Pancef, 100mg/5ml suspension 100ml/53g

Composition

100 ml of suspension contains the Active ingredient:

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

Auxiliary substances:

sucrose,

xanthan gum,

sodium benzoate,

orange flavor.

Pharmacological action

Cephalosporin antibiotic of the third generation for parenteral use.

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

Highly active against Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis (including beta-lactamase producing strains), Escherichia coli, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Klebsiella pneumoniae, Klebsiella 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 strains of Staphylococcus, Enterobacter and Clostridium are resistant to cefixime.

Pharmacokinetics:  

When taken orally, the bioavailability is 40-50%. Food increases the maximum absorption time by 0.8 h. TCmax – 2-6 h for tablets and suspensions of 400 mg / 5 ml and 2-5 h for suspensions of 200 mg/5 ml. Cmax after oral use of 100,200 and 400 mg-1-1.3,2-3 and 3.5-4.4 mcg / 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 in the treatment of otitis media).

Cmax in the urine after use at doses of 100,200 and 400 mg is 73,107 and 164 mcg / ml, respectively. High concentrations of the drug persist for a long time in the blood serum, bile, and urine. T1 / 2 – 3-4 hours, with renal insufficiency-6.4-11.5 hours. Volume of distribution-0.11 l / kg.

Plasma protein binding is 65-70%. Excreted by the kidneys in unchanged form-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 (up to 6 months), pregnancy, lactation. With caution. Advanced age, kidney failure, colitis (in the anamnesis), pregnancy.

Side effects

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

Nervous system disorders: 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.

Hematopoietic disorders: pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bleeding.

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

Other: candidiasis, hypovitaminosis B development, shortness of breath.

How to take, course of use and dosage

Inside. In the average daily dose for adults and children over 12 years of age with a body weight of more than 50 kg-400 mg 1 time a day or 200 mg 2 times a day. The daily dose for children weighing less than 50 kg is 3-9 mg / kg; if necessary, the dose can be increased to 12 mg/kg. Frequency of use for adults-2 times; for 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 1 time a day or 4 mg / kg every 12 hours. For children aged 5-11 years, the daily dose of suspension is 6-10 ml, at the age of 2-4 years-5 ml, at the age of 6 months to 1 year-2.5-4 ml.

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

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

Method of preparation of the suspension: turn the bottle upside down and shake the powder. Add 40 ml of chilled boiled water in 2 steps and shake until a homogeneous suspension is formed. After that, it is necessary to allow the suspension to settle for 5 minutes to ensure complete dissolution of the powder. Shake the finished 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. If an allergic reaction occurs, stop using the drug and, if necessary, take appropriate measures.

As with other antibacterial agents, 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 developing pseudomembranous colitis.

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

Form of production

Pellets for suspension preparation.

Active ingredient

Cefixime

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Description

Children as prescribed by a doctor

Indications

Otitis Media, Tonsillitis, Urinary Tract Infections, Sinusitis, Bronchitis, Sore Throat, Pharyngitis