Composition, form of production and packaging
Capsules gelatinous, the size в„–2, with the case and a cover of light green color; contents of capsules - granular powder from white to yellowish color.
1 caps.
cephalexin monohydrate 263 mg,
which corresponds to the content of cephalexin 250 mg
Excipients: magnesium stearate, microcrystalline cellulose PH 102.
The composition of the capsule shell: titanium dioxide (E171), iron dye yellow oxide (E172), indigocarmine (Indigotine I) (E132), gelatin.
8 pcs. - blisters (2) - packs of cardboard.
Capsules gelatinous, the size в„–0, with a cover of dark green color and the case of a greenish-yellow color; contents of capsules - granular powder from white to yellowish color.
1 caps.
cephalexin monohydrate 525.9 mg,
which corresponds to the content of cephalexin 500 mg
Excipients: magnesium stearate, microcrystalline cellulose PH 102.
The composition of the shell of the capsule: titanium dioxide (E171), iron dye yellow oxide (E172), iron dye oxide black (E172), indigocarmine (Indigotine I) (E132), gelatin.
8 pcs. - blisters (2) - packs of cardboard.
Granules for the preparation of a suspension for ingestion of a yellow-orange color; with the addition of water a yellow-orange suspension with a characteristic fruity smell is formed.
5 ml of finished couscous.
cephalexin (in the form of monohydrate) 250 mg
Auxiliary substances: sodium saccharinate, citric acid anhydride, iron oxide yellow oxide (E172), guar gum, sodium benzoate, simethicone S 184, sucrose, strawberry flavor, apple flavor, raspberry aroma, tutti frutti flavor.
40 g (for the preparation of 100 ml of suspension) - bottles of dark glass (1) complete with a measuring spoon with a volume of 5 ml and a risk for a volume of 2.5 ml - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Cephalosporin antibiotic of the first generation. It acts bactericidal, disrupts the synthesis of the cell wall of microorganisms. Resistant to lactamases.
Has a wide range of activities. It is active against gram-positive microorganisms - Staphylococcus spp., (Including penicillinase-producing and non-producing penicillinase strains Staphylococcus aureus, penicillin-sensitive strains of Staphylococcus epidermidis), Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes), Corynebacterium diphtheriae; Gram-negative microorganisms - Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella catarrhalis, Proteus mirabilis; Treponema spp., Radiant fungi.
Ineffective against Pseudomonas aeruginosa, Proteus spp. (indolpositive strains), Morganella morganii, Mycobacterium tuberculosis, Enterococcus faecalis, Haemophilus spp., Enterobacter spp., Serratia spp., Pseudomonas spp., Aeromonas spp., Acinetobacter spp., methicillin-resistant strains, anaerobic microorganisms.
It is resistant to penicillinase of staphylococci, but is destroyed by cephalosporinase of gram-negative microorganisms.
PHARMACOKINETICS
After ingestion quickly and well absorbed. Bioavailability is 90-95%, food intake slows down absorption, but does not affect its completeness. The time to reach C maxafter ingestion of 0.25, 0.5 or 1 g is 1 hour, the C max values ​​are 9, 18 and 32 μg / ml, respectively.
The therapeutic concentration persists for 4-6 hours. The connection with plasma proteins is 10-15%. V d - 0.26 l / kg.
It is distributed relatively evenly in various tissues and body fluids: lungs, liver, heart, kidneys, bile, gall bladder, bones, joints, respiratory tract. Poorly penetrates the unchanged BBB. Passes through the placenta, in small amounts excreted in breast milk, is found in the amniotic fluid.
It is not metabolized.
T 1/2 - 0.9-1.2 hours. The total ground clearance is 380 ml / min. It is excreted by the kidneys - 70-89% unchanged (2/3 - glomerular filtration, 1/3 - tubular secretion);with bile - 0.5%. Kidney clearance - 210 ml / min.
If there is a violation of the excretory function of the kidneys, the concentration in the blood increases, and the time of excretion by the kidneys lengthens, T 1/2 after ingestion - 5-30 hours. Moderately withdrawn by hemodialysis, well - with peritoneal dialysis.
INDICATIONS
- infections of the upper and lower respiratory tract (pharyngitis, otitis media, sinusitis, tonsillitis, bronchitis, acute and exacerbation of chronic pneumonia, bronchopneumonia, empyema and lung abscess);
- infections of the genitourinary system (pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, endometritis, gonorrhea, vulvovaginitis);
- skin and soft tissue infections (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis);
- infections of bones and joints (including osteomyelitis).
