AUGMEX Korea United medicine for infection treatment (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Amoxicillin, clavulanic acid
Ingredient Tonsillitis, pharyngitis, otitis media, sinusitis, cystitis, skin and soft tissue, acute bronchitis, chronic bronchitis, pneumonia

Ingredient

Composition information	Content
Amoxicillin	500mg
Clavulanic Acid	125mg

Uses

indications

AugMex 625 mg is indicated in cases of infections in adults and children including:

Acute sinusitis (must be fully diagnosed).

Acute otitis media.

Skin and soft tissue infections in some tissue inflammation, bite animals, serious tooth abscesses cause spill inflammation.

Should refer to the orthodox guide on the appropriate use of antibacterial drugs.

Pharmacokology

Mechanism of impact

Amoxicillin is a semi-synthetic penicillin antibiotic (beta-lactam antibiotic) that inhibits one or more enzymes (commonly known as proteins associated with penicillin, Pbps) during bacterial peptidoglycan biosynthesis, this is a structural component in bacterial cell membranes. Inhibiting peptidoglycan synthesis weakens cell membranes, resulting in bacterial cells that are solved and dead.

Amoxicillin is easily decomposed by beta-lactamase enzymes produced by resistance bacteria and therefore the effect of the impact of amoxicillin individually does not include bacteria that produce these enzymes. Clavulanic acid has a beta-lactam structure similar to penicillin. It is inactivated the beta lactamase enzymes should prevent the loss of active amoxicillin.

individual clavulanic acid has no clinical antibacterial effects.

Pharmacy pharmacological relationship

Time above the minimum inhibitory concentration range (T> MIC) is thought to be an effective determinant of Amoxicillin.

resistance mechanism

Two main resistance mechanisms for amoxicillin/clavulanic acid are:

Inactivity by bacterial beta-lactamase enzymes of bacteria is not inhibited by clavulanic acid, including group B, C and D.

changing Pbps structure, reducing the affection of bactericidal agents with targets. Reducing the permeability of bacteria or the mechanism of pumping can cause or contribute to resistance, especially in Gram -negative bacteria.

Diving point

The interrupt point of the minimum inhibitory concentration (mic) for amoxicillin/clavulanic acid as recommended from the European Commission for antibiotic testing (EUCAST).

bacteria

Sensitive interrupt points (kg/ml).

sensitive

Average sensitivity

Resistance

≤ 1

≤ 2

≤ 0.25

Enterococcus1

≤ 4

≤ 0.25

0.25

≤ 0.5

1 - 2 - 2
2

-

-

8

≤ 4

For the purpose of assessing the sensitivity level, the concentration of clavulanic acid is fixed to 2 mg/l.

2 report values according to oxacillin concentrations.

3 values in the table are based on ampicillin interrupt points.

4 points of resistance R> 8 mg/l ensure that all strains of isolation with antibody mechanisms are reported as not sensitive.

5 The interrupt point value in the table is based on the point point of benzylpenicillin.

Sensitive strains

Aerobic gram-positive bacteria: Enterococcus Faecalis, Gardnerella Vaginalis, Staphylococcus aureus (sensitive to methicillin) £, coagulase-negative staphylococci (sensitive to methicillin), streptococcus agalactiae, streptoccus peNumoniae1, streptoccus pneumoniae Streptococcus pyogenes and other beta-haemolytic streptococci strains, streptococcus viridans.

Aerobic gram -negative bacteria: capnocytophaga spp.

Anaerobic bacteria strains: Bacteroides Fragilis, Fusobacterium nucleatum, Prevotella spp.

Strains can be resistant

Aerobic Gram -positive bacteria: Enterococcus Faecium $.

Aerobic gram -negative bacteria: Escherichia Coli, Klebsiella Oxytoca, Klebsiella Pneumoniae, Proteus Mirabilis, Proteus Vulgaris.

Natural resistance strains

Aerobic gram -negative bacteria: Acinetobacter sp., Citrobacter Freundii, Entobacter sp.

Other bacteria strains: Chlamydophila Pneumoniae, Chlamydophila Psittaci, Coxiella Burnnetti, Mycoplasma Pneumoniae.

average sensitive $ without resistance.

£ All staphylococci strains of methicillin resistance are resistant to amoxicillin/clavulanic acid.

1streptococcus pneumoniae resistance to penicillin should not be treated with amoxicillin/clavulanic acid.

2 sensitivity strains have been reported in some European countries with a greater frequency of more than 10%.

pharmacokinetic

absorption

Amoxicillin and clavulanic acid are completely dissociated in water solutions in physiological pH. Both active ingredients are well absorbed and fast through oral. After drinking, amoxicillin and clavulanic acid have about 70%. The characteristic of both active ingredients in plasma is the same and the time to achieve the peak level in plasma (TMAX) of each substance is about 1 hour.

