CEPMOX-Clav 875mg/125mg Imexpharm medicine for acute sinusitis caused by bacteria, acute otitis media (2 blisters x 7 tablets)

Dosage form Box of 2 blisters x 7 tablets
Specifications Amoxicillin, clavulanic acid
Ingredient Imexpharm Pharmaceutical Joint Stock Company

Ingredient

Composition informationContent
Amoxicillin875mg
Clavulanic acid125mg

Uses

Indications

CEPMOX-CLAV 875mg/125mg drug is indicated in cases of infections caused by sensitive bacterial strains of the drug:

  • Acute sinusitis caused by bacteria.
  • Acute otitis media. Wide.

    ATC code: J01CR02.

    Amoxicilin is a synthetic antibiotic in the penicillin group, which has a bactericidal effect due to drugs attached to one or more protein near the penicillin of bacteria (PBPS) to inhibit peptidoglycan biosynthesis, which is an important component of bacterial cell walls. This inhibition weakens the cell wall leading to bacteria decomposed and dies. Amoxicillin is easily destroyed by beta-lactamase enzymes and therefore the antibacterial spectrum of the single amoxicillin does not include bacteria that produce these enzymes.

    Clavulanic acid is a beta-lactam, structurally related to penicillins. Clavulanic acid has the ability to inhibit beta-lactamase enzymes and thus prevent inactivity to amoxicillin. Clavulanic acid monomers do not have clinical antibacterial effects.

    resistance mechanism:

    Two resistance mechanisms with amoxicillin combination and clavulanic acid:

    Inactivity by beta-lactamase is not inhibited by clavulanic acid including beta-lactamase layer B, C, D.

    Change of penicillin -mounted proteins (Pbps), thus reducing the affection of antibacterial agents at the position.

    A decrease in the permeability of bacterial cells or pumping mechanisms can cause or contribute to the resistance of bacteria, especially in Gram -negative bacteria.

    antibacterial spectrum of the drug:

    Sensitive bacteria:

  • Aerobic Gram -positive bacteria: Enterococcus Faecalis, Gardnerella Vaginalis, Staphylococcus aureus (Methicilin sensitive) 1, Staphylococcus spp. negative with coagulase (sensitive to methicilin), streptococcus agalactiae, streptococcus pneumoniae2, streptococcus pyogenes and streptococcus spp, other B hemolysis, streptococcus malidans. Eikenella Corrosens, Haemophilus Influenzae3, Moraxella Catatrhalis, Pasteurella Mulfocida. Right:
  • Aerobic Gram -positive bacteria: Enterococcus Faecium4.
  • Aerobic gramy bacteria: Acinetobacter sp., Citrobacter Freundii, Enterobacter sp. Chlamydophila Pneumoniae, Chlamydophila Psittaci, Coxiella Burnetii, Mycoplasma Pneumoniae.
  • 1 all Staphylococcus spp. To resist methicilin is resistant to amoxicillin/acid Clavulanic.

    2 Amoxicilin/Acid Clavulanic combination may not be suitable for treating streptococcus pneumoniae resistance to penicillin.

    3 has reported on sensitive strains in some countries in the European Union (EU) with a frequency higher than 10%.

    4 natural intermediaries have no resistance mechanism.

    Pharmacokinetics

    absorption

    Amoxicillin and clavulanic acid are completely dissociated in water solution in physiological pH. Both ingredients are well absorbed and quickly after drinking. Oral bioavailability of amoxicillin and clavulanic acid is about 70%. The characteristics of two plasma components are the same and the time to reach the peak concentration (TMAX) of each component is about 1 hour.

    Dynamic pharmacokinetic results in a study, oral amoxicillin/clavulanic acid (875 mg/125 mg, twice daily) in a state of hunger for healthy volunteers presented below:

    Average pharmacokinetic parameters (± standard deviation SD) .

