Expiration date: 11/2025

Form of issue, composition and packaging

Tablets, film-coated white color, elliptical, marked "TFM" blue on one side; in cross section, a core of light yellow color.

1 tablet contains:

cefditoren 200 mg

(in the form of cefditoren pivoxil) 

Excipients: mannitol as needed (approximately 35 mg), sodium Caseinate 100 mg, croscarmellose sodium 150 mg, sodium tripolyphosphate 4 mg, magnesium stearate 5 mg, white Opadray 35 mg (gipromelloza 21.9 mg, titanium dioxide 10.9 mg, macrogol 400 2.2 mg), Carnauba wax 0.06 mg, ink Opacode blue (shellac in IMS 74 OP 50.41%, n-butanol 24.35%, aluminium Lacquer based on diamond blue FCF dye 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%, ammonia solution concentrated 1.94%).

10 PCs. - blisters of PVC/aluminium foil (2) - packs of cardboard.

Clinical and pharmacological group: cephalosporin III generation

Pharmaco-therapeutic group: Antibiotic, cephalosporin

Indications

Treatment of infections caused by microorganisms sensitive to cefditoren:

• upper respiratory 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 furunculus.
  

Dosage regimen

Inside.

The tablets should be swallowed whole, drinking enough water, preferably after meals.

The recommended dose depends on the severity of the infection, the initial condition of the patient and potential causative agents of the infection.

Adults and children over 12 years old

Pharyngotonsillitis acute, acute sinusitis, and uncomplicated infections of 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 h for 14 days.

Elderly patients

For elderly patients, except in cases of severe hepatic and/or renal impairment, dose adjustment is not required.

Impaired renal function

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 should not exceed 200 mg twice a day. In patients with severe renal insufficiency (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.

Impairment of liver function

In patients with mild or moderate hepatic impairment dose adjustment is not required (classes a or B child-Pugh). In severe hepatic insufficiency (class C by child-Pugh), the data to assign the recommended dose have not been obtained.

Side effect

Adverse events, presented below, are listed depending on the anatomical and physiological classification and frequency of occurrence. Frequency of occurrence is determined 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 isolated cases).

From the metabolic and nutritional: rarely - anorexia.

From the nervous system: often - headache; rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.

From the body of the vision: rarely - photosensitivity.

From 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, dyspepsia; rarely - constipation, flatulence, vomiting, oral candidiasis, belching, pseudomembranous colitis, dry mouth, perversion of taste; very rarely - aphthous stomatitis.

From the liver and biliary tract: rarely - impaired liver function.

From the skin and subcutaneous fat: rarely: rash, itching, urticaria.

From the musculoskeletal system and connective tissue: very rarely-myalgia.

With the genitourinary system: frequent: Candida vaginitis; rare - vaginitis, leukorrhea.

Other: rarely-fever, asthenia, generalized pain syndrome, increased sweating.

From the laboratory parameters: sometimes-leukopenia, thrombocytosis, increased alanine aminotransferase (ALT); rarely - increased blood clotting time, hyperglycemia, hypokalemia, bilirubinemia, increased concentrations of aspartate aminotransferase (ACT), alkaline phosphatase, albuminuria.

In addition, isolated cases of eosinophilia, thrombocytopenia, reduction of thromboplastin time, thrombocytopenia, increase in the concentration of lactate dehydrogenase (LDH), hypoproteinemia and increase in the concentration of creatinine are described.

There have also been isolated reports of the following adverse events.

From the hematopoietic organs: hemolytic anemia, lymphadenopathy.

From the side of water-electrolyte metabolism: dehydration.

From the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, thinking disorder, libido enhancement, collapse.

From the nervous system: amnesia, impaired coordination, muscle hypertonicity, meningitis, tremor.

On the part of the organ of vision: impaired vision, disorders of the organ of vision, eye pain, blepharitis.

From the side of cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular extrasystoles, postural hypotension.

From the gastrointestinal tract: hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, glossitis, hiccups, changing the color of the tongue.

From the urinary system: dysuria, pain in region of kidneys, nephritis, nocturia, polyuria, urinary incontinence, urinary tract infection.

With the genitourinary system: pain in the breast, menstrual disorders, metrorrhagia, erectile dysfunction.

Other: unpleasant smell of the body, chills.

The following adverse reactions were not recorded as adverse events after the use of cefditoren, but they are characteristic of cephalosporins

Allergic reactions: allergic reactions including Stevens-Johnson syndrome, multiform exudative erythema, serum sickness, toxic epidermal necrolysis.

From the urinary system: impaired renal function, toxic nephropathy.

