Spectraceph, 400 mg 10 pcs

Treatment of infections caused by microorganisms sensitive to ceftiditorin:

– upper respiratory tract infections: acute tonsillopharyngitis, acute maxillary 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.

Indications

Treatment of infections caused by microorganisms sensitive to ceftiditorin:

– upper respiratory tract infections: acute tonsillopharyngitis, acute maxillary sinusitis;

– lower respiratory tract infections: exacerbation of chronic bronchitis, community-acquired pneumonia;

– uncomplicated skin and subcutaneous fatty tissue infections: phlegmon, infected skin wounds, abscess, folliculitis, impetigo and furunculosis.

Active ingredient

Composition

White film-coated tablets, elliptical, marked “TFM” blue on one side;

On the cross section the core is light yellow.

cefditorin 400 mg
(in the form of cefditorin pivoxil)

Auxiliary substances:

– Mannitol as needed (approximately 35 mg),

– Caseinate sodium 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 50.41%, N-butanol 24.35%, Aluminum dye-based varnish

Brilliant blue FCF 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%,

ammonia solution concentrated 1.94%).

How to take, the dosage

Ingestion.

The tablets should be swallowed whole with plenty of water, preferably after a meal.

The recommended dose depends on the severity of the infection, the patient’s baseline condition, and the potential pathogens.

Adults and children over 12 years of age

Acute pharyngotonsillitis, acute maxillary sinusitis and uncomplicated skin and subcutaneous fatty tissue infections: 200 mg every 12 hours for 10 days.

Exacerbation of chronic bronchitis: 200 mg every 12 hours for 5 days.

Inpatient pneumonia: 200 mg every 12 hours for 14 days. In severe cases, a dose of 400 mg every 12 h for 14 days is recommended.

Patients in the elderly

In elderly patients, except in cases of severe hepatic and/or renal dysfunction, no dose adjustment is required.

Dose adjustment is not required in patients with mild renal impairment. In patients with moderate renal impairment (creatinine clearance 30-50 ml/min) the recommended dose should not exceed 200 mg twice daily. In patients with severe renal failure (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.

Hepatic impairment

In patients with mild to moderate hepatic impairment, no dose adjustment is required (Child-Pugh grades A or B). In severe hepatic impairment (Child-Pugh class C), no data are available to allow prescribing the recommended dose.

Interaction

Antacids

The co-administration of ceftiditorin pixil and antacids containing magnesium hydroxide, aluminum, after meals reduces the Cmax and AUC of ceftiditorin by 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 ceftiditorin pixil should be 2 h.

Probenecid

The co-administration of probenecid and ceftiditoren pivoxil decreases renal excretion of the antibiotic, increasing Cmax by 49%, AUC by 122%, and increasing cefditoren half-life by 53%.

H2-histamine receptor blockers

The simultaneous administration of intravenous famotidine and oral cefditorin pivoxil decreases Cmax and AUC by 27% and 22%, respectively. Thus, concomitant use of cefditorene pivaxil and histamine H2-receptor blockers is not recommended.

Special Instructions

If a hypersensitivity reaction develops, treatment should be discontinued and the patient should be given appropriate treatment.

As with other broad-spectrum antibiotics, treatment with ceftiditorin may lead to an overgrowth of resistant microflora. For this reason, monitoring of patients receiving this medication is recommended, especially for long-term treatment.

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

Prothrombin activity may decrease during treatment with cephalosporins. For this reason in patients from risk group (with renal or hepatic insufficiency or in case of previous anticoagulant treatment) it is necessary to control prothrombin time.

Diarrhea during or after treatment, especially with its severe, persistent character and the presence of blood admixture, may indicate pseudomembranous colitis. In mild cases of diarrhea, withdrawal of the drug is sufficient; in severe cases, therapy with antibiotics to which Clostridium difficile shows sensitivity and administration of infusion therapy are indicated.

Like other cephalosporins, cefditorin can lead to false-positive results of direct Coombs test, detection of glucose in urine by copper recovery test, but not by enzyme test. Because of the high risk of false-negative results of the ferricyanide plasma or blood glucose test, it is recommended that patients be treated with glucose oxidase or glucose hexokinase methods to determine glucose concentrations in blood or plasma during cefditorin treatment.

When combining cephalosporins with aminoglycosides and/or loop diuretics, especially in patients with impaired renal function, an increased risk of nephrotoxicity is possible.

