Ospamox pills p/o 500mg №12×1

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Ospamox tabl plen. about. 500mg per blister. in pack. No. 12×1
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Oblong biconvex tablets with notches on both sides, from white to slightly yellowish. Composition Active ingredient: amoxicillin. One tablet contains 500 mg amoxicillin trihydrate. Excipients: magnesium stearate, polyvidone (K25), sodium starch glycolate, microcrystalline cellulose; film shell: titanium dioxide (E171), talc, methylhydroxypropyl cellulose. Pharmacotherapeutic group Antibacterial agents for systemic use; beta-lactam antibacterial agents, penicillins; broad spectrum penicillins. ATX code: J01CA04. Pharmacokinetics Amoxicillin is completely soluble in aqueous solution at physiological pH. It is rapidly and well absorbed after oral administration. When administered orally, the bioavailability of amoxicillin reaches approximately 70%. The time to reach peak concentration (Tmax) is approximately one hour. In a group of healthy volunteers, when taking amoxicillin at a dose of 250 mg three times a day on an empty stomach, the maximum serum concentration was 3.3 ± 1.12 μg / ml, the median time to reach the maximum concentration was 1.5 hours (range 1.0-2, 0), the value of the AUC (0-24 h) is 26.7 ± 4.56 μg * h / ml, the half-life (T1 / 2) is 1.36 ± 0.56 h. In the dose range from 250 to 3000 mg bioavailability (parameters: AUC and Cmax) is linearly proportional to the dose. Simultaneous ingestion of food does not affect absorption. The drug can be removed by hemodialysis. Approximately 18% of the total content of amoxicillin in plasma is in a protein-bound state. The apparent volume of distribution is about 0.3-0.4 l/kg. After intravenous administration, amoxicillin is found in the gallbladder, abdominal wall tissues, skin, adipose tissue, muscle tissue, synovial and peritoneal fluids, bile and pus. Amoxicillin penetrates weakly into the cerebrospinal fluid. In animal studies, there was no evidence of a significant retention of drug components in tissues. Amoxicillin passes into breast milk. Penetrates through the placental barrier. Amoxicillin is partially excreted in the urine in the form of inactive penicillic acid in amounts equivalent to no more than 10-25% of the original dose. It is excreted mainly by the kidneys. Amoxicillin in healthy individuals is characterized by an average half-life of about one hour and an average total clearance of about 25 l / h. Approximately 60-70% of amoxicillin is excreted unchanged in the urine in the first 6 hours after a single dose of 250 mg or 500 mg. Excretion in the urine within a 24-hour period is 50-85%. Concomitant use of probenecid causes a delay in the excretion of amoxicillin. Age The half-life of amoxicillin in children aged 3 months to 2 years, older children and adults is similar. In very young children (including premature newborns) in the first week of life, the drug should not be used more than twice a day due to the immaturity of the renal excretion pathway. Since the elderly are more likely to have decreased renal function, caution should be exercised in the selection of doses, and monitoring of renal function may also be required. Gender The pharmacokinetics of amoxicillin does not depend on the gender of the patient. Impaired renal function The total plasma clearance of amoxicillin decreases in proportion to the decrease in renal function. Liver failure Treatment of patients with liver failure is carried out with caution, regular monitoring of liver function is required. Preclinical safety data Preclinical studies have shown that the use of the drug does not pose a danger to humans. Carcinogenicity studies of amoxicillin have not been conducted. Indications for use Treatment of the following infections in adults and children: acute bacterial sinusitis; acute otitis media; acute streptococcal tonsillitis and pharyngitis; exacerbations of chronic bronchitis; community-acquired pneumonia; acute cystitis; asymptomatic bacteriuria in pregnant women; acute pyelonephritis; typhoid and paratyphoid fever; phlegmon infection of the prosthetic joint; eradication of Helicobacter pylori; Lyme disease. Prevention of endocarditis. Official guidelines on the appropriate use of antibacterials should be taken into account. Contraindications Hypersensitivity to the active substance, any penicillin or any of the excipients of the drug; a history of severe immediate hypersensitivity reaction (eg, anaphylaxis) to another beta-lactam drug (eg, cephalosporin groups, carbapenems or monobactams). Directions and Precautions Hypersensitivity Reactions Prior to initiating therapy with Ospamox, a thorough history should be taken for hypersensitivity reactions to penicillins, cephalosporins or other beta-lactams (see “Contraindications” and “Side Effects”). There have been reports of the development of serious hypersensitivity reactions, sometimes fatal, (including anaphylactoid and severe skin adverse reactions) in patients receiving penicillin therapy. The development of such reactions is more likely in individuals with a history of hypersensitivity to penicillin and in individuals with atopy. With the development of allergic reactions, it is required to stop therapy with Ospamox and prescribe another suitable therapy. Non-susceptible organisms Ospamox is not