Universal reference book for medicines
Name of the preparation: FIBELL

Active substance: amoxicillin, clavulanic acid

Type: Antibiotic of a broad-spectrum penicillin group with a beta-lactamase inhibitor

Manufacturer: SPINCOMED (India) produced by PROTECH BIOSYSTEMS (India)
Typical clinico-pharmacological article
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
The combined preparation of amoxicillin and clavulanic acid is a beta-lactamase inhibitor.
It acts bactericidal, inhibits the synthesis of the bacterial wall.

It is active against aerobic Gram-positive bacteria (including strains producing beta-lactamases): Staphylococcus aureus;
aerobic Gram-negative bacteria : Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp .; as well as aerobic Gram-negative bacteria(including strains producing beta-lactamases): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida previously Pasteurella), Campylobacter jejuni;anaerobic gram-negative bacteria (including strains producing beta-lactamases): Bacteroides spp., including Bacteroides fragilis.
Clavulanic acid inhibits II, III, IV and V types of beta-lactamases, is not active against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.
Clavulanic acid has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents enzymatic degradation of amoxicillin under the influence of beta-lactamases.
PHARMACOKINETICS
After oral administration, both components are rapidly absorbed into the digestive tract.
Simultaneous food intake does not affect absorption. T Cmax - 45 min. After oral administration at a dose of 250/125 mg every 8 hours, C max amoxicillin is 2.18-4.5 μg / ml, clavulanic acid is 0.8-2.2 μg / ml, in a dose of 500/125 mg every 12 hours C max amoxicillin is 5.09-7.91 μg / ml, clavulanic acid 1.19-2.41 μg / ml, 500/125 mg every 8 hours C max amoxicillin - 4.94-9.46 μg / ml, clavulanic acid 1.57-3.23 μg / ml, at a dose of 875/125 mg C max of amoxicillin - 8.82-14.38 μg / ml, clavulanic acid - 1.21-3.19 μg / ml.
After intravenous administration at doses of 1000/200 and 500/100 mg C max, amoxicillin is 105.4 and 32.2 μg / ml, respectively, and clavulanic acid is 28.5 and 10.5 μg / ml.

The time to reach the maximum inhibitory concentration of 1 μg / ml for amoxicillin is similar when administered after 12 hours and 8 hours in both adults and children.


Connection with plasma proteins: amoxicillin - 17-20%, clavulanic acid - 22-30%.


Metabolised both components in the liver: amoxicillin - 10% of the administered dose, clavulanic acid - 50%.


T 1/2 after taking in a dose of 375 and 625 mg - 1 and 1.3 h for amoxicillin, 1.2 and 0.8 h for clavulanic acid, respectively.
T 1/2 after iv introduction at a dose of 1200 and 600 mg - 0.9 and 1.07 h - for amoxicillin, 0.9 and 1.12 h for clavulanic acid, respectively. It is excreted mainly by the kidneys (glomerular filtration and tubular secretion): 50-78 and 25-40% of the administered dose of amoxicillin and clavulanic acid, respectively, in unchanged form during the first 6 hours after administration.
INDICATIONS
- bacterial infections caused by susceptible pathogens: infections of the lower respiratory tract (bronchitis, pneumonia, empyema of the pleura, lung abscess);

- infections of the ENT organs (sinusitis, tonsillitis, otitis media);

- infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, chancroid, gonorrhea);

- skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection);

- osteomyelitis;

- postoperative infections;

- prevention of infections in surgery.

DOSING MODE
Inside, in / in.


Doses are given in terms of amoxicillin.
The dosage regimen is set individually, depending on the severity of the course and localization of the infection, the sensitivity of the pathogen.

Children under 12 years - in the form of a suspension, syrup or drops for oral administration.
Single dose is established depending on the age: children up to 3 months - 30 mg / kg / day in 2 divided doses; 3 months and older - with infections of mild severity - 25 mg / kg / day in 2 doses or 20 mg / kg / day in 3 doses, insevere infections - 45 mg / kg / day in 2 doses or 40 mg / kg / day in 3 divided doses.

Adults and children over 12 years of age or with a body weight of 40 kg or more: 500 mg 2 times / day or 250 mg 3 times / day.
For infections of severe severity and infections of the respiratory tract - 875 mg 2 times / day or 500 mg 3 times / day.

The maximum daily dose of amoxicillin for adults and children over 12 years is 6 g, for children under 12 years, 45 mg / kg of body weight.


The maximum daily dose of clavulanic acid for adults and children over 12 years is 600 mg, for children under 12 years of age it is 10 mg / kg of body weight.


If swallowing is difficult in adults, the use of a suspension is recommended.


When preparing the suspension, syrup and droplets, use water as the solvent.


With IV introduction to adults and adolescents over 12 years of age, 1 g (for amoxicillin) 3 times a day, if necessary 4 times a day.
The maximum daily dose is 6 g. For children 3 months to 12 years - 25 mg / kg 3 times a day; in severe cases - 4 times a day; for children under 3 months: premature and in the perinatal period - 25 mg / kg 2 times a day, in the postperinatal period - 25 mg / kg 3 times a day.