DOSING MODE
Inside, 30-60 minutes before meals, washed down with water.
The average dose for adults and children over 10 years is 250-500 mg every 6 hours. The daily dose of the drug should be at least 1-2 g, if necessary, can be increased to 4 g. The duration of the course of treatment is 7-14 days. For infections caused by group A beta-hemolytic streptococcus , the minimum duration of treatment is 10 days.
Adult patients with renal dysfunction daily dose reduced with regard to the value of CC: with KK 5-20 ml / min the maximum daily dose is 1.5 g / day; with SC less than 5 ml / min - 0.5 g / day. The daily dose is divided into 4 divided doses.
Children up to 10 years of age, the drug is recommended to be administered in the form of a suspension for oral administration. With a body weight of less than 40 kg, the average daily dose is 25-100 mg / kg body weight; frequency of reception - 4 times / day. With an average otitis - a dose of 75 mg / kg / day, the frequency of reception - 4 times / day. With streptococcal pharyngitis, infections of the skin and soft tissues, the frequency of reception is 2 times / day. In severe infections, the daily dose can be increased to 100 mg / kg of body weight, and the frequency of intake - up to 6 times / day.
Preparation of the suspension: in the vial add water to the risks and shake well. The prepared suspension is stable at room temperature for 14 days. Before each use, the suspension must be shaken. 5 ml of the finished suspension contains 250 mg of cephalexin.
SIDE EFFECT
Allergic reactions: rash, hives, Quincke's edema, erythema, rarely - eosinophilia, toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactic shock.
On the part of the digestive system: pain in the abdomen, dry mouth, anorexia, nausea, vomiting, diarrhea, toxic hepatitis, cholestatic jaundice, increased activity of hepatic transaminases and alkaline phosphatase, candidiasis of the intestine, oral cavity, pseudomembranous enterocolitis.
From the nervous system: dizziness, weakness, headache, agitation, hallucinations, convulsions.
On the part of the genitourinary system: interstitial nephritis, genital and anal itching, vaginitis, vaginal discharge, candidiasis of genital organs.
From the hematopoiesis: leukopenia, neutropenia, thrombocytopenia.
From the musculoskeletal system: arthralgia, arthritis.
Laboratory indicators: increased prothrombin time.
CONTRAINDICATIONS
- Children under 3 years of age (for a dosage form - capsules);
- Hypersensitivity (including to other beta-lactam antibiotics).
With caution - renal failure, pseudomembranous colitis (in the anamnesis), pregnancy, lactation, breast age (up to 6 months - for suspension).
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.
If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.
APPLICATION FOR FUNCTIONS OF THE LIVER
Adult patients with renal dysfunction daily dose reduced with regard to the value of CC: with KK 5-20 ml / min the maximum daily dose is 1.5 g / day; with SC less than 5 ml / min - 0.5 g / day. The daily dose is divided into 4 divided doses.
APPLICATION FOR CHILDREN
Contraindication: children under 3 years of age (for a dosage form - capsules). Children up to 10 years of age, the drug is recommended to be administered in the form of a suspension for oral administration.
SPECIAL INSTRUCTIONS
Patients with allergic reactions to penicillins and carbapenems in history may have increased sensitivity to cephalosporin antibiotics.
During treatment with cephalexin, a positive direct Coombs reaction is possible, as well as a false positive urine reaction to glucose.
During the treatment it is not recommended to use ethanol.
In patients with impaired renal function, cumulation is possible (correction of the dosing regimen is required).
With staphylococcal infection, there is a cross-resistance between cephalosporins and isoxazolylpenicillins.
OVERDOSE
Symptoms: vomiting, nausea, epigastric pain, diarrhea, hematuria.
Treatment: activated charcoal (more effective than lavage), maintenance of airway patency, monitoring of vital functions, blood gases, electrolyte balance.
DRUG INTERACTION
When used simultaneously with furosemide, ethacrynic acid, nephrotoxic antibiotics (eg, aminoglycosides), the risk of kidney damage increases.
Salicylates and indomethacin slow the excretion of cephalexin.
Cefalexin reduces the prothrombin index, increases the effect of indirect anticoagulants.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Store in a dry, protected from light, out of reach of children at a temperature of 15 В° to 25 В° C. Shelf life - 3 years.
