Tzedek

Tzedeks is considered a semisynthetic cephalosporin antibiotic of the third generation, intended for oral use.

The internationally patented term for the drug is Ceftibuten.

This description of the drug Zedex is a simplified and augmented version of the official version of the annotation to the medication. Before making a decision about the use of the drug, it is always recommended to consult a doctor and read the manufacturer's annotation that comes with the drug.

The information provided by us is for informational purposes, it should not be used as an instruction for independent treatment.

Remember: only an expert should make a decision about the need to use this or that drug, and also prescribe dosage and treatment regimen.

Indications Tzedek

Medicated medication Cedex is used to treat infectious conditions that were caused by bacteria sensitive to the action of the drug.

• Infectious diseases of the upper parts of the respiratory system, in particular, inflammation of the nasal sinuses, nasopharynx, as well as children's and adult scarlet fever.
• Infectious pathologies of the lower parts of the respiratory system: inflammation of the bronchi ( acute bronchitis, chronic bronchitis ), lungs ( pneumonia ), in patients who are able to take oral treatment.
• Inflammation of the middle ear in pediatrics.
• Infectious diseases of the urinary system, with complications and without them: inflammation of the bladder, urinary ducts, etc.
• Inflammatory processes in the intestine and stomach, provoked by bacteria Salmonella, Escherichia, Shigella, Helicobacterium.
• Diarrhea.

Tzedek in angina

Angina (acute form of tonsillitis) requires the appointment of antibiotics, in particular, Tsedeksa, if the disease is caused by microbes, which happens in most cases. Less often, the disease can be caused by a viral and fungal infection: in such cases, the use of antibiotics is impractical.

The most common cause of angina is staphylococcus, or β-hemolytic streptococcus g. A. Bacteria enter the inflamed zone (tonsils) from both the external environment and the bloodstream from other foci of infection in the body.

Cedex in angina may be prescribed only by a doctor, taking into account the identified pathogen and the severity of the disease. The drug should be treated under the supervision of a medical specialist, strictly following the treatment regimen.

Tzedek at otitis

Otitis is an otolaryngological disease that occurs with an inflammatory reaction in the ear. To treat such a disease without the help of antibiotics, which will suppress the development of pathogenic microorganisms in the middle ear, is impossible. Therapy with antibiotics is the basis of treatment of acute purulent otitis media.

Cedex in otitis is most often prescribed when there is no way for some reason to determine the sensitivity of the bacterial flora to the action of antibiotics, because the preparation of Cedex has a fairly wide range of action. Sometimes, in severe cases, the combined use of several antimicrobial agents is possible, which greatly extends the range of action of drugs.

Tzedek in pneumonia

Pneumonia - an inflammatory disease of the lungs, can be a consequence or complication of the inflammatory process in the bronchi. In the treatment of pneumonia necessarily include antibiotic therapy, since pathogens are usually caused by infectious microbial agents.

Of course, when choosing a drug for the treatment of pneumonia, many factors must be taken into account. This is the presence of contraindications, and the development of "addiction" of microbes to antibiotics, and the speed of getting the drug into the infectious focus. However, one of the defining properties in the choice of the drug is the spectrum of antibiotic action.

Tzedek in pneumonia, as a rule, is a preparation of the "first line", the first choice. It can be replaced by an alternative drug only when allergic reactions occur.

Often, doctors use a combination of antimicrobial agents to accelerate the healing process and achieve the required level of active substance in the body.

Tzedek for children

Antimicrobial drug Tsedeks often used in pediatrics, more often simultaneously with immunostimulants and vitamin complexes. What makes Tzedek good for children?

The active substance of this drug is ceftibuten - a fairly strong antibacterial component, which is often used to treat diseases in which any other antibiotics are powerless. Tsedeks an order of magnitude stronger, for example, penicillin preparations and even some representatives of its own cephalosporin group.

Of course, Tsedeks also has shortcomings: it does not have the action of enterococcal and staphylococcal infection, as well as some other types of microbes.

Nevertheless, this does not prevent active use of the drug in the following childhood diseases:

• angina, scarlet fever, inflammatory processes in the ear and sinuses of the nose;
• acute course of bronchitis and pulmonary inflammation;
• some microbial lesions of the digestive tract, in particular, the small intestine and stomach;
• children's pyelonephritis and cystitis;
• infectious lesion of the osteoarticular apparatus, skin.

Release form

Tzedek is produced in the following dosage forms:

• Cedex tablets are capsules for oral administration, white, dense, with a black designation on the surface of the Cedax® capsule. Inside the capsule contains a light powder, possibly with a yellowish or brownish tinge;
• Tzedex powder is a powdery substance for making an oral suspension, with a yellowish tint and a cherry flavor.

