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Sefpotek 200 mg No. 10 tablet p.p.o.

APPROVED by the Order of the Chairman of the Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan dated "____"______________200, No. ______________ Instructions for the medical use of the drug CEFPOTEK Trade name Sefpotek International nonproprietary name Cefpodoxime Dosage form Film-coated tablets, 200 mg Composition One tablet contains the active substance - cefpodoxime proxetil 260.90 mg (equivalent to 200 mg cefpodoxime), excipients: microcrystalline cellulose & sodium carboxymethylcellulose (Avicel RC 591), sodium lauryl sulfate, hydroxypropylcellulose - L, aerosil 200, magnesium stearate, shell composition: hydroxypropyl methylcellulose (E464), microcrystalline cellulose (E460), stearic acid (E570), titanium dioxide (E171) Description White film-coated tablets, oblong in shape, with a score on one side and the marking “NOBEL” on the other. Pharmacotherapeutic group: Other beta-lactam antibacterial drugs. Third generation cephalosporins ATC code J01DD13 Pharmacological properties Pharmacokinetics Cefpodoxime proxetil is a prodrug, absorbed from the gastrointestinal tract (GIT) and de-esterified to the active metabolite - cefpodoxime. When taking 100 mg of cefpodoxime proxetil on an empty stomach, about 50% of the taken cefpodoxime is absorbed systemically. Above the recommended dosage level (from 100 to 400 mg), a dose-dependent level and degree of absorption of cefpodoxime is detected. When taking a therapeutic dose (from 100 to 400 mg), the time to reach maximum concentration (Tmax) is about 2-3 hours and the half-life (T1/2) ranges from 2.09 to 2.84 hours. The average Cmax value is about 1 .4 mcg/ml at a dosage of 100 mg, 2.3 mcg/ml at a dosage of 200 mg and 3.9 mcg/ml at a dosage of 400 mg. In patients with normal renal function, neither accumulation nor significant changes in other pharmacokinetic parameters are observed after repeated doses of the drug up to 400 mg every 12 hours. From 22 to 33% of cefpodoxime is bound to serum proteins and from 21 to 29% to plasma proteins. Sefpotek is well distributed in organs and tissues. In the lung tissue, the drug concentration is about 0.63 mcg/g after 3 hours, about 0.52 mcg/g after 6 hours, about 0.19 mcg/g after 12 hours, which is about 70 - 80% of plasma concentrations; in the bronchial mucosa - 0.9 mcg/kg (50%), in alveolar cells - 0.1 - 0.2 mcg/kg (10%), and in the pleural and inflammatory fluid accumulates up to 70 - 100% of the plasma concentration blood. SEFPOTEK penetrates the lungs and tonsil tissue and maintains a constant concentration of the drug for 12 hours when taking a therapeutic dose and exceeds MIC90 (minimum inhibitory concentration) for Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae. The concentration of cefpodoxime in lung tissue after 6 - 8 hours is many times higher than MIC90 for the following respiratory pathogens: M. (B.) catarrhalis - 2 times, H. influenzae and S. pneumoniae - 20 times, S. pyogenes - approximately 70 times. Approximately 90% of cefpodoxime after administration is excreted in urine within 12 hours. Use in the elderly In elderly people, including those with bronchopulmonary infection, there is a slight increase in T1/2 and blood concentrations, but this does not require dose adjustment, with the exception of patients with reduced renal function. In elderly patients, the plasma half-life of cefpodoxime averages 4.2 hours (3.3 hours in younger patients). Other pharmacokinetic parameters (Cmax, AUC (area under the curve) and Tmax) remain unchanged. Use in patients with impaired renal function In patients with reduced renal impairment (with creatinine clearance from 50 to 80 ml/min), the half-life in plasma averages 3.5 hours. In patients with moderate (with creatinine clearance from 30 to 49 ml /min) or severe (with creatinine clearance from 5 to 29 ml/min) renal failure, the half-life increases to 5.9 and 9.8 hours, respectively. Use in patients with impaired liver function In patients with liver cirrhosis, absorption is reduced to some extent, and excretion from the body remains unchanged. The mean T1/2 value of cefpodoxime and renal clearance in patients with liver cirrhosis also