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Article about Cefaclor

The description

White or white powder with a yellowish shade, with a specific odor. When water free of carbon dioxide (freshly boiled and chilled water) is added to the contents of the bottle, a suspension of white or light yellow color with a characteristic orange odor is obtained. Stratification of the suspension is allowed, which is removed by agitation.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Other beta-lactam antibiotics.

Directions for use

Infectious and inflammatory diseases caused by microorganisms sensitive to cefaclor: diseases of the upper and lower respiratory tract (including pneumonia), urinary tract infection, skin and soft tissue infections; otitis media, sinusitis.

Dosage and administration

Indoors, regardless of food intake.

From cefaclor powder, it is necessary to prepare a suspension. To do this, first shake the powder in a bottle, then add boiled drinking water cooled to room temperature up to the "60 ml" mark and shake vigorously. Once the foam is deposited, add an additional volume of suspension to 60 ml with water and shake well. The suspension is ready for use.

The dosing regimen is defined individually, taking into account the severity and location of the infection, the sensitivity of the suspected or established pathogen:

  • for adults and elderly patients with mild infections caused by microorganisms very sensitive to cefaclor, 5 ml suspension (250 mg cefaclor) every 8 hours;
  • adults and elderly patients with more serious infections caused by moderately sensitive microorganisms, 10 ml suspension (500 mg cefaclor) every 8 hours;
  • Children: The usual daily dose is 20 (30) mg / kg of body weight, divided into 3 single doses (every 8 hours).
  • In case of more severe infections, otitis media, sinusitis and infections caused by less sensitive pathogens, the total recommended daily dose is 40 (50) mg / kg.
  • For bronchitis and pneumonia: the usual dose is 20 mg / kg of body weight, divided into 3 single doses (every 8 hours).
  • In case of acute otitis media, pharyngitis, uncomplicated urinary tract infections: the total daily dose can be divided into two single doses (every 12 hours).

The maximum daily dose should not exceed 1 g.

The safety and efficacy of cefaclor have not been established for children under one month of age.

The dosing device for the suspension of cefaclor 250 mg / 5 ml does not allow the use of the drug for children under 1 year.

The maximum daily dose for adults is 80 ml of suspension (4 g of cefaclor) per day.

The maximum daily dose for children is 20 ml of suspension (1 g of cefaclor) per day.

The duration of treatment is 7-10 days. Treatment is continued for 2-3 days after the clinical symptoms of the infection have subsided. The duration of treatment for infections caused by hemolytic P streptococcus should be at least 10 days.

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Patients with renal insufficiency:

In mild to moderate renal failure, there is usually no need to adjust the dose. In patients with severe renal impairment, use with caution, under the supervision of laboratory tests.

Hemodialysis patients:

With hemodialysis, the half-life of the drug from blood serum is reduced by 25-30%. If regular hemodialysis is required, a loading dose of 250 mg-1 g of cefaclor before hemodialysis and a therapeutic dose of 250 mg-500 mg as a maintenance dose between hemodialysis procedures are recommended.

When you miss the next dose, you should take the medicine as soon as possible, do not double the dose to make up for the missed dose. The patient should be warned of the need to consult a doctor when skipping several doses of the drug in order to correct the treatment and to identify a possible worsening of the disease.

Side effect

On the part of the blood and lymphatic system: rarely - reversible neutropenia, agranulocytosis, aplastic or hemolytic anemia, reversible thrombocytopenia, lymphocytosis, leukopenia; unknown frequency - eosinophilia.

On the part of the immune system: rarely - allergic reactions, such as measles-type rashes, itching and hives, anaphylactic reactions (in patients allergic to penicillin), drug fever, lymphadenopathy. Anaphylactoid reactions can occur with unique symptoms, including angioedema, asthenia, edema (including swelling of the face and limbs), shortness of breath, paraesthesia, fainting or vasodilation; the frequency is unknown - serum sickness, erythema multiforme, rash or other skin manifestations. Infections and infestations: superinfection and development of microorganisms or fungi resistant to cefaclor in case of long-term therapy or repeated use of the drug.

