Cefalexin Hemofarm Capsules 500mg N16
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Active ingredients
Cephalexin
Release form
Capsules
Composition
1 capsule contains: Cefalexin monohydrate 263 mg, which corresponds to the content of cefalexin 250 mg. Additional substances: magnesium stearate, microcrystalline cellulose PH 102. The composition of the capsule shell: titanium dioxide (E171), iron dye yellow oxide (E172), indigo carmine (Indigotin I) ( E132), gelatin.
Pharmacological effect
Cephalosporin antibiotic I generation. Bactericidal effect, violates the synthesis of the cell wall of microorganisms. Resistant to lactamase. Has a wide spectrum of action. Active against Gram-positive microorganisms - Staphylococcus spp., (Including producing and non-producing penicillinase strains of 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. (indolent), Morganella, Morocco, Morocco. , but cephalosporinase of gram-negative microorganisms is destroyed.
Pharmacokinetics
After ingestion, it is quickly and well absorbed. Bioavailability - 90-95%, food intake slows down the absorption, but does not affect its fullness. The time to reach Cmax after ingestion is 0.25, 0.5 or 1 g - 1 hour, the value of Cmax is 9, 18 and 32 μg / ml, respectively. Therapeutic concentration lasts for 4-6 hours. Communication with plasma proteins is 10-15%. Vd - 0.26 l / kg. It is distributed relatively evenly in various tissues and body fluids: lungs, liver, heart, kidneys, bile, gall bladder, bones, joints, airways. It penetrates poorly through unchanged BBB. Passes through the placenta, in a small amount excreted in breast milk, it is found in the amniotic fluid. It is not metabolized. T1 / 2 - 0.9-1.2 h. Total clearance - 380 ml / min. Excreted by the kidneys - 70-89% unchanged (2/3 - glomerular filtration, 1/3 - cannular secretion); with bile - 0.5%. Renal clearance is 210 ml / min. When the excretory function of the kidneys is impaired, the concentration in the blood increases and the time for elimination by the kidneys is extended, T1 / 2 after oral administration is 5-30 hours. Moderately eliminated by hemodialysis, well - by peritoneal dialysis.
Indications
- infections of the upper and lower respiratory tract (pharyngitis, otitis media, sinusitis, sore throat, bronchitis, acute and exacerbation of chronic pneumonia, bronchopneumonia, empyema and lung abscess) - urinary tract infections, gonorrhea, vulvovaginitis); - infections of the skin and soft tissues (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis); - infections of bones and joints (including osteomyelitis).
Contraindications
- children's age up to 3 years (for the dosage form - capsules); - hypersensitivity (including to other beta-lactam antibiotics).
Precautionary measures
With care - renal failure, pseudomembranous colitis (in history), pregnancy, lactation period, infancy (up to 6 months - for suspension).
Use during pregnancy and lactation
The use of the drug during pregnancy and lactation is possible only in the case when the intended benefit to the mother outweighs the potential risk to the fetus. If you need to take the drug during lactation, you should stop breastfeeding.
Dosage and administration
Inside, 30-60 minutes before a meal, drinking water. The average dose for adults and children over 10 years old 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. Duration of treatment - 7-14 days. In infections caused by beta-hemolytic streptococcus group A, the minimum duration of treatment is 10 days. For adults with impaired renal function, the daily dose is reduced based on the CC value: for CC 5-20 ml / min, the maximum daily dose is 1.5 g / day; with CC less than 5 ml / min - 0.5 g / day. The daily dose is divided into 4 doses. For children under the age of 10 years, the drug is recommended to be prescribed in the form of a suspension for oral administration. With a body weight less than 40 kg, the average daily dose is 25-100 mg / kg body weight; the frequency of admission - 4 times / day. With otitis media, the dose is 75 mg / kg / day, the dose rate is 4 times / day. With streptococcal pharyngitis, infections of the skin and soft tissues, the frequency of administration is 2 times / day. In case of severe infections, the daily dose may be increased to 100 mg / kg of body weight, and the dose rate may be up to 6 times / day. Preparation of the suspension: add risks to the vial 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 prepared suspension contains 250 mg of cefalexin.
Side effects
Allergic reactions: rash, urticaria, angioedema, erythema, rarely - eosinophilia, toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactic shock. From 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, ha lucinations, convulsions. From the urogenital system: interstitial nephritis, pruritus of the genital organs and anus, vaginitis, vaginal discharge, candidiasis of the genital organs. From the side of hematopoietic organs: leukopenia, neutropenia, thrombocytopenia. From the side of the musculoskeletal system: arthralgia, arthritis . Laboratory parameters: an increase in prothrombin time.
Overdose
Symptoms: vomiting, nausea, epigastric pain, diarrhea, hematuria. Treatment: activated carbon (more effective than lavage), maintenance of airway patency, monitoring of vital functions, blood gases, electrolyte balance.
Interaction with other drugs
When used simultaneously with furosemide, ethacrynic acid, nephrotoxic antibiotics (for example, aminoglycosides), the risk of kidney damage increases. Salicylates and indomethacin slow down the excretion of cephalexin. Cephalexin reduces the prothrombin index, enhances the effect of indirect anticoagulants.
special instructions
Patients with a history of allergic reactions to penicillins and carbapenems may have an increased sensitivity to cephalosporin antibiotics. A positive direct Coombs reaction and a false positive urine response to glucose are not recommended during cephalexin treatment. Patients with impaired function of urine are not recommended to use ethanol. cumulation is possible (correction of the dosage regimen is required). In the case of a staphylococcal infection, there is cross-resistance between cephalosporins and isoxazolyl nicillinam.