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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 29.04.2022
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Tablet: Zamur 500mg axetil (Zamur 500mg) is an oral prodrug of the bactericidal cephalosporin antibiotic Zamur 500mg, which is resistant to most β (beta)-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of infections caused by susceptible bacteria. Susceptibility to Zamur 500mg axetil (Zamur 500mg) will vary with geography and time and local susceptibility data should be consulted where available.
Indications include: Upper respiratory tract infections for example, ear, nose and throat infections, such as otitis media, sinusitis, tonsillitis and pharyngitis. Lower respiratory tract infections for example, pneumonia, acute bronchitis, and acute exacerbations of chronic bronchitis. Genito-urinary tract infections for example, pyelonephritis, cystitis and urethritis. Skin and soft tissue infections for example, furunculosis, pyoderma and impetigo. Gonorrhoea, acute uncomplicated gonococcal urethritis, and cervicitis. Treatment of early Lyme disease and subsequent prevention of late Lyme disease in adults and children over 12 years old.
Zamur 500mg is also available as the sodium salt (Zamur 500mg) for parenteral administration. This permits the use of sequential therapy with the same antibiotic, when a change from parenteral to oral therapy is clinically indicated.
Where appropriate Zamur 500mg axetil (Zamur 500mg) is effective when used following initial parenteral Zamur 500mg sodium (Zamur 500mg) in the treatment of pneumonia and acute exacerbations of chronic bronchitis.
Injection: Zamur 500mg (as sodium) (Zamur 500mg) is a bactericidal cephalosporin antibiotic which is resistant to most beta-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria. Susceptibility to Zamur 500mg (as sodium) (Zamur 500mg) will vary with geography and time and local susceptibility data should be consulted where available.
Indications include: Respiratory tract infections for example, acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess and post-operative chest infections. Ear, nose and throat infections for example, sinusitis, tonsillitis, pharyngitis and otitis media. Urinary tract infections for example, acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. Soft-tissue infections for example, cellulitis, erysipelas and wound infections. Bone and joint infections for example, osteomyelitis and septic arthritis. Obstetric and gynaecological infections, pelvic inflammatory diseases. Gonorrhoea particularly when penicillin is unsuitable. Other infections including septicaemia, meningitis and peritonitis. Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.
Usually Zamur 500mg (as sodium) (Zamur 500mg) will be effective alone, but when appropriate it may be used in combination with an aminoglycoside antibiotic, or in conjunction with metronidazole (orally or by suppository or injection), especially for prophylaxis in colonic or gynaecological surgery.
Where appropriate Zamur 500mg (as sodium) (Zamur 500mg) is effective when used prior to oral therapy with Zamur 500mg (as axetil) (Zamur 500mg) in the treatment of pneumonia and acute exacerbations of chronic bronchitis.
Zamur 500mg (Zamur 500mg) is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.
Zamur 500mg is used to treat many kinds of bacterial infections, including severe or life-threatening forms.
Zamur 500mg may also be used for purposes not listed in this medication guide.
Tablet: The usual course of therapy is seven days (range 5 to 10 days).
Zamur 500mg axetil (Zamur 500mg) should be taken after food for optimum absorption.
Sequential Therapy: Pneumonia: 1.5 g Zamur 500mg sodium (Zamur 500mg) three times a day or twice a day [intravenous (i.v.) or intramuscular (i.m.)] for 48 to 72 hours, followed by Zamur 500mg axetil (Zamur 500mg) oral therapy 500 mg twice a day for 7 to10 days.
Acute Exacerbations of Chronic Bronchitis: 750 mg Zamur 500mg sodium (Zamur 500mg) three times a day or twice a day (i.v. or i.m.) for 48 to 72 hours, followed by Zamur 500mg axetil (Zamur 500mg) oral therapy 500 mg twice a day for 5 to 10 days.
Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.
Zamur 500mg axetil (Zamur 500mg) tablets should not be crushed and are therefore unsuitable for treatment of patients, such as younger children, who cannot swallow tablets. In children Zamur 500mg axetil (Zamur 500mg) oral suspension may be used.
There is no experience of using Zamur 500mg axetil (Zamur 500mg) in children under the age of 3 months.
Injection: Zamur 500mg (as sodium) (Zamur 500mg) Injection is for intravenous (i.v.) and/or intramuscular (i.m.) administration. Zamur 500mg (as sodium) (Zamur 500mg) is also available as the axetil ester Zamur 500mg (as axetil) (Zamur 500mg) for oral administration. This permits the use of sequential therapy with the same antibiotic, when a change from parenteral to oral therapy is clinically indicated.
