Producer: "Pharma International" Jordan
Code of automatic telephone exchange: J01DD13
Release form: Liquid dosage forms. Suspension. Tablets.
General characteristics. Structure:
International name: Cefpodoxime
Chemical name: tsefpodoksy; 1-(izopropoks karboniloksit) ethyl (6R, 7R)-7-[2-(2-amino-4-тиазолил) - (z)-2-(metioksiimino) acetamido] - 3-метиоксиметил - 3-цефем - 4-carboxylat;
Main physical and chemical characteristics: tablets of an oval form with an oboyevypukly surface, film coated, cream-white color, with a notch. The surface of tablets has a print of "PhI" on the one hand and "CF 1" or "CF 2" - from another;
1 tablet contains a tsefpodoksim of a proksetil 100 mg of a tsefpodoksim are equivalent;
1 tablet contains a tsefpodoksim of a proksetil 200 mg of a tsefpodoksim are equivalent;
Excipients: silicon dioxide colloid, sodium a lauryl sulfate, cellulose microcrystallic, ferrous oxide yellow, sodium starch glikolit, magnesium stearate, opadr OY-Lbely.
- The tablets containing 100 or 200 mg of Tsefodoks in a film cover No. 10.
- Powder in bottles of 50 ml for preparation of suspension of 50 mg / 5 ml or 100 mg / 5 ml (for pediatric practice) No. 1.
Pharmacodynamics. Цефодокс (tsefpodoksy proksetit) —? - a laktamny antibiotic ІІІ generations for oral administration. The bactericidal effect of drug is caused by oppression of synthesis of components of a bacterial wall of microorganisms. Drug is active rather many gram-positive, gram-negative, aerobic and anaerobic microorganisms.
The action spectrum of a tsefpodoksim covers such microorganisms:
sensitive gram-positive bacteria — Streptococcus pneumoniae, streptococci of group A (S. pyogenes), group B (S. agalactiae), the C, F and G groups, and also S. mitis, S. Sanguis, S. Salivarius and Corynebacterium diphtheriae;
sensitive gram-negative bacteria — Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis (the strains which are producing and not producing? - lactamazu), Neisseria meningitidis, Neisseria gonorrhoeae, Escherichia coli, Klebsiella Spp. (K. pneumoniae; K. oxytoca), Proteus mirabilis;
moderately sensitive bacteria — metitsillinchuvstvitelny staphylococcus, the strains which are producing and not producing a penicillinase (S. aureus and S. epidermidis).
To a tsefpodoksim, as well as other cephalosporins, such bacteria are steady: энтерококк, metitsillinrezistentny staphylococcus (S. aureus, S. epidermidis), Staphylococcus saprophyticus, Pseudomonas aeruginosa and Pseudomonas spp., Clostridium difficile, Bacteroides fragilis.
Pharmacokinetics. Active ingredient of drug is soaked up in a small bowel and hydrolyzed to an active metabolite of a tsefpodoksim. Cmax indicators in a blood plasma are reached for 2–3 h after a single dose and make 1,2 and 2,5 mg/l for doses of 100 and 200 mg respectively.
Contacts proteins of a blood plasma (preferential with albumine) on unsaturated type. The Minimum Inhibiting Concentration (MIC) of a tsefpodoksim concerning the majority of activators comes to light in a parenchyma of lungs, a mucous membrane of bronchial tubes, pleural liquid, almonds, intersticial liquid and a secret of a prostate.
Well gets into tissues of kidneys. Within 12 h after reception of a single dose MIK90 concerning the majority of causative agents of infections of kidneys and urinary tract is reached. It is removed preferential with urine, T? makes about 2,4 h.
Indications to use:
the infections caused by activators, sensitive to a tsefpodoksim:
- ENT organs (including sinusitis, tonsillitis, pharyngitis); for treatment of tonsillitis and pharyngitis of Tsefodoks appoint at a persistent or recurrent infection, and also in cases of the known or suspected resistance of the activator to shirokoprimenyaemy antibiotics;
- respiratory tracts (including an acute bronchitis, a recurrence or exacerbations of chronic bronchitis, bacterial pneumonia, the bronchiolitis complicated by bacterial superinfection);
- uncomplicated infections of upper and lower urinary tract (including acute pyelonephritis and cystitis);
- skin and soft tissues (abscesses, cellulitis, contaminated wounds, furuncles, folliculitis, paronychia, anthrax and ulcers);
- uncomplicated gonococcal urethritis.
Route of administration and doses:
Pill of Tsefodoks is taken inside during meal for increase in absorption.
