Cedex

Cedex is considered a third-generation semi-synthetic cephalosporin antibiotic, intended for oral use.

The international patented term for the drug is Ceftibuten.

This description of the medicinal product Cedex is a simplified and supplemented version of the official version of the annotation to the medicinal product. Before deciding to use the medicinal product, it is recommended to consult a doctor and read the annotation prepared by the manufacturer, which is supplied with the drug.

The information we provide is for informational purposes only and should not be used as instructions for self-treatment.

Remember: only a specialist should decide on the need to use a particular drug, as well as prescribe the dosage and treatment regimen.

Indications Cedex

The medicinal drug Cedex is used to treat infectious conditions caused by bacteria sensitive to the action of the drug.

• Infectious pathologies of the upper respiratory tract, in particular, inflammation of the nasal sinuses, nasopharynx, as well as childhood and adult scarlet fever.
• Infectious pathologies of the lower respiratory tract: inflammation of the bronchi ( acute bronchitis, chronic bronchitis ), lungs ( pneumonia ), in patients who are able to take oral treatment.
• Otitis media in pediatrics.
• Infectious pathologies of the urinary system, with and without complications: inflammation of the bladder, urinary tract, etc.
• Inflammatory processes in the intestines and stomach caused by bacteria such as salmonella, escherichia, shigella, and helicobacter.
• Diarrhea.

Cedex for sore throat

Angina (acute tonsillitis) requires antibiotics, particularly Cedex, if the disease is caused by microbes, which is the case in most cases. Less often, the disease can be caused by a viral or fungal infection: in such cases, the use of antibiotics is inappropriate.

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

Cedex for sore throat can only be prescribed by a doctor, taking into account the identified pathogen and the severity of the disease. Therapy with the drug must be carried out under the supervision of a medical specialist, strictly following the treatment regimen.

Tsedex for otitis media

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

Cedex for otitis is most often prescribed when it is not possible for one reason or another to determine the sensitivity of the bacterial flora to the action of antibiotics, because the drug Cedex has a fairly wide spectrum of action. Sometimes, in severe cases, it is possible to combine several antimicrobial drugs, which significantly expands the amplitude of the action of drugs.

Cedex for pneumonia

Pneumonia is an inflammatory disease of the lungs, which can be a consequence or complication of the inflammatory process in the bronchi. Antibiotic therapy is necessarily included in the treatment regimen for pneumonia, since the causative agent of the pathology is usually infectious microbial agents.

Of course, when choosing a drug for the treatment of pneumonia, it is necessary to take into account many factors. These include the presence of contraindications, the development of "addiction" of microbes to antibiotics, and the speed of the drug's entry into the infectious focus. However, one of the determining properties when choosing a drug is the spectrum of action of the antibiotic.

Cedex for pneumonia is usually a first-line drug, the first choice. It can be replaced by an alternative drug only if allergic reactions occur.

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

Cedex for children

The antimicrobial drug Cedex is often used in pediatrics, often simultaneously with immunostimulants and vitamin complexes. What is good about Cedex for children?

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

Of course, Cedex also has its drawbacks: it does not act on enterococcal and staphylococcal infections, as well as on some other types of microbes.

However, this does not prevent the drug from being actively used for the following childhood diseases:

• tonsillitis, scarlet fever, inflammatory processes in the ear and sinuses;
• acute course of bronchitis and pulmonary inflammation;
• some microbial infections of the digestive tract, in particular the small intestine and stomach;
• childhood pyelonephritis and cystitis;
• infectious lesion of the musculoskeletal system and skin.

Release form

Cedex 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 capsule "Cedax®". Inside the capsule there is a light powder, possibly with a yellowish or brownish tint;
• Cedex powder is a powdery substance for the preparation of an oral suspension, with a yellowish tint and cherry aroma.

Each capsule contains: the active ingredient ceftibuten dihydrate 0.4 g, as well as additional components (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 using pharmaceutical ink, which consists of pharmaceutical glaze, iron oxide, monoethylene glycol monoethylate, additive E 322 lecithin, simethicone.

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

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

Cedex suspension should be of uniform consistency, light yellowish hue, with a pleasant cherry aroma. Cherry aroma is given to Cedex by 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 fairly large number of bacteria synthesizing β-lactamases, as well as penicillin-resistant microbial cells.

The active substance Cedex is resistant to plasmid penicillinase and cephalosporinase, except for cephalosporinase synthesized by citrobacteria and enterobacteria, as well as bacteroides, morganella and serratia. Like other β-lactam antibacterial drugs, Cedex is not recommended for use in infectious lesions by bacteria that have resistance associated with a change in membrane permeability or with a 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 (Haemophilus influenzae, Moraxella, Escherichia, Klebsiella, indole-positive (including vulgar) Proteus, Salmonella, Shigella, etc.).

There is no evidence of clinical activity of the drug against group C and G streptococci, as well as against some gram (-) bacteria that do not produce a large number of chromosomal cephalosporinases. Cedex is inactive against most anaerobic bacteria, including bacteroides.

