Spectracef pills 200mg, 20pcs

Composition

In 1 tablet:

– cefditoren-200 mg

Auxiliary substances:  

– 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 (21.9 mg hypromellose, titanium dioxide 10.9 mg, macrogol-400 2.2 mg);

Wax Carnauba 0.06 mg;

– Ink Opacode blue (shellac IN IMS 74 OP 50.41%, N-butanol 24.35%, Aluminum varnish based

on diamond blue dye FCF 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%,

concentrated ammonia solution 1.94%).

Pharmacological action

of Cefditoren pivoxil, a semi-synthetic beta-lactam antibiotic, is a prodrug of cefditoren (third-generation cephalosporin).

The mechanism of action of the drug is associated with inhibition of bacterial wall synthesis due to its affinity for penicillin-binding proteins.

Indications

Treatment of infections caused by cefditoren-sensitive microorganisms:

– 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 fat: phlegmon, infected skin wounds, abscess, folliculitis, impetigo and furunculosis.

Use during pregnancy and lactation

Pregnancy

Clinical data on the use of cefditoren pivoxil in pregnant women have not been obtained. Although animal studies have not shown any embryotoxic or teratogenic effects of the drug, Spektracef should not be used during pregnancy unless the expected benefit to the mother exceeds the potential risk to the fetus.

Lactation period

There are insufficient data on the penetration of cefditorene into breast milk. Therefore, breast-feeding should be discontinued when using Spektracef.

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 class C child-Pugh;

— patients on hemodialysis;

— hypersensitivity reactions to the protein casein in history;

primary carnitine deficiency;

— children’s age till 12 years;

— simultaneous use of cefditoren pivoxil and histamine H 2-receptors.

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

Side effects

The adverse events presented below are listed according to the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is defined as follows: very common (≥1/10), common (≥1/100 and < 1/10), uncommon (≥1/1000 and < 1/100), rare (≥1/10 000 and < 1/1 000), very rare (

From the side of metabolism and nutrition: rarely – anorexia.

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

From the side of the visual organ:  very rarely – photosensitivity.

On the part of ENT organs:  very rarely – pharyngitis, rhinitis, sinusitis, tinnitus.

Respiratory, thoracic and mediastinaldisorders: very rare – bronchospasm.

From the gastrointestinal tract: very often-diarrhea; often-nausea, abdominal pain, dyspepsia; rarely-constipation, flatulence, vomiting, oral candidiasis, belching, pseudomembranous colitis, dry mouth, taste distortion; very rarely-aphthous stomatitis.

Liver and biliary tract disorders:  rarely-impaired liver function.

Skin and subcutaneous fat disorders: rare: rash, pruritus, urticaria.

Musculoskeletal and connective tissue disorders:  very rarely – myalgia.

From the genitourinary system: often: candida vaginitis; rarely-vaginitis, leucorrhoea.

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

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

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

The following adverse events were also reported separately.

From the side of hematopoietic organs: hemolytic anemia, lymphadenopathy.

From the side of water-electrolyte metabolism: dehydration.

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

Nervous system disorders:  amnesia, coordination disorders, muscle hypertonus, meningitis, tremor.

From the side of the visual organ: visual impairment, visual disturbances, eye pain, blepharitis.

From the cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular extrasystole, postural hypotension.

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

From the urinary system: dysuria, kidney pain, nephritis, nocturia, polyuria, urinary incontinence, urinary tract infection.

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

Other services: unpleasant body odor, chills.

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

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

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

Liver and biliary tract disorders: cholestasis.

From the side of hematopoietic organs: aplastic anemia.

Interaction

Antacids

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

Probenecid

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

H2-histamine receptor blockers

Concomitant use of famotidine intravenously and cefditoren pivoxil orally resulted in a decrease in Cmax and AUC by 27% and 22%, respectively. Therefore, concomitant use of cefditoren pivoxil and histamine H2-receptor blockers is not recommended.

How to take, course of use and dosage

Inside.

Tablets should be swallowed whole, washed down with a sufficient amount of water, preferably after a meal.

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

Adults and children over 12 years of age

Acute pharyngotonsillitis, acute sinusitis, and uncomplicated skin and subcutaneous fat infections: 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 impairment, no dose adjustment is required.

Impaired renal function

No dose adjustment is required in patients with mild renal impairment. In patients with moderate renal insufficiency (creatinine clearance 30-50 ml / min), the recommended dose should not exceed 200 mg twice daily. In patients with severe renal insufficiency (creatinine clearance less than 30 ml/min), the maximum daily dose should not exceed 200 mg. In patients undergoing hemodialysis, the recommended dose has not been established.

Impaired liver function

In patients with mild to moderate hepatic impairment, no dose adjustment is required (Child-Pugh Class A or B). In severe hepatic insufficiency (Child-Pugh class C), no data have been obtained that allow the recommended dose to be prescribed.

Overdose

Symptoms

If the drug is overdosed, the patient may experience symptoms such as nausea, vomiting, and diarrhea.

Treatment

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

Special instructions

If a hypersensitivity reaction develops, 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 an overgrowth of resistant microflora. For this reason, monitoring of patients receiving this drug is recommended, especially in the case of long-term treatment.

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

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

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, only discontinuation of the drug is sufficient, in more severe cases, therapy with antibiotics to which Clostridium difficile is sensitive is indicated, and the appointment of infusion therapy.

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

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

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

Influence on the ability to drive motor vehicles and manage mechanisms

Cefditoren pivoxil has not been reported to affect the ability to drive a car and/or other mechanisms. At the same time, it should be borne in mind that taking the drug Spektracef may be accompanied by such undesirable phenomena as vomiting, headache.

Storage conditions

 In a dark place, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Cefditoren

Conditions of release from pharmacies

By prescription

Dosage form

Tablets