Active substanceCeftibutenCeftibuten
Similar drugsTo uncover
  • Cedex®
    capsules inwards 
  • Cedex®
    powdersuspension inwards 
  • Dosage form: & nbspPowder for the preparation of a suspension for oral administration.
    Composition:
    1 g of powder contains:

    active substance: ceftibuten (in the form of ceftibutene dihydrate) - 144.0 mg;

    Excipients: polysorbate-80 - 0.4 mg, simethicone - 0.8 mg. gum xanthan-16.0 mg, silicon dioxide-10.0 mg. titanium dioxide - 18.0 mg. sodium benzoate-4.0 mg. cherry flavoring - 3.66 mg, sucrose - up to 1.0 g.

    In 1 ml of the prepared suspension contains 36 mg tssfshteppa.
    Description:Powder from light yellow to dark yellow with a characteristic cherry smell. Suspension obtained according to the instructions (28 ml of water is added in portions to the vial of the preparation and mixed each time), homogeneous, light yellow with a characteristic cherry smell.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.D.14   Ceftibuten

    Pharmacodynamics:Ceftibuten, like most other beta-lactam antibiotics, has a bactericidal effect, suppressing the synthesis of the bacterial cell wall. A drug It acts on many microorganisms that produce beta-lactamases and are resistant to penicillins and other cephalosporins.

    Microbiology. Ceftibuten 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 Citrolnicler spp.. Enlerobacler spp., Bacteroides spp., Morganella spp. to Serralia spp. Like other beta-lactams, ceftibutene should not be used for infections caused by bacterial strains whose resistance to beta-lactams is due to common mechanisms, such as changes in membrane permeability or modification of penicillin-binding proteins (PSB) (eg, penicillin-resistant Streptococcus pneumoniae). Ceftibuten interacts mainly with PSB-3 Escherichia coli. which leads to the formation of filamentous forms at the concentration. which is 1 / 4-1 / 2 of the minimum inhibitory concentration (MPK), and lysis at a concentration twice that of the MIC. The minimum bactericidal concentration (MBC) of ceftibutene for strains Escherichia coli, sensitive and resistant to ampicillin, approximately equal to the MIC.

    Ceftibuten is active in vitro and in clinical practice with respect to most strains of the following microorganisms:

    -gram positive microorganisms: Streptococcus pyogenes. Streptococcus

    pneumoniae (with the exception of penicillin-resistant strains):

    -gram-negative microorganisms: Haemophilus influenzae and Moraxella catarrhal is (Branhamella), including strains producing beta-lactamase, Escherichia coli, Klebsiella spp., Serralia spp., Morganella morganii.

    Ceftibuten is inactive with respect to Enterococcus spp., Staphylococcus spp., Acinetohacter spp., Listeria spp., Elavohacterium spp., Pseudomonas spp., Hafnia spp. Has a weak activity against anaerobes, including most species Bacteroides spp., Campylobacter spp., Yersinia spp. Destroyed by cephalosporinases of chromosomal origin Citrobacter spp., Enlerobacler spp., Bacteroides spp.

    Pharmacokinetics:
    Ingestion ceftibutene almost completely absorbed (90%) and is excreted mostly unchanged in kidneys.
    The degree of binding ceftibutsy with plasma proteins is low (62-64%). The main derivative of ceftibutene. circulating in plasma (ceftibuten-trans), is apparently formed by direct conversion of ceftibutsia (cis-form). Ceftibuten trans does not have microbiological activity in vitro and in vivo in relation to staphylococci, enterococci. Acinetobacter spp., Bordetella, Listeria spp., Flavobacterinni spp., Pseiuionwnas spp., Campylobacter spp., Yersinia spp., Hafnia spp. The concentration of ceftibutene-trans in plasma or urine is usually about 10% or less of the concentration of ceftibutene.

    Bioavailability of ceftibutene depends on the dose in the therapeutic dose range (<400 mg) and varies from 75% to 94%.

    Equilibrium concentrations of ceftibutene (if administered every 12 hours) in plasma are achieved after taking the fifth dose.

    The half-life of ceftibutene from the plasma is 2 to 4 hours (2.5 hours on the average) and does not depend on the dose or schedule of application.

    Simultaneous food intake affects the bioavailability of the CEDEX ® powder to prepare a suspension of 36 mg / ml.

    The effect of writing on the bioavailability of Cedex® was studied in 18 healthy male volunteers who took 400 mg of the suspension in the morning on an empty stomach or immediately after breakfast. The results obtained showed a decrease in CmOh by 26% and a decrease in the iodine area of ​​the pharmacokinetic curve "concentration-time" (AUC) 17% after a high-calorie breakfast and. respectively, by 17% and 12% after a low-calorie breakfast.