Pharmacokinetics

When taken orally, Cedex is absorbed by more than 90%, leaving the body mostly through the urinary system. The peak level of the active substance in the blood is detected 120-180 minutes after a single dose of 400 mg (0.4 g). The maximum plasma concentration can be from 15 to 17 mcg / ml. The binding of the active component of the drug to plasma proteins is from 62 to 64%. The concentration of the main derivative of ceftibuten (active substance) in the blood or urine can be as little as 10% of the amount of the active substance.

The bioavailability of the drug is directly dependent on the dosage. The drug taken in a dose of less than or equal to 0.4 g can be bioavailable by 75-94%.

A stable level of the active substance in the blood (when taking the drug twice a day) is detected after the fifth dose of the drug.

The half-life of the active substance is about 150 minutes. This period cannot be changed by either the dosage or the frequency of taking the drug.

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

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

Ceftibuten is found in urine for 24 hours after taking 0.4 g of the drug. The maximum level in urine is 264 mcg/ml: this limit can be detected during the first 240 minutes. About 24 hours after a single dose of the drug, its amount in urine can be 10.5 mcg/ml.

No precise information is provided on the drug content in the cerebrospinal fluid. It is assumed that this amount may not be sufficient for a therapeutic effect.

In elderly patients, a stable concentration of the active component (when taking Cedex twice a day) is observed after the fifth dose of the drug.

Dosing and administration

How to take Cedex?

The drug is intended for internal use only. 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 (encapsulated preparation). It is taken regardless of food intake.

For the treatment of microbial sinusitis, inflammatory processes in the bronchi and infectious lesions of the urinary system, Cedex is prescribed to be taken at 0.4 g/day at a time.

For the treatment of community-acquired pneumonia in patients for whom oral treatment is not contraindicated, the optimal dosage should be 0.2 g twice a day at equal 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 do not undergo significant changes in the case of renal insufficiency. For this reason, a change in dosage and treatment regimen may be required only with reduced creatinine clearance < 50 ml per minute. If such clearance is determined as 30-49 ml per minute, then the daily amount of the drug should be reduced to 0.2 g. If clearance is 5-29 ml per minute, then it is recommended to switch to a daily intake of 0.1 g of the drug.

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

For patients who undergo hemodialysis procedures up to 3 times a 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 it 60-120 minutes before or after meals.

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How to take Cedex for children?

Cedex is produced in various medicinal forms. However, when treating children, a special children's version of the drug is used, which is produced and dispensed in powder form. From such a powdery substance, a suspension for oral use can be prepared.

Cedex powder, in addition to the active ingredient, contains sucrose, xanthan gum, silicon dioxide, simethicone, titanium dioxide, preservative E 211 and polysorbate, as well as a substance that gives the suspension a pleasant cherry flavor.

How to dilute Cedex?

Regarding how to take Cedex for children, the following points should be highlighted:

• pour 25 ml of water into a special measuring container, which is included with the preparation;
• Pour ½ of this volume of water into a jar with the powdered preparation and shake thoroughly;
• add the remaining volume of water and mix again until smooth.

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

If the child is over 10 years old or weighs over 45 kg, he may be prescribed an adult dosage of the drug (0.4 g/day).

To make it easier to determine the dosage of the drug, the powder comes with a special dosing spoon with marks of 0.045 g, 0.09 g, 0.135 g and 0.185 g.

Use Cedex during pregnancy

There were no specially targeted studies of the use of Cedex during pregnancy. Experiments were conducted only on animals. As a result of the experiments, no pathological effects of the drug on the course of pregnancy, as well as on the development of the fetus and newborn baby were revealed.

But, even taking into account all of the above, doctors do not recommend boldly prescribing Cedex to pregnant women. Antibiotics are drugs that can cause harm gradually, and one can never say with certainty about the harmlessness of a particular drug. Cedex is prescribed during pregnancy only after carefully weighing the possible danger of the drug and its benefits in treatment.

The active substance of the drug is not found in the milk of a nursing mother, but here too experts advise caution. If possible, you should avoid taking Cedex while breastfeeding.

Contraindications

• Tendency to allergic reactions to cephalosporin antibiotics or other excipients.
• Children under 6 months of age (experimental studies on the possibility of using the drug in six-month-old children have not been conducted).
• Children under 10 years of age can take only suspensions of the drug. The capsule form presents difficulties in dosing the drug in younger children.
• Hereditary disorders of carbohydrate metabolism, including fructose intolerance, inability to absorb glucose or galactose, etc.

The drug can be prescribed with great caution in case of a tendency to allergic reactions to drugs of the penicillin group, in case of chronic and acute lesions of the digestive tract, in case of severe renal failure, as well as in patients undergoing hemodialysis.

Side effects Cedex

The most common side effects of Cedex include:

• attacks of nausea;
• bowel disorder;
• headaches.

Less commonly observed:

• development of an inflammatory process in the gastric mucosa;
• pain in the epigastric region;
• dizziness, increased fatigue, drowsiness;
• skin rashes;
• vomiting attacks;
• taste disturbance;
• rhinitis or sinusitis.