    875 mg/ 125 mg

    875 11.64 ± 2.78

    1.5

    (1.0 - 2.5)

    53.52 ± 12.31 1.19 ± 0.21

    875 mg/ 125 mg

    125 2.18 ± 0.99

    (1.0 - 2.0)

    10.16 ± 3.04

    0.96 ± 0.12

    * Middle (interval)

    Distribution

    About 25% of total clavulanic acid in plasma and 18% of total amoxicillin in plasma is linked to protein. Expression integral is about 0.3 - 0.4 l/kg for amoxicillin and about 0.2 l/kg for clavulanic acid.

    After intravenous injection, both amoxicillin and clavulanic acid have been found in the gallbladder, abdominal tissue, skin, fat, muscle tissue, fluid and abdominal fluid, face and pus of the wound. Amoxicillin does not allocate much in cerebrospinal fluid.

    Animal studies show that there is no storage of drug metabolites in the body. Like other antibiotics penicillin, amoxicillin can be distributed into tamarind milk. A very small salary Clavulanic acid has also been discovered in breast milk.

    both amoxicillin and clavulanic acid have passed the placenta fence.

    Metabolism

    about 10 - 25% amoxicillin in the starting dose is excreted in urine in the form of peniciloic acid that does not work. Clavulanic acid metabolizes a lot in the human body, excreted into urine, feces and in the form of carbon dioxid while exhaling.

    Elimination

    Amoxicillin is excreted mainly through the kidneys, while clavulanic acid is eliminated by the mechanism through both the kidneys and external kidneys.

    Combining amoxicillin/clavulanic acid has an average selling time for about 1 hour and the total clearance is about 25 l/hour in healthy people. Nearly 60 - 70% amoxicillin and 40 - 65% of Clavulanic acid are eliminated in urine in the form of unchanged in the first 6 hours after taking a single tablet with amoxicillin/clavulanic acid with a content of 250 mg/125 mg or 500 mg/125 mg. Different studies show that about 50 - 85% amoxicillin and 27 - 60% of Clavulanic acid are eliminated through urine after 24 hours. Clavulanic acid is most eliminated in the first 2 hours after taking the drug.

    Concentrated with probenecid may slow down amoxicillin, but does not affect the elimination of clavulanic acid through the kidney.

    Age

    Amoxicillin's sale time in children from 3 months to 2 years old is equivalent to older children and adults. In newborns (including premature babies), in the first week after birth, do not use more than 2 times/day because the emissions through the kidneys have not been fully developed. Because the elderly people have a higher impairment of renal function, it is necessary to be cautious when choosing the dose and monitoring the kidney function throughout the treatment process.

    Gender

    After drinking amoxicilin/clavulanic acid in healthy women and men shows that gender does not significantly affect the pharmacokinetics of both amoxicillin and clavulanic acid.

    kidney failure

    The total serum clearance coefficient of amoxicillin/clavulanic acid decreases corresponding to the impaired renal function. The decrease in amoxicillin clearance is more significant than clavulanic acid, because the ratio of amoxicillin elimination through the kidneys is higher, so the dose for patients with renal impairment must prevent excessive accumulation of amoxicilin while maintaining the appropriate level of clavulanic acid.

    Hepatic failure

    Patients with liver failure should be carefully indicated and monitored liver function periodically.

    Before taking CEPMOX-Clav 875mg/125mg Imexpharm medicine for acute sinusitis caused by bacteria, acute otitis media (2 blisters x 7 tablets)

    How to use

    CEPMOX-CLAV 875mg/125mg drug used orally. To reduce the possibility of non -tolerant drugs in the gastrointestinal tract, should take medicine during meals.

    Dosage

    The dosage is usually shown according to the content of amoxicillin/clavulanic acid unless it is stated according to the dose of each individual ingredient.

    The choice of the dose of CEPMOX-clav 875mg/125mg depends on the following factors:

  • The pathogenic bacteria and the ability to be sensitive to antibacterial agent. Clavulanic) should be considered when necessary.

