Biocemet DT 500mg/62.5mg Imexpharm treat tonsillitis, sinusitis, otitis media (14 tablets)
Dosage form Box of 2 blisters x 7 tablets
Specifications Amoxicillin, clavulanic acid
Ingredient Imexpharm
Ingredient
| Composition information | Content |
| Amoxicillin | 500mg |
| Clavulanic Acid | 62.5mg |
Uses
Indications
Biocemet DT drug indicated to treat infections caused by bacteria sensitive to drugs in adults and children such as:
Amoxicillin is a semi -synthetic antibiotic belonging to the penicillin group (betalactam antibiotic). Amoxicilin has bactericidal effects that attach to one or more protein of bacterial penicillin (Pbps) to inhibit peptidoglycan biosynthesis, which is a component of bacterial cell walls. Finally, bacteria decompose by the enzymes of self -destruction of bacterial cell walls.
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 penicillin. 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.
Mobile pharmacokinetic/pharmacokinetic association
Time of antibiotic concentration is higher than the minimum inhibitory concentration (t> mic) is the main parameter that shows the effect of amoxicillin.
resistance mechanism
The two main mechanisms of resistance to amoxicillin/clavulanic acid combination are:
antibacterial spectrum of drugs
Sensitive bacteria:
1 all Staphylococcus spp. Resistance to methicilin are resistant to amoxicillin/clavulanic acid combination.
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.
pharmacokinetic
absorption
Amoxicillin and clavulanic acid are completely dissociated in water solution in physiological pH. Both ingredients are well absorbed and quickly after drinking.
Absorption of amoxicillin/clavulanic acid is improved when taken at the beginning of the meal. After drinking, 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 in the plasma (TMAX) of each component is about 1 hour.
Amoxicillin and clavulanic acid concentration in serum when using a combination of amoxicillin/clavulanic acid is equivalent to the concentration achieved when using amoxicilin or clavulanic acid separately by oral at the same dose level.
Distribution
About 25% Clavulanic acid and 18% amoxicillin associated with plasma proteins. Expression distribution volume is about 0.3 to 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 gallbladder, abdominal tissue, skin, fat, muscle tissue, fluid and abdominal fluid, bile and pus of the wound. Amoxicillin is not much distributed 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 breast milk. A very small amount of 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 in exhaled gas.
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 of about 25 l/hour in healthy people.
Nearly 60 - 70% amoxicillin and 40 - 65% Clavulanic acid are eliminated in urine in the form of unchanged in the first 6 hours after taking only one tablet with amoxicillin/clavulanic acid with a content of 250mg/125mg or 500mg/125mg. Different studies show that about 50 - 85% amoxicillin and 27 - 60% of Clavulanic acid are eliminated through urine for 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 of age 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 pronounced than clavulanic acid, as the ratio of amoxicillin eliminates through the kidneys is higher. Therefore, the dose for patients with renal impairment must prevent excessive accumulation of amoxicillin while maintaining the appropriate clavulanic acid level.
Hepatic failure
Patients with liver failure should be carefully indicated and monitored liver function periodically.
Before taking Biocemet DT 500mg/62.5mg Imexpharm treat tonsillitis, sinusitis, otitis media (14 tablets)
How to use
Instructions on how to open packaging
Use your hands or sharp tools to open in the border on the blister to get the tablet. Do not press, press to remove the pill from the blister to avoid the broken or break. If the pills are not intact, still make the drug into the water and use it according to the instructions. Use the tablet immediately after removing the blister
Biocemet DT dispensing tablets are used by oral.
Mixing pills in a little water, stirring and drinking immediately. You can put the pill in the mouth to disintegrate, then swallow and drink immediately with plenty of water.
Time of taking drugs
Should drink at the beginning of the meal to minimize the possibility of intolerance in the digestive tract and drink with plenty of water to avoid the ability to create crystals.
Dosage
The dosage is usually expressed in the content of amoxicillin/clavulanic acid unless it is specified according to the dose of each individual component. The choice of the dose of biocemet dt depends on the following factors:
Adults and children ≥ 40 kg: The total daily dose of Biocemet DT is 2000mg amoxicillin/250mg Clavulanic acid, divided into 2 times/day and 3000mg amoxicillin/375mg 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.
specific dose:
Adults and children weighs ≥ 40 kg
recommended dose (calculated by mg/kg weight): 40mg/5mg/kg/day to 80mg/10mg/kg/day, divided into 3 times/day, depending on the severity of the infection. Dosage should not exceed 3000mg/375 mg/day.
or recommended dose is calculated in the form of preparation:
Patients with creatinine clearance (CrCl) below 30 ml/minute: do not recommend the use of amoxicillin/clavulanic acid combination at 8/1 ratio, so there is no data on dose adjustment.
Patients with liver failure
Be cautious when using and periodically checking liver function during drug 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?
Overdose
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.
Amoxicillin crystals have also been found in urine tubes, especially after using high doses through the injection. Therefore, it is necessary to periodically check the catheter.
How to handle
Stop using drugs, treat symptoms on the gastrointestinal tract and monitor water and electrolyte balance.
It is possible to remove amoxicillin/acid clavulanic from circulation by hemolysis method.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a dose? Use the next dose after at least 4 hours. Do not use double dose to compensate for the forgotten dose.
Side Effects
Adverse drugs (ADRS) most common are diarrhea, nausea and vomiting.
ADRS is recorded from clinical studies and during the circulation process.
The frequency is determined as follows: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR
Infections and parasites:
Nervous system disorders:
Unknown: interstitial nephritis, urinary crystal 11.
1: See carefully when used.
2: See the contraindication and caution when used.
3: See the cautious section when used.
4: Often occurs when taking the drug in high doses, you can take the drug at the beginning of the meal to minimize the effects on the gastrointestinal tract.
