Kefsyn/Kefsyn 750

Kefsyn/Kefsyn 750

cefuroxime

Manufacturer:

GXI

Distributor:

Metro Drug
Full Prescribing Info
Contents
Kefsyn: Cefuroxime axetil.
Kefsyn 750: Cefuroxime sodium.
Description
Kefsyn FC tab: White, elongated, biconvex, on one side scored and plain on the other side film-coated tablets.
Each film-coated tablet contains: Cefuroxime Axetil, BP eq. to Cefuroxime 500 mg.
Kefsyn granules for oral susp: Cefuroxime (as axetil) (KEFSYN) 250 mg/5 mL granules for oral suspension when reconstituted gives a pink suspension with white spheroidal granules and strawberry flavored containing 250 mg Cefuroxime (as axetil) per teaspoonful (5 mL) of suspension.
Each 5 mL of reconstituted suspension contains: Cefuroxime (as axetil), USP 250 mg.
Kefsyn 750: Faintly yellow powder.
Each vial contains: Cefuroxime (as sodium), USP 750 mg.
Each ampoule contains: Sterile Water for Injection, BP 10 mL.
Action
Kefsyn FC tab: Pharmacotherapeutic group: Antibacterials for systemic use, second-generation cephalosporins.
Pharmacology: In vivo bactericidal activity of Cefuroxime is due to Cefuroxime's binding to essential target proteins and the resultant inhibition of cell wall synthesis.
Cefuroxime has bactericidal activity against a wide range of common pathogens, including many beta-lactamase-producing strains. Cefuroxime is stable to many bacterial beta-lactamases, especially plasmid-mediated enzymes that are commonly found in enterobacteriaceae.
Pharmacodynamics: Mechanism of action: Cefuroxime axetil owes its in vivo bactericidal activity to the parent compound Cefuroxime. Cefuroxime is a well characterised and effective antibacterial agent which has bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains.
Cefuroxime has good stability to bacterial β-lactamase, and consequently is active against many ampicillin-resistant or amoxicillin-resistant strains.
The bactericidal action of Cefuroxime results from inhibition of cell wall synthesis by binding to essential target proteins.
Pharmacokinetics: Cefuroxime is absorbed from the gastrointestinal tract and is rapidly hydrolysed in the intestinal mucosa and blood to release Cefuroxime; absorption is enhanced in the presence of food. Peak plasma concentrations are reported about 2 to 3 hours after an oral dose.
The sodium salt is given by intramuscular or intravenous injection. Peak plasma concentrations of about 27 micrograms/mL have been achieved 45 minutes after an intramuscular dose of 750 mg with measurable amounts present 8 hours after a dose. Up to 50% of Cefuroxime in the circulation is bound to plasma proteins.
The plasma half-life is about 70 minutes and is prolonged in patients with renal impairment and in neonates. Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid, and aqueous humour, but only achieves therapeutic concentrations in the CSF when the meninges are inflamed. It crosses the placenta and has been detected in breast milk.
Cefuroxime is excreted unchanged, by glomerular filtration and renal tubular secretion, and high concentrations are achieved in the urine. On injection, most of the dose of Cefuroxime is excreted within 24 hours, the majority within 6 hours. Probenecid competes for renal tubular secretion with Cefuroxime resulting in higher and more prolonged plasma concentrations of Cefuroxime.
Small amounts of cefuroxime are excreted in bile.
Plasma concentrations are reduced by dialysis.
Kefsyn granules for oral susp: Pharmacology: Pharmacodynamics: Bacteriology: Cefuroxime axetil owes its in vivo bactericidal activity to the parent compound, cefuroxime. Cefuroxime is a well-characterized and effective antibacterial agent which has bactericidal activity against a wide range of common pathogens, including beta-lactamase producing strains. Cefuroxime has good stability to bacterial beta-lactamase, and consequently is active against many ampicillin-resistant or amoxicillin-resistant strains. The bactericidal action of cefuroxime results from inhibition of cell wall synthesis by binding to essential target proteins.
Cefuroxime is usually active against the following organisms in vitro: Aerobes Gram-negative: Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae (including penicillinase and non-penicillinase producing strains), Escherichia coli, Klebsiella spp, Proteus mirabilis, Providencia spp, Proteus rettgeri.
Aerobes Gram-positive: Staphylococcus aureus (including penicillinase producing strains, excluding methicillin-resistant strains), Staphylococcus epidermidis (including penicillinase producing strains, excluding methicillin-resistant strains), Streptococcus pyogenes (and other beta-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus Group B (Streptococcus agalactiae).
Anaerobes: Gram-positive cocci and Gram-negative cocci (including Peptococcus and Peptostreptococcus species), Gram-positive bacilli (including Clostridium species), Gram-negative bacilli (including Bacteroides and Fusobacterium species), Propionibacterium spp.
Other organisms: Borrelia burgdorferi.
The following organisms are not susceptible to cefuroxime: Clostridium difficile, Pseudomonas spp, Campylobacter spp, Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, Legionella spp.
Some strains of the following genera are not susceptible to cefuroxime: Enterococcus (Streptococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp, Citrobacter spp, Serratia spp, Bacteroides fragilis.