    Ceftibuten easily penetrates into body fluids and tissues. In the fluid of the skin bladder, which was experimentally induced in healthy volunteers receiving ceftibutene in a daily dose of 400 mg, the concentration of ceftibutene was comparable to that in plasma or exceeded it (by comparison AUC). Ceftibuten is determined in the middle ear fluid in children with acute otitis media, where its concentration is approximately equal to or greater than its concentration in the plasma. The concentration of ceftibutene in the lung tissue is approximately 40% of the concentration in the plasma. In the nasal, tracheal, bronchial secretion, bronchoalveolar lavage fluid and its cellular suspension, the concentrations of ceftibutene are approximately 46. 20. 24.6 and 81% of the plasma concentration, respectively. Ceftibuten is detected in the urine within 24 hours after taking 400 mg: the maximum concentration in urine is 264 μg / ml and is reached within the first 4 hours: after 20-24 hours after a single administration of ceftibutene, its concentration in urine is 10.5 μg / ml .

    There is no data on the concentration of ceftibutene in cerebrospinal fluid, however, when oral cephalosporins are used, their content in the cerebrospinal fluid does not usually reach the therapeutic level.

    In elderly people, equilibrium concentrations of ceftibutene (when administered every 12 hours) are achieved after taking the fifth dose. Average AUC in this group is slightly higher than in younger patients. With repeated use of ceftibutene in elderly people, cumulation was negligible.


    Indications:
    Treatment of infections caused by microorganisms sensitive to ceftibutene:

    -infection of the upper respiratory tract, including pharyngitis, tonsillitis, acute sinusitis in adults;

    - acute otitis media in children;

    - Infections of the lower respiratory tract in adults, including exacerbation of chronic bronchitis and community-acquired pneumonia, in those cases where oral therapy is possible;

    -infection of the urinary tract: acute and chronic pyelitis, cystopyelitis, cystitis, urethritis.
    Contraindications:
    -Increased sensitivity to ceftibutene, cephalosporins or any component of the drug.

    -Child up to 6 months due to the fact that the safety and efficacy of CEDEX® in children less than 6 months of age, including newborns, have not been established.

    - Congenital disorders of carbohydrate metabolism: intolerance to fructose, impaired absorption of glucose / galactose, or insufficiency of sucrose / isomaltase.
    Carefully:
    Assign the drug to patients:
    with known or suspected allergy to penicillins;
    - with complicated gastrointestinal diseases, especially chronic colitis in the anamnesis;
    -with an average degree and severe renal insufficiency (creatinine clearance less than 50 ml / min) and patients on hemodialysis;
    - with allergic reactions, including in the history (except as indicated in the section "Contraindications").
    Pregnancy and lactation:
    Controlled studies of drug use in pregnant women have not been conducted. Studies in animals have not revealed its damaging effect on the course of pregnancy or childbirth, on embryonic or postnatal development.However, when prescribing Cedex®, pregnant women should compare the benefits to the mother and the risk to the fetus. Cedex® is not recognized in breast milk in nursing women, but use of the drug in women during lactation should be taken with caution.
    During the period of breastfeeding the drug is used only if the intended benefit to the mother exceeds the potential risk for the child.
    Dosing and Administration:

    For oral administration. Suspension of Cedex® should be taken approximately 2 hours before or 1 hour after meals. Before using the preparation, the vial with the finished suspension should be vigorously shaken.

    The duration of treatment with Cedex® is usually 5 to 10 days.

    In the treatment of infections caused by Streptococcus pyogenes, Cedex® in

    The therapeutic dose should be used for at least 10 days.

    Adults. The recommended dose of Cedex® is 400 mg / day (11.1 ml

    suspension per day).

    In the treatment of acute bacterial sinusitis, exacerbation of chronic bronchitis and urinary tract infections (acute and chronic pyelitis, cystopyelitis, cystitis, urethritis), the drug can be used 400 mg once a day.

    In the treatment of community-acquired pneumonia in patients who have oral therapy, the recommended dose is 200 mg (5.6 ml of suspension) every 12 hours. The duration of therapy is 5-10 days, depending on the severity and type of the disease.

    Adult patients with impaired renal function. With mild renal insufficiency, the pharmacokinetics of the Cedex® preparation does not change significantly, so a dose change is required only when the creatinine clearance is less than 50 ml / min.

    If the clearance of creatinine is 30 to 49 ml / min, then the daily dose should be reduced to 200 mg. With the clearance of creatine from 5 to 29 ml / min, the recommended daily dose is 100 mg (2.8 ml suspension).