Very rarely, the following symptoms may appear:

• addition of infection involving clostridia;
• decrease in the amount of hemoglobin, leukocytes and eosinophils in the blood;
• convulsive states.

When using any of the cephalosporin antibiotics, including Cedex, signs of allergy may occur (skin rash, itching, respiratory failure, bronchospasm, anaphylactic shock, Quincke's edema, toxic-epidermal necrolysis). Such manifestations as dysbacteriosis, loose stools, inflammation of the intestinal mucosa are also common. Prothrombin time and INR increase in the blood. The kidneys may be affected: toxic nephropathy, renal dysfunction, internal bleeding may develop, and sometimes glucosuria appears.

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Overdose

Overdose of Cedex does not occur with pronounced symptoms of intoxication. Studies conducted on healthy adult patients allow us to state that a single dose of 2 g does not cause complicated adverse effects. At the same time, all the results of clinical and laboratory tests were within the normal range.

An antidote to the drug Cedex has not been developed: for this reason, if an overdose is suspected, it is recommended to wash out the stomach; you can also take activated charcoal or another sorbent drug.

Large amounts of the drug can be removed from the body by hemodialysis. Whether peritoneal dialysis is effective in overdose has not been tested.

Interactions with other drugs

Experimental studies have established drug interactions between Cedex and other medications, such as antacids (aluminum and magnesium compounds) in high doses, ranitidine hydrochloride, and the bronchodilator theophylline. No suspicions of significant interactions between these medications have been found. The effect of Cedex on the blood levels or the pharmacokinetic properties of theophylline when taken orally has not been determined.

No data on drug interactions with any other medications were obtained.

Any cephalosporin antibiotics, including Cedex, can sometimes affect the prothrombin index, leading to its prolongation. This is especially true for patients who have previously taken oral anticoagulants.

Such patients require constant monitoring of the prothrombin index; vitamin K may be additionally prescribed.

No effect of Cedex on laboratory and biochemical test results was detected.

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Storage conditions

The encapsulated form of the drug is usually stored in places inaccessible to children, at temperatures ranging from +2° to +25°C.

The powdered substance for use as a suspension should be stored in dry, dark places, in a temperature range of +2° to +25°C.

Special instructions

Price of Cedex

The price of the medicine Cedex may differ depending on the pricing policy of a particular pharmacy chain. The price of Cedex should be clarified with managers and representatives of a particular pharmacy directly when ordering the medicine. Since prices for medicines can change quickly for many reasons, then if the price suits you, it is better to reserve the medicine in advance.

Average prices for Cedex in Ukraine are as follows:

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

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Analogues of Cedex

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

However, not all drugs have such analogues. This is most often due to the inexpediency of their release, or the impossibility of additional production. The impossibility is explained by the regulation of processes in the pharmaceutical market, a certain strategy of pharmaceutical companies that produce drugs, as well as some economic reasons.

Cedex is one of those products that has no analogues. The active ingredient Ceftibuten is not present in any other known pharmaceutical product.

Of course, if necessary, you can consult a doctor and replace Cedex with another cephalosporin, but this will no longer be a similar drug, but a completely different one. Self-replacement of one cephalosporin antibiotic with another is strongly discouraged.

Suprax or Cedex?

Most often, the drug Cedex is replaced by another representative of β-lactam cephalosporin antibiotics, Suprax. This drug is not a direct analogue of Cedex, as it contains another active ingredient - Cefixime.

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

If you are faced with a dilemma of what to take, Suprax or Cedex, consult a doctor: only a specialist can determine the appropriateness of a particular drug in your particular case. You cannot make an independent replacement: since the drugs are different, sometimes it may be necessary to adjust the dosage and regimen of taking the drug.

Reviews of Cedex

If the treatment is prescribed by a qualified specialist, then treatment with Cedex can usually be very effective. In the treatment of many diseases, especially in pediatrics, reviews of Cedex are quite positive.

However, it is important to remember that uncontrolled use of antibiotics, and Cedex is no exception, can lead to very, very unpleasant consequences. Follow the treatment regimen, do not miss the time of taking the medicine, do not lower or increase the dosage on your own. The course of Cedex therapy must be completed in full. That is, if you are prescribed a course of treatment for 10 days, and you feel better after 5 days, then you should not interrupt treatment with the drug under any circumstances: the therapeutic course must be completed, otherwise you risk acquiring a chronic course of the disease, or acquiring a number of complications.

If you have long-standing bowel problems, you should take the drug with caution. If you feel a negative effect of the drug on bowel function, you should bring this to the attention of your doctor.

Do not forget that during the period of therapy with Cedex, however, as with the use of any other broad-spectrum antibiotics, a change in the intestinal microflora may occur, which, in turn, will lead to an upset stomach and inflammation of the intestinal mucosa. Talk to your doctor about the necessary measures to prevent this condition so as not to disrupt intestinal function. Drink fermented milk products: fresh kefir, natural yogurt, sourdough, eat homemade cottage cheese and sauerkraut.

Shelf life

The shelf life of Cedex is up to 2 years, after which the drug must be disposed of.

The prepared suspension (diluted powder) can be stored for 14 days in the refrigerator.