Spectraceph
Spectracef: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Spectracef
ATX code: J01DD16
Active ingredient: cefditoren (cefditoren)
Producer: Tedec-Meiji Farma (Spain)
Description and photo updated: 22.11.2018
Prices in pharmacies: from 849 rubles.
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Spectracef is an antibacterial drug, cephalosporin.
Release form and composition
Spectracef is available in the form of film-coated tablets: elliptical, white, blue “TFM” inscription on one side, light yellow core (200 mg each: 10 pcs. In blisters, in a cardboard box 2 or 50 blisters; 400 mg each: 5 pcs. in blisters, in a cardboard box 2 or 100 blisters; 10 pcs. in blisters, in a cardboard box 2 or 50 blisters).
1 tablet contains:
- active substance: cefditoren (in the form of cefditoren pivoxil) - 200 or 400 mg;
- auxiliary components: croscarmellose sodium, mannitol, sodium tripolyphosphate, sodium caseinate, carnauba wax, magnesium stearate, Opadrai white (titanium dioxide, hypromellose, macrogol-400), ink - Opakod blue (shellac IN IMS 74 OP, propylene glycol, N-butanol, titanium dioxide, aluminum varnish based on brilliant blue dye FCF, ammonia concentrated solution, isopropanol).
Pharmacological properties
Pharmacodynamics
Spectracef is an antibiotic, belongs to the group of third generation cephalosporins. Its active ingredient - cefditoren pivoxil - is a semi-synthetic beta-lactam antibiotic, a prodrug of cefditoren. The action of the drug is due to the affinity of cefditoren with penicillin-binding proteins, which allows it to inhibit the synthesis of the bacterial wall.
The pharmacodynamic feature of Spectracef is its ability (when administered at a dose of 200 mg with an interval of 12 hours) for 6 hours to maintain a plasma concentration level that exceeds the minimum inhibitory concentration (MIC) in relation to 90% of microorganisms for Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes strains of Streptococcus pneumoniae, Haemophilus parainfluenzae, sensitive to penicillin. The use of Spectracef at a dose of 400 mg 2 times a day allows maintaining the level of its concentration exceeding the IPC for more than 6 hours. This exceeds the MIC for 50% of the microorganisms resistant to penicillin Streptococcus pneumoniae.
Resistance to cefditoren in Streptococcus viridans and Streptococcus pneumoniae can be caused by a change in the penicillin-binding protein, in Staphylococcus speciales (spp.) - by the appearance of an additional (PBP2a) penicillin-binding protein. Most of the most common plasmid and chromosomal beta-lactamases of gram-negative bacteria are resistant to the drug.
Cross-resistance between Spectracef and antibiotics of other groups was not observed. But the possible presence of some similar mechanisms of action determines a certain degree of drug resistance to all antibiotics.
The MIC for microorganisms susceptible to cefditoren is recommended to be maintained at a level of up to 0.5 μg / ml, for microorganisms with intermediate sensitivity - from 0.5 to 2 μg / ml, for resistant microorganisms - 2 μg / ml and higher.
Due to the prevalence of acquired resistance in individual pathogens, when prescribing Spectracef, it is advisable to obtain information about the sensitivity of the infection in a particular region, especially when treating a severe infectious disease.
With a 90% probability, the following types of microorganisms are usually susceptible to cefditoren:
- aerobic gram-positive: Streptococci (group C and G), methicillin-sensitive strains of Streptococcus agalactiae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae;
- aerobic gram-negative: Moraxella catarrhalis, Haemophilus influenzae;
- anaerobic: Peptostreptococcus spp., Clostridium perfringens.
Microorganisms resistant to cefditoren:
- aerobic gram-positive: Enterococcus spp., methicillin-resistant strains of Staphylococcus aureus;
- aerobic gram-negative: Pseudomonas aeruginosa, Acinetobacter baumannii;
- anaerobic microorganisms: Clostridium difficile, Bacteroides fragilis;
- others: Mycoplasma spp., Chlamydia spp., Legionella spp.
Gram-negative microorganisms containing chromosomal beta-lactamases (including Serratia marcescens, Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii, Morganella morganii), despite their sensitivity to cefditoren in vitro, should be classified as resistant infections.