The Spectracef contains approximately 13.1 mg (for 200 mg tablets) and 26.2 mg (for 400 mg tablets) of sodium per dose, which should be considered when prescribing the drug in patients on a low-sodium diet.

Influence on driving and operating machinery

There have been no reported effects of cefditorin pixil on driving and/or other machinery. At the same time, it should be taken into account that administration of Spectracef may be accompanied by such adverse events as vomiting, headache.

Contraindications

– hypersensitivity to cefditorene, other cephalosporins or any other component of the drug.

– severe allergic reactions to penicillins and other beta-lactam antibacterials;

– Child-Pugh class C hepatic impairment;

– patients on hemodialysis;

– history of hypersensitivity reactions to casein protein;

– primary carnitine deficiency;

– children under 12 years of age;

– concurrent use of cefditorin pivoxil and histamine H2-receptor blockers.

With cautiousness: patients with hypersensitivity to other beta-lactam antibiotics because of the possibility of cross-allergic reactions; simultaneous use with aminoglycosides and diuretics (furosemide); patients with GI pathology (including a history of colitis).

Side effects

The undesired phenomena presented below are listed according to anatomico-physiological classification and frequency of occurrence. The frequency is defined as follows: very common (≥1/10), common (≥1/100 and < 1/10), infrequent (≥1/1000 and < 1/100), rare (≥1/10 000 and < 1/1 000), very rare (< 1/10 000, including individual cases).

Metabolism and nutrition: rarely – anorexia.

Nervous system disorders:often – headache; rarely – nervousness, dizziness, insomnia, somnolence, sleep disorders.

An organ of vision:very rarely – photosensitivity.

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

As to the respiratory system,organs of the chest and mediastinum: very rarely – bronchospasm.

From the gastrointestinal tract: very common – diarrhea; common – nausea, abdominal pain, dyspepsia; rare – constipation, flatulence, vomiting, oral candidiasis, belching, pseudomembranous colitis, dry oral mucosa, perversion of taste; very rare – aphthous stomatitis.

Hepatic and biliary tract disorders: frequently – liver function failure.

Skin and subcutaneous fat: rarely: rash, itching, urticaria.

Musculoskeletal and connective tissue disorders: very rarely – myalgia.

In the urinary tract:often: candidal vaginitis; rarely – vaginitis, perspiration.

Others: rarely: fever, asthenia, generalized pain syndrome, increased sweating.

From laboratory parameters: sometimes – leukopenia, thrombocytosis, increased concentration of alanine aminotransferase (ALT); rarely – increased clotting time, hyperglycemia, hypokalemia, bilirubinemia, increased concentration of aspartataminotransferase (ACT), alkaline phosphatase, albuminuria.

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

on the organs of hematopoiesis:hemolytic anemia, lymphadenopathy.

On the side of water-electrolyte metabolism:dehydration.

Psychiatric side:dementia, depersonalization, emotional lability, euphoria, hallucinations, thought disorder, increased libido, collapse.

Nervous system disorders: amnesia, impaired coordination, muscle hypertonicity, meningitis, tremor.

Visual organ:weakness of vision, visual disturbances, pain in the eyes, blepharitis.

Cardiovascular aspects:atrial fibrillation, heart failure, tachycardia, ventricular extrasystole, postural hypotension.

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

Uses of the urinary system:dysuria, renal pain, nephritis, nycturia, polyuria, urinary incontinence, urinary tract infection.

Urogenital system disorders:pain in the breast area, menstrual cycle disorders, metrorrhagia, erectile dysfunction.

Others:unpleasant body odor, chills.

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

Urinary system disorders:renal dysfunction, toxic nephropathy.

In the liver and biliary tract:cholestasis.

Hematopoietic organs: aplastic anemia.

Overdose

Symptoms

In case of overdose of the drug, the patient may have such symptoms as: nausea, vomiting, diarrhea.

Treatment

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

Pregnancy use

Pregnancy

There are no clinical data on the use of cefditorin pivoxil in pregnant women. And although animal studies have shown no embryotoxic or teratogenic effects of the drug, Spectracef should not be used during pregnancy unless the expected benefit to the mother exceeds the potential risk to the fetus.

Lactation period

There is insufficient data on cefditorin penetration into breast milk. Therefore, breastfeeding should be discontinued when using Spectraceph.