Cefaclor Stade - instructions for use, dose, side effects, contraindications

Active substanceCefaclorCefaclor

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Cefaclor Stade®

granulescapsulessuspension inwards

SHTADA Artznajmittel AG Germany

Cefaclor Stade®

granulescapsules inwards

SHTADA Artznajmittel AG Germany

Dosage form: & nbsp

capsules; Granules for preparation of suspension for oral administration

Composition:

Capsules 0.5 g

Active substance:

1 capsule contains 524.48 mg of cefaclor monohydrate, equivalent to 500.00 mg of cefaclor.

Excipients:

Dimethicone, cornstarch, magnesium stearate.

Capsule shell (upper part):

Gelatin, purified water, titanium dioxide (E 171), indigotine (E 132).

Capsule shell (lower part):

Gelatin, purified water, titanium dioxide (E 171).

Granules for the preparation of a suspension for ingestion 125 mg / 5 ml

Active substance:

One vial (63.5 g of granules) to obtain 100 ml of the suspension contains 2.6224 g of cefaclor monohydrate, corresponding to 2.5 g of cefaclor.

5 ml (1 measuring spoon) of the prepared suspension contain 131 mg of cefaclor monohydrate, which corresponds to 125 mg of cefaclor.

Excipients:

Dimethicone, xanthan gum, cornstarch, strawberry flavor, sodium lauryl sulfate, methylcellulose, sucrose.

5 ml (1 measuring spoon) of the prepared suspension contain 3 g of sucrose (carbohydrates), which corresponds to 52 kJ or 12 kcal.

Granules for suspension for oral administration 250 mg / 5 ml

Active substance:

1 vial (63.5 g of granules) to obtain 100 ml of the suspension contains 5,049-5,547 g of cefaclor monohydrate, which corresponds to 5.0 g of cefaclor.

5 ml (1 measuring spoon) of the prepared suspension contains 262 mg of cefaclor monohydrate, which corresponds to 250 mg of cefaclor.

Excipients:

Dimethicone, xanthan gum, corn starch, strawberry flavor, ^ sodium lauryl sulfate, methylcellulose, sucrose.

5 ml (1 measuring spoon) of the prepared suspension contain 3 g of sucrose (carbohydrates), which corresponds to 52 kJ or 12 kcal.

Description:

Hard gelatin capsules (blue opaque / white opaque), "Oel" size (23.8 mm, 0.68 ml) containing a white to slightly yellowish powder.

Granules for the preparation of a suspension for ingestion 125 mg / 5 ml

White or white with a yellowish hue of color, homogeneous granules with a strawberry smell.

Suspension:

White to slightly yellowish color suspension with strawberry odor.

Granules for suspension for oral administration 250 mg / 5 ml

White or white with a yellowish hue of color, homogeneous granules with a strawberry smell.

Suspension:

White or slightly yellowish suspension with strawberry odor.

Pharmacotherapeutic group:Antibiotic-cephalosporin.

ATX: & nbsp

J.01.D.C.04 Cefaclor

Pharmacodynamics:

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 beta-lactamases, but is resistant to penicillinases.

The following gram-positive and gram-negative microorganisms are considered to be sensitive to Cefaclor:

Staphylococcus spp.,

Streptococcus pneumoniae,

Escherichia coli,

Proteus mirabilis,

Klebsiella spp,

Heamophilus influenzae, including ampicillin resistant strains,

Neisseria gonorrhoeae, including penicillinase-forming strains,

Bacteroides spp (excluding fragilis),

Moraxella catarrhalis,

Citrobacter diversus,

Propionibacterium,

Peptococcus spp,

Peptostreptococcus spp.

The following microorganisms are considered resistant to cefaklor:

Listeria spp, Bordetella spp, Mycoplasma spp, Chlamydia spp, Enterococcus faecalis and faecium, Pseudomonas spp, Bacteroides fragilis spp, Campylobacter jejuni, most strains of Enterobacter, Morganella morganii, Proteus vulgaris, Providencia, Serratia, Acinetobacter.

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 the maximum plasma concentration was reached 60 minutes after administration and was, respectively, about 7, 15 and 26 mg / l.

In children who received cefaclor fasting at a dose of 10 mg / kg and 15 mg / kg, the maximum concentration in the serum was about 10.8 mg / l and 13.1 mg / l, respectively. After 10 days of admission cefaclor in the body did not accumulate.

Although eating does not affect the degree of absorption (area under the curve), it reduces the rate of absorption, resulting in an increase in the time to reach maximum concentration (tmax) and a 30 percent reduction in maximum concentration (Cmax).

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 the bile. The binding to serum proteins is about 25%. Below are the concentrations of cephakpor in the tissues and fluids of the human body at various intervals after administration.

Cloth / physiological	Dose (mg)	Concentration (μg / ml or
liquid		μg / g)
Sputum	500 and 3x500	0-3
Amygdala	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
Prostate	500	0,24-1,94
Bile	1000	5,9-12,1
Milk	500	0,35-0,64
The 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 cephakpor.

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 is excreted by the kidneys.

92% of the dose of radioactively labeled cephakpor is excreted by the kidneys and 4% through the gastrointestinal tract.

