Cephalexin caps 500 mg x16 Hemofarm

Nosological classification (ICD-10)

• A54 Gonococcal infection
• H66 Suppurative and unspecified otitis media
• J06 Acute upper respiratory tract infections of multiple and unspecified localization
• L00-L08 Infections of the skin and subcutaneous tissue
• M60.0 Infectious myositis
• M65.0 Tendon sheath abscess
• M65.1 Other infectious tenosynovitis
• M71.0 Abscess of bursa
• M71.1 Other infectious bursitis
• M86 Osteomyelitis
• N30 Cystitis
• N71 Inflammatory diseases of the uterus, except the cervix
• N74.3 Gonococcal inflammatory diseases of the female pelvic organs (A54.2+)

Composition and release form

8 pcs in blister; There are 2 blisters in a box.

in bottles with 40 g of granulate for the preparation of an oral suspension of 100 ml, complete with a dosage spoon; 1 set in box.

Cefalexin

Release form, composition and packaging

Capsules

1 caps.

• cephalexin 250 mg
• -“- 500 mg

Granules for preparation of suspension for oral administration

5 ml of ready-made suspension. cephalexin 250 mg

Clinical and pharmacological group: I generation cephalosporin

pharmachologic effect

Has a bactericidal effect. Active against gram-positive (staphylococci, including penicillinase-forming, streptococci, pneumococci) and gram-negative microorganisms: E. coli, Salmonellae, Shigellae, Neisseriae, Proteus mirabilis, various strains of Haemophilus influenzae, Klebsiella pneumoniae, pale spirochetes and radiant fungi. Enterococci are resistant to the drug. Ineffective against Pseudomonas aeruginosa, indole-positive strains of Proteus, Mycobacterium tuberculosis, anaerobic microorganisms.

Pharmacokinetics

The drug is stable in an acidic environment and is quickly and almost completely (95%) absorbed when taken orally. The degree and rate of absorption do not depend on food intake.

The therapeutic concentration in the blood after a single use lasts for 4-6 hours.

It is excreted in significant quantities in the urine unchanged.

A small part is excreted in bile.

Penetrates poorly through the blood-brain barrier.

Indications

• treatment of infectious diseases of mild and moderate severity caused by microorganisms sensitive to the drug, including infectious diseases of the genitourinary organs, respiratory tract, ENT organs, skin and soft tissues; otitis media, osteomelitis, endometritis, gonorrhea;
• continuation of treatment of severe infectious diseases caused by microorganisms sensitive to the drug after initial treatment with parenteral cephalosporins.

Dosage regimen

Adults are prescribed 250-500 mg every 6-12 hours for diseases caused by microorganisms sensitive to the drug. For infectious diseases caused by less sensitive microorganisms, the daily dose is 2-4 g. The minimum daily dose is 1 g. Children are prescribed at the rate of 25-50 (up to 100) mg/kg body weight.

Children under 10 years of age are recommended to prescribe the drug in the form of a suspension.

The frequency of administration is 4 times a day.

The maximum daily dose for adults and children over 6 years of age is 4 g.

The duration of treatment is 7-14 days. For infectious diseases caused by streptococci, the course of treatment should last at least 10 days.

It is recommended to take the drug 30-60 minutes before meals with water.

Side effect

From the gastrointestinal tract and liver: diarrhea, transient increase in the activity of liver transaminases.

From the hematopoietic system: eosinophilia, neutropenia.

From the central nervous system: headaches, dizziness, weakness.

Allergic reactions: rarely - itching, skin reactions, anaphylactic shock. It is possible to develop superinfection, in particular, candidiasis of the vaginal mucosa.

Contraindications

Hypersensitivity to cephalosporin antibiotics.

Pregnancy and lactation

Data not provided.

special instructions

In patients with impaired renal function, the drug is prescribed with caution in reduced doses.

Caution should be used in patients with hypersensitivity to penicillins, as there is a possibility of cross-allergy between penicillins and cephalosporins.

The use of the drug during pregnancy and lactation is possible only for health reasons.

During the treatment period, you should not drink alcohol. During treatment, a positive direct Coombs reaction is possible, as well as a false positive urine reaction to sugar.

The use of cephalosporins simultaneously with anticoagulants may lead to an increase in prothrombin time.

There was no incompatibility with other drugs when taken orally.

Overdose

Data not provided.

Drug interactions

Not described.

Storage conditions and periods

Store at a temperature of 15 to 25°C, protected from light and moisture.