No more than 750 mg should be injected at one intramuscular site.
General Dosing Recommendations: Adults: Many infections respond to 750 mg three times daily by i.m. or i.v. injection. For more severe infections the dose should be increased to 1.5 g three times daily given i.v. The frequency of administration may be increased to 6-hourly if necessary, giving total daily doses of 3 to 6 g. Where clinically indicated, some infections respond to 750 mg or 1.5 g twice daily (i.v. or i.m.) followed by oral therapy with Zamur 500mg (as axetil) (Zamur 500mg).
Infants and Children: 30 to 100 mg/kg/day given as 3 or 4 divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
Neonates: 30 to 100 mg/kg/day given as 2 or 3 divided doses..
Gonorrhea: Adults: 1.5 g as a single dose (as 2 x 750 mg injections given i.m. with different sites e.g. each buttock).
Meningitis: Zamur 500mg (as sodium) (Zamur 500mg) is suitable for sole therapy of bacterial meningitis due to sensitive strains.
Adults: 3 g given i.v. every 8 hours.
Infants and Children: 150 to 250 mg/kg/day given i.v. in 3 or 4 divided doses
Neonates: The dosage should be 100 mg/kg/day given i.v.
Prophylaxis: The usual dose is 1.5 g given i.v. with induction of anaesthesia for abdominal, pelvic and orthopaedic operations. This may be supplemented with two 750 mg i.m. doses 8 and 16 hours later.
In cardiac, pulmonary, oesophageal and vascular operations, the usual dose is 1.5 g given i.v. with induction of anaesthesia, continuing with 750 mg given i.m. three times daily for a further 24 to 48 hours.
In total joint replacement, 1.5 g Zamur 500mg (as sodium) (Zamur 500mg) powder may be mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer.
Sequential Therapy: Adults: Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.
Pneumonia: 1.5 g Zamur 500mg (as sodium) (Zamur 500mg) three times daily or twice daily (given i.v. or i.m.) for 48 to 72 hours, followed by 500 mg twice daily Zamur 500mg (as axetil) (Zamur 500mg) (Zamur 500mg axetil) oral therapy for 7 to 10 days.
Acute Exacerbations of Chronic Bronchitis: 750 mg Zamur 500mg (as sodium) (Zamur 500mg) three times daily or twice daily (given i.v. or i.m.) for 48 to 72 hours, followed by 500 mg twice daily Zamur 500mg (as axetil) (Zamur 500mg) (Zamur 500mg axetil) oral therapy for 5 to 10 days.
Renal Impairment: Tablet: Zamur 500mg is primarily excreted by the kidneys. In patients with markedly impaired renal function it is recommended that the dosage of Zamur 500mg be reduced to compensate for its slower excretion.
Zamur 500mg is also available as the axetil ester for oral administration. This permits parenteral therapy with Zamur 500mg to be followed by oral therapy in situations where a change from parenteral to oral is clinically indicated.
Injection: Zamur 500mg is excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of Zamur 500mg (as sodium) (Zamur 500mg) should be reduced to compensate for its slower excretion.
It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily) until the creatinine clearance falls to 20 mL/min or below.
In adults with marked impairment (creatinine clearance 10 to 20 mL/min) 750 mg twice daily is recommended and with severe impairment (creatinine clearance <10 mL/min) 750 mg once daily is adequate.
For patients on haemodialysis a further 750 mg dose should be given i.v. or i.m. at the end of each dialysis. In addition to parenteral use, Zamur 500mg (as sodium) (Zamur 500mg) can be incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 litres of dialysis fluid).
For patients in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units a suitable dosage is 750 mg twice daily. For low-flux haemofiltration follow the dosage recommended under impaired renal function.
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What is the most important information I should know about Zamur 500mg?
Do not take this medication if you are allergic to Zamur 500mg, or to similar antibiotics, such as Cefzil, Keflex, Omnicef, and others.
Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have liver or kidney disease, diabetes, a history of intestinal problems, or if you are malnourished.
Zamur 500mg can make birth control pills less effective, which may result in pregnancy. Tell your doctor if you are taking birth control pills to prevent pregnancy. You may need to use another form of birth control during treatment with Zamur 500mg.
Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Zamur 500mg will not treat a viral infection such as the common cold or flu.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using Zamur 500mg.
Use Zamur 500mg tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Zamur 500mg tablets by mouth with or without food.
- Swallow Zamur 500mg tablets whole. Do not break, crush, or chew before swallowing.