Each capsule is represented by: an active component of ceftibutene dihydrate 0.4 g, as well as additional constituents (microcrystalline cellulose fibers, sodium carboxymethyl starch, magnesium stearate). The capsule wall consists of gelatin, sodium lauryl sulfate and titanium dioxide. The designation "Cedax®" on the surface of the capsule is made with a pharmaceutical carcass that consists of pharmaceutical glaze, iron oxide, monoethyleneglycol monoethylate, E 322 additive lecithin, simethicone.

Capsules Cedex consist of two parts, glued together with a special substance, consisting of gelatin and polysorbate.

Powdered substance for the preparation of the suspension: 1 g of substance contains 0.144 g of ceftibutene. 1 ml of the finished suspension contains 0.036 g of active substance.

Suspension Cedex should be a homogeneous consistency, a yellowish light shade, with a pleasant aroma of cherries. The cherry flavor gives the preparation Cedex syrup, obtained from cherries.

Pharmacodynamics

The active substance of the drug, like many other β-lactam antibiotics, has an antimicrobial effect based on the suppression of the formation of the bacterial membrane. Cedex affects a sufficiently large number of bacteria synthesizing β-lactamase, as well as penicillin-resistant microbial cells.

The active substance Cedex is resistant to plasmid penicillinase and cephalosporinase, in addition to cephalosporinase, synthesized by cytobacteria and enterobacteria, as well as bacteroids, morganella and serrations. Like other β-lactam antibacterial drugs, Cedex is not recommended for use in infectious diseases by bacteria that have resistance associated with changes in membrane permeability, or with modification of penicillin-binding proteins.

Cedex is used when the body is affected by the following bacteria:

• Gram (+) bacteria (streptococci, excluding penicillin-resistant strains);
• gram (-) bacteria (hemophilic rod, moraxell, escherichia, klebsiella, indolpositive (including vulgar) proteus, salmonella, shigella, etc.).

There is no evidence of the clinical activity of the drug for streptococcus groups C and G, as well as for some gram (-) bacteria that do not produce a large number of chromosomal cephalosporinases. Tzedex is inactive with respect to most anaerobic bacteria, including bacteroids.

Pharmacokinetics

Through oral administration, Cedex is absorbed more than 90%, leaving the body mostly through the urinary system. The peak level of the active substance in the blood is found 120-180 minutes after a single dose of 400 mg (0.4 g). The limiting plasma concentration can be from 15 to 17 μg / ml. Binding of the active ingredient of the preparation with plasma proteins is from 62 to 64%. The concentration of the main derivative of ceftibutene (active substance) in the blood or urinary excreta can be only 10% of the amount of the active substance.

Biological availability of the drug has a direct dependence on the dosage. The drug taken in a dose of less than or equal to 0.4 g can be bioavailable at 75-94%.

Stable level of active substance in the blood (with the drug twice a day) is found after the fifth dose.

The half-life of the active substance is about 150 minutes. This period can not vary from the dosage, nor from the frequency of taking the drug.

The effectiveness of the drug does not depend on the time of food intake, however, when using Zedex during or immediately after eating food, its absorption slows down.

The active component easily enters the tissue structures and body fluids. It is found in the liquid medium of the middle ear, in the nasal, tracheal and bronchial secretions.

Ceftibuten is found in the urinary fluid during the day after consuming 0.4 g of the drug. The limiting level in urine is 264 μg / ml: this limit can be detected during the first 240 minutes. About a day after a single use of the drug, its amount in the urinary fluid may be 10.5 μg / ml.

Precise information on the content of the drug in cerebrospinal fluid is not available. It is assumed that this amount may not be sufficient for the therapeutic effect.

In elderly patients, a stable concentration of the active ingredient (with Tzedek twice a day) is observed after the fifth dose.

Dosing and administration

How to take Zedex?

The drug is intended only for internal administration. The duration of therapy can be, on average, 5-10 days. Infectious diseases caused by streptococcus pyogenes should be treated with a course of at least 10 days.

The optimal daily dosage of Cedex for adults is 0.4 g (capsule preparation). Reception is conducted regardless of eating.

For the treatment of microbial sinusitis, inflammation in the bronchi and infection of the urinary system, Cedex should be taken at 0.4 g / day at a time.

For the treatment of community-acquired pneumonia in patients who are not contraindicated for oral treatment, the optimal dosage should be 0.2 g twice daily at regular intervals. The duration of such treatment is from 5 to 10 days, taking into account the presence of complications and the type of disease.

Patients with functional disorders of renal function should take into account that the pharmacokinetic properties of Cedex in the absence of kidneys do not undergo significant changes. For this reason, a change in dosage and treatment regimen may be required only with a lowered creatinine clearance <50 ml per minute. If such clearance is defined as 30-49 ml per minute, then the daily amount of the drug should be reduced to 0.2 g. If the clearance is 5-29 ml per minute, it is recommended to switch to a daily intake of 0.1 g of the drug.