Pharmacokinetics: After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed in the intestinal mucosa and blood to release cefuroxime into the circulation. Optimum absorption occurs when it is administered shortly after meal. Following administration of cefuroxime axetil tablets, peak serum levels (2.9 mg/L for a 125 mg dose, 4.4 mg/L for a 250 mg dose, 7.7 mg/L for a 500 mg dose and 13.6 mg/L for a 1 g dose) occur approximately 2.4 hours after the dosing when taken with food. Absorption of cefuroxime axetil suspension is enhanced in the presence of food. The rate of absorption of cefuroxime from the suspension compared with the tablets is reduced, leading to later, lower peak serum levels and slightly reduced systemic bioavailability (4%-17% less). The serum half-life is between 1 and 1.5 hours. Protein-binding has been variously stated as 33%-50% depending on the methodology used. Cefuroxime is not metabolized and is excreted by glomerular filtration and tubular secretion. Concurrent administration of probenecid increases the area under the mean serum concentration-time curve by 50%. Serum levels of cefuroxime are reduced by dialysis.
Toxicology: Preclinical Safety Data: Animal toxicity studies indicated that cefuroxime axetil is of low toxicity with no significant findings.
Kefsyn 750: Pharmacotherapeutic group: Antibacterials for systemic use, second-generation cephalosporins.
Pharmacology: Mechanism of action: Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin-binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.
Pharmacokinetics: The sodium salt is given by intramuscular or intravenous injection. Peak plasma concentrations of about 27 micrograms/mL have been achieved 45 minutes after an intramuscular dose of 750 mg with measurable amounts present 8 hours after a dose. Up to 50% of Cefuroxime in the circulation is bound to plasma proteins. The plasma half-life is about 70 minutes and is prolonged in patients with renal impairment and in neonates.
Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid, and aqueous humour, but only achieves therapeutic concentrations in the CSF when the meninges are inflamed. It crosses the placenta and has been detected in breast milk.
Cefuroxime is excreted unchanged, by glomerular filtration and renal tubular secretion, and high concentrations are achieved in the urine. On injection, most of the dose of Cefuroxime is excreted within 24 hours, the majority within 6 hours. Probenecid competes for renal tubular secretion with Cefuroxime resulting in higher and more prolonged plasma concentrations of Cefuroxime. Small amounts of cefuroxime are excreted in bile.
Plasma concentrations are reduced by dialysis.
Indications/Uses
Kefsyn FC tab/Kefsyn 750: Used in the treatment of susceptible infections such as bone and joint infections, bronchitis (and other lower respiratory tract infections), gonorrhea, meningitis (although treatment failures have been reported in H. influenzae meningitis), otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft-tissue infections), and urinary tract infections. It is also used for surgical infection prophylaxis.
Kefsyn granules for oral susp: For the treatment of lower and upper respiratory tract infections, genitourinary tract infections, skin and soft tissue infections and gonorrhea.
Dosage/Direction for Use
Kefsyn FC tab: For Uncomplicated Urinary Tract Infections: 125 mg twice daily.
For Respiratory Tract Infections: 250 to 500 mg twice daily.
A dose for children more than 3 months of age: 125 mg twice daily or 10 mg/kg twice daily to a maximum of 250 mg daily.
Children over 2 years of age with otitis media: 250 mg twice daily or 15 mg/kg twice daily to a maximum of 500 mg daily.
Adults with Pneumonia or with Acute Exacerbations of Chronic Bronchitis: 1.5 g twice daily or 750 mg twice daily, respectively, in parenteral route followed by oral Cefuroxime 500 mg twice daily in each case.
For Lyme disease in adults: 500 mg is given twice daily for 20 days.
For Uncomplicated Gonorrhea: A single 1 g oral dose of Cefuroxime can be given. In each case an oral dose of Probenecid 1 g may be given with Cefuroxime. Or as prescribed by the physician.
Kefsyn granules for oral susp: The usual course of therapy is seven days. (Range 5-10 Days.)
For optimal absorption cefuroxime axetil should be taken with food.
Adults: Most infections: 250 mg BID.
Urinary tract infections: 125 mg BID.
Mild to moderate lower respiratory tract infections e.g. bronchitis: 250 mg BID.
More severe lower respiratory tract infections, or if pneumonia is suspected: 500 mg BID.
Pyelonephritis: 250 mg BID.
Uncomplicated gonorrhoea: Single dose 1 g.
Children: When prescription of a fixed dose is preferred, the recommended dose for most infections is 125 mg twice daily. In children aged two years or older with otitis media or where appropriate, with more severe infections the dose is 250 mg twice daily, to a maximum of 500 mg daily. There is no clinical trial data available on the use of Cefuroxime axetil (KEFSYN) in children under the age of 3 months. In infants and children, it may be preferable to adjust dosage according to weight or age. The dose in infants and children 3 months to 12 years is 10 mg/kg twice daily for most infections to a maximum of 250 mg daily. In otitis media or more severe infections the recommended dose is 15 mg/kg twice daily to a maximum of 500 mg daily. The following two tables divided by age group and weight serve as a guideline for simplified administration from measuring spoons (5 mL) for the 125 mg/5 mL or the 250 mg/5 mL suspension.
10 mg/kg dosage for most infections: See Table 1.