Pharmacokinetics
After taking Spectracef orally in the gastrointestinal tract, cefditoren pivoxil is absorbed. Under the influence of esterases, it is hydrolyzed to cefditoren. The maximum concentration (Cmax) of cefditoren in blood plasma is reached after about 2.5 hours. Against the background of taking it at a dose of 200 mg after meals, it is 0.0026 mg / ml, at a dose of 400 mg - 0.0041 mg / ml. Compared with intravenous administration, the absolute bioavailability of cefditoren when taken orally is 15–20%.
The presence of food in the gastrointestinal tract accelerates the absorption of cefditoren pivoxil and increases Cmax by 50% and AUC (total concentration of the drug in blood plasma over a certain period of time) by 70%.
Plasma protein binding - 88%.
There is no accumulation of the drug.
The volume of distribution is within 40–65 liters.
Penetrates into the mucous membrane and bronchial secretions, after a single dose of 400 mg, the concentration of cefditoren corresponds to 60 and 20% of its concentration in blood plasma. The concentration of the antibiotic in the interstitial fluid reaches 40% after 8 hours, and after 12 hours - 56% of the plasma AUC.
The half-life (T1 / 2) is approximately 1-1.5 hours. Total clearance is about 25-30 l / h, renal clearance is up to 80-90 ml / min.
Part of cefditoren is converted to inactive metabolites.
It is excreted through the kidneys in the form of pivaloylcarnitine conjugate, up to 18% of the dose taken - unchanged. The part of the drug that has not been absorbed is excreted through the intestines.
The pharmacokinetics of cefditoren pivoxil does not change significantly depending on the gender of the patient.
Elderly patients do not need dose adjustment, except for those with severe renal and / or hepatic impairment.
When conducting studies, the value of the AUC of cefditoren in patients with impaired renal function with repeated administration of tablets at a dose of 400 mg increases as the degree of impairment worsens. Changes in pharmacokinetic parameters with mild renal impairment are not considered clinically significant. When determining the dose for patients with moderate and severe renal failure, it should be borne in mind that there has been an increase in the AUC indicator approximately 3 times. For patients on hemodialysis, the data obtained do not allow recommending the use of any doses of Spectracef.
When conducting a study on the effect of liver dysfunctions, it was found that with mild and moderate severity (classes A, B according to the Child-Pugh classification), the pharmacokinetic parameters of cefditoren pivoxil (at a dose of 400 mg) increase slightly. At the same time, a slight increase in the dose of the drug excreted by the kidneys was noted. There are no data on the effect of the drug in severe hepatic impairment.
Indications for use
According to the instructions, Spectracef is indicated for the treatment of infectious diseases caused by microorganisms that are sensitive to it:
- acute sinusitis, acute tonsillopharyngitis;
- community-acquired pneumonia, exacerbation of chronic bronchitis;
- uncomplicated forms of infected skin wounds, folliculitis, phlegmon, impetigo, furunculosis, abscess.
Contraindications
- severe allergic reactions to beta-lactam antibacterial agents, including penicillins;
- being on hemodialysis;
- Child-Pugh class C liver failure;
- primary carnitine deficiency;
- a history of casein protein hypersensitivity;
- simultaneous use with blockers of histamine H 2 -receptors;
- period of pregnancy;
- breast-feeding;
- age up to 12 years;
- hypersensitivity to cephalosporins or drug components.
With caution, Spectracef should be prescribed for hypersensitivity to other beta-lactam antibiotics, diseases of the gastrointestinal tract (including a history of colitis), concomitant therapy with diuretics (furosemide) and aminoglycosides.
During pregnancy, in exceptional cases, Spectracef may be prescribed if the expected therapeutic effect for the mother exceeds the potential threat to the fetus.
Instructions for the use of Spectracef: method and dosage
Spectracef tablets are taken orally, after a meal, swallowing whole and drinking plenty of water.
The doctor prescribes the dose based on the potential pathogen and the severity of the infection, taking into account the clinical condition of the patient.
The tablets should be used, strictly observing the interval of 12 hours between doses of the next dose.
Recommended dosage for patients over 12 years old:
- acute sinusitis, acute pharyngotonsillitis, uncomplicated infections of the skin and subcutaneous fat: 200 mg 2 times a day. The duration of the course of treatment is 10 days;
- exacerbation of chronic bronchitis: 200 mg 2 times a day. The course of treatment is 5 days;
- community-acquired pneumonia: 200 mg 2 times a day for 14 days. In severe cases, a dose of 400 mg is recommended every 12 hours for 14 days.