Sometimes specialists prefer to change the frequency of the drug. For example, Cedex is allowed to use once every two days, with a clearance of 30 to 49 ml per minute, or once every three days with a clearance of 5 to 29 ml per minute.

Patients who undergo hemodialysis procedures up to 3 times per week, the drug is prescribed at 0.4 g at the end of each procedure.

In childhood, it is preferable to prescribe a suspension of the drug, taking 60-120 minutes before or after eating.

[2]

How to take Zedex to children?

Tzedek produced in various dosage forms. However, when treating children, a special, children's version of the drug is used, which is produced and released in powder form. From such a powdery substance, a suspension for oral administration may be further prepared.

Cedex powder, in addition to the active ingredient, is represented by sucrose, xanthan gum, silicon dioxide, simethicone, titanium dioxide, E21 preservative and polysorbate, as well as a substance giving the suspension a pleasant cherry flavor.

How to breed Tzedek?

Concerning how to take Zedex to children, it is necessary to highlight the following points:

• in a special measuring container, which is attached to the preparation, pour 25 ml of water;
• ½ of this volume of water is poured into a jar with a powdered preparation and carefully shaken;
• add the remaining volume of water and mix again until uniform.

In pediatrics, the dose of the drug is calculated as 9 mg / kg per day, with the maximum dosage can not be more than 400 mg / day. Most often, the medication is taken once a day, in severe cases, the dose is divided into two doses.

If the child is more than 10 years old, or the weight of his body is more than 45 kg, then the adult dosage of the drug (0.4 g / day) may be prescribed to him.

In order to determine the dosage of the drug was more convenient, a special spoon-dispenser with risks of 0,045 g, 0,09 g, 0,135 g and 0,185 g

Use Tzedek during pregnancy

Specially targeted studies of the use of Cedex during pregnancy have not been conducted. Experiments were made only on animals. As a result of the experiments, the pathological effect of the drug on the course of the pregnancy period, as well as the development of the fetus and the newborn baby, was not revealed.

But, even considering all of the above, doctors do not advise to appoint Tsedeks to pregnant women safely. Antibiotics are drugs that can harm gradually, and one can never say with certainty about the harmlessness of a given drug. Tzedek during pregnancy appoint, only well commensurate the possible danger of the drug and its benefits in treatment.

The active substance of the drug is not found in the milk of the nursing mother, but even here experts advise caution. If possible, Zedex should be avoided while breastfeeding.

Contraindications

• Propensity to allergic reactions to antibiotics of the cephalosporin group or to other auxiliary components.
• Children under 6 months of age (no studies have been performed on experimental use of the drug in half-year-old children).
• Children under 10 years can take only suspension of the drug. The encapsulated form presents difficulties for dosing the drug in younger children.
• Hereditary disorders of carbohydrate metabolism, including the failure of fructose, the inability to absorb glucose or galactose, etc.

The drug can be administered with great care, with a tendency to allergic reactions to penicillin group drugs, with chronic and acute lesions of the digestive tract, with severe kidney failure, and also to patients undergoing hemodialysis.

Side effects Tzedek

Of the most common side effects of Tzedeks can be identified:

• bouts of nausea;
• stool disorder;
• pain in the head.

More rarely you can observe:

• development of the inflammatory process of the gastric mucosa;
• pain in the epigastric region;
• dizziness, fatigue, drowsiness;
• skin rashes;
• fits of vomiting;
• a disorder of taste sensations;
• rhinitis or sinusitis.

Very rare symptoms may appear:

• accession of infection with clostridia;
• decrease in the number of hemoglobin leukocytes and eosinophils in the blood;
• convulsive conditions.

When using any of the antibiotic agents of the cephalosporin series, including Cedex, there may be signs of allergy (skin rash, itching, respiratory failure, bronchial spasm, anaphylactic shock, Quincke edema, toxic-epidermal necrolysis). Quite often, and such manifestations as dysbiosis, liquid stool, inflammation of the intestinal mucosa. Prothrombin time and MNO increase in the blood. The kidneys can be affected: the development of toxic nephropathy, renal dysfunction, internal bleeding, and sometimes there is a glucosuria.

[1]

Overdose

Overdose of Cedex does not occur with severe symptoms of intoxication. Studies that were conducted in adult healthy patients suggest that a single dose of the drug at a dosage of 2 g does not give rise to complicated adverse effects. At the same time, all the results of clinical and laboratory tests were in the limit of normal indices.

Antidote to the drug Tsedeks not developed: for this reason, if you suspect an overdose it is recommended to do a gastric lavage, you can also take activated charcoal or another sorbent drug.

A large amount of the drug can be removed from the body through hemodialysis. Whether peritoneal dialysis will be effective in overdose is not tested.

