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 information | Content |
| Amoxicillin | 875mg |
| Clavulanic acid | 125mg |
Uses
Indications
CEPMOX-CLAV 875mg/125mg drug is indicated in cases of infections caused by sensitive bacterial strains of the drug:
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:
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:
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:
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
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
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:
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.
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