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15 mg/kg dosage for otitis media and more serious infections: See Table 2.

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To enhance compliance and improve the dosing accuracy in very young children, a dosing syringe can be used with amber bottle containing 50 mL of suspension. However, dosing in spoonfuls should be considered a more favorable option if the child is able to take the medication from the spoon. If required, the dosing syringe may also be used in older children (see dosing tables as follows). The recommended doses for the pediatric dosing syringe are expressed in mL or mg and according to bodyweight in Tables 3 and 4 as follows. (See Tables 3 and 4.)
10 mg/kg/dose (Pediatric dosing syringe): See Table 3.

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15 mg/kg/dose (Pediatric dosing syringe): See Table 4.

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Cefuroxime is also available as the sodium salt for parenteral administration. This permits parenteral therapy with cefuroxime to be followed by oral therapy in situations where a change from parenteral to oral treatment is clinically indicated.
Kefsyn 750: Cefuroxime may be administered intravenously or intramuscularly.
Adults: The usual dose of Cefuroxime is 750 mg three times daily by I.M. or I.V. Injection, which may be increased to 1.5 g three times daily I.V. in severe infections. The frequency of administration can be increased to six-hourly, if necessary, giving total doses of 3 g to 6 g daily.
Infants and children: 30 to 60 mg/kg/day increased to 100 mg/kg daily, if necessary, given as three or four divided doses. A dose of 60 mg/kg/day will be appropriate for most infections.
Elderly: As prescribed by the physician.
Dosage in impaired renal function: As Cefuroxime is excreted by the kidneys, the dosage of Cefuroxime should be reduced in patients with creatinine clearance below 20 mL/min, 750 mg twice daily is recommended and with 10 mL/min, 750 mg once daily is adequate. For patients on hemodialysis, a further 750 mg dose should be given at the end of each dialysis. In case of continuous peritoneal dialysis, 750 mg twice daily is recommended.
Overdosage
Kefsyn FC tab: Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment.
Serum levels of Cefuroxime can be reduced by haemodialysis and peritoneal dialysis.
Kefsyn granules for oral susp/Kefsyn 750: Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of Cefuroxime can be reduced by hemodialysis or peritoneal dialysis.
Contraindications
Cefuroxime is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics.
Warnings
Kefsyn 750: Before instituting therapy with Cefuroxime, careful history of hypersensitivity reactions to Cefuroxime, cephalosporins, penicillins or other drugs should be obtained. Therefore, caution should be exercised while treating such patients, as cross sensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.
If an allergic reaction to Cefuroxime occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Cefuroxime, and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia, such as, Clostridium difficile which is a primary cause of "antibiotic-associated colitis". In case of the occurrence of pseudomembranous colitis, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against Clostridium difficile.
Special Precautions
Kefsyn FC tab: Hypersensitivity reactions: Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity. As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with Cefuroxime must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to Cefuroxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if Cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
Jarisch-Herxheimer reaction: The Jarisch-Herxheimer reaction has been seen following Cefuroxime axetil treatment of Lyme disease. It results directly from the bactericidal activity of Cefuroxime axetil on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.
Overgrowth of non-susceptible microorganisms: As with other antibiotics, use of Cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. Enterococci and Clostridium difficile), which may require interruption of treatment. Antibacterial agent-associated pseudomembranous colitis have been reported with nearly all antibacterial agents, including Cefuroxime and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhea during or subsequent to the administration of Cefuroxime. Discontinuation of therapy with Cefuroxime and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Interference with diagnostic tests: The development of a positive Coombs Test associated with the use of Cefuroxime may interfere with cross matching of blood. As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime axetil.