Duration of treatment - up to 14 days, acute otitis media - up to 10 days.


For the prevention of postoperative infections in operations lasting less than 1 hour, during introductory anesthesia administered at a dose of 1 g IV.
With longer operations - 1 g every 6 hours during the day. With a high risk of infection, administration can be continued for several days.

In chronic renal insufficiency , dose adjustment and the frequency of administration are carried out depending on the CC: at a QC greater than 30 ml / min, dose adjustment is not required;
with CC 10-30 ml / min : inside - 250-500 mg / day every 12 hours; I / O - 1 g, then 500 mg IV; with CC less than 10 ml / min - 1 g, then 500 mg / day IV or 250-500 mg / day orally at one time. For children, the dose should be reduced in the same way.

Patients on hemodialysis 250 mg or 500 mg orally at one time or 500 mg IV, 1 additional dose during dialysis and 1 additional dose at the end of the dialysis session.

SIDE EFFECT
On the part of the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of hepatic transaminases, in isolated cases - cholestatic jaundice, hepatitis, hepatic insufficiency (more often in the elderly, men with prolonged therapy), pseudomembranous and hemorrhagic colitis can also develop after therapy), enterocolitis, black "hairy" tongue, darkening of tooth enamel.


On the part of the hematopoiesis: reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.


From the nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, convulsions.


Local reactions: in some cases - phlebitis in the place of intravenous administration.


Allergic reactions: urticaria, erythematous rashes, rarely - multiforme exudative erythema, anaphylactic shock, angioedema, extremely rare - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustules .


Other: candidiasis, development of superinfection, interstitial nephritis, crystalluria, hematuria.

CONTRAINDICATIONS
- hypersensitivity (including to cephalosporins and other beta-lactam antibiotics);

- infectious mononucleosis (including when there is a measles-like rash);

- phenylketonuria;

- episodes of jaundice or impaired liver function as a result of amoxicillin / clavulanic acid in history;

- CC less than 30 ml / min (for tablets 875 mg / 125 mg).

With caution: pregnancy, lactation, severe hepatic insufficiency, gastrointestinal diseases (including colitis in history, associated with the use of penicillins), chronic renal failure.

PREGNANCY AND LACTATION
With caution: pregnancy, lactation.

Cases of development of necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes were revealed.

APPLICATION FOR FUNCTIONS OF THE LIVER
In chronic renal insufficiency , dose adjustment and the frequency of administration are carried out depending on the CC: at a QC greater than 30 ml / min, dose adjustment is not required;
with CC 10-30 ml / min : inside - 250-500 mg / day every 12 hours; I / O - 1 g, then 500 mg IV; with CC less than 10 ml / min - 1 g, then 500 mg / day IV or 250-500 mg / day orally at one time. For children, the dose should be reduced in the same way. With QC less than 30 ml / min, tablets 875 mg / 125 mg are contraindicated.

Patients on hemodialysis 250 mg or 500 mg orally at one time or 500 mg IV, 1 additional dose during dialysis and 1 additional dose at the end of the dialysis session.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in cases of jaundice or violations of liver function as a result of the use of amoxicillin / clavulanic acid in the anamnesis.

With caution: severe hepatic impairment



APPLICATION FOR CHILDREN
Children under 12 years - in the form of a suspension, syrup or drops for oral administration.
Single dose is established depending on the age: children up to 3 months - 30 mg / kg / day in 2 divided doses; 3 months and older - with infections of mild severity - 25 mg / kg / day in 2 doses or 20 mg / kg / day in 3 doses, insevere infections - 45 mg / kg / day in 2 doses or 40 mg / kg / day in 3 divided doses.
The maximum daily dose of amoxicillin for children under 12 years is 45 mg / kg of body weight.


The maximum daily dose of clavulanic acid for children under 12 years is 10 mg / kg body weight.

SPECIAL INSTRUCTIONS
In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.


To reduce the risk of side effects from the gastrointestinal tract, you should take the drug while eating.


It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.


Can give false positive results in determining glucose in the urine.
In this case, it is recommended to use a glucose oxidant method for determining the concentration of glucose in the urine.

After reconstitution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.


In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.


Cases of development of necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes were revealed.


Since the tablets contain the same amount of clavulanic acid (125 mg), it should be noted that 2 tablets of 250 mg (for amoxicillin) are not equivalent to 1 tablet of 500 mg (for amoxicillin).

OVERDOSE
Symptoms: a violation of the function of the gastrointestinal tract and water-electrolyte balance.


Treatment: symptomatic.
Hemodialysis is effective.
DRUG INTERACTION
Antacids, glucosamine, laxative drugs, aminoglycosides slow down and reduce absorption;
ascorbic acid increases absorption.
Bacteriostatic medicinal products (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index).
With the simultaneous administration of anticoagulants, it is necessary to monitor blood coagulability.
Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which forms PABC, ethinyl estradiol - the risk of bleeding "breakthrough".

Diuretics, allopurinol, phenylbutazone, NSAIDs, and other drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

Allopurinol increases the risk of skin rash.

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