Amoklav Pharmland tablets p/o 500mg/125mg №6×3

Name:
Amoclave Pharmland 500mg/125mg.
Description:
Tablets are white or almost white, oval, with a score on one side, film-coated. Marbling is allowed on the surface of the tablets. The main active ingredient is Amoxicillin. Release form Coated tablets. Dosage 500mg/125mg. Pharmacological action Amoxicillin in combination with beta-lactamase inhibitors. PBX J01CR02. Amoklav is indicated for the treatment of the following infections in adults and children: Acute bacterial sinusitis (adequately diagnosed) Acute otitis media Exacerbation of chronic bronchitis (adequately diagnosed) Community-acquired pneumonia Cystitis Pyelonephritis Soft tissue, skin, subcutaneous tissue infections, animal bites, severe dental abscess with the spread of inflammation to the subcutaneous tissue Infections of bones and joints, in particular, osteomyelitis. Consideration should be given to official guidelines on the appropriate use of antibacterial drugs. Route of administration and doses Doses are prescribed depending on the content of amoxicillin / clavulanic acid in the preparation, except in cases where doses are set depending on the content of one of the components. When choosing the dose of Amoclav for the treatment of individual infections, the following should be considered: Suspected pathogens and their sensitivity to antibacterial drugs (see “Precautions”) The severity and location of the infection The patient’s age, weight and kidney function. If necessary, it is possible to use other dosages of Amoclav (including higher doses of amoxicillin and / or different ratios of amoxicillin / clavulanic acid) (see “Precautions”). For adults and children weighing 40 kg or more, the total daily dose of Amoclav-625 is 1500 mg amoxicillin / 375 mg clavulanic acid when used in accordance with the recommendations below. For children weighing less than 40 kg, the maximum daily dose of Amoklav-625 tablets is 2400 mg amoxicillin / 600 mg clavulanic acid when used in accordance with the recommendations below. If it is necessary to use a higher daily dose of amoxicillin, it is recommended to use other dosages of Amoklav in order to avoid taking unreasonably high daily doses of clavulanic acid (see “Precautions”). The duration of the course should be determined taking into account the patient’s response to treatment. A number of infections (including osteomyelitis) require a longer course of treatment. Treatment should not be continued for more than 14 days without a review of the clinical situation (see “Precautions” for long-term use). Adults and children weighing 40 kg or more 1 tablet 500 mg / 125 mg three times a day. Children weighing less than 40 kg 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day in three divided doses. There are no clinical data on the use of Amoclav with a 4:1 active ingredient ratio of more than 40 mg / 10 mg / kg per day in children under 2 years of age. Elderly patients Dose adjustment is not required. Patients with impaired renal function Dose adjustment is based on the maximum recommended dose of amoxicillin. In patients with a creatinine clearance value (CrCl) of more than 30 ml / min, dose adjustment is not required. Adults and children weighing 40 kg or more CrCl: 10-30 ml / min 1 tablet 500 mg / 125 mg 2 times / day CrCl <10 ml / min 1 tablet 500 mg / 125 mg 1 time / day Hemodialysis 1 tablet 500 mg/125 mg every 24 hours. Additionally, 1 tablet of 500 mg / 125 mg is prescribed during and after dialysis (to compensate for the decrease in the serum concentration of amoxicillin and clavulanic acid). Children weighing less than 40 kg CrCl: 10-30 ml / min 15 mg / 3.75 mg / kg 2 times / day (no more than 500 mg / 125 mg 2 times / day) CrCl <10 ml / min 15 mg / day 3.75 mg/kg once/day (maximum 500 mg/125 mg) Hemodialysis 15 mg/3.75 mg/kg once/day One additional dose of 15 mg/3.75 mg/kg should be given before hemodialysis . To restore the concentration of the active ingredients of Amoclav in the blood, a second additional dose of 15 mg / 3.75 mg / kg should be administered after a hemodialysis session. Patients with impaired liver function Treatment is carried out with caution; regularly monitor liver function (see "Contraindications" and "Precautions"). Method of application Amoklav is intended for oral administration. It is recommended to take the drug at the beginning of a meal to minimize gastrointestinal disturbances and improve the absorption of amoxicillin / clavulanic acid. Use during pregnancy and lactation Studies conducted on animals have not revealed teratogenic effects in Amoclav. Amoclav should be avoided during pregnancy, especially in the first trimester, unless deemed necessary by the physician. Amoclav can be prescribed during lactation. With the exception of the risk of sensitization, Amoklav does not cause any other undesirable symptoms