- Zamur 500mg tablets works best if it is taken at the same time each day.
- To clear up your infection completely, take Zamur 500mg tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Zamur 500mg tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose, and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zamur 500mg tablets.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Bone and joint infections (injection only): Treatment of bone and joint infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
Chronic obstructive pulmonary disease, acute exacerbation (tablets only): Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis in adults and adolescents ≥13 years of age caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains).
Lower respiratory tract infections (injection only): Treatment of lower respiratory tract infections, including pneumonia, caused by S. pneumoniae, H. influenzae (including ampicillin-resistant strains), Klebsiella spp., S. aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli.
Lyme disease (early) (tablets only): Treatment of adults and adolescents ≥13 years of age with early Lyme disease caused by Borrelia burgdorferi.
Otitis media, acute (tablets and oral suspension only): Treatment of pediatric patients ≥3 months of age with acute bacterial otitis media caused by S. pneumoniae, H. influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or S. pyogenes.
Pharyngitis/tonsillitis (tablets and oral suspension only): Treatment of mild to moderate pharyngitis/tonsillitis caused by S. pyogenes in adults and pediatric patients ≥3 months of age.
Limitations of use: Efficacy in the prevention of rheumatic fever has not been established in clinical trials. Efficacy in the treatment of penicillin-resistant strains of S. pyogenes has not been demonstrated.
Septicemia (injection only): Treatment of septicemia caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pneumoniae, E. coli, H. influenzae (including ampicillin-resistant strains), and Klebsiella spp.
Sinusitis, acute bacterial (tablets and oral suspension only): Treatment of mild to moderate acute bacterial maxillary sinusitis caused by S. pneumoniae or H. influenzae (non-beta-lactamase-producing strains only).
Limitations of use: Effectiveness for sinus infections caused by beta-lactamase-producing H. influenzae or M. catarrhalis in patients with acute bacterial maxillary sinusitis has not been established. Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, Zamur 500mg is no longer recommended as monotherapy for initial empiric treatment (IDSA [Chow 2012]).
Skin and skin-structure infections (impetigo) (oral suspension only): Treatment of pediatric patients 3 months to 12 years of age with skin or skin-structure infections (impetigo) caused by S. aureus (including beta-lactamase-producing strains) or S. pyogenes.
Skin and skin-structure infections (injection; tablets [uncomplicated infections only]): Treatment of adults and pediatric patients >3 months of age with skin and skin-structure infections (including impetigo) caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pyogenes, E. coli, Klebsiella spp., and Enterobacter spp.
Surgical prophylaxis (injection only): Prophylaxis of infection in patients undergoing surgical procedures that are classified as clean-contaminated or potentially contaminated procedures.
Urinary tract infections (tablets and injection only): Treatment of adults and pediatric patients >3 months of age with urinary tract infections caused by E. coli and Klebsiella spp.
Off Label Uses
Bite wound, prophylaxis or treatment (animal or human bite)
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), Zamur 500mg, in combination with an agent appropriate for anaerobes, is an effective and recommended alternative option for prophylaxis and treatment of animal bite wounds.
Clinical experience also suggests the utility of Zamur 500mg as an alternative agent for prophylaxis and treatment of human bite wounds.
Intraabdominal infection, community-acquired (mild to moderate infection in low-risk patients)
Based on the Surgical Infection Society/IDSA guidelines for the diagnosis and management of complicated intraabdominal infection in adults and children, Zamur 500mg, in combination with metronidazole, is an effective and recommended empiric treatment option for the management of community-acquired intraabdominal infection, and, as monotherapy, for the management of mild to moderate acute cholecystitis.
Lyme disease (Borrelia spp. infection), early disseminated or late disease
Based on the IDSA guidelines for the clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis, Zamur 500mg is effective and recommended for the treatment of early disseminated Lyme disease (isolated facial nerve palsy [alternative agent] or mild carditis) or late Lyme disease (arthritis without neurologic involvement).
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What other drugs will affect Zamur 500mg?
Probenecid: Probenecid, when given together or right before administration with Zamur 500mg, slows down tubular secretion of Zamur 500mg and produces higher and more prolonged serum Zamur 500mg concentrations. This drug interaction is usually used beneficially in treating gonorrhea.
Zamur 500mg's peak serum concentrations and t½ are increased by up to 30% with concomitant administration of probenecid. Area under the concentration-time curve of Zamur 500mg is also increased by 50%. A decrease in Zamur 500mg's apparent volume of distribution by about 20% has been reported with concurrent administration of probenecid.
