Cefeditor | Spectraceph tablets coated. captivity. about. 200 mg 20 pcs.
Special Price
$38.80
Regular Price
$47.00
In stock
SKU
BID497084
Release form
White film coated tablets, elliptical, with blue TFM marking on one side on a cross section of the core is light yellow in color.
White film coated tablets, elliptical, with blue TFM marking on one side on a cross section of the core is light yellow in color.
Release form
White film coated tablets, elliptical, with blue TFM marking on one side on a cross section of the core is light yellow in color.
Packing
Pack of 20 pcs
Pharmacological action
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 the synthesis of the bacterial wall due to its affinity for penicillin-binding proteins.
Indications
Treatment of infections caused by cefditorin-sensitive microorganisms:
- upper respiratory tract infections: acute tonsillopharyngitis, acute maxillary sinusitis
- lower respiratory tract infections: exacerbation of hypoinflammation of the liver and lemoglossa: infected skin wounds, abscess, folliculitis, impetigo and furunculosis.
Contraindications
- Hypersensitivity to cefditoren, other cephalosporins, or any other component of the drug.
- severe allergic reactions to penicillins and other beta-lactam antibacterial drugs
- class C liver failure according to Child-Pugh
- for patients hemodialysis
- a history of hypersensitivity to casein protein
- primary carnitine deficiency
- children under 12 years old
- simultaneous use of cefditoren pivoxil and histamine H2 receptor blockers.
Caution: for patients with hypersensitivity to other beta-lactam antibiotics due to the possibility of developing cross-allergic reactions, the simultaneous use of aminoglycosides and diuretics (furosemide) in patients with gastrointestinal tract pathology (including a history of colitis).
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 the embryotoxic or teratogenic effects of the drug, Spectracef should not be used during pregnancy unless the expected benefit to the mother outweighs the potential risk to the fetus.
Lactation
There is insufficient data on the penetration of cefditoren into breast milk. Therefore, when using the drug Spectracef, breastfeeding should be discontinued.
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 excessive growth of resistant microflora. For this reason, it is recommended to monitor patients receiving this drug, especially in the case of long-term treatment.
In patients with severe renal impairment, periodic monitoring of renal function is recommended.
During the course of treatment with cephalosporins, a decrease in prothrombin activity is possible. For this reason, patients at risk (with renal or hepatic insufficiency or in the case of a previous prescription of anticoagulants) need to control prothrombin time.
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, just discontinuing the drug is enough, in more severe, antibiotic therapy is indicated, to which Clostridium difficile is sensitive, and the appointment of infusion therapy.
Like other cephalosporins, cefditorin can lead to a false-positive result of a direct Coombs test, the detection of glucose in the urine using a copper recovery test, but not using an enzyme test. Due to the high risk of a false-negative result of a ferricyanide test for determining glucose in plasma or blood, it is recommended that patients undergo cefditoren treatment to determine glucose concentration in blood or plasma using glucose oxidase or glucose-hexokinase methods.
Combining cephalosporins with aminoglycosides and / or loop diuretics, especially in patients with impaired renal function, may increase the risk of nephrotoxicity.
Spectraceph 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 to patients on a low sodium diet.
Effects on ability to drive vehicles and control mechanisms
No effect of cefditoren pivoxil on ability to drive a car and / or other mechanisms has been reported. At the same time, it should be borne in mind that taking the drug Spectracef may be accompanied by such undesirable effects as vomiting, headache.
Composition
In 1 tablet:
- cefditoren -200 mg
Excipients:
- Mannitol as much as (approximately 35 mg)
- Sodium caseinate 100 mg
- Croscarmellose sodium 150 mg
- Sodium tripolyphosphate 4 mg
- Magnesium stearate 5 mg
- Opadry white 35 mg (hypromellose 21.9 mg, titanium dioxide 10.9 mg, macrogold-2.2 2.2 mg) Carnauba wax 0.06 mg
- Ink Opacode blue (shellac IN IMS 74 OP 50.41%, N-butano l 24.35%, Aluminum varnish based on
dye brilliant blue FCF 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%,
ammonia solution concentrated 1.94%).
Dosage and administration
Inside. Tablets should be swallowed whole with a sufficient amount of water, preferably after meals. The recommended dose depends on the severity of the infection, the patient's initial condition and potential pathogens.
Side effects
Adverse events are listed below, depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and < 1/1 000), very rarely (<1/10 000, including isolated cases).
