Spectraceph tabs 200mg #20

Spectraceph user manual

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Active substance, group, Dosage form

Cepheditorin, Antibiotic-cephalosporin, film-coated tablets.

Contraindications

- Hypersensitivity to cefditoren, other cephalosporins or any other component of Spectraceph;
- severe allergic reactions to penicillins and other beta-lactam antibacterials;
- hepatic insufficiency of class C in Child-Pugh;
- patients on hemodialysis;
- a hypersensitivity reaction to protein casein in history;
- primary carnitine insufficiency;
- children's age till 12 years;
- simultaneous use of cefeditorin pivoksila and blockers of histamine H2 receptors.
The drug should not be used during pregnancy, except when the expected benefit to the mother exceeds the potential risk to the fetus. If you need to use the drug during lactation, breastfeeding should be discontinued.

Care should be taken when specifying Spectraceph

- patients with increased sensitivity to other beta-lactam antibiotics because of the possibility of developing cross-allergic reactions;
- patients who simultaneously use aminoglycosides and diuretics (furosemide);
- patients with pathology of the gastrointestinal tract (including colitis in the anamnesis).

Dosing and Administration (Instruction)

Tablets are taken orally, swallowing whole, with plenty of water, preferably after eating. The recommended dose depends on the severity of the infection, the initial condition of the patient and the potential causative agents of the infection.

Adults and children over 12 years of age

Acute pharyngthongsillitis, acute sinusitis and uncomplicated infections of the skin and subcutaneous fat: 200 mg every 12 hours for 10 days.
Exacerbation of chronic bronchitis: 200 mg every 12 hours for 5 days.
Community-acquired pneumonia: 200 mg every 12 hours for 14 days. In severe cases, recommend a dose of 400 mg every 12 hours for 14 days.
Elderly patients, except for severe violations of the liver and / or kidney function, dose adjustment is not required.
In patients with mild renal impairment, dose adjustment is not required. In patients with moderate renal insufficiency (creatinine clearance 30-50 ml / min), the recommended dose of Spectraceph should not exceed 200 mg twice a day. In patients with severe renal failure (creatinine clearance less than 30 ml / min), the maximum daily dose should not exceed 200 mg. In patients on hemodialysis, the recommended dose is not established.
Patients with mild to moderate liver dysfunction do not need dose adjustment (Child-Pugh classes A or B). There are no data available to prescribe the recommended dose for patients with severe hepatic impairment (Child-Pugh class C).

Pharmachologic effect

The active ingredient of Spectraceph cefeditorin pivoksil - semisynthetic beta-lactam antibiotic, a prodrug of cefditoren (third generation cephalosporin). The mechanism of action of the drug is associated with the inhibition of bacterial wall synthesis due to its affinity for penicillin-binding proteins.
When the drug is administered at a dose of 200 mg twice a day, its plasma concentration exceeds the minimum inhibitory concentration for 90% of microorganisms (MIC90) for Moraxella catarrhalis, Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pyogenes and penicillin-susceptible strains of Streptococcus pneumoniae for at least 50% of the time from the dosing interval. The administration of cefeditorin 400 mg twice daily provides maintenance of its concentration above the MIC for 51% of the time from the dosing interval, which exceeds the MIC of 50% of microorganisms (MPC50) for penicillin-resistant Streptococcus pneumoniae.
Cefditoren as a third generation cephalosporin has common resistance mechanisms for this group of antibiotics. The resistance of Gram-positive microorganisms can be associated with a change in the penicillin-binding protein Streptococcus pneumoniae and Streptococcus viridans, or the appearance of an additional penicillin-binding protein (PBP2a) in Staphylococcus spp. Cefditoren is resistant to most of the most common chromosomal and plasmid beta-lactamases of gram-negative bacteria. However, like other cephalosporins, cefditoren is hydrolyzed by broad spectrum beta-lactamases mediated by plasmids. In addition, the cause of resistance can be the development of chromosomal beta-lactamase in mutant strains Enterobacter spp., Citrobacter spp., Morganella spp. and Serratia spp. The mechanism of action of cefditoren is similar to other cephalosporin antibiotics and differs from the mechanism of action of other groups of antibiotics. In general, there was no evidence of cross-resistance between cefditoren and other groups of antibiotics. However, in rare cases, some mechanisms of action (for example, related to the impermeability of the internal membrane or the presence of a mechanism for active removal of the antibiotic from the cell) may be similar for all groups of antibiotics. This causes a certain level of resistance to all antibiotics.
The prevalence of acquired resistance may vary depending on the geographical area, as well as individual pathogens. For this reason, it is desirable to obtain information on the sensitivity of microorganisms in a particular region, especially when treating a serious infection. In cases where the resistance of pathogens is doubtful, you can seek help from a specialist who will assess the advisability of prescribing cefditorin in a specific clinical case.
Usually sensitive species (resistance less than 10%, European data)

