Cefixime (as cefixime trihydrate) .......................... 50 mg
Excipients q.s ...................................................... 1 sachet
Powder for oral suspension.
Box of 24 sachets x 0.75 g.
ATC code: J01DD08
The active ingredient of Hafixim 50 Kids is cefixime which is an oral third-generation cephalosporin antibiotic and has marked bactericidal activity. Bactericidal mechanism of cefixime is similar to that of other cephalosporins: Cefixime binds to target proteins (penicillin-binding proteins), resulting in inhibition of mucopeptide synthesis of the bacterial cell wall. The mechanism of bacterial resistance to cefixime is the reduction of affinity of cefixime to target proteins or the reduction of permeability of bacterial cell membranes to the drug.
Cefixime is stable against hydrolysis by many plasmid- and chromosomally medicated beta-lactamases. The drug generally is more stable than are cefaclor, cefoxitin, cefuroxime, cephalexin, and cephradin.
Cefixime is active against most of the following microorganisms, in vitro and in clinical infections:
Gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-negative bacteria: Haemophilus influenzae (beta-lactamase-producing and non-beta-lactamase-producing strains), Moraxella catarrhalis (most beta-lactamase-producing strains), Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae (penicillinase-producing or nonpenicillinase-producing strains).
Cefixime is also active in vitro against most of the following microorganisms, but their clinical significance is unknown:
Gram-positive bacteria: Streptococcus agalatiae.
Gram-negative bacteria: Haemophilus parainfluenzae (beta-lactamase-producing or non-beta-lactamase-producing strains), Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp, Salmonella spp, Shigella spp, Citrobacter amalonaticus, Citrobacter diversus, Serratica marcescens.
Cefixime is not active against Enterococcus, Staphylococcus, Pseudomonas aeruginosa, and most strains of Bacteroides and Clostridia.
Approximately 30% - 50% of a single dose of cefixime is absorbed by the gastrointestinal tract, whether taken before or after meals. The half-life of cefixime is usually about 3 to 4 hours and may be prolonged when there is renal impairment. About 65% of cefixime in blood is bound to plasma proteins. It crosses the placenta. Relatively high concentrations may be achieved in bile and urine. Approximately 20% of an oral dose is excreted unchanged in urine within 24 hours. Up to 60% may be eliminated by nonrenal mechanisms. The drug is not cleared significantly from the blood by hemodialysis.
Cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, including anaphylaxis have been reported in some patients on cefixime. When cutaneous adverse reactions occur, cefixime should be discontinued and appropriate therapy should be taken.
Cefixime should be given with caution to patients with a history of hypersensitivity to penicillin and cephalosporins.
Haemolytic anaemia has been described for cefixime.
Because serum concentrations of cefixime are higher and more prolonged in patients with renal impairment than in patients with normal renal function, doses and/or frequency of administration of the drug should be decreased in patients with impaired renal function, including those undergoing hemodialysis.
Safety and efficacy of cefixime in children younger than 6 months of age have not been established.
Cefixime should be used with caution in patients with a history of GI disorders and colitis. Prolonged use of cefixime may result in overgrowth of drug-resistant bacteria, particularly Clostridium difficile which is a primary cause of severe diarrhoea. The cefixime therapy should be discontinued and other antibiotics (metronidazole, vancomycin, etc.) should be substituted. In addition, diarrhea generally appears during the first or second day of cefixime therapy. If the diarrhea state is mild, the cefixime therapy does not require to discontinue. Cefixime also alters intestinal bacteria flora. Modification of the usual dosage of cefixime generally is not necessary in geriatric adults, unless renal function is substantially impaired (creatinine clearance < 60 ml/ min).
Pregnancy and lactation:
No evidence of harm to the foetus due to cefixime has revealed. This drug should be used during pregnancy only if clearly needed.
It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinue nursing temporarily during treatment with this drug.
Effects on works:
Cautions should be exercised in drivers, machine users, workers at height, and other cases.
Concomitant administration of probenecid reportedly increases peak serum concentration and the AUC of cefixime and decreases renal clearance and volume distribution of the drug.
Cefixime enhances the effect of an anticoagulant (e.g., warfarin). Concomitant administration of cefixime and carbamazepine has resulted in increased plasma carbamazepine concentrations.
The administration of cefixime may be result in a false-positive reaction for glucose in the urine using Clinitest, Benedict's solution, or Fehling's solution.
A false-positive direct Coombs test has been reported during treatment with cefixime.
Concomitant administration of cefixime and nifedipine increases bioavailability of cefixime as a result of higher peak plasma concentrations and AUC.
Common:
GI effects: GI disorders, including diarrhea, abdominal pain, nausea, vomiting, flatulence, loss of appetite, dry mouth. Nervous system effects: headache, dizziness, nervousness, insomnia, fatigue. Hypersensitivity: erythema, urticaria.