From the side of metabolism and nutrition: rarely - anorexia.
From the nervous system: often - headache rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.
From the side of the organ of vision: very rarely - photosensitivity.
On the part of ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, tinnitus.
From the respiratory system, chest organs and including individual cases).
From the side of metabolism and nutrition: rarely - anorexia.
From the nervous system: often - headache rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.
From the side of the organ of vision: very rarely - photosensitivity.
On the part of ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, tinnitus.
From the respiratory system, chest organs and including individual cases).
From the side of metabolism and nutrition: rarely - anorexia.
From the nervous system: often - headache rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.
From the side of the organ of vision: very rarely - photosensitivity.
On the part of ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, tinnitus.
From the respiratory system, chest organs andmediastinum: very rarely - bronchospasm.
From the gastrointestinal tract: very often - diarrhea often - nausea, abdominal pain, dyspepsia rarely - constipation, flatulence, vomiting, candidiasis of the oral cavity, belching, pseudomembranous colitis, dry mucous membranes of the mouth, taste perversion is very rare - aphthous stomatitis .
From the liver and biliary tract: rarely - impaired liver function.
From the skin and subcutaneous fat: rarely: rash, itching, urticaria.
From the musculoskeletal system and connective tissue: very rarely - myalgia.
From the genitourinary system: often: candidal vaginitis rarely - vaginitis, white.
Other: rarely - fever, asthenia, generalized pain, excessive sweating.
On the part of laboratory indicators: sometimes - leukopenia, thrombocytosis, an increase in the concentration of alanine aminotransferase (ALT) is rare - an increase in blood coagulation time, hyperglycemia, hypokalemia, bilirubinemia, an increase in the concentration of aspartate aminotransferase (ACT), alkaline phosphatase, albuminuria.
In addition, isolated cases of eosinophilia, thrombocytopenia, a decrease in thromboplastin time, thrombocytopathy, an increase in the concentration of lactate dehydrogenase (LDH), hypoproteinemia and an increase in the concentration of creatinine have been described.
There have also been separate reports of the following adverse events.
From the hemopoietic organs: hemolytic anemia, lymphadenopathy.
From the side of water-electrolyte metabolism: dehydration.
From the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, disordered thinking, increased libido, collapse.
From the nervous system: amnesia, impaired coordination, muscle hypertonicity, meningitis, tremor.
From the side of the organ of vision: impaired vision, disturbances from the organ of vision, eye pain, blepharitis.
From the cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular extrasystole, postural hypotension.
From the gastrointestinal tract: 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: pain in the mammary gland, menstrual irregularities, metrorrhagia, erectile dysfunction.
Other: body odor, chills.
The following adverse reactions have not been reported as adverse events after the use of cefditoren, but they are typical for 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.
From the liver and biliary tract: cholestasis.
Hematopoietic organs: aplastic anemia.
Drug Interactions
Antacids
The combined use of cefditoren pivoxil and antacids containing magnesium hydroxide, aluminum, after eating, reduces Cmax and AUC of cefditoren by 14% and 11%, respectively. Although the clinical significance of this fact is unknown, it is recommended so that the period between the administration of antacids and cefditoren pivoxil is 2 hours.
Probenecid
The combined use of probenecid and cefditoren pivoxil reduces the excretion of the antibiotic by the kidneys, increasing Cmax by 49%, AUC by 122% and increasing the half-life of cefditoren by 53%.
Blockers of H2 histamine receptors
The simultaneous administration of famotidine intravenously and cefditoren pivoxil inside causes a decrease in Cmax and AUC by 27% and 22%, respectively. Thus, the simultaneous use of cefditoren pivoxil and histamine H2 receptor blockers is not recommended.
Overdose
Symptoms
Symptoms such as nausea, vomiting, diarrhea may occur when a drug is overdosed.
Treatment
Symptomatic therapy has been shown in the development of the clinical picture of drug overdose.
Storage conditions
Store in the original package at a temperature not exceeding 30 РC. Keep out of reach of children.
Shelf life
Shelf life
Dosage 200 mg: 3 years
Dosage 400 mg: 2 years.
Do not use after the expiration date printed on the package.
Deystvuyushtee substance
cefditoren
Terms and conditions otpuska from
pharmacies by prescription
dosage form
tablets
Possible product names
Spectraceph tablets 200 mg, 20 pcs.
