Universal reference book for medicines
Product name: CEFACLOR STADA (CEFACLOR STADA)

Active substance: cefaclor

Type: Cephalosporin II generation

Manufacturer: STADA Arzneimittel (Germany) manufactured by CIMEX (Switzerland)
Composition, form of production and packaging
Granules for the preparation of a suspension for oral administration of
5 ml of ready-mixed sushi.

cefaclora monohydrate 131 mg,

in t.ch.
cefaclor 125 mg
Excipients: simethicone, corn starch, methylcellulose, sodium dodecyl sulfate, sucrose, xanthan gum, strawberry flavor.

63.5 g - 100 ml vials (1) complete with a measuring spoon - packs of cardboard.

63.5 g - 100 ml vials (2) complete with a measuring spoon - packs of cardboard.

Granules for the preparation of a suspension for ingestion of white or white with a yellowish tint of color, homogeneous, with strawberry odor;
prepared suspension of white or slightly yellowish color, with strawberry odor.
5 ml of finished couscous.

cefaclora monohydrate 262 mg,

in t.ch.
cefaclor 250 mg
Excipients: dimethicone, xanthan gum, corn starch, strawberry flavor, sodium lauryl sulfate, methylcellulose, sucrose.

63.5 g - bottles of dark glass with a volume of 100 ml (1) complete with a measuring spoon - packs of cardboard.

Capsules 1 caps.

cefaclora monohydrate 524.48 mg,

in t.ch.
cefaclor 500 mg
Excipients: dimethicone, corn starch, magnesium stearate.

The composition of the capsule shell: gelatin, purified water, titanium dioxide (E171), indigotine (E132).

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Cephalosporin antibiotic of the second generation.

Like all beta-lactam antibiotics, cefaclor inhibits the biosynthesis of the cell wall of breeding bacteria.
The type of its action is bactericidal.
Like all cephalosporins of the first and second generation, Cefaclor is characterized only by intermediate resistance to β-lactamases, but is resistant to penicillinases.

The following Gram-positive and Gram-negative microorganisms are considered sensitive to Cefaclor: Staphylococcus spp., Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella spp, Heamophilus influenzae, including ampicillin resistant strains, Neisseria gonorrhoeae, including penicillinase-producing strains, Bacteroides spp (excluding fragilis), Moraxella catarrhalis, Citrobacter diversus, Propionibacterium, Peptococcus spp, Peptostreptococcus spp.

The following microorganisms are considered resistant to cefaclor: Listeria spp., Bordetella spp., Mycoplasma spp., Chlamydia spp., Enterococcus faecalis, Enterococcus faecium, Pseudomonas spp., Bacteroides fragilis, Campylobacter jejuni, most strains of Enterobacter spp., Morganella morganii, Proteus vulgaris , Providencia spp., Serratia spp., Acinetobacter spp.

PHARMACOKINETICS

From 75% to 92% of the dose of cefaclor is absorbed, mainly from the upper part of the small intestine.
After a single dose of cefaclor on an empty stomach at a dose of 250 mg, 500 mg and 1000 mg C max in plasma was achieved 60 minutes after administration and was, respectively, about 7, 15 and 26 mg / l.
In children receiving fasting cefaclor at a dose of 10 mg / kg and 15 mg / kg, C max in the serum was about 10.8 mg / l and 13.1 mg / l, respectively.
After 10 days of taking cefaclor in the body did not accumulate.
Although eating does not affect the degree of absorption (AUC), it reduces the rate of absorption, resulting in an increase in the time to reach C max and a 30% decrease in C max .

After 4-6 hours after taking the active drug, as a rule, it is not detected in the plasma.

Distribution

Cefaclor is distributed in various tissues and physiological fluids.
For example, high concentration is achieved in the prostate gland and in bile. The binding to serum proteins is about 25%. Below are the concentrations of cefaclor in the tissues and fluids of the human body at various intervals after administration.
Tissue / physiological fluid Dose (mg) Concentration (μg / ml or μg / g)

Sputum 500 and 3x500 0-3

Tonsil 500 and 3x500 6-8

1000 2.8

Interstitial fluid 500 0.625-1.7

1000 1.45-3.3

Pus 500 0.4

Leather 1000 2.8

Fascia 1000 1.5

Tubular bone 1000 1.9

The prostatic gland 500 0.24-1.94

Bile 1000 5.9-12.1

Milk 500 0.35-0.64

Amniotic fluid 500 1.3-3.63

Metabolism and excretion

In solution, cefaclor is chemically unstable and disintegrates spontaneously in physiological fluids, for example, in urine.
Therefore, the degree of true metabolic clearance is difficult to assess. Metabolized drug, if present, constitutes a very small fraction of the decomposition products of cefaclor.
Excretion occurs mainly through the kidneys.
For 8 hours after admission, 50-70% of the dose in the form of a microbiologically active drug and up to 30% of the dose in the form of inactive decay products are excreted by the kidneys.
92% of the dose of radiolabeled cefaclor is excreted by the kidneys and 4% by the gastrointestinal tract.