Mobile pharmacokinetic research results on healthy volunteers, of which amoxicillin/clavulanic acid (500 mg/125 mg used three times daily) are taken when hungry is presented in the table below.

Average pharmacokinetic parameters (± sd).

Active ingredients

Dose

cmax

Tmax*

AUC (0-24H)

t1/2

(mg)

(µg/ml)

(h)

(µg.h/ml)

(h)

500

7.9 ± 2.26

1.5 (1.0 - 2.5)

53.5 ± 8.87

1.15 ± 0.20

Clavulanic

125

2.4 ± 0.83

1.5 (1.0 - 2.0)

15.72 ± 3.86 0.98 ± 0.12

* Average (interval)

Distribution

About 25% of the total amount of plasma clavulanic acid and 18% of the total amount of amoxicillin in plasma is associated with protein. The apparent distribution volume 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 are found in bile, bladder, abdominal surgery, skin, fat, muscle tissue, fluid and abdominal fluid, bile and latex. Amoxicillin does not distribute much into the cerebrospinal fluid.

From animal studies, there is no evidence of the existence of drug derivatives for both active ingredients. Like most penicillin, Amoxicillin can be found in breast milk. Small amount of clavulanic acid is also found in breast milk.

Both amoxicillin and clavulanic acid can pass through the placenta fence.

Metabolism

Amoxicillin is partly secreted into the urine in the form of a substance that does not have a penicilloic acidic activity with an amount of about 10 to 25% of the original dose. Most Clavulanic acid is metabolized and eliminated through urine and feces, and through the airway in the form of carbon dioxyd gas.

Elimination

The main elimination of amoxicillin is through the kidneys, while clavulanic acid is eliminated through the kidney and outside the kidneys.

Amoxicillin/Clavulanic acid has an average time for an hour and an average total total total clearance of about 25 l/h in healthy people. About 60 to 70% amoxicillin and about 40 to 65% of Clavulanic acid eliminated in the form of unchanged urine for the first 6 hours after taking a single dose of a single -dose of 500 mg/125 mg. Different studies found the urine excretion amount of about 50 - 85% for amoxicillin and 27 - 60% for clavulanic acid within 24 hours. In the case of clavulanic acid, most of the drugs are eliminated for 2 hours after taking the drug

Used with probenecid slowly eliminate amoxicillin but do not slow down the elimination of clavulanic acid through the kidneys.

Age

Amoxicillin's sale time in children from 3 months to 2 years old is similar to older children and adults. For young children (including children born in a monthly) new birth within a week, should not be used more than 2 times a day because the excretion through the kidney is not complete. Because the elderly often has impaired renal function, should be careful when choosing the type of kidney function monitoring if necessary.

Gender

After taking amoxicillin/acid clavulanic in healthy men and women, gender does not significantly affect the kineticness of amoxicillin or clavulanic acid.

kidney failure

The total clearance of amoxicillin/clavulanic acid in serum decreases corresponding to the impaired renal function. Amoxicillin's removal decline is more pronounced than clavulanic acid, because amoxicillin is more eliminated by the kidneys. Therefore, the dosage in patients with renal failure must prevent excessive accumulation amoxicillin while maintaining the appropriate level of clavulanic acid.

Before taking AUGMEX Korea United medicine for infection treatment (2 blisters x 10 tablets)

How to use

AUGMEX uses oral. It is recommended to take medicine when it minimizes the ability to intolerine drugs in the digestive tract.

Dosage

The dose is indicated as amoxicillin/clavulanic acid content unless the dose is calculated by each active ingredient.

Select the dose for AUGMEX to treat each infection case should consider the following factors:

The suspected cause of disease and the ability to be sensitive to antibacterial drugs. When used as recommended below. For children

The treatment time should be decided depending on the patient's response. Some bacterial infections (such as osteomyelitis) need longer treatment. Do not prolong the treatment for more than 14 days without re -assessing the benefits and risks of this treatment.

adults and children> 40 kg

The dose of 500 mg/125 mg is used 3 times daily.

Children

20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day divided into 3 times a day.

Because it is impossible to split pills, children weighing less than 25 kg should not use Augmex tablets.

The table below lists absorption dose (mg/kg of body weight) on children weighing 25 kg to 40 kg when using only 1 tablet of 500 mg/125 mg.

Body weight [kg]

Dosage for a one -time taken as recommended [mg/kg] body weight

12.5

14.3

16,7

20,0

6.67 - 20

3.1

3.6

4,2

5,0

1.67 - 5

Elderly

There is no need to adjust the dose.