5: Including fake colitis and hemorrhage colitis (see caution when used).
6: The enamel color change has been reported in children, but it rarely occurs. Good dental hygiene can be prevented because this symptom can be removed by brushing.
7: 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.
8: This unwanted effect has been recorded in patients treated with cephalosporin antibiotics and other penicillin groups (see caution when used).
9: Stop treating the drug if the dermatitis reaction is hypersensitivity (see caution when used).
10: See caution when using.
11: See overdose and management.
Notify the physician the unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Biocemet dt drugs contraindicated in the following cases:
Be cautious when using
Before starting treatment with biocemet dt, the patient's allergic history should be carefully investigated with penicillin, cephalosporin or other betalactam drugs.
Serious and sometimes fatal allergic reactions (such as anaphylaxis) have been recorded in patients treated with penicillin drugs. These reactions often occur in patients with a history of allergies to penicillin and other allergens. If the allergic reaction occurs, it is necessary to stop using amoxicillin/clavulanic acid and choose another appropriate treatment.
This drug is not suitable for the treatment of bacterial infections caused by bacteria that have been resistant to beta -lactam antibiotics under the intermediary mechanism of beta - lactamase enzymes inhibited by clavulanic acid. Do not use this medication to treat bacterial infections caused by s.pneumonia resistant to penicillin.
Convulsions can occur in patients with impaired renal function or high doses.
Avoid using drugs for patients suspected of having a mononoculatic hypereminocyte due to these patients at risk of measles rash when using amoxicillin.
Using allopurinol while being treated with amoxicillin may increase the risk of skin allergies.
Taking drugs that can sometimes cause excessive growth in non -sensitive bacteria.
The appearance of the whole body erythema with pustules at the beginning of the treatment may be a manifestation of acute generalized exanthematous pustulosis (AGEP). Stop using the drug if these manifestations appear and contraindicated with any drug contains amoxicillin. - Precautions when used in combination with amoxicilin/clavulanic acid for patients with impaired liver function.
Unwanted effects in the liver mainly occur in male patients, the elderly and the patient must be treated for a long time, rarely occurs in children. Typically, signs and symptoms often occur during or after a short time of treatment, but in some cases may not be clear until several weeks after stopping treatment. These symptoms can often recover on their own. However, there are still cases of serious, even death, but very rare, mainly in patients with serious illness or use in combination with drugs that are at risk of affecting the liver.
Colitis associated with antibiotics has been reported with almost all antibacterial agents including amoxicillin that is mild to life -threatening. Therefore, diagnostic diagnosis should be conducted in patients with diarrhea during or after drug use. If colitis is related to antibiotics, it is necessary to stop using amoxicillin/clavulanic acid immediately, notify the doctor for appropriate treatment. Contraindicated intestinal inhibitors in this case.
Periodically check the functions of organs such as kidney and liver function, hematological index during long -term treatment.
Prothrombin time has been reported in patients treated with amoxicillin/clavulanic acid, but it rarely occurs. The patient's condition should be monitored when used simultaneously with anticoagulants. It is possible to adjust the oral anticoagulant dose if necessary to maintain the concentration of anticoagulants as desired.
Dosage for patients with renal failure should be adjusted depending on the degree of renal failure.
Very rare cases of urinary crystal phenomenon in patients who reduce urine excretion, mainly in patients taking drugs in the form of injection. Patients should maintain the balance of oral fluid and the amount of urine output to reduce the ability to cause urinary amoxicillin crystals, especially when taking the drug in high doses. In patients with urine pipes, regular urine test.
During the treatment of amoxicillin, the glucose oxidase enzyme should be used when the glucose test is needed in the urine because of the non -enzyme methods that can give false positive results.
Clavulanic acid in the drug can cause nonsense cohesion of IgG and albumin on red blood cell membranes, resulting in a false positive result of the Coombs test.
The drug can cause fake positive testing Bio - radaratories platelia aspergillus eia due to cross -reactions with polysaccharids and polyfuranose are not Aspergillus. Therefore, in patients taking amoxicilin and clavulanic acid, caution if tested by this method gives positive results and should be further determined by other diagnostic methods.
Information related to the ingredients of the drug: The drug contains fd & c yellow 5 alum lake and indigo carmin lake, so it should be cautious when taking the drug for patients with atopic allergies.
Use drugs for women during pregnancy and lactation
Pregnant women
Animal studies show that the drug is not directly or indirectly harmful to pregnancy, embryo/fetal development, birth or development after birth.
The 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.
breastfeeding women
Amoxicilin and clavulanic acid are both breast milk (no information about the effect of clavulanic acid on breastfed babies). This can lead to diarrhea or mucous fungal infection in breastfed babies, thus stop breastfeeding to ensure safety for babies. Children's sensitivity to drugs should be considered.
Amoxicilin/Clavulanic Acid is only used during breastfeeding after being evaluated by a doctor between the benefits and potential risks.
The effect of drugs on driving and operating machinery
There are no studies on the effects of the drug on the ability to drive and operate machinery. However, some unwanted effects of the drug such as allergic reactions, dizziness, convulsions ... can affect patient concentration and reaction ability.
Therefore, cautious when using the drug for these objects. If the patient has the above unwanted effects, it is not advisable to drive or operate machinery.
Drug interaction
oral anticoagulant drugs
Not yet recorded any interactions even though oral anticoagulants and penicillin antibiotics have been widely used in practice. 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, should carefully monitor Prothrombin or INR time when starting or stopping using Biocemet DT. Can adjust anticoagulant dose if needed.
methotrexate
Penicillin antibiotics reduce methotrexate secretion, thus increasing the toxicity of methotrexate.
Probenecid
Avoid simultaneously 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.
Storage
not more than 300C, avoid moisture and light.
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