The mean T 1/2 of the pparatus is 45 min (29-60 min).
It is dose-dependent, i.e. after a single administration of a higher dose (eg, 500 mg or 1000 mg), T 1/2 is slightly longer than after a single dose of lower doses.
T 1/2 of whey is increased with impaired renal function, but when receiving such patients cefaclor 3 times / day the drug in the body is not cumulated.
With anuria T1/2, cefaclor from serum is up to 3.5 hours. Cefaclor is excreted during hemodialysis. Hemodialysis reduces T 1/2 of serum by 25-30%. The apparent volume of distribution is about 26 liters. The renal clearance of cefaclor is between 188-230 ml / min, and the total clearance is 370-455 ml / min.
The results of the study of pharmacokinetics in children and adults do not practically differ.

INDICATIONS

For the treatment of acute and chronic infections of different severity, caused by microorganisms sensitive to cefaclor:

- infections of the upper and lower respiratory tract;

- infections of the ear, throat and nose, for example, inflammation of the middle ear, sinusitis, tonsillitis and pharyngitis;

- infections of the kidneys and urinary tract, incl.
gonorrhea;
- infections of the skin and soft tissues.

DOSING MODE

Inside.
Adults and children older than 10 years - 0.25-0.5 g 3 times / day.
Capsules are recommended to drink with a small amount of water.

To young children to appoint in the form of a suspension.

Children up to 1 month - the dose is not defined, from 1 month and older - at 6.7-13.4 mg / kg every 8 hours or 10-20 mg / kg every 12 hours. The maximum daily dose is 40 mg / kg, but not more than 1 g / day.
The median continuation of the treatment is 7-10 days. Do not shorten the duration of the drug.
Preparation of a suspension for oral administration.

In a vial of granules, pour water to the mark and shake thoroughly.
After the foam settles, add water to the mark. The suspension is ready for use.
In the fridge (2 ° -8 ° C), the prepared Cefaclor Stade suspension is stored for 14 days.

Before each use, the contents of the vial are shaken carefully.

The dose is measured with the attached measuring spoon.

Suspension of Cefaclor Stade can be taken with food, it does not affect the absorption of the drug.

1 measuring spoon (5 ml) of Cefaclor Stade suspension 125 mg / 5 ml contains 125 mg of cefaclor.

Age of Child Usual Dose Increased Dose for Severe Infections and Inflammation of the Middle Ear Low dose for mild infections

Up to 6 months of 2.5 ml 3 times / day for 2.5 ml 4 times / day -

From 6 months to 1 year for 2.5 ml 4 times / day for 5 ml 3 times / day -

1-2 years for 5 ml 3 times / day for 5 ml 4 times / day or 10 ml 2 times / day -

3-5 years 10 ml in the morning, 5 ml in the afternoon, 10 ml in the evening on 10 ml 3 times / day

6-10 years for 10 ml 3 times / day for 10 ml 4 times / day or 20 ml 2 times / day for 10 ml 2 times / day (morning and evening)

1 measuring spoon (5 ml) of Cefaclor Stade suspension 250 mg / 5 ml contains 250 mg of cefaclor.

Age of Child Usual Dose Increased Dose for Severe Infections and Inflammation of the Middle Ear Low dose for mild infections

1-2 years for 2.5 ml 3 times / day for 2.5 ml 4 times / day or 5 ml 2 times / day -

3-5 years 5 ml in the morning, 2.5 ml in the afternoon, 5 ml in the evening for 5 ml 3 times / day -

6-10 years for 5 ml 3 times / day for 5 ml 4 times / day or 10 ml 2 times / day for 5 ml 2 times / day (morning and evening)

In case of kidney disease, there is no need to change the dose of Cefaclor Stade.
With hemodialysis, T 1/2 of the serum drug is reduced by 25-30%. If a regular hemodialysis is necessary before the hemodialysis procedure, a shock dose of 250 mg to 1 g of cefaclor is recommended. Between the procedures of hemodialysis the drug is used in the above doses.
SIDE EFFECT

Allergic reactions: skin rash, skin itching, itching in the genital area, urticaria, eosinophilia, arthralgia, fever, dyspnea, angioedema, conjunctivitis, syncope, polymorphic erythema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis ( Lyell's syndrome), anaphylaxis.