The average half-life from the plasma is 45 minutes (29-60 minutes). It is dose-dependent, i.e. after a single dose of a higher dose (for example, 500 mg or 1000 mg), the half-life is somewhat longer than after a single dose of lower doses. The half-life of serum is increased with impaired renal function, but when taking such patients cefaclor three times a day, the drug in the body is not cumulated.In anuria, the half-life of cefaclor from serum is 3.5 hours. Cefaclor is excreted by hemodialysis. Hemodialysis reduces the half-life of serum by 25-30%. The apparent volume of distribution is about 26 liters. The renal clearance of cefaclor is between 188 and 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.

Contraindications:Hypersensitivity (including other beta-lactam antibiotics), children under 3 years (capsules).

Carefully:Pronounced allergic diseases, bronchial asthma in history; chronic renal failure, leukopenia, hemorrhagic syndrome; acute 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.

Dosing and Administration:

Inside. Adults and children older than 10 years - 0.25-0.5 g 3 times a day.

Capsules are recommended to drink with a small amount of water.

Children up to 1 months - the dose is not defined, from 1 month and older - to 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. It is desirable to appoint small children in the form of a suspension.

The average duration of 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 a refrigerator (2-8 ° C), the prepared suspension Cefaclor STADA® 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 Cefaclor STADA® can be taken with food, it does not affect the absorption of the drug.

1 measuring spoon (5 ml) of Cefaclor suspension

STADA® 125 mg / 5ml contains 125 mg of cefaclor.

Age of child	Usual Dose	Increased dose in severe infections and inflammation of the middle ear	Low dose for mild infections
Up to 6 months	2.5 ml 3 times a day	2.5 ml 4 times a day	-
From 6 months to 1 year	2.5 ml 4 times a day	5 ml 3 times a day	-
1 -2 years	5 ml 3 times a day	5 ml 4 times a day or 10 ml 2 times a day	-
3-5 years	10 ml in the morning, 5 ml in the afternoon, 10 ml in the evening	10 ml 3 times a day	-
6-10 years	10 ml 3 times a day	10 ml 4 times a day or 20 ml 2 times a day	10 ml 2 times a day (morning and evening)

1 measuring spoon (5 ml) of the suspension Cefaclor STADA® 250 mg / 5ml 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	2.5 ml 3 times a day	2.5 ml 4 times a day or 5 ml 2 times a day	-
3-5 years	5 ml in the morning, 2.5 ml in the afternoon, 5 ml evening	5 ml 3 times a day	-
6-10 years	5 ml 3 times a day	5 ml 4 times a day or 10 ml 2 times a day	5 ml 2 times a day (morning and evening)

Patients with kidney disease.

With renal disease, no change in the dose of Cefaclor SHTADA® is required. With hemodialysis, the half-life of the drug from serum 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 effects:

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

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

From the genitourinary system: vaginitis.

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

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

From the hematopoiesis: hypoplastic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hemolytic anemia, bleeding.

From the cardiovascular system: increase in blood pressure.

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

Other: Candidamycosis, superinfection, increased sweating.

Overdose:

Symptoms: nausea, vomiting, diarrhea

Treatment: Activated carbon, providing the necessary ventilation and perfusion, monitoring and maintaining the required level of blood gases, serum electrolytes.

Hemodialysis is not effective.

Interaction:

Enhances the effect of indirect anticoagulants

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

The antibacterial effect increases the aminoglycosides, metronidazole, polymyxins, rifampicin, weaken chloramphenicol, tetracyclines.

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

H2-histamine blockers (cimetidine, ranitidine, nisatidine, roxatidine, famotidine) do not affect the speed and degree of absorption.

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

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 norepinephrine, antihistamines or glucocorticosteroids.

Form release / dosage:

Capsules 0.5 g.

Granules for oral suspension 125 mg / 5 ml.

Granules for the preparation of a suspension for oral administration 250 mg / 5 ml.

Packaging:

Capsules 0.5 g pack 10 pieces per blister.

1, 2 or 3 blisters together with instructions for the use of the drug are placed in a cardboard box.

Granules for the preparation of suspension for ingestion of 125 mg / 5 ml.

To 63.5 g in a bottle of dark glass with a label of 100 ml, sealed with a screwed polypropylene cap.

1 bottle, measuring spoon and instructions for medical use of the drug are placed in a cardboard box.

Granules for suspension for oral administration 250 mg / 5 ml

To 63.5 g in a bottle of dark glass with a white risk and label 100 ml, sealed with a screwed polypropylene cap.

1 bottle, measuring spoon and instructions for use in a cardboard box.

Storage conditions:

List B.

Capsules 0.5 g

Store 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

Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Granules for suspension for oral administration 250 mg / 5 ml

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. Granules - 3 years

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

Terms of leave from pharmacies:On prescription

Registration number:П N011081 / 01

Date of registration:13.12.2007

Date of cancellation:2017-08-29

The owner of the registration certificate:SHTADA Artznajmittel AGSHTADA Artznajmittel AG Germany

Manufacturer: & nbsp

STADA Arzneimittel, AG Germany

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp29.08.2017

Illustrated instructions

Instructions

Cefaclor Stade® (Cefaclor Stada®)