Cefuroxime axetil should be given with caution to patients with renal impairment, dosage reduction may be necessary.
Renal and haematological status should be monitored especially during prolonged and high dose therapy.
Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop serious diarrhea during or after antibiotic use.
Kefsyn granules for oral susp: Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams. As with other antibiotics, use of Cefuroxime axetil (KEFSYN) may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible organisms (e.g. Enterococci and Clostridium difficile), which may require interruption of treatment. Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop serious diarrhea during or after antibiotic use. The sucrose content of Cefuroxime axetil (KEFSYN) suspension and granules should be taken into account when treating diabetic patients, and appropriate advice provided. Cefuroxime axetil (KEFSYN) contains aspartame, which is a source of phenylalanine and so should be used with caution in patients with phenylketonuria.
Ability to perform tasks that require judgement, motor or cognitive skills: As this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.
Kefsyn 750: Although Cefuroxime rarely produces alterations in kidney function, evaluation of renal status during treatment is recommended, especially in patients receiving the maximum doses.
Cephalosporins should be given with caution to patients receiving concurrent diuretics. Caution is advised in patients with marked to severe renal impairment; reduced dosages should be administered. As with other antibiotics, prolonged use of Cefuroxime results in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential.
In case superinfection occurs, appropriate measures should be taken.
Use in Children: Safety and effectiveness of Cefuroxime in children below 3 months of age have not been established.
Use In Pregnancy & Lactation
Kefsyn FC tab: Pregnancy: Cefuroxime axetil should be administered with caution during the early months of pregnancy. This drug should be used during pregnancy only, if clearly needed.
Cefuroxime is excreted in human milk, and consequently caution should be exercised when Cefuroxime axetil is administered to a nursing mother.
Kefsyn granules for oral susp: There is no experimental evidence of embryophatic or teratogenic effects attributed to cefuroxime axetil but, as with all drugs it should be administered with caution during early months of pregnancy. Cefuroxime is excreted in human milk, and consequently caution should be exercised when cefuroxime axetil is administered to a nursing mother.
Kefsyn 750: As there are no well-controlled clinical trials of Cefuroxime in pregnant women, it should be administered only, if necessary and with caution.
Cefuroxime is excreted in human milk, and consequently caution should be exercised when Cefuroxime axetil is administered to a nursing mother.
Adverse Reactions
Kefsyn FC tab: Gastrointestinal disturbances, including diarrhea, nausea, and vomiting, have occurred in some patients receiving Cefuroxime axetil.
There have been rare reports of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Mild to moderate hearing loss has been reported in some children given Cefuroxime for the treatment of meningitis.
Kefsyn granules for oral susp: Adverse drug reactions to cefuroxime axetil are generally mild and transient in nature. The frequency categories assigned to the adverse reactions as follows are estimates, as for most reactions suitable data (for example, from placebo-controlled studies) for calculating incidence were not available. In addition, the incidence of adverse reactions associated with cefuroxime axetil may vary according to the indication. Data from large clinical studies were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (eg, those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency. Placebo-controlled trial data were not available. Where incidences have been calculated from clinical trial data, these were based on drug-related (investigator assessed) data.
The following convention has been used for the classification of frequency: Very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and <1/100), rare (>1/10,000 and <1/1,000), very rare (<1/10,000).
Infections and infestations: Common: Overgrowth of Candida.
Blood and lymphatic system disorders: Common: Eosinophilia. Uncommon: Positive Coombs' test, thrombocytopenia, leucopenia (sometimes profound). Very rare: Hemolytic anemia.