From the nervous system: often - headache; frequency not known - dizziness, drowsiness, restlessness, convulsions.

From the cardiovascular system: transient increase in blood pressure.

From the gastrointestinal tract: often - diarrhea, colitis, nausea, vomiting, abdominal discomfort; rarely - pseudomembranous colitis. From the hepatobiliary system: reversible increase in the activity of liver enzymes (transaminases, alkaline phosphatase) in blood serum, hepatitis, cholestatic jaundice.

Skin and subcutaneous tissue: rarely - Stevens-Johnson syndrome (erythema multiforme), toxic epidermal necrolysis, exfoliative dermatitis.

Vessels: transient increase in blood pressure.

Kidneys and urinary tract: rarely - reversible interstitial nephritis, proteinuria, pathological changes in urinalysis.

From the reproductive system and the mammary gland: genital itching, vaginitis and vaginal candidiasis.

Mental disorders: the frequency is not known - nervousness, confusion, insomnia, hypertension, reversible hyperactivity and hallucinations.

Laboratory indicators: a slight increase in blood urea or creatinine, a positive Coombs test.

If these side effects appear, as well as a reaction not listed in the package leaflet, you should consult a doctor.

Cons-indications

  • Hypersensitivity to cefaclor, to other cephalosporin antibiotics or to one of the auxiliary components of the drug;
  • A severe immediate hypersensitivity reaction to any other beta-lactam antibiotic;
  • phenylketonuria.

Overdose

Overdose is manifested by nausea, vomiting, diarrhea, epigastric pain.

Cefaclor has low toxicity. Even high doses given over time are well tolerated. Only if the dose is exceeded, which is greater than a daily dose, should activated charcoal be administered at least 5 times, induce vomiting or gastric lavage.

There is no specific antidote. Regarding the efficacy of forced diuresis, peritoneal dialysis or hemodialysis and hemoperfusion via activated charcoal, no adequate study could recommend their use. Supportive and symptomatic treatment is recommended.

Interaction with other drugs

Cefaclor, suppressing the intestinal flora, interferes with the synthesis of vitamin K. Therefore, when used simultaneously with drugs that reduce platelet aggregation (non-steroidal anti-inflammatory drugs, salicylates, sulfinpyrazone), the risk of bleeding increases. For the same reason, with simultaneous administration of anticoagulants, an increase in anticoagulant action is noted. Therefore, regular monitoring of prothrombin time with dose adjustment if necessary is recommended.

Probenecid slows the elimination of cefaclor by reducing its tubular secretion.

Cefaclor should not be combined as far as possible with bacteriostatic antibacterial agents (e.g. chloramphenicol, erythromycin, sulfonamides and tetracyclines), as the effect of cefaclor may be reduced.

Cefaclor improves the nephrotoxicity of butadione, aminoglycosides and polymyxins. Cholestyramine reduces the absorption of cefaclor.

Effect on laboratory diagnostic tests:

The use of cefaclor can lead to false positive results in the determination of glucose in the urine by non-enzymatic methods. Therefore, during treatment with cefaclor, enzymatic methods should be used to determine the glucose in the urine.

Safety precautions

Used with caution in case of renal failure, gastrointestinal diseases (colitis, ulcerative colitis) in the anamnesis.

Before starting treatment with cefaclor, it is necessary to check for hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other medicines. Cefaclor should be used with caution in patients sensitive to penicillin, due to possible cross hypersensitivity, including anaphylaxis. In case of allergic reactions, the use of cefaclor should be stopped and appropriate treatment should be carried out.

Cefaclor should be used with caution in patients with severe renal impairment. In patients with anuria, the half-life of cefaclor is increased from 2.3 to 2.8 hours (compared to 0.6 to 0.9 hours in healthy individuals).

