Cefalexin
Producer: LLC Pharmlend Republic of Belarus
Code of automatic telephone exchange: J01DA01
Release form: Firm dosage forms. Powder.
General characteristics. Structure:
Active ingredient: 271,135 mg of cefalexin of monohydrate (in terms of cefalexin of 250 mg).
Excipients: sucrose, sodium carboxymethylcellulose, Natrium benzoicum, colloid silicon dioxide, dye Tartrazine of a supr, orange essence.
Semi-synthetic tsefalosporinovy antibiotic for oral use with pronounced bactericidal effect.
Pharmacological properties:
Pharmacodynamics. Cefalexin - 7-(D - a-amino-a-fenilatsetamido) - 3 - methyl - 3 - цефем - 4 - carat - bonovoy acids monohydrate - represents the semi-synthetic tsefalosporinovy antibiotic intended for oral use.
Oppresses transpendidazu-the enzyme participating in biosynthesis of a mukopeptid of a cell wall of bacteria renders bactericidal effect. It is steady in acid medium.
Pharmacokinetics. After intake on an empty stomach quickly (during 1-2 h) and almost completely (to 95%) it is soaked up from a GIT. Meal slows down a resorption, without influencing its completeness. Therapeutic concentration in blood remains 4-6 hours. Proteins of plasma about 15% communicate. Well gets into fabrics (lungs, kidneys, a liver, heart), passes through a placenta, in a small amount it is found in breast milk. T1/2 makes of plasma of 30 min. to 2 h. It is removed generally by kidneys (by glomerular filtering and canalicular secretion) in an invariable look (70-89%), in small quantity - with bile.
In vitro cefalexin is active concerning the following microorganisms:
- hemolitic streptococci;
- staphylococcus, including a coagualase - positive, a coagualase - negative and a penicillinase - the forming strains;
- Streptococcuspneumoniae;
- Escherichiacoli;
- Proteusmirabilis;
- Klebsiellasp;
- Haemophilus influenzae;
- Moraxella (Branhamella) catarrhalis.
Note: The majority of strains of enterococci (and some strains of stafilokokk are steady Enterococcusfaecalis (mainly Streptococcusfaecalis) in relation to cefalexin. Drug is not active concerning the majority of strains of Enterobactersp, Morganellamorganii (mainly Proteusmorganii) and Proteusvulgaris. Drug is not active also concerning Pseudomonas or Acinetobactercalcoaceticus (mainly Mima and Herellasp). In the researches invitro staphylococcus found cross stability between Cefalexin and antibiotics like Methicillinum.
Indications to use:
Pyoinflammatory processes of various localization; infections of upper and lower parts of respiratory tracts (tonsillitis, pharyngitis, quinsy, an acute pneumonia, bronchial pneumonia, etc.), average otitis, sinusitis, infections of skin and soft tissues (a furunculosis, abscesses, pyodermas, a lymphangitis, etc.), acute and chronic pyelonephritises, cystitis, uretrita, prostatitises, gynecologic infections, gonorrhea, acute and chronic osteomyelitis and other diseases caused by microorganisms, sensitive to drug.
Route of administration and doses:
Appoint inside. With powder add the cooled boiled water to a bottle approximately to a half of a bottle, close a cover, and vigorously shake up. Add water to a ring tag on a bottle. Before use suspension needs to be shaken up.
Cefalexin is acid resisting connection and can be appointed irrespective of meal.
Adults. The dosage varies within 1-4 g a day, in the divided doses. A usual dosage are 250 mg each 6 hours. At the following infections it is possible to enter a dose of 500 mg each 12 hours: streptococcal pharyngitis, skin infections, uncomplicated cystitis at patients is more senior than 15 years. Treatment of cystitis should be continued within 7-14 days.
At heavier infections, or the infections caused by less sensitive microorganisms higher doses can be required. If the daily dose higher than 4 g is required, it is necessary to consider purpose of cefalexin in suitable doses.
Children. To children drug is appointed according to age.
Frequency rate of administration of drug – 4 times/days. Treatment duration - 7-14 days. At the infectious diseases caused by streptococci, the course of treatment has to make not less than 10 days.
At streptococcal pharyngitis at patients years are aged more senior and at skin infections the general day dose can be divided and is entered each 12 hours.
At heavy infections the dose can be doubled.