For adults and children 12 years with normal function of kidneys are aged more senior recommend such doses:
|Infections||General daily dose, mg||Dosing mode|
|Infections of ENT organs|
|Sinusitis||400||200 mg 2 times a day|
|Other infections (including tonsillitis, pharyngitis)||200||100 mg 2 times a day|
|Including an acute bronchitis, a recurrence or exacerbations of chronic bronchitis, bacterial pneumonia||200–400 (depending on sensitivity of the activator)||100–200 mg 2 times a day|
|Uncomplicated infections of urinary tract|
|Upper (acute pyelonephritis)||400||200 mg 2 times a day|
|Lower (cystitis)||200||100 mg 2 times a day|
|Infections of skin and soft tissues|
|Abscess, cellulitis, contaminated wounds, furuncles, folliculitis, paronychia, anthrax and ulcers||400||200 mg 2 times a day|
|Uncomplicated gonococcal urethritis||200||Once|
Duration of treatment depends on disease severity and is defined individually.
Patients of advanced age. There is no need to change a dose to elderly people with normal function of kidneys.
Abnormal liver function. There is no need to change doses for patients with a liver failure.
|Clearance of creatinine, ml/min.||The recommended dose|
|> 40||There is no need to korrigirovat a dose|
|39–10||100 or 200 mg (depending on infection type) each 24 h|
|<10||100 or 200 mg (depending on infection type) each 48 h|
The patient who is on a hemodialysis appoint 100 or 200 mg (depending on infection type) after each session of dialysis.
Suspension of Tsefodoks is intended for use in pediatrics. The prepared suspension is accepted inside during meal for absorption strengthening.
For preparation of suspension it is necessary to turn and stir up a bottle to fluff up powder, to add boiled cold water to the mark specified on a bottle to 2 receptions, everyone time shaking up a bottle before formation of homogeneous suspension. It is possible to accept suspension not earlier than in 5 min. after preparation. Before each reception ready suspension needs to be stirred up carefully. After preparation ready suspension is stored for 14 days in the refrigerator.
To children aged from 5 months up to 12 years appoint in a dose 10 mg/kg of body weight a day (the maximum daily dose — 400 mg), apply in 2 receptions with an interval of 12 h (the maximum single dose — 200 mg). Duration of treatment depends on disease severity and is defined individually.
Abnormal liver function. There is no need to change doses for children with a liver failure.
|Clearance of creatinine, ml/min.||The recommended dose|
|> 40||There is no need to korrigirovat a dose|
|39–10||The single dose calculated depending on body weight each 24 h|
|<10||The single dose calculated depending on body weight each 48 h|
The patient who is on a hemodialysis appoint the single dose calculated depending on body weight after each session of dialysis.
Features of use:
Approximately at 5–10% of patients with an allergy to penicillin note cross-responsiveness on cephalosporins therefore before purpose of cephalosporins it is necessary to find out possible existence from the patient of an allergy to penicillin and to provide strict medical observation from the 1st day of use of Tsefodoks.
To patients with an allergy to other cephalosporins, it is necessary to remember a possibility of a cross allergy on tsefpodoksy. Цефодокс it is not necessary to appoint the patient with the instruction in the anamnesis to reaction of hypersensitivity to cephalosporins. Hypersensitivity reactions (anaphylaxis) on? - laktamny antibiotics can be heavy, sometimes — lethal. At emergence of the first signs of hypersensitivity it is necessary to stop drug use.
Цефодокс is not the main antibiotic at therapy of staphylococcal pneumonia and it should not be applied at therapy of the atypical pneumonia caused by bacteria like Legionella, Mycoplasma and Chlamydia.
For patients with a renal failure it is necessary to korrigirovat the dosing mode depending on clearance of creatinine (the recommended doses are given in the table). Tsefodoks's use in combination with potentially nephrotoxic drugs (aminoglycosides, furosemide) can worsen function of kidneys. Throughout treatment recommend to control indicators of function of kidneys.
Side effects are possible, including from a GIT (for example vomiting, nausea, an abdominal pain). Always patients should appoint antibiotics with care with gastrointestinal diseases, especially colitis.
At treatment by Tsefodoks and other antibiotics of a broad spectrum of activity disturbance of balance of intestinal microflora can lead to developing of diarrhea, colitis, including the pseudomembranous colitis caused by Clostridium difficile toxin. These side reactions most of which often can arise at the patients applying tsefpodoksy in high doses throughout long time should be considered as potentially heavy.
It is necessary to conduct a research on Clostridium difficile existence. At suspicion of colitis it is necessary to suspend Tsefodoks's use immediately. It is necessary to confirm the diagnosis sigma - and a rektoskopiya and in case of clinical need to appoint other antibiotic (Vancomycinum). It is necessary to avoid use of drugs which can be the cause of a delay of a chair.
As well as concerning others? - laktamny antibiotics, at long use of Tsefodoks development of a neutropenia is possible, it is very rare — an agranulocytosis. Monitoring procedure of indicators of blood is required, at a neutropenia therapy is stopped.
At some patients throughout treatment the positive direct test of Koombs is possible. Decrease in level of hemoglobin can be observed, it is very rare — hemolitic anemia.
