Spectracef pills 200mg, 14pcs

Composition

Active ingredient: cefditorene pivoxil in terms of cefditorene 200 mg. Excipients: mannitol as needed (approximately 35 mg), sodium caseinate 100 mg, croscarmellose sodium 150 mg, sodium tripolyphosphate 4 mg, magnesium stearate 5 mg, Opadray white 35 mg (hypromellose 21.9 mg, titanium dioxide 10.9 mg, macrogol-400 2.2 mg), Carnauba wax 0.06 mg, Opacode blue ink (shellac IN IMS 74 OP, FD & C blue No. 1 50.41%, butanol 24.35%, aluminum varnish based on diamond blue dye 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%, concentrated ammonia solution 1.94%).

Pharmacological action

Mechanism of action of Cefditoren pivoxil is a semi-synthetic beta-lactam antibiotic, a prodrug of cefditoren (third-generation cephalosporin). The mechanism of action of the drug is associated with inhibition of bacterial wall synthesis due to its affinity for penicillin-binding proteins.

Pharmacokinetic / pharmacodynamic specificities When the drug is administered at a dose of 200 mg twice daily, its plasma concentration exceeds the minimum inhibitory concentration against 90% of microorganisms (MPC 90) for Moraxella catarrhalis, Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pyogenes and penicillin-sensitive strains Streptococcus pneumoniae for at least 50% of the time from the dosing interval. use of cefditoren at a dose of 400 mg twice daily ensures that its concentration is maintained above the minimum inhibitory concentration (MPC) for 51% of the time from the dosage interval, which exceeds the minimum inhibitory concentration for 50% of microorganisms (MPC 50) for penicillin-resistant Streptococcus pneumoniae.

Mechanisms of resistance Cefditoren as a third-generation cephalosporin has common mechanisms of resistance for this group of antibiotics. Resistance of gram-positive microorganisms may be associated with changes in the penicillin-binding protein of 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 may be the production of chromosomal beta-lactamase in mutant strains of Enterobacter spp., Citrobacter spp., Morganellaspp. 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 cross-resistance between cefditoren and other groups of antibiotics. However, in rare cases, some mechanisms of action (for example, due to the impermeability of the inner 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 leads to a certain level of resistance to all antibiotics.

Minimum suppressive concentration (MPC)Recommended MPC values for cefditoren that allow classification of microorganisms with high, intermediate sensitivity and resistance: sensitive – ≤ 0.5 mcg / ml, with intermediate sensitivity – > 0.5 mcg / ml and sensitivity The table below provides information on the sensitivity spectrum of most microorganisms for approved indications for use.

The prevalence of acquired resistance may vary depending on the geographical area, as well as in individual pathogens. For this reason, it is desirable to obtain information about the sensitivity of microorganisms in a particular region, especially in the treatment of severe infection. In cases where the resistance of pathogens is questionable, you can seek help from a specialist who will assess the feasibility of prescribing cefditoren in a particular clinical case.

1-clinical efficacy has been shown for sensitive pathogens according to approved indications. 2-some strains with high penicillin resistance may have reduced sensitivity to cefditoren. Strains that are resistant to cefotaxime and ceftriaxone should not be considered sensitive to cefditoren.

Gram-negative microorganisms that contain chromosomal beta-lactamases, such as Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Morganella morganii, Serratia marcescens, should be considered as resistant to cefditoren, despite their apparent susceptibility in vitro.

Indications

Treatment of infections caused by cefditoren-sensitive microorganisms:

• upper respiratory tract infections: acute tonsillopharyngitis, acute sinusitis;
• lower respiratory tract infections: exacerbation of chronic bronchitis, community-acquired pneumonia;
• uncomplicated infections of the skin and subcutaneous fat: phlegmon, infected skin wounds, abscess, folliculitis, impetigo and furunculosis.