Cephalosporins as a class, tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coombs' test (which can interfere with cross-matching of blood) and very rarely, hemolytic anemia.
Immune system disorders: Hypersensitivity reactions including: Uncommon: Skin rashes. Rare: Urticaria, pruritus. Very rare: Drug fever, serum sickness, anaphylaxis.
Nervous system disorders: Common: Headache, dizziness.
Gastrointestinal disorders: Common: Gastrointestinal disturbances including diarrhoea, nausea, abdominal pain. Uncommon: Vomiting. Rare: Pseudomembranous colitis.
Hepatobiliary disorders: Common: Transient increase in hepatic enzyme levels [ALT (SGPT), AST (SGOT), LDH]. Very rare: Jaundice (predominantly cholestatic), hepatitis.
Skin and subcutaneous tissue disorders: Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis). See also immune system disorders.
Kefsyn 750: Cefuroxime is generally well tolerated. Adverse reactions have been generally mild and transient in nature.
Local reactions: Transient pain at the site of intramuscular injection, which is more likely to occur with higher doses.
Hypersensitivity reactions: Skin rashes (maculopapular and urticaria), drug fever and very rarely anaphylaxis have been reported.
Gastrointestinal: Diarrhea and nausea. Pseudomembranous colitis may occur during or after treatment.
Blood: Decreased hemoglobin concentration and/or eosinophilia, leukopenia and neutropenia may occur. As with other cephalosporins, there have been very rare reports of thrombocytopenia.
Hepatic: Transient rise in serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT), and bilirubin may occur.
Drug Interactions
Kefsyn FC tab: Probenecid reduces the renal clearance of Cefuroxime.
Kefsyn granules for oral susp: Drugs that reduce gastric acidity may result in lower bioavailability of Cefuroxime axetil (KEFSYN) compared with that of the fasting state and tend to cancel the effect of enhanced absorption after meal. In common with other antibiotics, Cefuroxime axetil (KEFSYN) may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives. As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. This antibiotic does not interfere in the alkaline picrate assay for creatinine.
Kefsyn 750: Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics, like furosemide and aminoglycosides, as these combinations are suspected of adversely affecting renal function, though this is not likely to be a problem at the recommended dose levels.
Caution For Usage
Kefsyn granules for oral susp: Instructions for Use/Handling/Direction for Reconstitution: Always shake the bottle vigorously before taking the medication. The reconstituted suspension when refrigerated between 2°C and 8°C can be kept for up to 14 days and 7 days at 30°C. If desired, Cefuroxime axetil (KEFSYN) suspension can be further diluted from amber bottle in cold juices or milk drinks and should be taken immediately.
Directions for reconstituting suspension in amber bottles: 1. Shake the bottle to loosen the granules. Remove the cap.
2. Add the total amount of water to the bottle as stated on its label. Replace the cap.
3. Invert the bottle and rock vigorously (for at least 15 seconds).
4. Turn the bottle into an upright position and shake vigorously.
5. Refrigerate immediately at between 2°C and 8°C.
6. In using a dosage syringe, allow the reconstituted suspension to stand for at least one hour before taking the first dose. The reconstituted suspension or granules should not be mixed with hot liquids.
Kefsyn 750: Direction for Reconstitution: Intramuscular Injection: Add 3 mL of sterile water for injection and shake gently for dispersion.
Intravenous Injection: Add 6 mL of sterile water for injection and shake gently for dispersion. Reconstituted solution stored at temperature not exceeding 30°C should be used within 24 hours. Reconstituted solution stored at refrigerated condition (2°C to 8°C) should be used within 7 days.
Storage
Kefsyn FC tab/Kefsyn 750: Store at temperatures not exceeding 30°C.
Kefsyn granules for oral susp: Cefuroxime axetil (KEFSYN) granules for oral suspension in amber bottles should be stored at temperatures not exceeding 30°C. The reconstituted suspension must be refrigerated immediately at between 2°C and 8°C, and can be kept for up to 14 days and 7 days at 30°C. Further diluted suspension added in children's cold fruit juices or milk should be taken immediately.
MIMS Class
Cephalosporins
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Kefsyn FC tab 500 mg
Packing/Price
10's (P63.72/film-coated tab)
Form
Kefsyn granules for oral susp 250 mg/5 mL
Packing/Price
50 mL x 1's (P444.67/box)
Form
Kefsyn 750 powd for inj 750 mg
Packing/Price
1's (P362.88/box)