    If a change in the frequency of application is preferable, the 400 mg Cedex® preparation can be used every 48 hours (once every 2 days) with a creatinine clearance of 30-49 mL / min or every 96 hours (1 every 4 days) with creatinine clearance of 5 -29 ml / min. Patients on hemodialysis two or three times a week, Cedex® can be administered 400 mg at the end of each hemodialysis session.

    Children. The recommended dose of the suspension for oral administration is 9 mg / kg / day (0.25 ml / kg / day), maximum 400 mg / day.

    Children from 12 years of age and weighing 45 kg or more Cedex® can be used in the recommended adult dose.

    In the treatment of pharyngitis, accompanied or not accompanied by tonsillitis, acute otitis media and urinary tract infections (acute and chronic pyelitis, cystopyelitis, cystitis, urethritis), the drug can be applied once a day. The duration of therapy is 5-10 days, depending on the severity and type of the disease.

    The safety and effectiveness of Cedex® in children less than 6 months of age, including newborns, have not been established.

    Preparation of a suspension for oral administration

    Before opening the vial with powder, shake it. The powder can have a specific odor, which is not a sign of unfitness. After mixing the powder with water, the finished suspension acquires a characteristic cherry smell.

    Measure the required amount of water (28 ml) by pouring water into a measuring cup (supplied) to the level of the hole. 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 well again until the powder is completely dissolved and 33 ml of a homogeneous suspension is obtained.To dispense 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, or other medical dosing product available to the patient.

    Side effects:

    In clinical trials involving about 3,000 patients, the most common side effects were nausea (3%), diarrhea (3%), and headache (2%).

    Undesirable reactions indicating body system and frequency often (> 1/100, <1/10); infrequently (>1/1000 <1/100); rarely (>1/10000, <1/1000); very rarely (<1/10000); frequency is not set (can not be determined based on available data)

    Side effects observed during a clinical trial or

    in the post-marketing period

    System-Organ Class

    Side effects

    Infectious and parasitic diseases

    Infrequently

    Candidiasis (oral cavity), vaginitis

    Rarely

    Colitis caused by Clostridium difficile

    Frequency not set

    Superinfection

    Violations of the blood and lymphatic system

    Infrequently

    Eosinophilia, a positive Coombs reaction, a decrease in hemoglobin, an increase in prothrombin time, an increase in the international normalized ratio (MHO)

    Rarely

    Leukopenia, thrombocythemia, aplastic anemia, hemolytic anemia, bleeding disorders, paitsitopenia, neutropenia, agranulocytosis

    Immune system disorders

    Frequency not set

    Serum sickness, allergies, including anaphylactic reactions, bronchospasm, skin rash, urticaria, reaction of increased photosensitivity, itching, angioedema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis

    Disorders from the metabolism and nutrition

    Infrequently

    Anorexia

    Disorders of the psyche

    Rarely

    Children: agitation, insomnia

    Frequency not set

    Psychotic disorders

    Disturbances from the nervous system

    Often

    Headache

    Infrequently

    Change of taste

    Rarely

    Convulsions

    Rarely

    Paresthesia, drowsiness In children: hyperkinesia

    Frequency not set

    Aphasia

    Hearing disorders and labyrinthine disorders

    Rarely

    Vertigo

    Disturbances from the respiratory system, chest and mediastinum

    Infrequently

    Nasal obstruction, dyspnea

    Disorders from the gastrointestinal tract

    Often

    Nausea, diarrhea

    Infrequently

    Gastritis, vomiting, abdominal pain, constipation, dryness of the oral mucosa. dyspepsia, flatulence, fecal incontinence.

    Frequency not set

    Melena

    Disturbances from the liver and bile ducts

    Infrequently

    Hyperbilirubinemia, increased activity of alanine aminotransferase, aspartate aminotransferase in serum

    Rarely

    Increase in lactate dehydrogenase activity in blood serum

    Frequency not set

    Hepatobiliary disorder, jaundice

    Disturbance of the skin and subcutaneous tissues

    Infrequently

    In children: diaper dermatitis

    Disorders from the nochek and urinary tract

    Infrequently

    Dizuria

    In children: hematuria

    Impaired renal function. toxic nephropathy, glucosuria, ketonuria

    General disorders and disorders in place of introduction

    Rarely

    Fatigue

    In children: irritability, fever

    Side effects of all cephalosporins: aplastic anemia, hemolytic anemia, internal bleeding, renal dysfunction, toxic

    nephropathy, hyperbilirubinemia, Coombs positive reaction, glucosuria, ketonuria, pancytopenia, neutropenia, agranulocytosis, drug fever, cholestasis.