suitable for the treatment of some types of infections, unless the pathogen has been identified and determined to be susceptible, or there is a strong likelihood that amoxicillin is effective against that pathogen. This is especially true when considering the treatment of patients with urinary tract infections and severe infections of the ear, throat and nose. Convulsions In patients with impaired renal function, as well as in patients receiving high doses of the drug, patients with predisposing factors (eg, a history of convulsions, treated epilepsy or meningeal disorders), convulsions may occur. Impaired renal function In patients with impaired renal function, the dose is adjusted according to the degree of impairment (see “Method of application and dose”). Skin reactions If generalized erythema occurs at the beginning of treatment, accompanied by the formation of pustules and fever, this may be a symptom of acute generalized exanthematous pustulosis. This reaction requires the abolition of Ospamox and is a contraindication for the further appointment of amoxicillin. If infectious mononucleosis is suspected, it is necessary to avoid the appointment of Ospamox, because after the use of amoxicillin against the background of this disease, the development of a measles-like rash was noted. Jarisch-Herxheimer reaction In the treatment of Lyme disease with amoxicillin, the Jarisch-Herxheimer reaction (fever, chills, headache, muscle pain and skin rash) has been observed. This is a consequence of the bactericidal activity of amoxicillin against the causative agent of Lyme disease, the spirochete Borrelia burgdorferi. This is a common, common, and self-limiting reaction to antibiotic treatment for Lyme disease. Overgrowth of non-susceptible organisms Long-term use of amoxicillin can sometimes lead to an overgrowth of non-susceptible organisms. Against the background of therapy with almost all antibacterial drugs, cases of antibiotic-associated colitis have been reported, which can vary in severity from mild to life-threatening. It is important to be aware of the possibility of this diagnosis in patients with diarrhea during or after antibiotic therapy. In case of development of antibiotic-associated colitis, treatment with Ospamox should be stopped immediately, consult a doctor and start appropriate treatment. In this situation, the use of drugs that depress peristalsis is contraindicated. Long-term therapy During long-term therapy, it is recommended to periodically evaluate the functions of various organ systems, including the kidneys, liver, and hematopoiesis. An increase in the level of liver enzymes and changes in the number of blood cells have been reported. Anticoagulants Rarely, prolonged prothrombin time has been reported with amoxicillin. With the simultaneous appointment of anticoagulants, proper monitoring must be carried out. To achieve the desired level of anticoagulation, dose adjustment of oral anticoagulants may be required (see “Interaction with other medicinal products and other forms of interaction” and “Side effects”). Crystalluria In very rare cases, crystalluria has been reported in patients with reduced diuresis, mainly during parenteral therapy. In the case of high doses of amoxicillin, it is recommended to maintain an adequate level of fluid intake and diuresis in order to reduce the likelihood of crystalluria caused by the use of amoxicillin. In patients with a catheter in the bladder, it is imperative to regularly check its patency. Interference with Diagnostic Test Results Elevated serum and urinary amoxicillin levels may interfere with the results of some laboratory tests. Due to the high concentrations of amoxicillin in the urine, false-positive results of analyzes carried out by chemical methods are very common. During treatment with Ospamox, the level of glucose in the urine should be monitored by enzymatic methods using glucose oxidase. The presence of amoxicillin may distort the results of the determination of estriol in pregnant women. Pregnancy and lactation Limited data on the use of amoxicillin during pregnancy do not indicate an increased risk of congenital anomalies. Ospamox can be used during pregnancy if the potential benefit outweighs the potential risk. Amoxicillin is excreted in breast milk in small amounts, which poses a risk of sensitization. Breastfed infants may develop diarrhea and fungal infections of the mucous membranes, so it may be necessary to stop breastfeeding. Therapy with Ospamox during breastfeeding is possible only after assessing the benefit / risk ratio by the attending physician. Data on the effect of amoxicillin on fertility are not available. Influence on the ability to drive vehicles and work with mechanisms Influence on the ability to drive vehicles and work with mechanisms has not been studied. However, it is possible to develop unwanted reactions (for example, allergic reactions, dizziness, convulsions), potentially affecting it. Method of administration and doses For oral administration. Tablets are washed down with a liquid (for example, a glass of water), without chewing or breaking. Eating does not reduce the absorption of amoxicillin. Therapy can be started parenterally in accordance with the recommendations for dosing the drug for intravenous administration and continued with the drug for oral administration. Doses The dose