Amoklav Pharmland tablets p/o 875mg/125mg No. 7×2

Name:
Amoklav Pharmland 875 mg/125 mg. Forms of release tablets МННА Moxicillin + clavulanic acid FTGAntibacterial agents for systemic use. Beta-lactam antibiotics, penicillins. Combinations of penicillins, including those with beta-lactamase inhibitors. ATC code J01CR02.
Description:
Tablets are white or almost white, capsule-shaped, with a score line on both sides, film-coated. Marbling is allowed on the surface of the tablets. Composition Each tablet contains: active ingredients: amoxicillin (in the form of amoxicillin trihydrate) – 875.0 mg, clavulanic acid (in the form of potassium clavulanate 1: 1) – 125.0 mg; excipients: sodium starch glycolate (type A), magnesium stearate, colloidal anhydrous silica, microcrystalline cellulose, Tabcoat TC-1709 MB white (hydroxypropyl methylcellulose, propylene glycol, ethyl cellulose, talc, titanium dioxide), talc, propylene glycol, dimethicone. Pharmacological properties This drug belongs to the group of beta-lactam antimicrobial agents and is a combination of semi-synthetic penicillin with a beta-lactamase inhibitor for systemic use. Inhibits the growth of microorganisms that cause infections. ATC code J01CR02. Indications for use Treatment of infections caused by susceptible microorganisms in adults and children. Acute bacterial sinusitis; Acute otitis media; Exacerbation of chronic bronchitis; community-acquired pneumonia; Cystitis; Pyelonephritis; Infections of the skin and soft tissues, incl. phlegmon, insect bites, severe dental abscess with spreading phlegmon; Infections of bones and joints, incl. osteomyelitis. 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 that developed against the background of the use of a combination of amoxicillin with clavulanic acid. Route of administration and recommended doses Amoklav-1000 is taken orally at the beginning of a meal to minimize gastrointestinal disturbances and improve the absorption of amoxicillin / clavulanic acid. Adults and children weighing ≥ 40 kg: Standard dose (for all indications): 1 tablet Amoklav-1000 twice a day. Higher dose (in particular for infections such as acute otitis media, sinusitis, lower respiratory tract infections and urinary tract infections): 1 tablet of Amoklav-1000 three times a day. Children weighing <40 kg: 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day in 2 divided doses. For the treatment of a number of infections (acute otitis media, sinusitis, infections of the lower respiratory tract), a dose of up to 70 mg / 10 mg / kg / day in 2 divided doses can be used. Table 1 shows the dose received (mg/kg of body weight) when taking one tablet of Amoklav-1000 with a dosage of active ingredients of 875 mg/125 mg in children weighing 25 kg to 40 kg. Body weight (kg) 40 35 30 25 Recommended single dose (mg/kg body weight) Amoxicillin (mg/kg body weight) at a single dose 21.9 25.0 29.2 35.0 12.5 – 22.5 (up to 35) Clavulanic acid, (mg/kg body weight) at a single dose 3.1 3.6 4.2 5.0 1.8 - 3.2 (up to 5) Tab. 1 It is not recommended to use Amoclav-1000 tablets in children under 6 years of age inclusive or weighing less than 25 kg, it is necessary to select a drug with an appropriate dosage of active ingredients and a dosage form (suspension for oral administration or powder for suspension). Elderly patients: dose adjustment is not required. Patients with impaired renal function: dose adjustment is not required in patients with a creatinine clearance value of more than 30 ml / min. In patients with creatinine clearance less than 30 ml / min, it is not recommended to use dosage forms of the combination of amoxicillin + clavulanic acid with a component ratio of 875 mg / 125 mg, due to the lack of recommendations on the dosing regimen for this group of patients. Patients with impaired liver function: treatment is carried out with caution; regularly monitor liver function. Interaction with other drugs Oral anticoagulants. An increase in international normalized ratio (INR) is possible. Monitoring of prothrombin time is recommended, and dose adjustment of oral anticoagulants (eg, acenocoumarol, warfarin) may be required. Methotrexate. Penicillins can reduce the excretion of methotrexate, leading to a potential increase in toxicity. It is recommended to control the concentration of methotrexate in the blood. Probenecid. Simultaneous use is not recommended. Probenicid can lead to a steady and prolonged increase in the blood concentration of amoxicillin, but not clavulanic acid. Mycophenolate mofetil. There is evidence of a decrease in the minimum concentration of the active metabolite of mycophenolate mofetil by approximately 50% in patients when taking a combination of amoxicillin with clavulanic acid. Changes in this concentration may not accurately reflect overall changes in mycophenolic acid exposure. In this regard, as a rule, no dose adjustment of mycophenolate mofetil is required in the absence of clinical signs of graft dysfunction. However, careful clinical monitoring should be carried out while taking Amoklav-1000, as well as shortly after the end of antibiotic treatment. 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), the frequency is unknown (estimation from the available data is not possible). The most common adverse drug reactions are diarrhea, nausea and vomiting. Infections and invasions: often - candidiasis of the skin and mucous membranes; frequency unknown - overgrowth of non-susceptible microorganisms. Hematopoietic and lymphatic system disorders: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; frequency unknown - reversible agranulocytosis, hemolytic anemia, prolongation of bleeding time and prothrombin time. Immune system disorders: frequency unknown - angioedema, anaphylaxis, a syndrome similar to serum sickness, allergic vasculitis. Nervous system disorders: infrequently - dizziness, headache; frequency unknown - convulsions, hyperactivity, aseptic meningitis. Gastrointestinal disorders: very often - diarrhea; often - nausea, vomiting, infrequently - digestive disorders; frequency unknown - antibiotic-induced colitis (including pseudomembranous and hemorrhagic colitis), black "hairy" tongue. Nausea is more common with high doses taken orally. Gastrointestinal reactions may be reduced by taking the drug at the start of a meal. On the part of the liver and biliary tract: infrequently - increased activity of aspartate aminotransferase (ACT) and / or alanine aminotransferase (ALT). A moderate increase in ACT and ALT activity was noted in patients treated with beta-lactam antibiotics, but the clinical significance of this phenomenon is unknown; frequency unknown - hepatitis and cholestatic jaundice. These adverse reactions have been reported with other penicillins and cephalosporins. Skin and subcutaneous fat disorders: infrequently - rash, itching, urticaria; rarely - erythema multiforme; frequency unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP). Renal and urinary tract disorders: frequency unknown - interstitial nephritis, crystalluria. If you experience any adverse reactions, including those not listed in this leaflet, you should stop taking the drug Amoklav-1000 and consult a doctor, especially if you experience symptoms such as difficulty breathing, shortness of breath, swelling of the eyelids, face or lips, itching , skin redness, skin rash, severe skin reactions; jaundice! Overdose If the number of tablets per day that you have taken exceeds the amount recommended by your doctor, or your child has swallowed the tablets, consult a doctor or call an ambulance! Stop taking the medicine! An overdose can be manifested by nausea, vomiting, diarrhea and a violation of the water and electrolyte balance. Convulsions may develop in patients with impaired renal function or when taking large doses. Control of blood pressure, heart rate. Gastric lavage and antacids are recommended as first aid. Precautions and special instructions Allergic reactions, including life-threatening ones, may occur, especially with hypersensitivity to beta-lactam antibiotics, and in individuals with atopy. Before starting therapy with Amoklav-1000, you should inform your doctor about past hypersensitivity to penicillins or cephalosporins. Measles-like rashes have been reported in patients with suspected infectious mononucleosis receiving amoxicillin. With prolonged treatment, the development of microorganisms resistant to the drug Amoklav-1000 is possible. Inform the doctor about the lack of effect of treatment. Appropriate adjustment of therapy is necessary. The appearance of pustules on erythematous skin areas with fever at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. The occurrence of this adverse reaction requires the withdrawal of the drug and is a contraindication to the further use of amoxicillin. The amoxicillin/clavulanic acid combination should be used with caution in patients with evidence of hepatic impairment. Perhaps the development of antibiotic-associated colitis observed during therapy with almost all antibacterial agents. This complication can progress to a life-threatening condition. Inform the doctor if diarrhea develops during or after completion of any course of antibiotic therapy! Stop treatment immediately, seek appropriate therapy! Reception of drugs that depress intestinal motility is contraindicated. In patients treated with a combination of amoxicillin with clavulanic acid, in rare cases, an increase in prothrombin time was observed. With the joint appointment of anticoagulants, it is necessary to carry out appropriate monitoring, it may be necessary to adjust the dose of the anticoagulant. In patients with a reduced amount of urine output, in very rare cases, the appearance of crystals in the urine was observed. When taking high doses, it is necessary to drink a sufficient amount of fluid to ensure the excretion of the drug in the urine and prevent crystalluria. In patients with urinary catheters, the patency of the catheter should be checked regularly. When taking anticoagulants at the same time, proper monitoring of the parameters of the coagulation system is required. Dose adjustment of oral anticoagulants may be required to achieve the desired therapeutic effect. Convulsions may occur in patients with impaired renal function or when taking high doses. In patients with renal insufficiency, dose adjustment is mandatory in accordance with the level of insufficiency. During the treatment of glucosuria, the assessment of glucose levels should be carried out using enzymatic methods with glucose oxidase, since other methods may give false positive results. It is possible to obtain false-positive laboratory results when performing a Coombs test or an enzyme-linked immunosorbent assay (ELISA). Positive test results in patients taking Amoklav-1000 should be interpreted with caution and confirmed by other diagnostic methods. Pregnancy and lactation Pregnancy Animal studies have not shown direct or indirect effects of the combination of amoxicillin with clavulanic acid on pregnancy, embryonic / fetal development, childbirth or postpartum development of the fetus. Limited data on the use of this drug in pregnant women do not indicate a potential risk of fetal malformations. One study in women with premature rupture of the membranes found that prophylactic therapy with a combination of amoxicillin and clavulanic acid may be associated with an increased risk of neonatal necrotizing enterocolitis. Amoclav-1000 should be avoided during pregnancy unless deemed necessary by a physician. Lactation Both active substances of the drug pass into breast milk (the effect of clavulanic acid on breastfed children is not known). In this regard, there is a possibility of diarrhea or a fungal infection of the mucous membranes in children who are breastfed, so it may be necessary to stop breastfeeding. The possibility of sensitization should be taken into account. The amoxicillin/clavulanic acid combination may only be used during breastfeeding after a benefit/risk assessment by the treating physician. Influence on the ability to drive vehicles and control mechanisms No special studies have been conducted, however, adverse reactions (allergic reactions, dizziness, convulsions) may occur, which may affect the ability to drive vehicles and other mechanisms. Storage conditions Store in a place protected from moisture and 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 leave By doctor's prescription. Packing: 7 tablets in foil/foil strip packaging. 2 or 3 blister packs with leaflet in secondary packaging. Information about the manufacturerBelarusian-Dutch Joint Venture Limited Liability Company "Pharmland" (JV LLC "Pharmland"), Republic of Belarus, Nesvizh, st. Leninskaya, 124 - 3; tel/fax (017) 262-49-94. Buy Amoklav Pharmland tablets p/o 875mg/125mg No. 7x2 7x2