LEKSANIR [Cefixime] 100 mg/5 ml Powder for suspension
LEKSANIR
instructions for the medical use of the medicinal
product
Tradename
Leksanir, Лексанир
International
non-proprietary name or generic name
Cefixime, Цефиксим
Composition
Each capsule contains:
Active substance: cefixime 400 mg
Excipients: magnesium stearate, avicel-102.
Each 5 ml of suspension contains:
Active substance: cefixime 100 mg
Excipients: sugar, xanthan gum,
sodium benzoate, strawberry flavor.
Dosage form
Capsules.
Powder for preparation of oral
suspension.
Pharmacotherapeutic group
Antibiotics (a group
of III generation cephalosporins).
Pharmacological properties
Pharmacodynamics
Semi-synthetic cephalosporin antibiotic of the third
generation for oral administration with a wide spectrum of action. It has a
bactericidal effect. The mechanism of action is due to the inhibition of the
synthesis of the cell membrane of the pathogen. Cefixime is resistant to β-lactamases produced by most gram-positive and
gram-negative bacteria.
In vitro, cefixime is active against gram-positive
bacteria: Streptococcus agalactiae; gram-negative bacteria: Haemophilus
parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca,
Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp.,
Citrobacter amalonaticus, Citrobacter diversceus. Serratia marcesceus.
In vitro and in clinical practice, cefixime is active
against gram-positive bacteria: Streptococcus pneumoniae, Streptococcus
pyogenes; gram-negative bacteria: Haemophilus influenzae, Moraxella
(Branhamella) catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria
gonorrhoeae.
Pseudomonas spp., Enterococcus (Streptococcus) serogroup
D, Listeria monocytogenes, most Staphylococcus spp. Are resistant to cefixime.
(including methicillin-resistant strains), Enterobacter spp., Bacteroides
fragilis, Clostridium spp.
Pharmacokinetics
When taken orally,
the bioavailability of cefixime is 40-50% regardless of food intake, however,
the Cmax of cefixime in serum is reached 0.8 hours faster when taking the drug
with food. Plasma protein binding, mainly albumin, is 65%. About 50% of the
dose is excreted in the urine unchanged within 24 hours, about 10% of the dose
is excreted in the bile. T1 / 2 depends on the dose and is 3-4 hours. In
patients with impaired renal function with CC from 20 to 40 ml / min, T1 / 2
increases to 6.4 hours, with CC 5-10 ml / min - up to 11.5 hours.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive
to the drug:
- pharyngitis, tonsillitis, sinusitis;
- acute and chronic bronchitis;
- otitis media;
- uncomplicated urinary tract infections;
- uncomplicated gonorrhea.
Contraindications
- hypersensitivity to cephalosporins and penicillins;
- children's age up to 6 months.
Method of
administration and dosage
Capsules
Inside
with plenty of water.
Adults
and children over 12 years old with body weight> 50 kg - 400 mg once a day.
Suspension
Inside.
Children
aged 6 months to 1 year - 2.5-4 ml per day, from 1 to 4 years - 5 ml per day,
5-10 years - 6-10 ml per day.
Children
under the age of 12 - at a dose of 8 mg / kg 1 time per day or 4 mg / kg 2
times a day (every 12 hours).
Suspension
preparation. Chilled boiled water is added to the vial
with the drug to the indicated mark, closed with a lid, shaken thoroughly until
a homogeneous suspension is formed. Allow to settle for 5 minutes. Shake the
finished suspension well before use. It should be used no later than 14 days
after preparation.
The
average duration of the course of treatment is 5-10 days. For diseases caused
by Streptococcus pyogenes, the course of treatment is at least 10 days. For
uncomplicated gonorrhea - 400 mg once.
In
case of impaired renal function, the dose is set depending on the Cl creatinine
in the blood serum: if Cl creatinine is 21-60 ml / min or in patients on
hemodialysis, the daily dose should be reduced by 25%; when Cl creatinine is 20
ml / min or less, or in patients on peritoneal dialysis, the daily dose should
be halved.
Special instructions
and precautions
It should be used with caution in elderly patients, patients with
chronic renal failure or pseudomembranous colitis (in history), in children
under 6 months of age.
With prolonged use, it is possible to disrupt the normal intestinal
microflora, which can lead to the growth of Clostridium difficile and cause the
development of severe diarrhea and pseudomembranous colitis.
In patients with a history of allergic reactions to penicillin,
manifestations of hypersensitivity to cephalosporin antibiotics are possible.
During treatment, a positive direct Coombs' reaction and a false
positive urine glucose reaction are possible.
Influence on the ability to drive
vehicles and mechanisms
Application during
pregnancy and during breastfeeding
Use during pregnancy is possible only if the intended
benefit to the mother outweighs the potential risk to the fetus.
If necessary, use during lactation should stop
breastfeeding.
Interaction with other
medicinal products
Reduces the prothrombin index, enhances the effect of
indirect anticoagulants. Cefixime should be used with caution in patients
taking coumarin anticoagulants such as warfarin. Since cefixime can enhance the
effects of anticoagulants, the combined use of these drugs can lead to an
increase in prothrombin time with the possible development of bleeding.
Antacids containing magnesium or aluminum hydroxide slow down the absorption of
the drug, so the drug should be used 1-2 hours before or 4 hours after taking the
above drugs. Taking cefixime can cause a false positive urine glucose test when
using Benedict's solution, Fehling's solution, or the Clinitest test. In this
case, it is recommended to use tests based on enzymatic glucose oxidase
reactions (eg Tes-Tape). It is possible to obtain a direct Coombs' test in
patients taking cefixime. When taken together with potentially nephrotoxic
drugs (such as aminoglycosides, polymyxin B, colistin and biomycin) and
diuretics (ethacrynic acid, furosemide), the risk of renal dysfunction
increases.
Side effect
From the digestive system: dry
mouth, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain,
dysbiosis, liver dysfunction (increased activity of hepatic transaminases,
alkaline phosphatase, hyperbilirubinemia, jaundice), gastrointestinal
candidiasis; rarely - stomatitis, glossitis, pseudomembranous enterocolitis.
From the nervous system: dizziness,
headache.
From the urinary system: interstitial
nephritis.
From the side of hematopoiesis: leukopenia, neutropenia, thrombocytopenia, hemolytic anemia.
Allergic reactions: urticaria,
skin flushing, pruritus, eosinophilia, fever.
Others: mycosis of the
genitals, vaginitis, candidiasis.
If any of the side effects indicated in the
instructions are aggravated, or you notice any other side effects not listed in
the instructions, inform your doctor.
Overdose
Symptoms:
increased risk of adverse reactions.
Treatment:
gastric lavage, symptomatic and supportive therapy,
incl. the appointment of antihistamines and glucocorticoids, oxygen therapy,
mechanical ventilation. In significant quantities, it is not excreted by hemo-
or peritoneal dialysis. The specific antidote is unknown.
Storage conditions
Capsules
Store in a dry and dark place at a temperature
not exceeding 25°C.
Suspension powder
Store in a cool and dry place at temperatures below 30°C.
Store the finished suspension at a temperature not exceeding 25°C for
no more than 14 days.
Keep out of the reach of children!
Shelf life
2 years. Do not use
after the expiration date printed on the package.
Vacation conditions
Dispensed by prescription.
Release form
Capsules
5 capsules in an aluminum foil blister. 1 blister
with instructions for use in a cardboard box.
Suspension powder
1 bottle of suspension powder. Bottle, measuring spoon with
instructions for use in a cardboard box.