of amoxicillin selected for the treatment of a particular infection depends on the following factors: the suspected pathogens and their likely sensitivity to antibacterial drugs; the severity and location of the infection; the age, body weight and kidney function of the patient, as indicated below. The duration of therapy is determined by the type of infection and response patient and, as a rule, should be as short as possible. Some infections require longer treatment (for long-term therapy, see section “Special instructions and precautions”). Patients on peritoneal dialysis Maximum dose: 500 mg/day. Impaired liver function It is necessary to carefully select the dose and regularly monitor liver function. If you miss a dose If you miss a dose, take your usual dose as soon as you remember. Then continue to take the drug according to the previous scheme. Do not take a double dose to make up for a missed one. Side effects The most common adverse reactions are diarrhea, nausea and skin rash. The following terminology was used to classify the incidence of adverse reactions: very common (? 1/10), frequent (from ? 1/100 to < 1/10), infrequent (from ? 1/1000 to < 1/100), rare ( from ? 1/10,000 to < 1/1,000), very rare (< 1/10,000), the frequency is unknown (based on the available data, an estimate is not possible). Infections and parasitic infestations Very rare: candidiasis of the skin and mucous membranes. Blood and lymphatic system disorders Very rare: reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia, prolongation of bleeding time and prothrombin time. Immune system disorders Very rare: severe allergic reactions including angioedema, anaphylaxis, serum sickness and allergic vasculitis. Frequency unknown: Jarisch-Herxheimer reaction. Nervous system disorders Very rare: hyperkinesia, dizziness and convulsions. Frequency unknown: aseptic meningitis. Gastrointestinal disorders Common: diarrhea and nausea. Uncommon: vomiting. Very rare: antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis), black hairy tongue. Liver and biliary tract disorders Very rare: Hepatitis, cholestatic jaundice, mild elevation of AST and/or ALT levels. Skin and subcutaneous tissue disorders Common: skin rash. Uncommon: itching, urticaria. Very rare: skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results (including an increase in the number of white blood cells (eosinophilia) and an increase in liver enzymes)), also called DRESS syndrome. Renal and urinary disorders Very rare: interstitial nephritis, crystalluria. Reporting adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through national adverse drug reaction and drug failure reporting systems. The patient, if he experiences any adverse reactions, is advised to consult a doctor. This recommendation applies to any possible adverse reactions, including those not listed in the instructions for use of the drug. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Overdose In case of overdose, gastrointestinal symptoms (nausea, vomiting, diarrhea) and water and electrolyte imbalance may develop. There have been cases of amoxicillin-associated crystalluria, in some cases leading to renal failure. Convulsions may occur in patients with impaired renal function and in patients taking high doses of the drug. Gastrointestinal disorders are treated symptomatically, with due attention paid to restoring fluid and electrolyte balance. Amoxicillin can be excreted from the body by hemodialysis. Interaction with other medicinal products and other forms of interaction Probenecid Probenecid reduces the secretion of amoxicillin by the renal tubules. The concomitant use of probenecid is not recommended because it may lead to an increase in blood levels of amoxicillin and longer maintenance. Allopurinol The simultaneous use of allopurinol during treatment with amoxicillin may increase the risk of developing allergic skin reactions. Tetracyclines Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal action of amoxicillin. Oral Anticoagulants Oral anticoagulants with penicillin antibiotics are commonly used in clinical practice, and interactions have not been reported. However, the literature describes cases of an increase in the international normalized ratio (INR) in patients receiving maintenance therapy with acenocoumarol or warfarin against the background of the prescribed course of amoxicillin. If it is necessary to prescribe these drugs simultaneously with amoxicillin, namely, when adding or stopping amoxicillin therapy, careful monitoring of prothrombin time or INR should be carried out. Moreover, dose adjustment of oral anticoagulants may be required (see "Special Instructions and Precautions" and "Side Effects"). Methotrexate Penicillins may reduce the excretion of methotrexate, leading to a potential increase in its toxicity. Packing 10 or 12 tablets in aluminium/PVC/PVDC blister. 1 blister containing 12 tablets, with instructions for medical use in a carton pack. 100 blisters containing 10 tablets each with instructions for medical use in a carton pack. Storage conditionsKeep out of the reach of children! Store in original packaging at a temperature not exceeding 25 °C. Shelf life 4 years. Do not use after the expiry date stated on the package. Leave conditions By prescription. Buy Ospamox tablets p/o 500mg No. 12x1 Price for Ospamox tablets p/o 500mg No. 12x1