Long use of a tsefpodoksim can lead to the excess growth of resistant microorganisms.
Period of pregnancy and feeding by a breast. Well controlled researches concerning use of a tsefpodoksim for pregnant women were not conducted therefore tablets of Tsefodoks can be applied during pregnancy only in case of reasonable need.
Tsefpodoksim gets into breast milk therefore in case of need its uses it is necessary to stop feeding by a breast.
Children. Цефодокс tablets are appointed to children aged 12 years are more senior. At children aged from 5 months up to 12 years recommend to apply Tsefodoks in the form of suspension.
Ability to influence speed of response at control of vehicles and work with other mechanisms. At use of a tsefpodoksim dizziness which can affect ability to control of vehicles and work with difficult mechanisms is possible.
apply such classification of frequency of emergence of side effects: very often (? 1/10), it is frequent (? 1/100, <1/10), infrequently (? 1/1000, <1/100), it is rare (? 1/10 000, <1/1000), it is very rare (<1/10 000).
Infections and invasions: seldom — the superinfection caused by some mushrooms of the sort Candida, insensitive to a tsefpodoksim; very seldom — the colitis connected using antibiotics.
From system of blood: seldom — an eosinophilia; very seldom — a leukopenia, a neutropenia, thrombocytopenia, a thrombocytosis, an agranulocytosis, decrease in concentration of hemoglobin, hemolitic anemia.
From immune system: seldom — hypersensitivity, anaphylactic reactions.
Metabolic disturbances: seldom — dehydration, gout, peripheral hypostases, increase in body weight.
From a musculoskeletal system: seldom — a mialgiya.
From a nervous system: infrequently — a cephalalgia; seldom — вертиго; very seldom — dizziness, sleeplessness, drowsiness, neurosis, irritability, nervousness, unusual dreams, deterioration in sight, confusion of consciousness, dreadful dreams, paresthesias.
From respiratory system: seldom — asthma, cough, nasal bleeding, rhinitis, goose breathing, bronchitis, suffocation, a pleural exudate, pneumonia, sinusitis.
From a GIT: seldom — diarrhea; infrequently — an abdominal pain, nausea; seldom — feeling of thirst, tenesmus, abdominal distention, vomiting, dyspepsia, dryness in a mouth, a loss of appetite, a lock, candidosis stomatitis, anorexia, an eructation, gastritis, ulcers on a mucous membrane of an oral cavity, pseudomembranous colitis.
From gepatobiliarny system: seldom — cholestatic hepatitis.
From skin and hypodermic fabrics: seldom — rashes, an itch, a small tortoiseshell, the increased perspiration, makulezny rash, fungal dermatitis, a peeling, a xeroderma, a hair loss, vesicular rashes, a solar erythema, a purpura, violent reactions (including Stephens's syndrome — Johnson), a toxic epidermal necrolysis, a multiformny erythema.
From urinogenital system: seldom — a hamaturia, infections of uric ways, a metrorrhagia, a dysuria, a frequent urination, a proteinuria, vaginal candidiasis.
From cardiovascular system: seldom — congestive heart failure, migraine, the accelerated heartbeat, a vazodilatation, a hematoma, arterial hypertension or hypotension.
From sense bodys: seldom — disturbance of flavoring feelings, irritation of eyes, a sonitus.
General disturbances: seldom — discomfort, fatigue, an adynamy, medicamentous fever, a stethalgia (pain can irradiate in a waist), fever, generalized pain, candidiasis, abscess, allergic reaction, a face edema, bacterial infections, parasitic infections.
Laboratory indicators: seldom — increase in indicators of the functional hepatic ASAT, ALAT tests, level of an alkaline phosphatase, bilirubin, urea and creatinine, false positive reaction of Koombs.
Interaction with other medicines:
Blockers histamine H2 receptors and antiacid drugs reduce bioavailability of drug. The combined use of drug with loopback diuretics can increase nephrotoxicity. Recommend to carry out careful monitoring of function of kidneys if Tsefodoks appoint along with the drugs having nephrotoxicity. Levels of a tsefpodoksim in a blood plasma increase at use of drug with probenetsidy.
Hypersensitivity to cephalosporins, penicillin. Children's age up to 12 years (for tablets); for suspension also — hereditary intolerance of a galactose, deficit of lactase or a sprue of a glucose/galactose, children's age up to 5 months.
Symptoms: nausea, vomiting, abdominal pain, diarrhea. In case of overdose, especially at patients with a renal failure, developing of encephalopathy, as a rule, reversible is possible at decrease in level of a tsefopodoksim in a blood plasma.
To store at a temperature below 30 °C. To protect from children. A period of validity - 2 years.
According to the recipe
The tablets containing 100 or 200 mg of Tsefodoks in a film cover No. 10.
Powder in bottles of 50 ml for preparation of suspension of 50 mg / 5 ml or 100 mg / 5 ml (for pediatric practice) No. 1.