Spectracef (cefditoren) coated tablets 200 mg. №20

Description

Spectracef (cefditoren) coated tablets 200 mg. №20

Composition

active substance: cefditoren;

1 tablet contains 245.1 mg of cefditorene pivoxil, which is equivalent to 200 mg of cefditoren;

excipients:

tablet core: mannitol (E 421), sodium caseinate, croscarmellose sodium, sodium tripolyphosphate, magnesium stearate;

tablet shell: Opadry Y-1-7000 (contains hypromellose, titanium dioxide (E 171), macrogol 400), carnauba wax;

inks for labeling tablets: Opacode S-1-20986 blue inks (containing shellac, FD&C blue №1 / diamond blue FCF varnish (E 133), titanium dioxide (E 171), propylene glycol, concentrated ammonia solution).

Dosage form

Film-coated tablets.

Main physical and chemical properties: elliptical tablets, film-coated white, marked “TMF” with blue ink on one side.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Other beta-lactam antibiotics. Cephalosporins of the third generation.
ATC code J01D D16.

Pharmacological properties

This is a 1st generation antibiotic cephalosporin. Acts bactericidal (kills microbes), inhibiting the synthesis of bacterial cell walls.

Indications

Shown Spectracef for infectious processes caused by microorganisms sensitive to this antibiotic:

• with otorhinolaryngological infections (pharyngitis, otitis media, sinusitis, angina);
• with infection of the lower respiratory tract (bronchitis, pneumonia, empyema, lung abscess);
• with infections of the genitourinary system (pyelonephritis, cystitis, urethritis, prostatitis);
• with infections of the skin, soft tissues (furunculosis, abscess, pyoderma, phlegmon);
• with infections of bones, joints (arthritis, osteomyelitis).

Contraindications

The drug Spectracef is not used:

• with allergies to cephalosporins, as well as penicillins, carbapenems;
• with intolerance to active / auxiliary components;
• with primary carnitine deficiency.

Application during pregnancy and lactation

It is allowed to use the drug Spectracef during pregnancy if prescribed by a doctor.
During treatment, breastfeeding is stopped.

Method of administration and dosage

Spectracef is administered orally (inside) immediately after a meal.
The dosage regimen is set by the doctor individually, taking into account the localization of the infection, the severity of the course, the data of bacteriological studies, the sensitivity of the pathogen.
The standard adult dose is 200-400 mg every 12 hours. The standard course is 7-14 days.

Overdose

Symptoms: nausea, diarrhea, vomiting, neuromuscular irritability, seizures.
Gastric lavage, the use of sorbents, breathing support, symptomatic therapy are recommended.

Side effects:

• Digestive disorders: decreased appetite, anorexia, nausea, diarrhea, vomiting, abdominal cramps / pains, dry mouth, flatulence, dyspepsia, gastritis, colitis, pseudomembranous enterocolitis, dysbiosis, intestinal candidiasis, candidal stomatitis, anal itching.
• Hepatobiliary disorders: a transient increase in the activity of liver transaminases (AST, ALT), alkaline phosphatase, bilirubin in the blood, cholestatic jaundice, toxic hepatitis.
• Hematological disorders: leukopenia, thrombocytopenia / thrombocytosis, neutropenia, agranulocytosis, eosinophilia, lymphopenia, increased prothrombin time, hemolytic anemia, pancytopenia, aplastic anemia, hemorrhages.
• Immune disorders: allergic reactions, incl. angioedema, anaphylactic shock (shortness of breath, bronchospasm, drop in blood pressure, loss of consciousness), drug fever.
• Dermatological disorders: erythematous rash, dermatitis, pruritus, urticaria, skin flushing, edema (face, neck, hands, feet), Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis.
• Neurological disorders: dizziness, headache, weakness, agitation, hallucinations, confusion, convulsive seizures are possible.
• Genitourinary disorders: renal dysfunction, toxic nephropathy, interstitial nephritis, pyuria, reversible fever, hypercreatininemia, eosinophiluria, acute tubular necrosis.
• Musculoskeletal disorders: joint damage, arthritis, arthralgia.
• Reproductive disorders: genital candidiasis, vaginitis, genital itching, vaginal discharge.
• Others: fatigue, false positive Coombs’ test, urine sugar test.