    Adults and children ≥ 40 kg, the total daily dose of CEPMOX-Clav 875mg/125mg is 1750mg amoxicillin/250mg clavulanic acid, divided into 2 times/day and 2625mg amoxicillin/375 mg Clavulanic acid, divided into 3 times/day.

    For children

    Treatment time should be considered depending on the response of the patient. Some bacterial infections (such as osteomyelitis) need longer -time treatment. Do not extend the treatment time more than 14 days without re -assessing the patient's condition.

    adults and children weighs ≥ 40 kg:

    Common dose (for all indications): 1 tablet/time x 2 times/day.

    High doses (especially in cases of otitis media between lower respiratory infections and urinary tract infections): 1 tablet/time x 3 times/day.

    Children weight

    Common dose: 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day, divided into 2 oral times.

    It is possible to consider increasing the dose to 70 mg/10 mg/kg/day, divided into 2 taken for some bacterial infections (such as otitis media, sinusitis, lower respiratory tract infections).

    Because the form of film tablets does not support the exact dosage division for children weighing less than 25 kg. Therefore, do not take medicine for this object.

    Children weigh from 25 kg to

    weight (kg) 40 35 30 25 CEPMOX -Clav 875 mg/125 mg) 21.9 25.0 29.2 35.0

    (increase to 35)

    clavulanic acid doses (mg/kg weight), single dose (equivalent to 1 tablet Cepmox -clav 875 mg/125 mg)

    3.1 3,6 4.2
    5.0

    (increase to 5)

    There is no clinical data on the use of amoxicillin/clavulanic acid in a ratio of 7: 1 for children under 2 months old. Therefore, the proposal for these subjects has not been implemented.

    Elderly: No need to adjust the dose, use as adult dose.

    Patients with renal failure:

    dose

    Against hemolysis

    It is not recommended to use amoxicillin/ clavulanic acid in a ratio of 7: 1. Therefore, there is no recommendation on the adjustment of the dose

    Some special notes on drug treatment before and after using the drug: There is no special requirement on drug treatment after use.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

    What to do when overdose?

    Symptoms:

    Symptoms on the gastrointestinal tract and water balance disorders, electrolytes may be an expression of overdose. Observed the urinary amoxicillin crystal, in some cases, the kidney failure.

    Seism can occur in patients with renal failure or high doses.The crystal of amoxicillin has also been found in urinary tractors, especially after using high doses through the injection. Therefore, it is necessary to periodically check the status of the circles.

    How to handle:

    Treatment of gastrointestinal symptoms, pay attention to water and electrolytes.

    It is possible to remove amoxicillin and clavulanic acid from circulatory by hemolysis method.

    In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

    What to do when you forget 1 dose? In case of forgetting to take a dose: Take it as soon as you remember. Use the next dose after at least 4 hours. Do not use double dose to compensate for the forgotten dose.

  • Side Effects

    The unwanted effects of the drug (ADRS) is the most common ADRS) is diarrhea, nausea and vomiting.

    ADRS is recorded from clinical studies and during the circulation of drugs. The frequency is determined as follows: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR

    Agency system frequency Infection with non -sensitive microorganisms. prothrombin1. head. vomit. ALT6

    Unknown Hepatitis7, jaundice of cholestasis 7 Form. Dress).

    2: See the contraindications and warning and caution.

    3: See the warning and caution when taking the drug.

    4: Often occurs when taking the drug in high doses, you can take the medicine at a meal to minimize the effects on the gastrointestinal tract.

    5: Including fake colitis and bleeding colitis (see the warning and caution when taking the drug).

    6: Average increase AST and/or ALT has been recorded in patients treated with beta-lactam antibiotics, however, the meaning of these findings is not known.

    7: This unwanted effect has been recorded in patients treated with cephalosporin antibiotics and other penicillin groups (see the warning and cautious use when taking the drug).

    8: Stop treating the drug if the dermatitis reaction is hypersensitivity (see the scene and caution when taking the drug).