Features of use:
Patients have to consider and note all side effects or cases of intolerance of drug. In the presence of allergic reactions to cefalexin it is necessary to stop administration of drug; to the patient at the same time adrenaline or other pressor amines, antihistamines or corticosteroids is appointed.
Prolonged use of cefalexin can lead to the increased growth of unreceptive organisms. Careful inspection of the patient is necessary. If during treatment there is superinfection, acceptance of the appropriate measures is necessary. Throughout the treatment period tsefalosporinovy antibiotics observed positive forward reactions (tests) of Coombs. Cefalexin has to be appointed with care to patients with disturbances of functions of kidneys. At the same time comprehensive clinical tests and laboratory researches as the safe dose can be lower, than usually recommended are necessary.
As a result of use of cefalexin mistakenly positive reaction to glucose in urine can be observed.
The patients having gastrointestinal diseases, in particular colitis should appoint antibiotics of a broad spectrum of activity with care.
Use at pregnancy and feeding by a breast. It is possible if the expected effect of therapy exceeds potential risk for a fruit. For the period of treatment it is necessary to stop breastfeeding.
Side effects:
At reception of cefalexin disorder of function of digestive tract (nausea, vomiting, abdominal pains, in rare instances diarrhea) is possible, at prolonged use - development of dysbacteriosis. After drug phase-out these phenomena usually pass.
Also allergic reactions in the form of rashes, a small tortoiseshell are possible, it is rare - a Quincke's disease. At emergence of these phenomena administration of cefalexin is stopped and carry out the desensibilizing therapy. At patients with hypersensitivity to penicillin allergic reactions to cefalexin are observed more often.
At prolonged treatment by cefalexin transistor increase in activity of transaminases in blood, in rare instances a reversible neutropenia, an eosinophilia can be observed.
Among other side reactions it should be noted a genital and proctal itch, genital candidiasis, vaginita and vulval allocations, dizziness, fatigue, a headache, alarming arousing, confusion of consciousness, a hallucination, an arthralgia, arthritis and disturbances in joints. Sometimes intersticial nephrite, eosinophilia, neutropenia, thrombocytopenia.
During reception of cefalexin false and positive reaction to sugar in urine when using reactants of Benedict and Felinga is possible.
Interaction with other medicines:
Furosemide, Acidum etacrynicum and nefrotoksichny antibiotics increase risk of damage of kidneys.
Strengthens effect of indirect anticoagulants. Salicylates and indometacin slow down removal.
Contraindications:
Allergic reactions in the anamnesis (anaphylaxis) to the penicillin derivative of penicillin, Penicillaminum or cephalosporins; digestive tract diseases, especially nonspecific ulcer colitis connected using antibiotics (cephalosporin can cause pseudomembranous colitis); the expressed disturbances of functions of a liver and kidneys.
It is careful to appoint a sick diabetes mellitus (5 ml of suspension contain 1,4 g of sucrose).
Overdose:
Manifestations. Symptoms of overdose can include nausea, vomiting, unpleasant feelings in epigastric area, diarrhea and a hamaturia. If other symptoms are observed they, apparently, are secondary in relation to the main state, allergic reaction or toxicity owing to reception of other drug.
Treatment. Except for cases when the dose exceeding a usual dose of cefalexin at 5-10 times was accepted, cleaning of a GIT is not necessary.
It is necessary to provide protection of respiratory tracts of the patient, supporting normal ventilation and perfusion.
It is necessary to control and support the vital signs of the patient carefully. Absorption of drugs from a GIT can be reduced by reception of absorbent carbon which in many cases is more effective, than vomiting or washing; administration of coal has to be provided instead of or in addition to cleaning of a stomach. Repeated doses of coal during time can accelerate removal of some drugs which were already absorbed. It is necessary to provide passability of respiratory tracts of the patient during the carrying out cleaning of a stomach or purpose of coal.
The artificial diuresis, peritoneal dialysis, hemodialysis or perfusion did not confirm the advantages.
Storage conditions:
In the place protected from moisture and light at a temperature not above +25 °C. To store in the place, unavailable to children. To store ready suspension at a temperature from +4 °C to +6 °C (in the refrigerator) in the place, unavailable to children. A period of validity 3 years, ready suspension - 7 days.
Issue conditions:
According to the recipe
Packaging:
Powder of cefalexin of 125 mg and 250 mg for preparation of suspension in polymeric bottles on 33 g and 36 g, respectively.