Tedema A. Meiji, Spain
White film coated tablets, elliptical, with blue TFM marking on one side on a cross section of the core is light yellow in color.
Packing
Pack of 20 pcs
Pharmacological action
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 the synthesis of the bacterial wall due to its affinity for penicillin-binding proteins.
Indications
Treatment of infections caused by cefditorin-sensitive microorganisms:
- upper respiratory tract infections: acute tonsillopharyngitis, acute maxillary sinusitis
- lower respiratory tract infections: exacerbation of hypoinflammation of the liver and lemoglossa: infected skin wounds, abscess, folliculitis, impetigo and furunculosis.
Contraindications
- Hypersensitivity to cefditoren, other cephalosporins, or any other component of the drug.
- severe allergic reactions to penicillins and other beta-lactam antibacterial drugs
- class C liver failure according to Child-Pugh
- for patients hemodialysis
- a history of hypersensitivity to casein protein
- primary carnitine deficiency
- children under 12 years old
- simultaneous use of cefditoren pivoxil and histamine H2 receptor blockers.
Caution: for patients with hypersensitivity to other beta-lactam antibiotics due to the possibility of developing cross-allergic reactions, the simultaneous use of aminoglycosides and diuretics (furosemide) in patients with gastrointestinal tract pathology (including a history of colitis).
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 the embryotoxic or teratogenic effects of the drug, Spectracef should not be used during pregnancy unless the expected benefit to the mother outweighs the potential risk to the fetus.
Lactation
There is insufficient data on the penetration of cefditoren into breast milk. Therefore, when using the drug Spectracef, breastfeeding should be discontinued.
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 excessive growth of resistant microflora. For this reason, it is recommended to monitor patients receiving this drug, especially in the case of long-term treatment.
In patients with severe renal impairment, periodic monitoring of renal function is recommended.
During the course of treatment with cephalosporins, a decrease in prothrombin activity is possible. For this reason, patients at risk (with renal or hepatic insufficiency or in the case of a previous prescription of anticoagulants) need to control prothrombin time.
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, just discontinuing the drug is enough, in more severe, antibiotic therapy is indicated, to which Clostridium difficile is sensitive, and the appointment of infusion therapy.
Like other cephalosporins, cefditorin can lead to a false-positive result of a direct Coombs test, the detection of glucose in the urine using a copper recovery test, but not using an enzyme test. Due to the high risk of a false-negative result of a ferricyanide test for determining glucose in plasma or blood, it is recommended that patients undergo cefditoren treatment to determine glucose concentration in blood or plasma using glucose oxidase or glucose-hexokinase methods.
Combining cephalosporins with aminoglycosides and / or loop diuretics, especially in patients with impaired renal function, may increase the risk of nephrotoxicity.
Spectraceph 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 to patients on a low sodium diet.
Effects on ability to drive vehicles and control mechanisms
No effect of cefditoren pivoxil on ability to drive a car and / or other mechanisms has been reported. At the same time, it should be borne in mind that taking the drug Spectracef may be accompanied by such undesirable effects as vomiting, headache.
Composition
In 1 tablet:
- cefditoren -200 mg
Excipients:
- Mannitol as much as (approximately 35 mg)
- Sodium caseinate 100 mg
- Croscarmellose sodium 150 mg
- Sodium tripolyphosphate 4 mg
- Magnesium stearate 5 mg
- Opadry white 35 mg (hypromellose 21.9 mg, titanium dioxide 10.9 mg, macrogold-2.2 2.2 mg) Carnauba wax 0.06 mg
- Ink Opacode blue (shellac IN IMS 74 OP 50.41%, N-butano l 24.35%, Aluminum varnish based on
dye brilliant blue FCF 11.25%, titanium dioxide 4.49%, propylene glycol 2.91%, isopropanol 4.65%,
ammonia solution concentrated 1.94%).
Dosage and administration
Inside. Tablets should be swallowed whole with a sufficient amount of water, preferably after meals. The recommended dose depends on the severity of the infection, the patient's initial condition and potential pathogens.
Side effects
Adverse events are listed below, depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and < 1/1 000), very rarely (<1/10 000, including isolated cases).
From the side of metabolism and nutrition: rarely - anorexia.
From the nervous system: often - headache rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.
From the side of the organ of vision: very rarely - photosensitivity.
On the part of ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, tinnitus.
From the respiratory system, chest organs and including individual cases).