Shelf life: 3 years.

The prepared suspension is stable at temperatures from 15 to 25°C for 14 days.

Directions for use and doses

Orally, 30–60 minutes before meals, with water. Adults: 250–500 mg every 6–12 hours for diseases caused by microorganisms sensitive to the drug. For infectious diseases caused by less sensitive microorganisms, the daily dose is 2–4 g. The minimum daily dose is 1 g.

Children are prescribed at a rate of 25–50 (up to 100) mg/kg. Children under 10 years of age are recommended to prescribe the drug in the form of a suspension. The frequency of administration is 4 times a day.

The maximum daily dose for adults and children over 6 years of age is 4 g. The duration of treatment is 7–14 days. For infectious diseases caused by streptococci, the course of treatment is at least 10 days.

Cephalexin caps 500 mg x16 Hemofarm

Trade name: Cefalexin International name: Cefalexin Pharmacological group: antibiotic-cephalosporin Pharmacological group according to ATC: J01DB01. Cephalexin Pharmacological action: antibacterial Pharmacodynamics: Cephalosporin antibiotic of the first generation. It has a bactericidal effect and disrupts the synthesis of the cell wall of microorganisms. Quite resistant to penicillinases of gram-positive microorganisms, destroyed by beta-lactamases of gram-negative microorganisms. Wide spectrum of action: active against gram-positive microorganisms: Staphylococcus spp., non-producing and producing penicillinase, Staphylococcus epidermidis (penicillin-resistant strains), Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes), Corynebacterium diphtheriae, Clostridium spp., Bacillus anthracis, Actinomyces israelii, gram-negative microorganisms: Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella catarrhalis (Branhamella), Proteus mirabilis, Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Treponema spp. Does not affect Pseudomonas aeruginosa, pseudomonas of other species, Proteus spp. (indole-positive strains), Mycobacterium tuberculosis, anaerobic microorganisms, Enterococcus faecalis, Haemophilus spp., Enterobacter spp., Serratia spp., Aeromonas spp., Acinetobacter spp., methicillin-resistant staphylococcal strains.

Pharmacokinetics: Absorption - 90%, acid-resistant, food intake slows down absorption, but does not affect its completeness. Bioavailability - 95%. TCmax - 1-2 hours. After oral administration in doses of 250, 500 and 1000 mg Cmax - 9, 18, and 32 mcg/ml, respectively. Distributed relatively evenly in various tissues and body fluids: lungs, bronchial mucosa, liver, heart, kidneys. Does not pass the BBB, penetrates the placenta, and is excreted in small amounts in breast milk. Distribution volume - 0.26 l/kg. Bonding with plasma proteins is 5-15%. T1/2 - 0.9-1.5 hours. 90% is excreted unchanged by the kidneys (2/3 - by glomerular filtration, 1/3 - by tubular secretion), with bile - 0.5%. Total clearance - 380 ml/min, renal clearance - 210 ml/min. Cmax in urine after oral administration in doses of 250, 500 and 1000 mg is 1, 2.2 and 5 mg/ml, respectively. If renal function is impaired, the concentration in the blood increases, and the elimination time lengthens, T1/2 - 20-40 hours.

Indications for use: Infections of the upper and lower respiratory tract (bronchitis, acute pneumonia and exacerbation of chronic pneumonia, empyema and lung abscess), genitourinary system (pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, endometritis, gonorrhea, vulvovaginitis, etc.), ENT -organs (pharyngitis, otitis media, sinusitis, tonsillitis, etc.), skin and soft tissues (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis, etc.), bones and joints (including osteomyelitis).

Contraindications: Hypersensitivity (including to other beta-lactam antibiotics).

Dosage regimen: Orally, 30-60 minutes before meals, with water. The average dose for adults is 0.25-0.5 g every 6 hours. If necessary, the daily dose is 4-6 g. Duration of treatment is 7-14 days. For children - preferably in the form of a suspension. For body weight less than 40 kg, the average daily dose is 25-50-100 mg/kg, frequency of administration is 2, 3, 4 times a day. For otitis media - dose 75 mg/kg/day, frequency of administration - 4 times a day. For streptococcal pharyngitis, skin and soft tissue infections in adults, adolescents, and children over 1 year of age, the dosage frequency is 2 times a day. In case of severe infections, the daily dose can be increased to 100 mg/kg, and the frequency of administration - up to 6 times a day. For infections caused by group A beta-hemolytic streptococcus, the minimum duration of treatment is 10 days. For adult patients with impaired renal function, the daily dose is set taking into account the CC value: with 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.