Contraindications

• Hypersensitivity to cefditoren, other cephalosporins or to any other component of the drug;
• severe allergic reactions to penicillins and other beta-lactam antibacterial drugs;
• liver failure class C child-Pugh;
• patients on hemodialysis;
• hypersensitivity reactions to the protein casein in history;
• primary carnitine deficiency;
• children up to age 12 years;
• the simultaneous use of cefditoren pivoxil blockers and H-2 histamine receptors.

With caution

Patients with hypersensitivity to other beta-lactam antibiotics due to the possibility of cross-allergic reactions. Concomitant use with aminoglycosides and diuretics (furosemide).

Patients with gastrointestinal disorders, including a history of colitis.

Side effects

The adverse events presented below are listed according to the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is defined as follows: very common (≥ 1/10), common (≥ 1/100 and From the side of metabolism and nutrition Occasionally: anorexia.

Nervous system disorders Often: headache. Rare: nervousness, dizziness, insomnia, drowsiness, sleep disorders.

From the side of the visual organ very rarely: photosensitivity.

On the part of ENT organs very rarely: pharyngitis, rhinitis, sinusitis, tinnitus.

Respiratory, thoracic and mediastinal disorders Very rare: bronchospasm.

From the gastrointestinal tract Very often: diarrhea. Often: nausea, abdominal pain, dyspepsia. Rarely: constipation, flatulence, vomiting, oral candidiasis, belching, pseudomembranous colitis, dry mouth, taste distortion. Very rare: aphthous stomatitis.

From the side of the liver and biliary tract Rarely: impaired liver function.

From the skin and subcutaneous adipose tissue Rarely: rash, pruritus, urticaria.

Musculoskeletal and connective tissue disorders Very rare: myalgia.

From the genitourinary system often: candida vaginitis. Rare: vaginitis, leucorrhoea.

Other reactionsreferences: fever, asthenia, generalized pain syndrome, excessive sweating.

From the side of laboratory indicatesin some cases: leukopenia, thrombocytosis, increased concentration of alanine aminotransferase (ALT). Rarely: increased blood clotting time, hyperglycemia, hypokalemia, bilirubinemia, increased concentration of aspartate aminotransferase (ACT), alkaline phosphatase, albuminuria.

In addition, isolated cases of eosinophilia, thrombocytopenia, decreased thromboplastin time, thrombocytopathies, increased lactate dehydrogenase (LDH), haproteinemia, and increased creatinine concentrations have been described.

There have also been isolated reports of the following adverse events::- from the side of hematopoietic organs: hemolytic anemia, lymphadenopathy;- from the side of water-electrolyte metabolism: dehydration;- from the side of the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, thinking disorders, increased libido, collapse; – nervous system disorders: amnesia, impaired coordination, muscle hypertonus, meningitis, tremor; – from the side of the visual organ: visual impairment, visual disturbances, eye pain, blepharitis;- from the cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular extrasystole, postural hypotension;- from the gastrointestinal tract: hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, glossitis, hiccups, discoloration of the tongue; – from the urinary system: dysuria, kidney pain, nephritis, nocturia, polyuria, urinary incontinence, urinary tract infection;- from the genitourinary system: breast pain, menstrual disorders, metrorrhagia, erectile dysfunction; – other reactions: unpleasant body odor, chills. The following adverse reactions were not reported as undesirable events after the use of cefditoren, but they are characteristic of cephalosporins:- allergic reactions: allergic reactions, including Stevens-Johnson syndrome, erythema multiforme, serum sickness, toxic epidermal necrolysis;- from the urinary system: impaired renal function, toxic nephropathy;- from the liver and biliary tract: cholestasis;- from the side of hematopoietic organs: aplastic anemia.

Interaction

Concomitant use of cefditorene pivoxil and antacids containing magnesium and aluminum hydroxide after meals reduces the Cmax and AUC of cefditorene by 14% and 11%, respectively. Although the clinical significance of this fact is unknown, it is recommended that the period between use of antacids and cefditoren pivoxil should be 2 hours.

