Spectracef Table 200mg №20

Release form, composition and packaging

Film Coated Tablets white, elliptical, marked "TFM" blue on one side; in cross-section, the core is light yellow.

Excipients: mannitol as needed (approximately 35 mg), sodium caseinate 100 mg, croscarmellose sodium 150 mg, sodium tripolyphosphate 4 mg, Magnesium stearate 5 mg, Opadry white 35 mg (hypromellose 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%, Aluminum lacquer based on diamond blue dye FCF 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%, ammonia concentrated solution 1.94%).

Indications

Treatment of infections caused by microorganisms sensitive to cefditoren:

- 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 fatty tissue: phlegmon, infected skin wounds, abscess, folliculitis, impetigo and furunculosis.

Dosage and administration

Inside

Tablets should be swallowed whole, drinking plenty of water, preferably after a meal.

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

Adults and children over 12 years old

Acute pharyngonitis, 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, with the exception of cases of severe hepatic and / or renal dysfunction, dose adjustment is not required.

Renal dysfunction

In patients with mild renal impairment, dose adjustment is not required. In patients with moderately severe renal failure (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 has not been established.

Liver dysfunction

In patients with mild or moderate hepatic impairment, dose adjustment is not required (classes A or B by Child-Pugh). In severe hepatic impairment (Child-Pugh class C), no data are available for prescribing the recommended dose.

Adverse effects

The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence.The 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 individual cases).

Metabolism and nutrition: rarely anorexia.

Nervous system: often - headache; rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.

Special senses: very rarely - photosensitivity.

From the ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, tinnitus.

On the part of the respiratory system, organs of the 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, dryness of the oral mucosa, taste perversion; very rarely - aphthous stomatitis.

Liver and biliary tract: rarely - abnormal liver function.

On the part of the skin and subcutaneous fat: seldom: rash, itching, urticaria.

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

From the genitourinary system: often: candidal vaginitis; rarely - vaginitis, whiter.

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

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

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

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

From the side of blood-forming organs: hemolytic anemia, lymphadenopathy.

From the water and electrolyte exchange: dehydration.

From the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, thought disorder, increased libido, collapse.

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

Special senses: impaired vision, disorders of the organ of vision, pain in the eyes, blepharitis.

Cardiovascular: atrial fibrillation, heart failure, tachycardia, ventricular premature beats, postural hypotension.

From the gastrointestinal tract: hemorrhagic colitis, ulcerative colitis, Gastrointestinal bleeding, glossitis, hiccups, discoloration of the tongue.

Urogenital: dysuria, pain in the kidney area, nephritis, nocturia, polyuria, urinary incontinence, urinary tract infection.

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

Other: unpleasant body odor, chills.

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

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

Urogenital: renal failure, toxic nephropathy.

Liver and biliary tract: cholestasis.

From the side of blood-forming organs: aplastic anemia.

Contraindications

- 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 of class C on Child-Pugh;

- patients on hemodialysis;

- hypersensitivity reactions to protein casein in history;

- primary Carnitine deficiency;

- children's age up to 12 years;

- simultaneous use of cefditorene pivoxil and histamine H blockers₂-receptors.

WITH caution: patients with hypersensitivity to other beta-lactam antibiotics due to the possibility of cross-allergic reactions; simultaneous use with aminoglycosides and diuretics (furosemide); patients with pathology of the gastrointestinal tract (including history of colitis).

Use during pregnancy and lactation

Pregnancy

Clinical data on the use of cefditorene pivoxil in pregnant women have not been obtained. And although animal studies have not shown embryotoxic or teratogenic effects of the drug, Spectracene should not be used during pregnancy unless the expected benefit to the mother outweighs the potential risk to the fetus.

Lactation period

Data on the penetration of cefditoren in breast milk is not enough. Therefore, when using the drug Spectracef breastfeeding should be discontinued.

Application for violations of the liver

In patients with mild or moderate hepatic impairment, dose adjustment is not required (classes A or B by Child-Pugh). In severe hepatic impairment (Child-Pugh class C), no data are available for prescribing the recommended dose.

Application for violations of kidney function

In patients with mild renal impairment, dose adjustment is not required. In patients with moderately severe renal failure (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 has not been established.

Use in children

Contraindicated in children under 12 years.

Use in elderly patients

For elderly patients, with the exception of cases of severe hepatic and / or renal dysfunction, dose adjustment is not required.

special instructions

With the development of hypersensitivity reactions, treatment should be discontinued, and the patient should be prescribed the necessary treatment.

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

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

During the course of treatment with cephalosporins, prothrombin activity may decrease. For this reason, in patients at risk (with renal or hepatic insufficiency or in the case of prior administration of anticoagulants), monitoring of prothrombin time is necessary.

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, it is enough to discontinue the drug; in more severe cases, antibiotic therapy, to which Clostridium difficile is sensitive, and the appointment of infusion therapy is indicated.

Like other cephalosporins, cefditoren can lead to a false-positive result of a direct Coombs test, the detection of glucose in the urine using a copper recovery test, but not using an enzyme test. Due to the high risk of a false-negative result of the ferricyanide glucose test in plasma or blood, it is recommendedthat during treatment with cefditoren, glucose oxidase or glucose hexokinase methods were used to determine the concentration of glucose in the blood or plasma of patients.

The combination of cephalosporins with aminoglycosides and / or loop diuretics, especially in patients with impaired renal function, may increase the risk of nephrotoxicity.

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

Influence on ability to drive motor transport and control mechanisms

The effect of cefditorene pivoxil on the ability to drive and / or other mechanisms was not reported. At the same time, it should be borne in mind that taking the drug Spectracef may be accompanied by such undesirable phenomena as vomiting, headache.

Overdose

Symptoms

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

Treatment

With the development of a clinical picture of drug overdose, symptomatic therapy is indicated.

Drug interaction

Antacids

The combined use of cefditorene pivoxil and antacids containing magnesium hydroxide, aluminum, after a meal reduces the performance of C_max and AUC cefditoren at 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 cefditoren pivoxil be 2 hours.

Probenecid

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

Blockers H₂histamine receptors

The simultaneous introduction of Famotidine intravenously and cefditoren pivoxil inside leads to a decrease in C_max and AUC by 27% and 22%, respectively. Thus, the simultaneous use of cefditorene pivoxil and histamine H blockers₂-receptors are not recommended.

Pharmacy sales terms

On prescription.

Terms and conditions of storage

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