From the side of the nervous system: agitation, anxiety, insomnia, dizziness, paresthesia, motor agitation, confusion, hallucinations, asthenia.

From the genitourinary system: vaginitis.

From the urinary system: a violation of kidney function, interstitial nephritis, dysuria, nocturia.

On the part of the digestive system: decreased appetite, dyspepsia (diarrhea, nausea, vomiting, constipation), pseudomembranous enterocolitis, abdominal pain, hepatitis, cholestatic jaundice.

On the part of the organs of hematopoiesis: hypoplastic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hemolytic anemia, hemorrhages.

From the cardiovascular system: increased blood pressure .

Laboratory indicators: hyperaemia, increased urea concentration, hypercreatininemia, increased activity of hepatic transaminases, hyperbilirubinemia .

Other: candidomycosis, superinfection, increased sweating.

CONTRAINDICATIONS

- Children's age up to 3 years (capsules);

- Hypersensitivity (including to other beta-lactam antibiotics).

With caution: severe allergic diseases,

bronchial asthma in history;
chronic renal failure, leukopenia, hemorrhagic syndrome; sharp
gastrointestinal diseases accompanied by vomiting and diarrhea;
diabetes mellitus (the presence of sucrose); hereditary intolerance to fructose, insufficiency of absorption of glucose-galactose, insufficiency of sucrose-isomaltase (granules for the preparation of a suspension for ingestion 125 mg / -250 mg); pregnancy, lactation.
PREGNANCY AND LACTATION

The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

Cefaclor is excreted in breast milk, so if it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution: chronic renal failure.

In case of kidney disease, there is no need to change the dose of Cefaclor Stade.
With hemodialysis, T 1/2 of the serum drug is reduced by 25-30%. If a regular hemodialysis is necessary before the hemodialysis procedure, a shock dose of 250 mg to 1 g of cefaclor is recommended. Between the procedures of hemodialysis the drug is used in the above doses.
APPLICATION FOR CHILDREN

Capsules are contraindicated in children under 3 years of age.

To young children to appoint in the form of a suspension.

Children up to 1 month - the dose is not defined, from 1 month and older - at 6.7-13.4 mg / kg every 8 hours or 10-20 mg / kg every 12 hours. The maximum daily dose is 40 mg / kg, but not more than 1 g / day.
The median continuation of the treatment is 7-10 days. Do not shorten the duration of the drug.
SPECIAL INSTRUCTIONS

If you miss a dose, take the drug as soon as possible.
If multiple doses are missed, you should consult your doctor to identify the possible worsening of the patient's condition as early as possible.
Do not stop taking the drug prematurely, tk.
a relapse of the disease is possible.
During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.

When hypersensitivity reactions appear, stop taking the drug and carry out appropriate emergency measures, such as intravenous injection of norepinephrine, antihistamines or GCS.

OVERDOSE

Symptoms: nausea, vomiting, diarrhea

Treatment: activated charcoal, provision of necessary ventilation and perfusion, control and maintenance at the required level of blood gases, serum electrolytes.Hemodialysis is not effective.

DRUG INTERACTION

Enhances the effect of indirect anticoagulants

Strengthens (mutually) the nephrotoxicity of aminoglycosides, polymyxins, phenylbutazone.

Antibacterial effect increases aminoglycosides, metronidazole, polymyxins, rifampicin, weaken chloramphenicol, tetracyclines.

Antacids containing magnesium or aluminum hydroxide, slow down the degree of absorption of the drug.

The blockers of histamine H2-receptors (cimetidine, ranitidine, nizatidine, roxatidine, famotidine) do not affect the rate and degree of absorption.

The tubular secretion blockers delay the excretion of cefaclor by the kidneys.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B.

Capsules 0.5 g stored in a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Granules for the preparation of a suspension for ingestion 125 mg / 5 ml stored in a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Granules for the preparation of a suspension for ingestion 250 mg / 5 ml stored at a temperature of no higher than 25 ° C.
The prepared suspension should be stored in the refrigerator for 14 days.
Keep out of the reach of children.

Shelf life: capsules - 3 years, pellets - 3 years

The drug is not to be used after the expiry date indicated on the package.

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