From the side of metabolism and nutrition: rarely - anorexia.
From the nervous system: often - headache rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.
From the side of the organ of vision: very rarely - photosensitivity.
On the part of ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, tinnitus.
From the respiratory system, chest organs and including individual cases).
From the side of metabolism and nutrition: rarely - anorexia.
From the nervous system: often - headache rarely - nervousness, dizziness, insomnia, drowsiness, sleep disorders.
From the side of the organ of vision: very rarely - photosensitivity.
On the part of ENT organs: very rarely - pharyngitis, rhinitis, sinusitis, tinnitus.
From the respiratory system, chest organs andmediastinum: very rarely - bronchospasm.
From the gastrointestinal tract: very often - diarrhea often - nausea, abdominal pain, dyspepsia rarely - constipation, flatulence, vomiting, candidiasis of the oral cavity, belching, pseudomembranous colitis, dry mucous membranes of the mouth, taste perversion is very rare - aphthous stomatitis .
From the liver and biliary tract: rarely - impaired liver function.
From the skin and subcutaneous fat: rarely: rash, itching, urticaria.
From the musculoskeletal system and connective tissue: very rarely - myalgia.
From the genitourinary system: often: candidal vaginitis rarely - vaginitis, white.
Other: rarely - fever, asthenia, generalized pain, excessive sweating.
On the part of laboratory indicators: sometimes - leukopenia, thrombocytosis, an increase in the concentration of alanine aminotransferase (ALT) is rare - an increase in blood coagulation time, hyperglycemia, hypokalemia, bilirubinemia, an increase in the concentration of aspartate aminotransferase (ACT), alkaline phosphatase, albuminuria.
In addition, isolated cases of eosinophilia, thrombocytopenia, a decrease in thromboplastin time, thrombocytopathy, an increase in the concentration of lactate dehydrogenase (LDH), hypoproteinemia and an increase in the concentration of creatinine have been described.
There have also been separate reports of the following adverse events.
From the hemopoietic organs: hemolytic anemia, lymphadenopathy.
From the side of water-electrolyte metabolism: dehydration.
From the psyche: dementia, depersonalization, emotional lability, euphoria, hallucinations, disordered thinking, increased libido, collapse.
From the nervous system: amnesia, impaired coordination, muscle hypertonicity, meningitis, tremor.
From the side of the organ of vision: impaired vision, disturbances from the organ of vision, eye pain, blepharitis.
From the cardiovascular system: atrial fibrillation, heart failure, tachycardia, ventricular extrasystole, postural hypotension.
From the gastrointestinal tract: 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: pain in the mammary gland, menstrual irregularities, metrorrhagia, erectile dysfunction.
Other: body odor, chills.
The following adverse reactions have not been reported as adverse events after the use of cefditoren, but they are typical for 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.
From the liver and biliary tract: cholestasis.
Hematopoietic organs: aplastic anemia.
Drug Interactions
Antacids
The combined use of cefditoren pivoxil and antacids containing magnesium hydroxide, aluminum, after eating, reduces Cmax and AUC of cefditoren by 14% and 11%, respectively. Although the clinical significance of this fact is unknown, it is recommended so that the period between the administration of antacids and cefditoren pivoxil is 2 hours.
Probenecid
The combined use of probenecid and cefditoren pivoxil reduces the excretion of the antibiotic by the kidneys, increasing Cmax by 49%, AUC by 122% and increasing the half-life of cefditoren by 53%.
Blockers of H2 histamine receptors
The simultaneous administration of famotidine intravenously and cefditoren pivoxil inside causes a decrease in Cmax and AUC by 27% and 22%, respectively. Thus, the simultaneous use of cefditoren pivoxil and histamine H2 receptor blockers is not recommended.
Overdose
Symptoms
Symptoms such as nausea, vomiting, diarrhea may occur when a drug is overdosed.
Treatment
Symptomatic therapy has been shown in the development of the clinical picture of drug overdose.
Storage conditions
Store in the original package at a temperature not exceeding 30 РC. Keep out of reach of children.
Shelf life
Shelf life
Dosage 200 mg: 3 years
Dosage 400 mg: 2 years.
Do not use after the expiration date printed on the package.
Deystvuyushtee substance
cefditoren
Terms and conditions otpuska from
pharmacies by prescription
dosage form
tablets
Possible product names
Spectraceph tablets 200 mg, 20 pcs.
Tedema A. Meiji, Spain
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