid in a bottle with powder of drug and to shake up, then to add other water and to shake up once again to a total disappearance of powder.

Overdose

At overdose by drug signs of toxicity were not registered.

Treatment: gastric lavage, carrying out hemodialysis.

Interaction

Cephalosporins in rare instances lower prothrombin activity that causes lengthening of a prothrombin time, especially in patients in risk group. At such persons it is necessary to control constantly MNO, a prothrombin time and in case of need to appoint vitamin K.

Terms of sale

According to the recipe.

Storage conditions

  • Capsules are recommended to be stored at a temperature up to 25 °C.
  • Powder needs to be stored in the dry, dark place at a temperature up to 25 °C.
  • Ready suspension is allowed to be stored in the refrigerator within two weeks (at a temperature of 2-8 °C).
  • To protect from children.

Period of validity

Two years.

Special instructions

At 5% of persons with an allergy to Penicillin also cross-reaction on cephalosporins comes to light.

At the patients accepting at the same time cephalosporins and penicillin heavy reactions of hypersensitivity are registered.

At therapy by Tsedeks the intestinal dysbiosis can cause diarrhea (including the pseudomembranous colitis connected by synthesis of the special toxic substance Clostridium difficile).

Tsedeks's analogs

The most available peroral analogs (drug substitutes) are included below: Auropodoks, Vineks, Doktsef, Ikzim, Lopraks, Sortsef, Supraks Solyutab, Supraks Komfortab, Tsepodem, Tsefiks, Tsefiksim, Tsefpodoksim Proksitel, Tseftadim.

Zdravzona

  • Tsedeks 400 mg No. 5 kapsulymerk Sharp and Doum
  • Tsedeks powder for suspension 180mg/5ml 30mlmerk Sharp and Doum

Drugstore of IFC

  • Tsedeks kaps 400 mg No. 5, S.I.F.I S.p.A.Италия
  • Tsedeks time. for susp. shouted. detsk. 36mg/ml fl 30 ml, S.I.F.I S.p.A.Италия
  • Tsedeks kaps 400 mg No. 5, Merck Sharp & Dohmessha
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Apteka24

  • ЦЕДЕКС®CIFI (Italy)
  • ЦЕДЕКС®CIFI (Italy)

Paniapteka

  • Tsedeks kaps. 400 mg No. to a 5shering-Pla
  • Tsedeks kaps. 400 mg No. to a 5shering-Pla
Section: Antibiotics Antimicrobic
in more detail

Education: Graduated from the Vitebsk state medical university majoring in "Surgery". At university headed Council of students' scientific society. Professional development in 2010 - in "Oncology" and in 2011 - in "A mammology, visual forms of oncology".

Experience: Work in an all-medical network 3 years the surgeon (The Vitebsk hospital of an emergency medical service, Lioznensky TsRB) and in combination the regional oncologist and the traumatologist. Work farm the representative within a year in the Rubicon company.

Provided 3 improvement suggestions on the subject "Optimization of an Antibioticotherapia depending on Species Composition of Microflora", 2 works took prizes in a republican competition review of student's scientific works (1 and 3 categories).
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