With a mild degree of impaired renal function, mild or moderate functional impairment of the liver and for elderly patients, dose adjustment of Spectracef is not required.
With moderate severity (CC 30-50 ml / min) of renal failure, the dose should not exceed 200 mg twice a day, with severe renal failure with CC less than 30 ml / min, the maximum daily dose is 200 mg.
Side effects
- from the side of metabolism and nutrition: rarely - anorexia;
- from the nervous system: often - headache; rarely - dizziness, sleep disorders, nervousness, drowsiness, insomnia; frequency not established - muscle hypertonicity, tremor, impaired coordination, amnesia, meningitis;
- on the part of the organ of vision: very rarely - photosensitivity; the frequency has not been established - pain in the eyes, disturbances on the part of the organ of vision, impaired vision, blepharitis;
- from the organ of hearing: very rarely - ringing in the ears;
- from the respiratory system, chest and mediastinal organs: very rarely - rhinitis, pharyngitis, sinusitis, bronchospasm;
- from the gastrointestinal tract: very often - diarrhea; often - dyspepsia, abdominal pain, nausea; rarely - dryness of the oral mucosa, flatulence, vomiting, constipation, taste perversion, belching, oral candidiasis, pseudomembranous colitis; very rarely - aphthous stomatitis; frequency not established - hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, glossitis, hiccups, discoloration of the tongue;
- from the hepatobiliary system: rarely - liver dysfunction;
- dermatological reactions: rarely - itching, skin rash, urticaria;
- from the connective tissue and musculoskeletal system: very rarely - myalgia;
- from the urinary system: the frequency has not been established - urinary tract infections, pain in the kidney, dysuria, polyuria, nocturia, urinary incontinence, nephritis;
- from the reproductive system: often - candidal vaginitis; rarely - leucorrhoea, vaginitis; frequency not established - metrorrhagia, menstrual irregularities, pain in the mammary glands, erectile dysfunction;
- laboratory indicators: sometimes - an increase in the concentration of alanine aminotransferase, leukopenia, thrombocytosis; rarely - hyperglycemia, increased blood coagulation time, hypokalemia, increased concentration of alkaline phosphatase, aspartate aminotransferase, bilirubinemia, albuminuria; frequency not established - eosinophilia, increased concentration of lactate dehydrogenase, decreased thromboplastin time, thrombocytopenia, thrombocytopathy, hypoproteinemia, increased creatinine levels, dehydration;
- from the side of the psyche: the frequency has not been established - hallucinations, emotional lability, dementia, euphoria, depersonalization, increased libido, thought disorder, collapse;
- on the part of the hematopoietic organs: the frequency has not been established - lymphadenopathy, hemolytic anemia;
- on the part of the cardiovascular system: the frequency has not been established - tachycardia, postural hypotension, heart failure, atrial fibrillation, ventricular extrasystole;
- others: rarely - generalized pain syndrome, fever, asthenia, excessive sweating; frequency not established - body odor, chills.
In addition, they were not recorded when taking Spectracef, but the following undesirable effects are characteristic of cephalosporins:
- on the part of the hematopoietic organs: aplastic anemia;
- from the immune system: allergic reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, serum sickness);
- from the urinary system: toxic nephropathy, impaired renal function;
- from the hepatobiliary system: cholestasis.
Overdose
Symptoms: diarrhea, nausea, vomiting.
Treatment: the appointment of symptomatic therapy.
special instructions
The development of a hypersensitivity reaction is the basis for immediate discontinuation of Spectracef and seeking medical attention.
It should be borne in mind that a broad-spectrum antibiotic can cause excessive growth of resistant microflora, especially with a long course of treatment.
In severe renal failure, treatment should be accompanied by periodic monitoring of the functional state of the kidneys.
If diarrhea develops, Spectracef should be discontinued. Severe diarrhea, including blood impurities, during or after treatment may be a symptom of pseudomembranous colitis. Therefore, after establishing an accurate diagnosis for the treatment of the disease, it is required to prescribe antibiotics, to which Clostridium difficile are sensitive, and maintenance therapy.
Due to the risk of a decrease in prothrombin activity during therapy with cephalosporins, patients who have previously taken anticoagulants or who suffer from renal and hepatic insufficiency need to ensure prothrombin time control.