Aerobic Gram-positive microorganisms

Streptococci groups C and G,
Methicillin-sensitive strains of Staphylococcus aureus1, Streptococcus agalactiae, Streptococcus pneumoniae1'2, Streptococcus pyogenes1

Aerobic Gram-negative microorganisms

Haemophilus influenzae1,
Moraxella catarrhalis1,

Anaerobic microorganisms

Clostridium perfringes,
Peptostreptococcus spp.,
Microorganisms with initial resistance to cefeditoren

Aerobic Gram-positive microorganisms

Enterococcus spp.,
Staphylococcus aureus resistant to methicillin.
Aerobic Gram-negative microorganisms:
Acinetobacter baumanii,
Pseudomonas aeruginosa.

Anaerobic microorganisms

The Bacteroides fragilis group,
Clostridium difficile,

Other

Chlamydia spp.,
Mycoplasma spp.,
Legionella spp.
1- Clinical efficacy was shown for susceptible pathogens according to approved indications.
2 - some strains with high resistance to penicillin may have a decreased sensitivity to cefjatoren. The strains resistant to cefotaxime and ceftriaxone should not be considered as sensitive to cefotoren.
Gram-negative microorganisms that contain chromosomal beta-lactamases, such as Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Morganella morganii, Serratia marcescens, must be considered as resistant to cefditoren, despite their apparent susceptibility in vitro.

Side effects of Spectraceph

The undesirable phenomena listed below are listed depending on the anatomical and physiological classification and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10,000 and < 1/1 000), very rarely (<1/10 000, including individual cases).
From the side of metabolism and nutrition: rarely - anorexia.
From the nervous system: often - headache; rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.
From the side of the organ of vision: very rarely - photosensitivity.
From the ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, ringing in the ears.
From the respiratory system, chest and mediastinum: very rarely - bronchospasm.
From the gastrointestinal tract: very often - diarrhea; often - nausea, abdominal pain, indigestion; rarely - constipation, flatulence, vomiting, candidiasis of the oral cavity, belching, pseudomembranous colitis, dryness of the oral mucosa, perversion of taste; very rarely - aphthous stomatitis.
From the liver and bile ducts: rarely - a violation of the liver.
From the skin and subcutaneous fat: rarely: rash, itching, urticaria.
From the side of the musculoskeletal system and connective tissue: very rarely - myalgia.
From the genitourinary system: often: candidal vaginitis; rarely - vaginitis, leucorrhoea.
Other: rarely - fever, asthenia, generalized pain syndrome, increased sweating.
On the part of laboratory indicators: sometimes - leukopenia, thrombocytosis, increased concentration of alanine aminotransferase (ALT); rarely - increase in clotting time, hyperglycemia, hypokalemia, bilirubinemia, increased concentrations of aspartate aminotransferase (ACT), alkaline phosphatase, albuminuria.
In addition, isolated cases of eosinophilia, thrombocytopenia, decrease of thromboplastin time, thrombocytopathy, increase in lactate dehydrogenase (LDH) concentration, hypoproteinemia and increase in creatinine concentration are described.
There were also separate reports about the following undesirable phenomena.
From the hemopoiesis: hemolytic anemia, lymphadenopathy.
From the side of water-electrolyte metabolism: dehydration.
On the part of the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, thinking disorder, increased libido, collapse.
On the part of the nervous system: amnesia, impaired coordination, muscle hypertonia, meningitis, tremor.
From the side of the organ of vision: weakening of vision, disturbances from the organ of vision, pain in the eyes, blepharitis.
From the cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular extrasystole, postural hypotension.
On the part of the gastrointestinal tract: hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, glossitis, hiccough, discoloration of the tongue.
From the urinary system: dysuria, pain in the kidney, jade, nocturia, polyuria, urinary incontinence, urinary tract infection.
On the part of the genitourinary system: pain in the mammary glands, menstrual irregularities, metrorrhagia, erectile dysfunction.
Other: unpleasant body odor, chills.
The following adverse reactions were not recorded as adverse events after the administration of cefditoren, but they are characteristic for cephalosporins
Allergic reactions: allergic reactions, including Stevens-Johnson syndrome, multi-form exudative erythema, serum sickness, toxic epidermal necrolysis.
From the urinary system: a violation of kidney function, toxic nephropathy.
From the liver and biliary tract: cholestasis.
On the part of the organs of hematopoiesis: aplastic anemia.
In case of an overdose of Spectraceph, the patient may have symptoms such as nausea, vomiting, diarrhea. With the development of a clinical picture of drug overdose, symptomatic therapy is indicated.