From the liver and biliary tract: cholestasis.

The bodies of the blood: aplastic anemia.

Contraindications to use

• hypersensitivity to cefditoren, other cephalosporins or any other component of the drug.
  
• severe allergic reactions to penicillins and other beta-lactam antibacterial drugs;
  
• liver failure in child-Pugh class C;
  
• patients on hemodialysis;
  
• hypersensitivity reactions to casein protein in the anamnesis;
  
• primary carnitine deficiency;
  
• children under 12 years old;
  
• simultaneous use of cefditoren pivoxil and histamine H2 receptor blockers.
  

With caution in: patients with hypersensitivity to other beta-lactam antibiotics because of the possibility of development of cross-allergic reactions; concurrent use with aminoglycosides and diuretics (furosemide); patients with gastrointestinal diseases (including colitis in anamnesis).

Application for pregnancy and breastfeeding

Pregnancy

Clinical data on the use of cefditoren pivoxil in pregnant women have not been obtained. Although studies in animals showed no embryotoxic or teratogenic effects of the drug, Spectracef should not be used during pregnancy except in those cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Lactation

Data on the penetration of cefditoren in breast milk is not enough. Therefore, the use of the drug, Spectracef breast-feeding should be discontinued.

Application for violations of liver function

In patients with mild or moderate hepatic impairment dose adjustment is not required (classes a or B child-Pugh). In severe hepatic insufficiency (class C by child-Pugh), the data to assign the recommended dose have not been obtained.

Application for violations of renal function

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 should not exceed 200 mg twice a day. In patients with severe renal insufficiency (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.

Use in children

Contraindicated for children under 12 years.

Application in elderly patients

For elderly patients, except in cases of severe hepatic and/or renal impairment, dose adjustment is not required.

Special instruction

With the development of hypersensitivity reaction, 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 excessive growth of resistant microflora. For this reason, it is recommended to monitor patients receiving this drug, especially in the case of long-term treatment.

In patients with severe renal insufficiency, it is recommended to periodically monitor kidney function.

During the course of treatment with cephalosporins may reduce the activity of prothrombin. For this reason, patients at risk (with renal or hepatic insufficiency or in the case of previous prescription of anticoagulants) need control prothrombin time.

The development of diarrhea during or after treatment, especially with its heavy, persistent nature and the presence of blood impurities, may indicate pseudomembranous colitis. In mild cases, diarrhea is enough only to cancel the drug, in the more severe therapy with antibiotics, which shows sensitivity to Clostridium difficult, and the appointment of infusion therapy.

Like other cephalosporins, cefditoren can lead to a false positive result of a direct Coombs test, detecting glucose in the urine using a copper recovery test, but not by an enzyme test. Because of the high risk of false-negative test result ferricyanide determination of glucose in plasma or blood, it is recommended that the treatment cefditoren to determine the concentration of glucose in the blood or plasma of the patients used glucotoxicity or glucotoxicity methods.

When combined with cephalosporins and aminoglycosides and / or loop diuretics, especially in patients with impaired renal function, there may be an increased risk of nephrotoxicity.

Spectracef contains approximately 13.1 mg (for tablets a dosage of 200 mg) and 26.2 mg (for tablets a dosage of 400 mg) of sodium in each dose that must be considered when prescribing the drug to patients on a diet low in sodium.

Influence on the ability to drive vehicles and management mechanisms

It was not reported about the influence of cefditoren pivoxil on the ability to drive and/or other mechanisms. At the same time it should be noted that the drug, Spectracef may be accompanied by such adverse events as vomiting, headache.

Overdose

Symptoms

With an overdose of the drug, the patient may experience symptoms such as nausea, vomiting, diarrhea.

Treatment

When developing a clinical picture of drug overdose, symptomatic therapy is indicated.

Drug interaction

Antacids

The combined use of cefditoren pivoxil and antacids containing magnesium hydroxide, aluminum, after eating reduces the performance of Cmax and AUC cefditoren by 14% and 11%, respectively. Although the clinical significance of this fact is unknown, it is recommended that the period between the introduction of antacids and cefditoren pivoxil was 2 hours.

Probenecid

The combined use of probenecid and cefditoren pivoxil reduces the excretion of antibiotic kidneys, increasing The Cmax by 49%, AUC by 122% and increasing the half-life of cefditoren by 53%.

H2-histamine receptor blockers

Simultaneous administration of famotidine intravenously and cefditoren pivoxil inside leads to a decrease in Cmax and AUC by 27% and 22% respectively. Thus, simultaneous use of cefditoren pivoxil and histamine H2 receptor blockers is not recommended.