    Side effects in children, common to all cephalosporins: diarrhea, vomiting, abdominal pain, loose stools, agitation, anorexia, dehydration, diaper dermatitis, dizziness, dyspepsia, fever, headache, hematuria, hyperkinesia. excitement, insomnia, irritability, nausea, itching. rash, hives.

    Overdose:
    In case of an accidental overdose of Cedex®, no signs of toxicity were noted. The antidote of ceftibutene does not exist, therefore, when overdosing, it is possible to wash the stomach. A significant portion of the dose of Cedex® can be removed from the blood by hemodialysis. The effectiveness of peritoneal dialysis is not established.
    In healthy adult volunteers who received the Cedex® single dose at a dose of up to 2 g, there were no serious adverse reactions, and all clinical and laboratory indicators remained within the normal range.
    Interaction:

    Special studies have investigated the interaction of ceftibutene with the following drugs: 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 ceftibutene on plasma concentration or the pharmacokinetics of theophylline upon ingestion is not known. Information on the interaction with other drugs has not been received to date.

    Cephalosporins, including ceftibutene, in rare cases can reduce prothrombin activity, which leads to an increase in prothrombin time, especially in patients previously stabilized by oral anticoagulant therapy. Patients at risk should be monitored for prothrombin time and MHO. If necessary, the introduction of vitamin K is recommended.

    Impact on laboratory results

    Effects of ceftibutene on the results of chemical or laboratory revealed. When using other cephalosporins, a false positive direct Coombs test was sometimes recorded. However, the results of a study using healthy human erythrocytes did not confirm the ability of cefgibutene to induce a positive Coombs test in vitro even at concentrations up to 40 μg / ml.

    Special instructions:
    Long-term treatment with broad-spectrum antibiotics can lead to the development of resistance of microorganisms to the drug.Patients with diabetes should be informed that 1 teaspoon of the suspension contains 1 g of sucrose.
    When developing seizures or an anaphylactic reaction, it is necessary to cancel the drug and begin the appropriate treatment.
    It is recommended to exercise extreme caution when using Cedex® with patients with allergic reactions of any kind (eg, hay fever and bronchial asthma), because they are not tolerated. these patients are at increased risk of severe hypersensitivity reactions.
    In connection with the content of sodium benzoate in the composition of the drug, hypersensitivity reactions can occur, manifested in the form of inflammation of the skin, eyes and mucous membrane. Infants may have an increased risk of jaundice.
    Approximately 10% of patients with penicillin allergy have a cross-reaction to cephalosporins. In patients who received both penicillins and cephalosporins. Hypersensitivity reactions (anaphylaxis) have been reported; There are cases of cross-reactivity with the development of anaphylaxis. In case of serious anaphylactic reactions, urgent therapy is indicated (for example, epinephrine, glucocorticosteroids, intravenous fluids, airway patency, oxygen administration, antihistamines, and dynamic observation).
    In the treatment of broad-spectrum antibiotics such as Cedex®, impaired intestinal microflora can lead to diarrhea, including pseudomembranous colitis associated with the production of Clostridium difficile toxin. In mild cases, it is sufficient to cancel the treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole. Do not use drugs that violate intestinal motility.
    The severity of diarrhea, accompanied or not accompanied by dehydration, can vary, 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, such as Cedex®.
    Effect on the ability to drive transp. cf. and fur:Data indicating that the administration of Cedex® affects the ability to drive vehicles and work with mechanisms has not been identified. Patients should be warned about the possibility of developing dizziness, seizures, in the appearance of which it is necessary to refuse to perform these activities.
    Form release / dosage:
    Powder for the preparation of a suspension for oral administration of 36 mg / ml.
    Packaging:
    By 8.3 g in a glass bottle of dark glass, closed with a two-component screw-on plastic lid, which has a ring of the first opening, protection from opening the bottle by children and a gasket. 1 bottle with instructions for use, a measuring spoon and a measuring cup in a cardboard bundle.
    Storage conditions:Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:
    2 years. Do not use after the expiration date.
    The prepared suspension can be stored for 14 days in a refrigerator (2-8 ° C).
    Terms of leave from pharmacies:On prescription
    Registration number:П N013725 / 02
    Date of registration:23.01.2009
    The owner of the registration certificate:MSD FARMASYUTIKALS, LLC MSD FARMASYUTIKALS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.
    Information update date: & nbsp10.11.2015
    Illustrated instructions
      Instructions
      Up