Pancef (Cefixim)suspension 100 mg / 5 ml 100 ml / 53 g

Alkaloid AD Skopje, Republic of Northern Macedonia

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Product Overview

Structure

100 ml of suspension contain the active substance:

cefixime (as cefixime trihydrate) 2,000 g-2,238 g


Excipients:

sucrose

xanthan gum,

sodium benzoate,

flavoring orange.

pharmachologic effect

3rd generation cephalosporin antibiotic for parenteral use. 


It acts bactericidal (disrupts the synthesis of the cell wall of microorganisms). It has a wide spectrum of action, which includes various aerobic and anaerobic gram-positive and gram-negative microorganisms, including Pseudomonas aeruginosa. Resistant to beta-lactamases of both gram-positive and gram-negative microorganisms.


It is highly active against Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis (including strains producing beta-lactamases), Escherichia coli, Proteusella gibelis bacteria, oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter spp. (including Citrobacter diversus), Serratia marcescens.


Pseudomonas spp., Acinetobacter spp., Some strains of Streptococcus, Enterococcus spp. (methicillin resistant strains), Listeria monocytogenes, Bacteroides fragilis, most of the strains of Staphylococcus, Enterobacter and Clostridium are resistant to cefixime.


Pharmacokinetics: 

When administered, bioavailability is 40-50%. Food increases the maximum absorption time by 0.8 hours. TCmax - 2-6 hours for tablets and suspension 400 mg / 5 ml and 2-5 hours for suspension 200 mg / 5 ml. Cmax after oral administration of 100, 200 and 400 mg - 1-1.3, 2-3 and 3.5-4.4 μg / ml, respectively. After taking the suspension, Cmax is 25-50% higher (due to the difference in bioavailability, it is not recommended to replace the suspension with tablets during treatment of otitis media).


Cmax in the urine after administration in doses of 100, 200 and 400 mg - 73, 107 and 164 μg / ml, respectively. High concentrations of the drug persist for a long time in blood serum, bile, and urine. T1 / 2 - 3-4 hours, with renal failure - 6.4-11.5 hours. Distribution volume - 0.11 l / kg.


Communication with plasma proteins - 65-70%. It is excreted by the kidneys unchanged - 50%, with bile - 10%.

Indications

Bacterial infections of the upper and lower respiratory tract (pharyngitis, tonsillitis, sinusitis, acute bronchitis and exacerbation of chronic bronchitis), urinary tract (uncomplicated); otitis media, uncomplicated gonorrhea of ​​the urethra and cervix.

Contraindications

Hypersensitivity, including to penicillins, penicillamine, children's age (up to 6 months), pregnancy, lactation. 
Carefully. Elderly age, renal failure, colitis (history), pregnancy.

Side effects

Allergic reactions: urticaria, skin hyperemia, pruritus, genital itching, eosinophilia, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome).


From the nervous system: headache, dizziness, tinnitus.


From the genitourinary system: vaginitis.


From the urinary system: impaired renal function, interstitial nephritis.


From the digestive system: nausea, vomiting, stomatitis, diarrhea, abdominal pain, constipation, pseudomembranous colitis, dysbiosis, cholestasis; cholestatic jaundice.


From the hemopoietic organs: pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bleeding.


Laboratory indicators: increased activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia, increased urea nitrogen, hypercreatininemia, increased prothrombin time.


Other: candidiasis, development of vitamin B deficiency, shortness of breath.

How to take, course of administration and dosage

Inside. In the average daily dose for adults and children over 12 years old with a body weight of more than 50 kg - 400 mg once a day or 200 mg 2 times a day.
The daily dose for children with body weight less than 50 kg is 3-9 mg / kg; if necessary, the dose can be increased to 12 mg / kg. Multiplicity of appointment for adults - 2 times; children - 2-3 times a day. The average duration of treatment is 7-10 days.


Children under 12 years of age are prescribed as a suspension, at a dose of 8 mg / kg once a day or 4 mg / kg every 12 hours.
For children aged 5-11 years, the daily dose of the suspension is 6-10 ml, aged 2-4 years - 5 ml, aged 6 months to 1 year - 2.5-4 ml.


For diseases caused by Streptococcus pyogenes, the course of treatment is at least 10 days.
With uncomplicated gonorrhea of ​​the urethra and cervix, 400 mg once.


In case of impaired renal function, the dose is set depending on the level of QC in serum: with QC of 21-60 ml / min or in patients on hemodialysis, the daily dose should be reduced by 25%; with CC of 20 ml / min or less, or in patients undergoing peritoneal dialysis, the daily dose should be reduced by 2 times.


Method of suspension: turn the bottle over and shake the powder. Add 40 ml of chilled boiled water in 2 stages and shake until a homogeneous suspension is formed. After this, it is necessary to allow the suspension to settle for 5 minutes to ensure complete dissolution of the powder. Shake the prepared suspension well before use.

Overdose

Treatment: gastric lavage.

Hemodialysis and peritoneal dialysis are ineffective.

Special instructions

Patients who have had a history of allergic reactions to penicillins may be hypersensitive to cephalosporin antibiotics. In case of an allergic reaction, it is necessary to stop the use of the drug and, if necessary, take appropriate measures.


As with other antibacterial drugs, prolonged use of cefixime can lead to the growth of Clostridium difficile, which is manifested by the development of severe diarrhea. In this case, it is especially important to consider the possibility of developed pseudomembranous colitis.

During treatment, a false positive direct Coombs reaction and a false positive urine reaction to glucose, ketonuria are possible.

Release form

Granules for suspension.

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