Side effects: Allergic reactions: urticaria, angioedema, erythematous rashes, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylaxis, arthralgia, arthritis, eosinophilia, itching of the genitals and anus. From the nervous system: dizziness, weakness, headache, agitation, hallucinations, convulsions. From the genitourinary and urinary system: vaginitis, vaginal discharge, genital candidiasis, interstitial nephritis. From the digestive system: abdominal pain, dry mouth, loss of appetite, nausea, vomiting, dyspepsia, diarrhea, toxic hepatitis, cholestatic jaundice, intestinal candidiasis, oral cavity, rarely - pseudomembranous enterocolitis. From the hematopoietic organs: neutropenia, thrombocytopenia, leukopenia. Laboratory indicators: increased activity of liver transaminases and alkaline phosphatase, increased prothrombin time. Overdose. Symptoms: vomiting, nausea, epigastric pain, diarrhea, hematuria. Treatment: activated charcoal (more effective than lavage), maintaining airway patency, monitoring vital signs, blood gases, electrolyte balance.

Interaction: Enhances the effect of indirect anticoagulants. Increases the nephrotoxicity of aminoglycosides, polymyxins, phenylbutazone, furosemide. Salicylates and indomethacin slow down the excretion of cephalexin by the kidneys. Drugs that reduce tubular secretion increase the concentration of the drug in the blood and slow down its elimination.

Special instructions: Patients with a history of allergic reactions to penicillins and carbapenems may have increased sensitivity to cephalosporin antibiotics. During treatment with cephalexin, a positive direct Coombs test is possible, as well as a false positive urine test for glucose. During the treatment period, it is not recommended to consume ethanol. The use of the drug during pregnancy and lactation is justified only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped. In patients with impaired renal function, accumulation is possible (adjustment of the dosage regimen is required). In staphylococcal infections, cross-resistance exists between cephalosporins and isoxazolylpenicillins. Carefully. Renal failure, pseudomembranous colitis (history), pregnancy, lactation, infancy (up to 6 months).

Manufacturer: Hemofarm AD, Serbia Registration certificate holder: Hemofarm AD, Serbia Forms of release: granules for the preparation of oral suspension 250 mg|5 ml, dark glass bottles, granules for the preparation of oral suspension 250 mg/5 ml, dark glass bottle with a notch, sealed with a plastic or metal lid with first opening control. Composition: cephalexin hydrate 250 mg [in terms of cephalexin] - 5 ml of ready suspension Belongs to VED Conditions of release: by prescription Shelf life: 3 years Registration data: P N011645/02 dated 09/02/2011, 03/20/2008 Status of the registration certificate: current Pharmaceutical article number: ND 42-10564-05, ND 42-10564-99, P N011645/02-020911

Manufacturer: AVVA RUS OJSC, Russia Registration certificate holder: AVVA RUS OJSC, Russia Release forms: 250 mg capsules, cellular contour packs, 250 mg capsules, polymer jars, 250 mg capsules, polymer bottles Ingredients: cephalexin 250 mg Belongs to VED Dispensing conditions : by prescription Shelf life: 2 years Registration data: LS-002617 dated 04/21/2010 Status of the registration certificate: valid (until 2011) Pharmaceutical article number: FS 42-3118-95, FSP 42-0236-6944-05

Manufacturer: Belmedpreparaty RUP, Belarus Registration certificate holder: Belmedpreparaty RUP, Belarus Release form: 250 mg capsules, cellular contour packaging Composition: cephalexin 250 mg Belongs to the Vital and Essential Drugs Dispensing conditions: by prescription Shelf life: 2 years Registration data: LS-000864 from 07/27/2010 Registration certificate status: valid Pharmaceutical article number: ND 42-8883-05, ND 42-8883-06, ND 42-8883-98

Manufacturer: Severnaya Zvezda ZAO, Russia Registration certificate holder: Severnaya Zvezda ZAO, Russia Release forms: 250 mg capsules, plastic bags, 250 mg capsules, cellular contour packaging, 250 mg capsules, polymer jars, 250 mg capsules, dark glass jars, capsules 250 mg, polymer bottles Composition: cephalexin monohydrate 250 mg [in terms of 100% substance] Belongs to the Vital and Essential Drugs Dispensing conditions: by prescription Shelf life: 2 years Registration data: LSR-002246/07 dated 08.17.2007 Registration certificate status: valid Pharmaceutical article number: FS 42-3118-95, FSP 42-7967-06