    9: See the warning and caution when taking the drug.

    10: See overdose and management.

    Instructions on how to handle ADR:

    If allergic reactions occur such as erythema, edema, anaphylactic shock, Stevens - Johnson syndrome, must be stopped, immediately treated emergency treatment with adrenalin, oxygen breathing, intravenous corticoid therapy and ventilation, including endotracheal placement and never being treated with drugs containing antibiotic components of penicilin or cephalosporin.

    Handling when fake colitis:

  • Mild: Stop drugs.
  • Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    CEPMOX-Clav 875mg/125mg drugs in the following cases:

  • Patients with a history of hypersensitivity to beta-lactam antibiotics, such as penicillin, cephalosporin, carbapenem, monobactam or any ingredients of the drug.

    Be cautious when using

    Before starting treatment with amoxicillin/clavulanic acid, need to learn about the patient's allergic history with penicilin, cephalosporin or other beta-lactam drugs.

    Patients treated with penicillin may have severe hypersensitivity reactions and sometimes fatal (anaphylaxis). These reactions are likely to occur in patients with a history of penicillin sensitivity and patients with allergies. If the allergic reaction occurs, the medication must be discontinued and have appropriate alternative therapy, in case the bacteria have been identified to cause sensitivity to amoxicillin, it is necessary to switch to single amoxicillin.

    In the case of the bacterial beta-lactamase enzyme secreted by bacteria is not inhibited by clavulanic acid, which leads to resistance to bacteria with beta-lactam antibiotics, does not use CEPMOX-CLAV 875mg/125mg for treatment. Do not use this medication to treat S. Pneumoniae resistant to penicillin.

    Convulsions can occur in patients with impaired renal function or patients using high doses.

    Avoid using amoxicillin/clavulanic acid for patients with monon cell leukemia due to the high risk of rash in these patients if they use amoxicillin. Simultaneous use of allopurinol with amoxicilin may increase the risk of skin allergies.

    Taking drugs that can sometimes cause excessive growth of non -sensitive bacteria.

    The appearance of all -body typhus with pustules in the first stage of treatment may be a symptom of acute generalized exanthematous pustulosis (AGEP). When there are signs, patients need to stop taking the drug and do not use amoxicillin -containing drugs to treat the disease in later cases.

    Be cautious when using amoxicillin/acid Clavulanic for patients with impaired liver function. Cases of liver occur mainly in male patients, elderly patients and prolonged and rare patients in children. Typically, signs and symptoms usually occur during treatment or after treatment for a short time, but in some cases may not be clear until several weeks after stopping treatment. These symptoms can often recover from themselves, but there are still cases of severe, even death, but very rare, often occurs in patients with serious illness or use in combination with drugs that affect the liver.

    Colitis caused by antibiotics occurs with most antibiotics, including amoxicillin, the level of mild to life -threatening fluctuations. Therefore, it should be noted that patients with diarrhea during or after antibiotic use. If colitis occurs, stop taking the drug immediately, and have appropriate therapeutic therapy. Contraindicated anti -spasms in this case.

    periodically evaluate the function of organ systems, including liver, kidney function and hematopoietic system during prolonged treatment.

    Increasing blood clotting time may occur and rare in patients using amoxicillin/clavulanic acid. The patient's condition should be monitored when used simultaneously with anticoagulants and adjust the dose of appropriate anticoagulants to maintain the desired anticoagulant level.

    In patients with impaired renal function, the dose adjustment should be adjusted according to the degree of renal failure.

    Little urine patients may experience cases of crystal but rare, mainly occur when taking injection drugs. When using high doses of amoxicilin, it is necessary to balance the amount of drinking water and release to reduce the ability to form amoxicillin crystals. Check regularly bladder tubes to avoid clogging.

    While treating amoxicillin, the glucose oxidase enzyme should be used when the glucose test is needed in the urine because non -enzyme methods can give fake positive results.