Probenecid concomitant use of probenecid and cefditoren pivoxil reduces renal excretion of the antibiotic, increasing Cmax by 49%, AUC by 122%, and increasing the half-life of cefditoren by 53%.

H2-histamine receptor blockers Simultaneous use of famotidine intravenously and cefditoren pivoxil orally leads to a decrease in Cmax and AUC by 27% and 22%, respectively. Therefore, concomitant use of cefditoren pivoxil and H2-histamine receptor blockers is not recommended.

How to take, course of use and dosage

Inside. Tablets should be swallowed whole, washed down with a sufficient amount of water, preferably after a meal. The recommended dose depends on the severity of the infection, the patient’s initial condition, and potential pathogens.

Adults and children over 12 years of age

• Acute pharyngotonsillitis, 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, a dose of 400 mg is recommended every 12 hours for 14 days.

Elderly patients For elderly patients, except in cases of severe hepatic and/or renal impairment, no dose adjustment is required.

Renal impairment No dose adjustment is required in patients with mild renal impairment. In patients with moderate renal insufficiency (creatinine clearance 30-50 ml / min), the recommended dose should not exceed 200 mg twice daily. In patients with severe renal insufficiency (creatinine clearance less than 30 ml/min), the maximum daily dose should not exceed 200 mg. In patients undergoing hemodialysis, the recommended dose has not been established.

Hepatic impairment In patients with mild or moderate hepatic impairment, no dose adjustment is required (Child-Pugh Class A or B). In severe hepatic insufficiency (Child-Pugh class C), no data have been obtained that allow the recommended dose to be prescribed.

Overdose

Symptoms If the drug is overdosed, the patient may experience symptoms such as nausea, vomiting, and diarrhea.

Treatment If the clinical picture of drug overdose develops, symptomatic therapy is indicated.

Special instructions

If a hypersensitivity reaction develops, treatment should be discontinued, and the patient should be prescribed the necessary treatment.

As with other broad-spectrum antibiotics, treatment with cefditoren can lead to an overgrowth of resistant microflora. For this reason, monitoring of patients receiving this drug is recommended, especially in the case of long-term treatment.

In patients with severe renal insufficiency, periodic monitoring of renal function is recommended.

During the course of treatment with cephalosporins, prothrombin activity may decrease. For this reason, prothrombin time monitoring is necessary in patients at risk (with renal or hepatic insufficiency or in the case of previous anticoagulant use). The development of diarrhea during or after treatment, especially with its severe, persistent nature and the presence of blood impurities, may indicate pseudomembranous colitis. In mild cases of diarrhea, only discontinuation of the drug is sufficient, in more severe cases, therapy with antibiotics to which Clostridium difficile is sensitive is indicated, and the appointment of infusion therapy. Like other cephalosporins, cefditoren can lead to a false positive result of the direct Coombs test, the detection of glucose in the urine using a copper reduction test, but not using an enzyme test. Due to the high risk of a false negative result of the ferricyanide test for determining glucose in plasma or blood, it is recommended that patients use glucose oxidase or glucose hexokinase methods to determine the concentration of glucose in blood or plasma during treatment with cefditoren. When cephalosporins are combined with aminoglycosides and/or loop diuretics, especially in patients with impaired renal function, the risk of nephrotoxicity may increase. Spectracef contains approximately 13.1 mg (for 200 mg tablets) and 26.2 mg (for 400 mg tablets) of sodium in each dose, which should be taken into account when prescribing the drug to patients on a low-sodium diet.

Influence on the ability to drive a car and/or other mechanisms

Cefditoren pivoxil has not been reported to affect the ability to drive a car and/or other mechanisms. At the same time, it should be borne in mind that taking the drug Spektracef may be accompanied by such undesirable phenomena as vomiting, headache.

Storage conditions

In the original packaging at a temperature not exceeding 30°C. Keep out of reach of children.

Active ingredient

Cefditoren

Conditions of release from pharmacies

By prescription

Dosage form

Tablets