remain unchanged. Ascites has no effect on indicators for patients with cirrhosis. No dose adjustment is required for this group of patients. Pharmacodynamics SEFPOTEK is a semisynthetic broad-spectrum antibiotic of the cephalosporin class. Cefpodoxime proxetil is a prodrug whose active metabolite is cefpodoxime. The bactericidal activity of cefpodoxime is to inhibit cell wall synthesis. SEFPOTEK showed activity against most strains of the following microorganisms: aerobic gram-positive microorganisms: - Staphylococcus aureus (including strains produced by penicillinase), Staphylococcus saprophyticus - Streptococcus pneumoniae (except for strains resistant to penicillin) - Streptococcus pyogenes - Streptococcus agalactiae - Streptococcus spp. (groups C, F, G) aerobic gram-negative microorganisms: - Escherichia coli - Klebsiella pneumoniae - Proteus mirabilis - Haemophilus influenzae (including strains produced by β-lactamase) - Moraxella (Branhamella) catarrhalis - Neisseria gonorrhoeae (including strains produced by penicillinase ) - Citrobacter diversus - Klebsiella oxytoca - Proteus vulgaris - Providencia rettgeri - Haemophilus parainfluenzae anaerobic gram-positive microorganisms: - Peptostreptococcus magnus Cefpodoxime is inactive against some strains of Pseudomonas and Enterobacter. Indications for use - upper respiratory tract infections caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae or Moraxella (Branchamella) catarrhalis, including acute otitis media, sinusitis, tonsillitis and pharyngitis - community-acquired pneumonia caused by S. pneumoniae or H. Influenzae - exacerbation of chronic bacterial bronchitis caused by S. pneumoniae, H. Influenzae or M. Catarrhalis - acute uncomplicated urethral or cervical gonorrhea caused by Neisseria gonorrhoeae. - acute uncomplicated anorectal infections in women caused by Neisseria gonorrhoeae - uncomplicated skin and soft tissue infections caused by Staphylococcus aureus or Streptococcus pyogenes - acute maxillary sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae and Moraxella catarrhalis - uncomplicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus Method of administration and dosage CEFPOTEK is indicated for oral administration with meals. The following table presents the recommended doses, duration of treatment, patient population (12 years and older), in addition to other doctor's instructions: Adults and adolescents 12 years and older Infection Total daily dose Dosage regimen Duration of treatment Upper respiratory tract infections caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae or Moraxella (Branchamella) catarrhalis, including acute otitis media, sinusitis, tonsillitis and pharyngitis For patients with normal renal function, as well as patients with liver failure, no dose adjustment is required. In general, there are no differences in the effectiveness and safety of use in elderly and young patients. For patients with severe renal failure (with creatinine clearance <30 ml/min), the interval between doses of the drug should be increased to 24 hours. For patients on hemodialysis, the dosing frequency should be 3 times a week after hemodialysis. Side effects Common (more than 1%) - nausea, abdominal pain, diarrhea - headache - vaginal fungal infections, vulvovaginal infections Rare (less than 1%) - dizziness, insomnia, drowsiness, anxiety, hallucinations, nervousness, attention disorder, confusion , night nightmares, eye irritation, tinnitus, malaise, fatigue, weakness - fever, chills, generalized and local pain (chest pain, back pain, myalgia) - migraine - gout - rapid heartbeat, congestive heart failure, vasodilation - anemia - arterial hypertension or hypotension, ischemic stroke, paresthesia - dry mouth and throat, thirst, loss of appetite, distortion and loss of taste, belching, vomiting, bloating, dyspepsia, pain during defecation - gastritis, gastrointestinal disorders, pseudomembranous colitis - candidal stomatitis, oral ulcers, diseases of the tongue, teeth. toothache - increased sweating, dehydration - peripheral edema, weight gain - dyspnea (shortness of breath), wheezing, cough, bronchitis, asthma - pleural effusion, pneumonia - nosebleeds, rhinitis, sinusitis - allergic reactions (Quincke's edema, urticaria) - rash, including macular, hematomas, itching, fungal dermatitis, dry and flaky skin, vesiculobullous rash, sensitivity to UV rays, hair loss - hematuria, proteinuria, dysuria, frequent urination, nocturia, vaginal pain, urinary tract infections and penis, uterine bleeding - fungal, bacterial, parasitic infections, abnormal microbiological parameters - reversible changes in laboratory parameters (short-term increase in AST, ALT, GGT, alkaline phosphatase, bilirubin and LDH) - eosinophilia, leukocytosis, lymphocytosis, granulocytosis, basophilia , monocytosis, thrombocytosis, decreased hematocrit, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, positive Coombs test, increased prothrombin time and PTT, hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia and hyponatremia, increased urea and creatinine) Contraindications - allergic reactions to cefpodoxime or cephalosporin antibiotics - pregnancy and lactation - children under 12 years of age Drug interactions When using the drug SEFPOTEK simultaneously with: - high doses of antacids (sodium carbonate and aluminum hydroxide) or H2-blockers (cimetidine), the level of peak plasma concentrations and extent of absorption of SEFPOTEK. As a result of this interaction, the level of absorption is not modified - with anticholinergic drugs for oral administration, the time to reach peak plasma concentration (Tmax) of cefpodoxime is delayed, the extent of absorption (AUC) of the drug remains unchanged - with probenecid, the renal excretion of cefpodoxime is inhibited and, as a result, the AUC and Cmax level, as with other beta-lactam antibiotics - substances that have a nephrotoxic effect, with simultaneous administration, the development of nephrotoxicity is possible, although nephrotoxicity was not noted during monotherapy with cefpodoxime proxetil. Cephalosporins, including cefpodoxime proxetil, may cause a positive Coombs test. Special instructions Before starting therapy with SEFPOTEK, patients should be carefully assessed for hypersensitivity to cefpodoxime, other cephalosporins, penicillins or other drugs. Particular caution must be exercised when prescribing the drug to patients with hypersensitivity to penicillin antibiotics, due to the development of a cross-allergic reaction between beta-lactam antibiotics. If an allergic reaction occurs, you must stop taking the drug. Serious hypersensitivity reactions to the drug may require therapy with epinephrine and other emergency measures, including oxygenation, intravenous fluids, antihistamines, and ventilation therapy as clinically indicated. The development of pseudomembranous colitis has been observed with almost all antibacterial agents, including cefpodoxime, and varies in severity: from moderate to life-threatening forms. Therefore, it is important to consider this diagnosis in patients who experience diarrhea after taking antibacterial drugs. Use in pediatrics The safety and effectiveness of the drug in children under 12 years of age has not been established. Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms Considering the side effects of the drug, care should be taken when driving a car and potentially dangerous mechanisms. Overdose Symptoms: nausea, vomiting, epigastric pain and diarrhea. Treatment: If a serious toxic reaction occurs as a result of drug overdose, cefpodoxime is usually eliminated from the body by hemodialysis or peritoneal dialysis, especially in cases where the renal system is at risk. About 23% of the dose taken is excreted from the body during a standard 3-hour hemodialysis procedure. Release form and packaging Film-coated tablets, 200 mg. In a blister pack of 5 or 7 tablets, 1 or 2 packages (7 tablets each) or 2, 3 or 4 packages (5 tablets each) in a cardboard box along with instructions for medical use. Storage conditions Store at a temperature not exceeding 25°C, in a dry place, protected from light. Keep out of the reach of children! Shelf life: 2 years Do not use after expiration of the shelf life. Conditions for dispensing from pharmacies By prescription Manufacturer NOBEL Ilach Sanai ve Tijaret A.Sh., Turkey Packaged by Nobel Almaty Pharmaceutical Factory JSC Republic of Kazakhstan Almaty, st. Shevchenko 162 E.