Determination of the concentration of glucose in the blood or plasma during the period of treatment with cefditoren should be done using the glucose oxidase or glucose hexokinase study method, since the results of a ferricyanide glucose test can give a false negative result.
It should be borne in mind that a direct Coombs test and copper recovery in determining the level of glucose in urine during treatment with cefditoren may give a false-positive result.
Patients on a diet with low sodium intake should take into account that 1 Spectracef tablet at a dose of 200 mg contains about 13.1 mg of sodium, 400 mg - 26.2 mg.
Influence on the ability to drive vehicles and complex mechanisms
Spectraceph does not affect the ability to drive vehicles and complex mechanisms. Nevertheless, during the period of treatment, it is recommended to be careful when performing potentially hazardous activities due to the risk of developing unwanted effects from the nervous system.
Application during pregnancy and lactation
The lack of clinical data on the teratogenic effect and toxic effects of cefditoren pivoxil on the embryo is the basis for contraindications to the use of Spectracef during pregnancy. The exceptions are those cases where, in the opinion of the doctor, the expected benefit from therapy to the mother is much higher than the potential risk to the fetus.
The use of Spectracef during breastfeeding is contraindicated. If you need to take pills during lactation, you should stop breastfeeding.
Pediatric use
The use of Spectracef for the treatment of children under the age of 12 is contraindicated.
With impaired renal function
The appointment of Spectracef to patients on hemodialysis is contraindicated.
With mild renal impairment, dose adjustment is not required.
The recommended dose for moderate renal failure (CC 30-50 ml / min) - 200 mg 2 times a day.
The maximum daily dose for severe renal failure (CC less than 30 ml / min) is 200 mg.
For violations of liver function
The use of Spectracef is contraindicated in severe (class C according to the Child-Pugh classification) hepatic insufficiency.
In mild to moderate (Child-Pugh class A or B) liver dysfunction, dose adjustment is not required.
Use in the elderly
In old age (in the absence of severe renal and / or liver dysfunction), there is no need for dose adjustment.
Drug interactions
With the simultaneous use of Spectracef:
- blockers of H 2 -histamine receptors: reduce Cmax and AUC of the drug, so their combination is not recommended;
- antacids containing aluminum hydroxide, magnesium: it is recommended to take 2 hours after cefditoren pivoxil, since their simultaneous intake after meals causes a decrease in antacids Cmax by 14%, in cefditoren - AUC by 11%;
- probenecid: leads to a decrease in the excretion of the drug by the kidneys, increasing the pharmacokinetic parameters of cefditoren: Cmax - by 49%, AUC - by 122%, T1 / 2 - by 53%;
- aminoglycosides, loop diuretics (furosemide): increase the risk of nephrotoxicity, especially with impaired renal function.
Analogs
The analogues of Spectracef are Torocef, Medaxon, Lorakson, Chizon, Ificef, Suprax Solutab, Pantsef, Ceforal Solutab, Cefogram, Cefpotec, Cefson, Ceftriaxon, Ceftriabol, Cefaxon.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 30 ° C.
Shelf life: tablets with a dosage of 200 mg - 3 years, 300 mg - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Spectraceph
Reviews of Spectracef give a high assessment of the effectiveness of the drug in the treatment of infectious diseases of the respiratory system, such as obstructive bronchitis and sinusitis. Patients report the onset of noticeable relief in the treatment of sinusitis one day after starting the use of the tablets. Indicate that Spectracef does not cause side effects, is well tolerated (including when treating children). It is advised to start taking an antibiotic only after examining sputum for the sensitivity of the causative agent of the infection to the active substance of the drug, and not relying on a visual diagnosis of the disease by a doctor.
Price for Spectracef in pharmacies
The price of Spectracef for a package containing 20 tablets at a dose of 200 mg can range from 1285 rubles, 10 tablets at a dose of 400 mg - from 1387 rubles.
Spectracef: prices in online pharmacies
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Drug name Price Pharmacy |
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Spectracef 200 mg film-coated tablets 14 pcs. 849 r Buy |
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Spectracef tablets p.o.p 200mg 14pcs 874 RUB Buy |
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Spectracef 200 mg film-coated tablets 20 pcs. 1257 RUB Buy |
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Spectracef 400 mg film-coated tablets 10 pcs. 1325 RUB Buy |
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Spectracef tablets p.o. 200mg 20 pcs. 1329 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