    Clavulanic acid causes nonsense cohesion of LGG and albumin on the red blood cell membrane, resulting in a false positive result of the Coombs test.

    The drug can cause false positive testing Bio-Rad Laboratories Platelia Aspergillus EIA due to cross-reactions with polysaccharide and polyfuranose are not Aspergillus. Therefore, for patients who are taking amoxicillin/clavulanic acid, should be cautious when reading the results if there is a positive result when testing by this method and should be redefined by other diagnostic methods.

    Using drugs for women during pregnancy and lactation

    Using drugs for pregnant women:

    Animal studies show that the drug is not directly or indirectly harmful to the ability to become pregnant, the development of the embryo, the birth or the development of postpartum.

    Data on the use of amoxicillin/clavulanic acid in pregnant women also shows that it does not increase the risk of birth defects in children, however, these research data are still limited. A single study in premature women due to early amniotic fluid shows that prophylactic treatment with amoxicillin/clavulanic acid may increase the risk of necrotizing bowelitis in infants.

    Therefore, patients should avoid taking the drug during pregnancy, unless the doctor is prescribed.

    Use medicine for breastfeeding women:

    Amoxicilin and clavulanic acid are both breast milk (no information about the effect of clavulanic acid on breastfed babies). Therefore, diarrhea and fungal infection on mucous membranes can occur in infant breastfeeding, need to stop breastfeeding when babies have the above manifestations. Only use the drug during breastfeeding after evaluating the benefits and risks of the treating doctor.

    The effect of the drug on driving and operating machinery

    has not had enough research to prove that the drug affects the ability to drive and operate machinery. However, unwanted effects such as allergies, dizziness, convulsions, ... can affect the ability to drive and operate machinery. Therefore, be cautious when driving and operating machinery if using the drug.

    Interactive drug

    Oral anticoagulant drugs

    Oral anticoagulants and penicillin antibiotics have been widely used in practice without any interactions. However, in the literature, it refers to increasing international normalization index (INR) in patients using acenocoumarol or warfarin simultaneously with amoxicillin. If it is necessary to use simultaneously, it is recommended to monitor the kidneys need prothrombin or INR time when starting or stopping amoxicillin/clavulanic acid. Can adjust anticoagulant dose if needed.

    methotrexate: penicillin reduces methotrexate excretion, thus increasing the toxicity of methotrexate.

    Probenecid: Avoid simultaneous use with probenecid. Probenecid reduces amoxicillin secretion in the renal tubules, thus increasing and prolonging the concentration of amoxicillin in the blood but does not affect clavulanic acid.

    mycophenolat mofetil:

    In patients who are taking Mycophenolat Mofetil, there has been a report on the 50% reduction of concentration before the dose of metabolites with mycophenolic acid activity (MPA) after treatment with amoxicilin/clavulanic acid. The change of concentration before this dose may not exactly show changes in the overall MPa exposure level. Therefore, it is not necessary to adjust the dose of mycophenolat mofetil without clinical evidence of grafting dysfunction. However, clinical monitoring should be closely monitored during the use of the drug and a short time after stopping treatment with antibiotics.

    affects tests:

    Should use the oxidase glucose enzyme method when needed to test glucose in urine micro -urine methods non -enzyme methods can give false positive results.

    Clavulanic acid causes nonsense cohesion of LGG and albumin on the red blood cell membrane, resulting in a false positive result of the Coombs test.

    The drug can cause false positive testing BIO-RAD Laboratories Platelia Aspergillus Elado Cross-reacting with polysaccharids and polyfuranose are not Aspergillus. Therefore, for patients who are taking amoxicillin/clavulanic acid, should be cautious when reading the results if there is a positive result when testing by this method and should be redefined by other diagnostic methods.

    The cavalry of the drug:

    Due to the lack of studies on the correspondence of the drug, not mixing this drug with other drugs.

  • Storage

    Not more than 30 ° C, avoid moisture and light.

    Other drugs

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