Although patients with moderate or severe renal impairment generally do not need a dose adjustment, however, due to the small number of patients receiving cefaclor under these conditions, the drug should be used with caution.

Prolonged use of cefaclor can lead to the spread of resistant microorganisms and the emergence of a secondary infection, which must be cured properly.

When using broad-spectrum antibiotics, including cephalosporins, there is a risk of developing diarrhea associated with mild to life-threatening antibiotics, including pseudomembranous colitis. If the patient develops persistent (bloody) severe diarrhea during antibiotic therapy or within 10 weeks of its completion, the development of antibiotic-associated colitis, which in most cases is caused by Clostridium difficile, should always be assumed . If this diagnosis is suspected or confirmed, appropriate treatment should be initiated. In this situation, the appointment of drugs that inhibit intestinal motility is contraindicated.

Patients who develop a rash should be closely monitored. If the skin lesions progress, you should immediately stop taking the medicine.

Isolated cases of the development of allergic reactions, such as Stevens-Johnson syndrome and Lyell syndrome (for example, a progressive rash, often with blisters, or accompanied by lesions of the mucous membranes), which have severe skin manifestations , have been noted. If symptoms appear that indicate the development of Stevens-Johnson syndrome and Lyell syndrome (for example, a progressive rash, often with blisters, or with mucosal damage), the drug should be stopped immediately.

As with other cephalosporin antibiotics, seizures cannot be excluded. Co-administration of other medicines (for example, oral contraceptives) may affect their effectiveness.

This medicine contains less than 1 mmol sodium (23 mg) in a dose, which is essentially "sodium-free".

The composition of the drug includes sucrose, so it should not be taken in patients with rare congenital intolerance to fructose, glucose-galactose malabsorption, sucrose-isomaltase deficiency. With prolonged use (2 weeks or more), sucrose can damage teeth.

The medicine contains aspartame, so it should not be taken in patients with phenylketonuria.

During the use of cefaclor, it is necessary to control the prothrombin time and the bleeding time.

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

Safety in use in premature infants and infants within the first month of life has not been established.

Studies of the selected microflora should be carried out to determine the sensitivity to antibacterial agents.

To reduce the development of antibiotic resistance and maintain the effectiveness of cefaclor and other antibacterial agents, cefaclor should only be used to treat infections that are actually or with a high degree of probability caused by bacteria sensitive to cefaclor. When information on the sensitivity of microflora becomes available, this information should be taken into account when prescribing or correcting antibiotic therapy. In the absence of such information, the empirical choice of antibiotic therapy may use local epidemiological data.

Pregnancy and breast feeding

The pregnancy

Cefaclor reaches the embryo / fetus via the placenta. Studies in laboratory animals have shown the absence of teratogenic effects and the negative effects of cefaclor on fertility. However, no controlled clinical trial has been conducted in pregnant women.

Therefore, the use of cefaclor during pregnancy is only possible in cases where the expected benefits to the mother outweigh the potential risk to the fetus.

Lactation

Cefaclor passes into breast milk. Small amounts of cefaclor are found in breast milk after taking a single dose of 500 mg. Average levels of approximately 0.2 μg / ml or less were detected within 5 hours. Traces were detected after 1 hour.

The use of cefaclor during breastfeeding can lead to changes in the intestinal flora with diarrhea and fungal colonization, so it may be necessary to stop breastfeeding. The possibility of raising awareness should also be considered. During lactation, Cefaclor should be used with caution, only after a thorough evaluation of the benefits and risks.

Influence on ability to drive and work with moving mechanisms

In general, experience with the use of cefaclor indicates that it does not affect concentration of attention and psychomotor reactions. However, rare side effects, such as hypotension or dizziness, may affect the ability to drive and other mechanisms, therefore, after taking the drug, the patient is advised to abstain from these activities until an individual reaction to the drug is established.

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