Interactions with other drugs

Experimental way was established the drug interaction of Cedex and other medications, such as anti-acid agents (aluminum and magnesium compounds) in large dosages, ranitidine hydrochloride, bronchodilator theophylline. No suspicion of a significant effect of these drugs on each other was found. The effect of Tzedex on the blood content or on the pharmacokinetic properties of theophylline during oral administration has not been determined.

Data on the drug interaction with any other medications was not obtained.

Any antibiotic of the cephalosporin group, including Cedex, may sometimes have an effect on the prothrombin index, leading to its elongation. In particular, this applies to patients who have previously taken oral anticoagulant drugs.

Such patients require constant monitoring of the prothrombin index, vitamin K can be prescribed additionally.

There was no evidence of any influence of Cedex on laboratory and biochemical analyzes.

[3]

Storage conditions

The encapsulated form of the drug is stored, as a rule, in places inaccessible to children's antics, with temperature indices ranging from + 2 ° to + 25 ° C.

Powdery substance for use as a suspension should be stored in dry, darkened places, in the temperature range of + 2 ° to + 25 ° C.

Special instructions

Price of Tsedex

The price of medication Cedex may differ depending on the price policy of a particular pharmacy network. Price Tsedeksa should be specified from managers and representatives of a pharmacy directly when ordering the drug. Since the prices for medicines can change rapidly for many reasons, then if the price suits you, the drug should be booked in advance.

Average prices for Tzedeks in Ukraine are as follows:

• Tsetde in powder, 36 mg / ml, 30 ml, Schering-Plow - from 12 to 14 $;
• Cedex, capsule form, 0.4 g 5 pieces, Schering-Plow - approximately $ 19-20 per package.

[4]

Analogues of Tsedex

Often, the pharmaceutical market offers similar drugs, the basic composition of which includes a similar active ingredient, with possibly another dosage form, or with the use of other additional substances.

However, not all drugs have such analogs. This is due, most often, to the inexpediency of their release, or to the impossibility of additional production. Impossibility can be explained by the regulation of processes in the pharmaceutical market, as defined by the strategy of pharmaceutical companies that produce medicines, as well as some economic reasons.

It is to such a means, which has no analogues, refers to Tzedek. The active ingredient Ceftibuten is not represented in any other known pharmaceutical product.

Of course, if necessary, you can consult a doctor and replace Zedex with another cephalosporin, but this will not be a similar one, but a completely different drug. Self-replacement of one cephalosporin antibiotic by another is strongly discouraged.

Suprax or Tzedek?

Most often the drug Tsedeks replaced with another representative of β-lactam antibiotics-cephalosporins Supraks. This drug is not a direct analogue of Cedex, since it contains in its composition another active ingredient - Cefixime.

However, Suprax is also a representative of the third generation of antibiotics, and is also available as a powdered substance for suspensions and in a capsule form. The drug has a broad antimicrobial effect, but Suprax can not be called a cheap substitute for Cedex: the price for Suprax ranges from $ 35 to $ 55 per package.

If you are faced with the dilemma of what to take, Suprax or Tzedex, contact your doctor: only an expert can determine the appropriateness of a particular drug in your particular case. It is impossible to make an independent replacement: since the preparations are different, sometimes dosage adjustment and the drug administration schedule may be required.

Reviews of Tzedek

If treatment is prescribed by a qualified specialist, then treatment with Tzedex can usually be very effective. When treating many diseases, especially in pediatrics, reviews about Tzedeks are quite positive.

However, it must be remembered that the uncontrolled use of antibiotics, and Tzedex is no exception, can lead to very, very unpleasant consequences. Follow the scheme of reception, do not skip the time of drug use, do not understate and do not increase the dosage yourself. The course of Zedex therapy should be completed completely. That is, if you are given a course of treatment for 10 days, and you have felt improvement after 5 days, then you can not interrupt the treatment with the drug in any case: the therapeutic course should be completed, otherwise you risk acquiring a chronic course of the disease, or you can purchase a number complications.

If you have a long-standing problem with the intestines, then take the drug with caution. At sensations of negative influence of a preparation on intestinal function it is necessary to pay to this attention of your doctor.

Do not forget that during the period of Zedex therapy, however, as with any other antibiotic of a wide range of effects, there may be a change in the intestinal microflora, which in turn will lead to a disorder of the stool and inflammation of the intestinal mucosa. Talk with your doctor about the necessary measures to prevent such a condition, so as not to disturb the intestinal function. Drink sour-milk products: fresh yogurt, natural yogurt, leaven, eat home-made cottage cheese and sauerkraut.

Shelf life

The shelf life of Cedex is up to 2 years, after which it is necessary to get rid of the drug.

The finished suspension (diluted powder) can be stored for 14 days in a refrigerator.