Special instructions

When developing a hypersensitivity reaction, treatment with Spectraceph should be discontinued, and the patient should be prescribed the necessary treatment.
As with the use of other broad-spectrum antibiotics, treatment with cefditoren may lead to an excessive growth of resistant microflora. For this reason, it is recommended that patients who receive this medication are monitored, especially in the case of prolonged treatment.
Patients with severe renal failure are advised to periodically monitor kidney function.
During the course of treatment with cephalosporins, a decrease in prothrombin activity is possible. For this reason, in patients at risk (with renal or hepatic insufficiency or in the case of prior appointment of anticoagulants), prothrombin time control is necessary.
The development of diarrhea during or after treatment, especially with its severe, persistent character and the presence of blood impurities, may indicate pseudomembranous colitis. In mild cases of diarrhea, it is enough to just cancel the drug, in more severe cases, antibiotic therapy, to which Clostridium difficile is sensitive, and the purpose of infusion therapy are indicated.
Like other cephalosporins, cefeditoren can lead to a false positive result of Coombs direct test, detection of glucose in the urine using a copper reduction test, but not with the help of an enzyme test. Because of the high risk of false negative results of a ferricyanide glucose test in plasma or blood, it is recommended that patients on the background of cefeditoren treatment to determine the concentration of glucose in blood or plasma use glucose oxidase or glucosehexoquinase methods.
When combined with cephalosporins with aminoglycosides and / or loop diuretics, especially in patients with impaired renal function, the risk of nephrotoxicity increases.
The Spectraceph contains approximately 13.1 mg (for tablets at a dosage of 200 mg) and 26.2 mg (for tablets with a dosage of 400 mg) of sodium in each dose, which should be considered when administering the drug to patients on a diet low in sodium.
It has not been reported on the effect of cefeditorin on the ability to drive a car and / or other mechanisms. At the same time, it should be taken into account that the reception of Spectraceph can be accompanied by such undesirable phenomena as vomiting, headache.

Interaction

Antatsidy: the combined use of cefeditorin pivoksila and antacids containing magnesium hydroxide, aluminum, after meals reduces the Cmax and AUC values ​​of cefditoren by 14% and 11%, respectively. Although the clinical significance of this fact is unknown, it is recommended that the period between the administration of antacids and cefeditorin of the pivocil be 2 hours.
Probenecid: The combined use of probenecid and cefeditorin of pivoxil reduces the excretion of the antibiotic by the kidneys, increasing the C max value by 49%, AUC by 122% and increasing the half-life of the cefeditorin by 53%.
Blockers of H2-histamine receptors: concomitant administration of famotidine intravenously and cefeditorin of pivoxil inward leads to a decrease in the Cmax and AUC values ​​by 27% and 22%, respectively. Thus, the simultaneous use of cefeditorin pivoksila and blockers of histamine H2 receptors is not recommended.