Project Description

Cefalexin

capsules 0,25 g – Capsulae Cephalexini 0,25

international nonproprietary name

Cefalexin – Cefalexinum

Ref

BP-0018

Pharmacotherapeutic group

Antibiotics. Cephalosporins.

Composition of the preparation

1 capsule contains 250 mg of Cefalexin.

Pharmacological action

Pharmacodynamics

Cefalexin is cephalosporin antibiotic of wide spectrum of action, it is active concerning the majority gram-positive (Staphylococcus, including penicillinas-producing, Streptococcus pneumoniae, etc.) and gram-negative (Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis) microorganisms. The majority of Streptococcus faecalis strains are steady against action of cefalexin. The antibiotic is not active in relation to Proteus morganii, Proteus rettgeri, Proteus vulgaris, Pseudomonas aeruginosa, the majority of strains of Enterobacter. Staphilococcuses, that are steady against Methicillin, steady and against Cefalexin

Pharmakokinetics

Cefalexin at intake is quickly absorbed, the maximal concentration of the antibiotic in blood plasma is achieved in 1,5-2 hours and is sustained at therapeutic level for 4-6 hours. The preparation gets through placenta, it is found in breast milk.

Cefalexin in the active form is eliminated from an organism basically by kidneys by glomerular filtration and canalicular secretion, it is found in urine in high concentration.

Indications 

Cefalexin is administrated at the infectious diseases of various localization caused by microorganisms sensitive to them: at diseases of genitourinary system (acute and chronic pyelonephritis in a stage of exacerbation, cystitis, prostatitis, endometritis, vulvovaginitis, etc.); infections of the upper and lower respiratory tract (bronchitis, acute pneumonia and exacerbation of chronic bronchopneumonia); infections of ENT-organs (angina, acute otitis media, sinusitis, etc.); purulent infections of skin and soft tissues (furunculosis, abscesses, pyoderma, etc.); lymphadenites, lymphangites; at acute and chronic (in a stage of an exacerbation) osteomyelitis for after-care after parenteral introduction of other antibiotics.

special indication

Treatment by Cefalexin is carried out under the control of sensitivity which is determined by means of the disks containing 30 mcg of the preparation by the standard technique. The isolated microorganism is considered sensitive to Cefalexin when diameter of zones is more than 17 mm, moderately sensitive – from 12 up to 17 mm.

False-positive reaction to sugar in urine is possible during Cefalexin intake at use of Benedict and Feling reagents.

special warning

Not established

Dosage and method of administration

Cefalexin is taken per orally irrespective of food intake. The single dose for adults is 0,25-0,5 g, daily – 1-2 g. The preparation is administrated to children in a dose of 25-50 mg/kg, the number of intake in a daily dose is 4 times a day.

At severe infections course and also at isolation of pathogenic organisms moderately sensitive to Cefalexin, a daily dose of the antibiotic can be enlarged for adults up to 4 g(as much as possible), for children – up to 100 mg/kg.

Daily dose is divided into 4 intakes. Duration of treatment is usually 7-14 days.

overdosage

Not established

safety measures

In patients with kidneys function failure the cumulation is possible (correction of dosage regimen is required).

It is necessary to stop breast feeding during Cefalexin treatment.

The preparation is administrated to pregnant women with care and only in case the prospective benefits for a mother exceed potential risk for a fetus.

Side effects

At reception of Cefalexin the disorders of gastrointestinal tract function (nausea, vomiting, abdominal pain, in rare cases diarrhea) are possible, at long-term intake – dysbacteriosis development. After the preparation withdrawn these phenomena usually pass.

Allergic reactions in the form of eruptions, urticarias are possiblealso, Quincke’s disease in rare cases. At occurrence of these phenomena the intake of Cefalexin should be terminated and desensitizing therapy should be carried out. In patients with hypersensibility to Penicillins the allergic reactions to Cefalexin are observed more frequently.

At long treatment by Cefalexin the transitional increase of transaminases activity in blood, in rare cases – reversible neutropenia, eosinophilia can be observed.

Contraindications

Administration of Cefalexin is counter-indicative at hypersensibility to antibiotics of cephalosporin group.

Interactions with other medicinal preparations

Furosemid, ethacrynic acid and nephrotoxic antibiotics increase risk of kidneys affection. Cefalexin activates action of indirect anticoagulants. Salicylates and Indomethacin decrease Cefalexin excretion.

The form of release

250 mg capsules. 10 capsules in a blister. 3 blisters in a pack. 20, 30 capsules in vials.