Aminoglycosides: The risk of nephrotoxicity may increase when aminoglycosides and cephalosphorins are given concomitantly. This has not been reported with Zamur 500mg use to date. Monitoring of the patient's renal function is advisable when these drugs are given together.
Diuretics: Studies suggest that the concomitant use of potent diuretics, including furosemide and ethacrynic acid, may increase the risk of renal toxicity with cephalosphorins. Renal impairment has been reported with concurrent treatment with potent diuretics eg, furosemide or aminoglycosides.
Oral Antacids:
Oral Contraceptives:
Interference with Laboratory Tests: A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling's solution, or with Clinitest tablets) but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood plasma glucose levels in patients receiving Zamur 500mg.
Positive direct antiglobulin (Coombs') test results have also been reported in a few patients receiving oral Zamur 500mg, however, it is not clear whether the mechanism of this reaction is immunologic in nature. This phenomenon can interfere with cross matching of blood.
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What are the possible side effects of Zamur 500mg?
Zamur 500mg (Zamur 500mg (Zamur 500mg injection) injection) is generally well tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely.
Local Reactions: Thrombophlebitis has occurred with IV administration in 1 in 60 patients.
Gastrointestinal: Gastrointestinal symptoms occurred in 1 in 150 patients and included diarrhea (1 in 220 patients) and nausea (1 in 440 patients). The onset of pseudomembranous colitis may occur during or after antibacterial treatment.
Hypersensitivity Reactions: Hypersensitivity reactions have been reported in fewer than 1% of the patients treated with Zamur 500mg (Zamur 500mg (Zamur 500mg injection) injection) and include rash (1 in 125). Pruritus, urticaria, and positive Coombs' test each occurred in fewer than 1 in 250 patients, and, as with other cephalosporins, rare cases of anaphylaxis, drug fever, erythema multiforme, interstitial nephritis, toxic epidermal necrolysis, and Stevens-Johnson syndrome have occurred.
Blood: A decrease in hemoglobin and hematocrit has been observed in 1 in 10 patients and transient eosinophilia in 1 in 14 patients. Less common reactions seen were transient neutropenia (fewer than 1 in 100 patients) and leukopenia (1 in 750 patients). A similar pattern and incidence were seen with other cephalosporins used in controlled studies. As with other cephalosporins, there have been rare reports of thrombocytopenia.
Hepatic: Transient rise in SGOT and SGPT (1 in 25 patients), alkaline phosphatase (1 in 50 patients), LDH (1 in 75 patients), and bilirubin (1 in 500 patients) levels has been noted.
Kidney: Elevations in serum creatinine and/or blood urea nitrogen and a decreased creatinine clearance have been observed, but their relationship to Zamur 500mg (Zamur 500mg (Zamur 500mg injection) injection) is unknown.
Postmarketing Experience with Zamur 500mg (Zamur 500mg (Zamur 500mg injection) injection) : In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with Zamur 500mg (Zamur 500mg (Zamur 500mg injection) injection) and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.
Neurologic: Seizure.
Non-site specific: Angioedema.
Cephalosporin-class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with Zamur 500mg (Zamur 500mg (Zamur 500mg injection) injection), the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Adverse Reactions: Vomiting, abdominal pain, colitis, vaginitis including vaginal candidiasis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, and hemorrhage.
Several cephalosporins, including Zamur 500mg (Zamur 500mg (Zamur 500mg injection) injection), have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Altered Laboratory Tests: Prolonged prothrombin time, pancytopenia, agranulocytosis.
Zamur 500mg (as axetil) (Zamur 500mg) 250 mg Tablet: Each tablet contains 250 mg of Zamur 500mg (as axetil).
Zamur 500mg (as axetil) (Zamur 500mg) 500 mg Tablet: Each tablet contains 500 mg of Zamur 500mg (as axetil).
Zamur 500mg (as axetil) (Zamur 500mg) 125 mg/5 mL Granules for Suspension: Each contains 125 mg Zamur 500mg (as axetil) per teaspoon (5 mL) of suspension.
Zamur 500mg (as axetil) (Zamur 500mg) 250 mg/5 mL Granules for Suspension: Each contains 250 mg Zamur 500mg (as axetil) per teaspoon (5 mL) of suspension.
Sachet: Zamur 500mg (as axetil) (Zamur 500mg) 125 mg Granules for Suspension: Each 4.22 g of single-use sachet contains 125 mg Zamur 500mg (as axetil).
However, we will provide data for each active ingredient