Manufacturer: Hemofarm AD, Serbia Registration certificate holder: Hemofarm AD, Serbia Release forms: 250 mg capsules, blister packs, 500 mg capsules, blister packs, 250 mg capsules, PVC/aluminum blister, 500 mg capsules, PVC/aluminum blister Composition: cephalexin hydrate 263/525.9 mg [euv.250/500 mg cephalexin] Belongs to the VED Conditions of release: by prescription Shelf life: 3 years Registration data: P N011645/01 dated 04/20/2011, 03/20/2008 Registration certificate status: current Pharmaceutical article number: ND 42-10563-05, ND 42-10563-99

Manufacturer: Shchelkovo Vitamin Plant OJSC, Russia Registration certificate holder: Shchelkovo Vitamin Plant OJSC, Russia Release form: 250 mg capsules, contour cell packaging, 250 mg capsules, polymer jars Ingredients: cephalexin 250 mg Dispensing conditions: by prescription Shelf life: 2 years Registration data: P N003253/01 dated July 14, 2004 Registration certificate status: inactive (since 2009) Pharmaceutical article number: FS 42-3118-95, FSP 42-0055-4788-03

Manufacturer: Sintez OJSC, Russia Registration certificate holder: Sintez OJSC, Russia Forms of release: powder for the preparation of an oral suspension 125 mg, heat-sealable bags made of Buflen material, powder for the preparation of an oral suspension 125 mg, polyethylene bottles 150 ml, powder for the preparation of an oral suspension 125 mg|5 ml, heat-sealable bags made of Buflen material, powder for the preparation of an oral suspension 125 mg|5 ml, polyethylene bottles 150 ml, powder for the preparation of an oral suspension 250 mg, bags heat-sealable from the material "Buflen", powder for the preparation of an oral suspension 250 mg, polyethylene bottles 150 ml, powder for the preparation of an oral suspension 500 mg, heat-sealable bags from the material "Buflen", powder for the preparation of an oral suspension 500 mg, polyethylene bottles 150 ml Composition: cephalexin 0.125/0.25/0.5/2.5 g - 1.75/3.5/7/35 g Belongs to the Vital and Essential Drugs Dispensing conditions: by prescription Shelf life: 2 years, after preparation - 6 days (at room temperature), 14 days (in the refrigerator) Registration data: P N000563/01 dated December 29, 2006 Status of the registration certificate: valid (until 2011) Pharmaceutical article number: FSP 42-0054-0590-00, FSP 42-0054-0590-06

Manufacturer: Lupin Ltd., India Registration certificate holder: Lupin Ltd., India Release form: substance-powder, two-layer polyethylene bags Registration data: P N013276/01 dated 02/11/2008 Registration certificate status: valid Pharmaceutical article number: ND 42-5244 -01, ND 42-5244-03, ND 42-5244-07, ND 42-5244-95

Manufacturer: Orchid Chemicals & Pharmaceuticals Ltd, India Registration certificate holder: Orchid Chemicals & Pharmaceuticals Ltd, India Release form: substance-powder, two-layer polyethylene bags Ingredients: cephalexin hydrate Shelf life: 4 years Registration data: P N012110/01 dated 29.02. 2008 Status of the registration certificate: valid Pharmaceutical article number: ND 42-10995-00, ND 42-10995-07

Manufacturer: Ranbaxy Laboratories Ltd, India Registration certificate holder: Ranbaxy Laboratories Ltd, India Release form: powder substance, multilayer polyethylene bags Ingredients: cephalexin hydrate Shelf life: 3 years Registration data: P N015962/01 dated 10/15/2004 Registration certificate status : inactive (since 2009) Pharmaceutical article number: ND 42-7125-04, ND 42-7125-97

Manufacturer: Unimark Remedies Ltd, India Registration certificate holder: Unimark Remedies Ltd, India Release form: substance-powder, double-layer polyethylene bags Ingredients: cephalexin Shelf life: 4 years Registration data: LSR-004598/09 dated 06/09/2009 Registration certificate status : current Pharmaceutical article number: ND 42-14736-07

Manufacturer: Biokhimik OAO, Russia Registration certificate holder: Biokhimik OAO, Russia Release form: film-coated tablets 250 mg, tablet Dispensing conditions: by prescription Registration data: P N003669/01 dated 08/31/2009 Status of the registration certificate: valid Pharmaceutical article number: РN003669/01-131011