in children who are breastfed. Influence on the ability to drive a car The drug does not affect the reaction rate when driving vehicles or other moving mechanisms. Precautions Before starting treatment with Amoclav, a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam drugs should be taken. Serious and occasionally fatal hypersensitivity reactions (anaphylactoid reactions) have been observed during penicillin therapy. They are most likely to develop in patients with hypersensitivity reactions to penicillins and a history of atopy. In the event of an allergic reaction, Amoclav therapy is discontinued and other suitable antibacterial drugs are prescribed. In cases of proven susceptibility of infectious agents to amoxicillin, the option of switching from Amoklav to amoxicillin should be considered in accordance with official guidelines. This dosage form of the drug is not suitable for use if there is a high risk that the suspected pathogens have resistance to beta-lactam drugs, not mediated by beta-lactamases sensitive to the inhibitory effect of clavulanic acid. Since there are no private data on T>MIC (minimum inhibitory concentration), and the results of the evaluation of comparable oral dosage forms are of marginal significance, then this dosage form (without additional amoxicillin) is potentially unsuitable for the treatment of infections caused by penicillin-resistant strains of S. pheumoniae. Seizures may develop in patients with impaired renal function or receiving high-dose therapy. Therapy with Amoklav should be avoided in case of suspected infectious mononucleosis, since after the use of amoxicillin against the background of this disease, the appearance of a measles-like rash was observed. The concomitant use of allopurinol during treatment with amoxicillin potentially increases the likelihood of skin allergic reactions. Prolonged use of the drug may lead to excessive reproduction of non-susceptible microorganisms. The development of generalized erythema with fever and the formation of pustules at the beginning of therapy is a potential symptom of acute generalized exanthematous pustulosis (AGEP) (see “Side Effects”). Such a reaction requires discontinuation of Amoklav therapy and is a contraindication to the subsequent administration of amoxicillin. Treatment of patients with hepatic insufficiency is carried out with caution. Adverse events from the liver were observed mainly in men and elderly patients and are potentially associated with long-term treatment. These adverse events in very rare cases were observed in children. In all groups of patients, signs and symptoms usually develop during or shortly after treatment, but in some cases they do not appear until a few weeks after stopping therapy. They are usually reversible. Serious adverse events from the liver can develop, extremely rarely with a fatal outcome. They were almost always observed among patients with serious underlying diseases or taking concomitant drugs that can affect the liver (see “Side effects”). Cases of antibiotic-associated colitis observed during therapy with almost all antibacterial drugs, including amoxicillin, can vary in severity from mild to life-threatening (see “Side Effects”). It is important to consider this diagnosis in patients with diarrhea during or after completion of any course of antibiotic therapy. In the event of the development of antibiotic-associated colitis, Amoklav therapy is immediately stopped, a doctor is consulted and appropriate treatment is carried out. In this situation, the use of drugs that depress peristalsis is contraindicated. During long-term therapy, periodic evaluation of the functions of various organ systems, including the kidneys, liver, and hematopoietic organs, is recommended. In rare cases, while taking the drug, prolongation of prothrombin time was noted. When taking anticoagulants at the same time, proper monitoring of coagulation parameters is mandatory. It may be necessary to adjust the dose of oral anticoagulants to achieve the desired level of anticoagulation. In patients with renal insufficiency, dose adjustment is required in accordance with the level of insufficiency (see “Method of application and dose”). In patients with reduced diuresis, crystalluria was observed in rare cases, mainly against the background of parenteral therapy. Sufficient fluid intake is recommended during high-dose amoxicillin therapy to reduce the likelihood of amoxicillin-associated crystalluria. In patients with a catheter installed in the bladder, it is imperative to regularly monitor its patency. During the treatment of glucosuria, the assessment of glucose levels is carried out using enzymatic methods with glucose oxidase, since non-enzymatic methods sometimes give false positive results. The presence of clavulanic acid in Amoclav can cause non-specific binding of IgG and albumin to erythrocyte membranes, which can lead to false positive Coombs test results. There have been cases of positive results of enzyme-linked immunosorbent assay (ELISA) for Aspergillus in patients treated with the drug, in whom the absence of infections caused by Aspergillus was subsequently determined. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses have been noted in the ELISA test for Aspergillus. Positive test results in patients taking Amoklav should be interpreted with caution and confirmed by other diagnostic methods. Interaction with other drugs Oral anticoagulants 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 are described. If necessary, the simultaneous administration of drugs carefully monitor the prothrombin time or INR at the beginning of treatment and after stopping treatment with amoxicillin. Dose adjustment of oral anticoagulants may be required. Methotrexate Penicillins may reduce the excretion of methotrexate, which is accompanied by an increase in toxicity. Probenecid Concomitant use of probenecid is not recommended. It reduces the secretion of amoxicillin in the renal tubules. Simultaneous use of probenecid with Amoclav may lead to an increase in the levels of amoxicillin (but not clavulanic acid) in the blood and their longer maintenance. Contraindications – Hypersensitivity to amoxicillin and/or clavulanic acid; excipients that are part of this drug. – A history of a severe immediate hypersensitivity reaction to the administration of other beta-lactam antibiotics (including cephalosporins, carbapenems, monobactams). – A history of cholestatic jaundice or impaired liver function associated with taking the combination of amoxicillin / clavulanic acid. Composition Active substances – amoxicillin (in the form of amoxicillin trihydrate) – 500.0 mg, clavulanic acid (in the form of potassium clavulanate) – 125.0 mg; excipients – microcrystalline cellulose, magnesium stearate, anhydrous colloidal silicon dioxide, sodium starch glycolate, Tabcoat TC-1709 MB white (hydroxypropyl methylcellulose, propylene glycol, ethylcellulose, talc, titanium dioxide), talc, propylene glycol, dimethicone. Overdose It is possible to develop symptoms from the gastrointestinal tract, as well as a violation of the water and electrolyte balance. There have been cases of amoxicillin-associated crystalluria, sometimes leading to renal failure. Seizures may develop in patients with impaired renal function or receiving high-dose therapy. For gastrointestinal symptoms, symptomatic treatment can be carried out along with the restoration of fluid and electrolyte balance. Amoxicillin and potassium clavulanate can be excreted from the body by hemodialysis. Side effects The following categories are used to classify the incidence of adverse effects: very common (>1/10), frequent (>1/100 to <1/10), infrequent (>1/1000 to <1/100), rare ( from >1/10000 to <1/1000), very rare (<1/10000), unknown frequency (estimation from the available data is not possible). The most common adverse drug reactions are diarrhea, nausea and vomiting. Infectious and parasitic diseases: Frequent: candidiasis of the skin and mucous membranes. Unknown frequency: overgrowth of non-susceptible microorganisms. Blood and lymphatic system disorders: Rare: reversible leukopenia (including neutropenia), thrombocytopenia. Unknown frequency: reversible agranulocytosis, hemolytic anemia, prolongation of bleeding time and prothrombin time. Immune system disorders: Unknown frequency: angioedema, anaphylaxis, serum sickness-like syndrome, allergic vasculitis. Nervous system disorders: Uncommon: dizziness, headache. Unknown frequency: convulsions. Gastrointestinal disorders: Common: diarrhoea. Uncommon: nausea, vomiting, dyspepsia. Unknown frequency: antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis, see "Precautions"). Liver and biliary tract disorders: Uncommon: increased levels of AST and/or ALT (moderate increases have been reported in patients treated with beta-lactam antibiotics, but the significance of these observations is unknown). Unknown frequency: hepatitis, cholestatic jaundice (these adverse events were observed against the background of the use of other penicillins and cephalosporins, see "Precautions"). Skin and subcutaneous tissue disorders: If any skin hypersensitivity reaction develops, treatment should be discontinued (see Precautions). Uncommon: skin rash, itching, urticaria. Rare: erythema multiforme. Frequency unknown: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP) (see "Precautions"). Renal and urinary disorders: Unknown frequency: interstitial nephritis, crystalluria. Storage conditionsKeep in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life 2 years. Do not use the medicinal product after the expiration date. Conditions of release By prescription. Buy Amoklav Pharmland tablets p/o 500mg/125mg No. 6x3