Uncommon:
GI effects: Clostridium difficile-associated severe diarrhea and pseudomembranous colitis. Systemic effects: anaphylaxis, angioedema, Stevens - Johnson syndrome, erythema multiforme, toxic epidermal necrosis. Hematologic effects: thrombocytopenia, leukopenia, transient eosinophilia; decreased hemoglobin concentration and hematocrit. Hepatic effects: hepatitis and jaundice; transient increases in AST, ALT, alkaline phosphatase, bilirubin and LDH. Renal effects: acute renal failure, temporary increases in blood non-protein nitrogen and plasma creatinine concentration. Other adverse effects: vaginitis and vaginal candidiasis.
Rare:
Hematologic effects: prolonged prothrombin time. Systemic effects: seizures.
Symptoms of cefixime overdosage may be seizures. Due to no specific drugs, symptomatic treatment is necessary. In case of overdosage, the drug should be immediately discontinued and gastric lavage is indicated, and the anticoagulants can be also employed with clinical recommendation. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
Store in dry places, not exceeding 30oC, protect from light.
36 months from the manufacturing date.
SIGNS AND RECOMMENDATIONS SHOULD BE NOTED:
Read the directions carefully before use.
For more information, please consult a physician.
This drug is for prescription only.
Note: The suspension should be orally taken right after dissolved.
Once opened, the drug sachet should be closed tightly; avoid desiccation to ensure drug quality.
Cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, including anaphylaxis have been reported in some patients on cefixime. When cutaneous adverse reactions occur, cefixime should be discontinued and appropriate therapy should be taken.
Cefixime should be given with caution to patients with a history of hypersensitivity to penicillin and cephalosporins.
Haemolytic anaemia has been described for cefixime.
Because serum concentrations of cefixime are higher and more prolonged in patients with renal impairment than in patients with normal renal function, doses and/or frequency of administration of the drug should be decreased in patients with impaired renal function, including those undergoing hemodialysis.
Safety and efficacy of cefixime in children younger than 6 months of age have not been established.
Cefixime should be used with caution in patients with a history of GI disorders and colitis. Prolonged use of cefixime may result in overgrowth of drug-resistant bacteria, particularly Clostridium difficile which is a primary cause of severe diarrhoea. The cefixime therapy should be discontinued and other antibiotics (metronidazole, vancomycin, etc.) should be substituted. In addition, diarrhea generally appears during the first or second day of cefixime therapy. If the diarrhea state is mild, the cefixime therapy does not require to discontinue. Cefixime also alters intestinal bacteria flora. Modification of the usual dosage of cefixime generally is not necessary in geriatric adults, unless renal function is substantially impaired (creatinine clearance < 60 ml/ min).
Pregnancy and lactation:
No evidence of harm to the foetus due to cefixime has revealed. This drug should be used during pregnancy only if clearly needed.
It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinue nursing temporarily during treatment with this drug.
Effects on works:
Cautions should be exercised in drivers, machine users, workers at height, and other cases.
For the treatment of infections caused by susceptible bacteria, including:
Otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes. Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae or Haemophilus influenzae or Moraxella catarrhalis.
Mild to moderate community-acquired pneumonia.
Uncomplicated urinary tract infections caused by E. coli or Proteus mirabilis.
Some cases of pyelonephritis and complicated urinary tract infections caused by susceptible Enterobacteriaceae, but the treatment results are lower than those of uncomplicated urinary tract infections.
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae; typhoid caused by Salmonella typhi; dysentery caused by susceptible Shigella.
It is required to isolate bacteria and make antibiogram. Antibiotic therapy may be started pending results of antibiogram, but appropriate therapy instituted if the result of antibiogram is given.
Hypersensitivity to any of the ingredients of the drug.
Patients with known hypersensitivity to beta-lactam antibiotics.
Dissolve the drug in sufficient amount of water (about 5 - 10 ml for one sachet), stir well before oral administration. The drug may be administered before or after a meal.
The duration of cefixime therapy depends on the type of infection; but therapy with the drug generally should be continued for at least 48 - 72 hours after evidence of eradication of the infection is obtained. The usual duration of cefixime therapy is 5 - 10 days (If cefixime is used in the treatment of infections caused by group A beta-hemolytic streptococci, therapy should be continued for at least 10 days to prevent rheumatic heart). For lower respiratory infections and otitis media, the treatment duration is 10 -14 days.
The safety and efficacy of cefixime have not been established in children less than 6 months.
Children aged more than 6 months up to 12 years: The recommended dosage is 8 mg/kg body weight/day administered as a single dose or in two divided doses every 12 hours.
Adults and children over 12 years: The recommended dosage is 400 mg daily given either as a single dose or in two divided doses every 12 hours. These subjects should find a suitable dosage form.
For the treatment of uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including beta-lactamase-producing strains), a single 400-mg dose of cefixime is recommended. Higher single doses of cefixime (e.g., 800 mg) also have been used.
Dosage in renal impairment: Adults with creatinine clearances of 21 - 60 ml/minute should receive 300 mg of cefixime daily, and adults with creatinine clearances less than 20 ml/minute should receive 200 mg of cefixime daily.
Or as directed by the physician.
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