Spectracef® [Cefditoren]

Spectratef tablets are used for infections caused by microorganisms sensitive to the drug:

• acute tonsillopharyngitis;
• acute sinusitis;
• exacerbation of chronic bronchitis;
• community-acquired pneumonia of mild or moderate severity;
• uncomplicated infections of the skin and subcutaneous tissue, in particular phlegmon, infected wounds, abscesses, folliculitis, impetigo and furunculosis.

Structure

The active substance is cefditoren (one tablet contains 245.1 mg of cefditoren pivoxil, which is equivalent to 200 mg of cefditoren).

Excipients: tablet core (beckons (E 421), sodium caseinate, croscarmellose sodium, sodium tripolyphosphate, magnesium stearate), tablet shell (Opadry Y-1-700 (contains hypromellose, titanium dioxide (E 171), macrogol 400), wax carnauba), ink for marking tablets (Opacode S-1-20986 blue ink (containing shellac, FD & C blue No. 1 / diamond blue FCF varnish (E 133), titanium dioxide (E 171), propylene glycol, concentrated ammonia solution )).

Contraindications

• hypersensitivity to cefditoren, other cephalosporins or any other component of the drug;
• since the drug contains sodium caseinate, this should be considered in patients with hypersensitivity to casein;
• immediate hypersensitivity reactions and / or severe history of hypersensitivity to penicillins or other beta-lactam antibiotics;
• primary carnitine deficiency.

Mode of application

The tablets should be swallowed whole with a sufficient amount of water.

Tablets should be taken either with food or immediately after a meal.

Recommended doses depend on the severity of the infection, the patients condition and potential pathogens.

Doses for adults

In acute tonsillopharyngitis, 200 mg of cefditoren every 12 hours for 10 days.

In acute sinusitis - 200 mg of cefditoren every 12 hours for 10 days.

With exacerbation of chronic bronchitis - 200 mg of cefditoren every 12 hours for 5 days.

With community-acquired pneumonia:

• mild severity - 200 mg of cefditoren every 12 hours for 14 days;
• moderate severity - 400 mg of cefditorin every 12 hours for 14 days.

For uncomplicated infections of the skin and subcutaneous tissue, 200 mg of cefditoren every 12 hours for 10 days.

Dose adjustment for special patient groups

For elderly patients, with the exception of patients with severe impaired renal and / or liver function, dose adjustment is not required.

Patients with impaired renal function. For patients with mild renal impairment, dose adjustment is not required. For moderate renal impairment (creatinine clearance 30–50 ml / min), the dose should not exceed 200 mg of cefditoren every 12 hours. In severe renal impairment (creatinine clearance <30 ml / min), the recommended dose is 200 mg of cefditoren once a day. For patients on hemodialysis, the recommended dose has not yet been determined.

Patients with impaired liver function. For patients with mild or moderate hepatic impairment (Child-Pugh Class A and B), dose adjustment is not required. For patients with severely impaired liver function (Child-Pugh Class C), the recommended dose has not yet been determined.

Application features

Pregnant women

Insufficient data on the use of cefditoren pivoxil in pregnant women. Therefore, the drug is used by pregnant women only when the expected benefit to the mother outweighs the potential risk to the fetus.

There is insufficient data on the allocation of cefditorin with breast milk. Therefore, it is not recommended to appoint women who are breastfeeding.

Children

The safety and effectiveness of the use of the drug in children has not been established.

Drivers

The drug may slightly or moderately affect the ability to drive vehicles and other mechanisms, since cefditoren pivoxil can cause side effects such as dizziness and drowsiness.

Overdose

No cases of cefditoren overdose have been reported.

Symptoms of an overdose: with an overdose of other cephalosporins, cerebral irritation was noted, which led to convulsions.

Overdose treatment: gastric lavage, symptomatic and supportive therapy.

The patient should be under medical supervision.

Cefditoren pivoxil is partially excreted by hemodialysis.

Side effects

Most often, adverse reactions from the gastrointestinal tract were noted.

Storage conditions

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

Shelf life is 3 years.