Renal impairment

Adjust the dose according to the maximum dose recommended by amoxicillin. There is no need to adjust the dose in patients with creatinine clearance (CrCl) greater than 30 ml/min.

Adults and children> 40 kg

CrCl: 10 - 30 ml/minute

500 mg/125 mg 2 times daily.

500 mg/125 mg once daily.

500 mg/125 mg every 24 hours, plus 500 mg/125 mg during the blood vessel so that the dose can be repeated after the end of the fertilizer (because the serum concentration of both amoxicillin and clavulanic acid decreases due to fertilizer).

CrCl: 10 - 30 ml/minute

15 mg/3.75 mg/kg 2 times daily (up to 500 mg/125 mg twice daily).

15 mg/3.75 mg/kg 1 time per day (maximum 500 mg/125 mg).

15 mg/3.75 mg/kg once a day.

Before the fertilizer uses 15 mg/3.75 mg/kg. To restore the drug concentration, use an additional 15 mg/3.75 mg/kg after the blood.

Be cautious when giving the drug and should check the liver function periodically.

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 and signs of overdose

Symptoms on the gastrointestinal tract and electrolyte water balance disorders may be an expression of overdose. The amoxicillin crystal has been observed, and in some cases leads to renal failure.

Convulsions may occur in patients with renal impairment or high doses of drugs. The amoxicillin report has crystallized in the bladder catheter, mainly after high -dose intravenous injection. Should regularly check the status of the bladder catheter.

Treatment

Treatment of symptoms on the gastrointestinal tract with notes on water and electrolyte balance. Amoxicillin/Clavulanic acid can be removed from the circulatory system by blood decentralization.

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

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using AUGMEX 625 mg, you may experience unwanted effects (ADR).

Very common, ADR> 1/10

Gastrointestinal disorders: diarrhea.

Common, 1/100

Infections and parasites: Candida infection of the skin mucosa.

Gastrointestinal disorders: Nausea (Nausea often occurs when taking higher doses. If the digestive tract reaction occurs, it may reduce the symptoms of how to take the drug during meals), vomiting.

Uncommon, 1/1000

Nervous system disorders: headache, dizziness.

Gastrointestinal disorders: indigestion.

Bile disorders: AST and/or ALT (acknowledges a moderate increase in AST and/or ALT concentrations in patients treated with beta-lactam antibiotics, but it is unclear the meaning of this phenomenon).

Skin and subcutaneous tissue disorders: rash on the skin, itching, urticaria.

Rare, 1/10000

Blood disorders and lymphatic systems: Reducing blood cells with recovery (including leukopenia), thrombocytopenia.

Skin and tissue disorders: Diverse roses.

Unknown frequency (not estimated based on available data)

Infections and parasites: The proliferation of non -sensitive strains.

Blood disorders and lymphatic systems: recovery granulocytes, hemolytic anemia, prolonged bleeding time and prothrombin time.

immune system disorders: edema due to blood vessel, anaphylaxis, serum disease syndrome, hypersensitivity vasculitis.

Gastrointestinal disorders: Inflammation associated with antibiotics (including fake bowelitis and bowelitis), black tongue.

Bile disorders: hepatitis, jaundice of cholestasis (recorded with other types of penicillin and cephalosporin).

Skin and subcutaneous skin disorders: Stevens-Johnson syndrome, epidermal necrosis of poisoning, anti-pustules of acne acne acne acne (AGEP), peeling skin with puffiness.

Kidney and urinary disorders: interstitial nephritis, urinary crystals.

Notify the doctor with unwanted effects when using the drug.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

AUGMEX 625 mg is contraindicated in the following cases:

Hypersensitivity to active ingredients, penicillin drugs or any excipients.

History of serious hypersensitivity occurs (such as anaphylaxis) with other beta lactam drugs (such as cephalosporin, carbapenem or monobactam).

History of jaundice impaired liver function caused by amoxicillin/acid clavulanic.

Be cautious when using

Before starting treatment with amoxicillin/clavulanic acid, should carefully ask patients about allergies to penicillin, cephalosporin or other beta-lactam drugs.

There have been reports on serious hypersensitivity reactions and sometimes death (anaphylaxis) in patients treated with penicillin. These reactions are more common in patients with a history of hypersensitivity to penicillin and people with atopic allergies. If the allergic reaction occurs, amoxicillin/clavulanic acid should be stopped and replaced with other antibiotics.

In case of sure that bacteria are sensitive to amoxicillin, it is advisable to consider transferring from amoxicillin/clavulanic acid to amoxicillin according to the sources of orthodox recommendations. AUGMEX should not be used when there is a high risk that bacteria have reduced sensitivity or resistance to beta-lactam drugs without intermediaries beta-lactamase sensitive to inhibition of clavulanic acid. This drug should not be used to treat infections caused by s.pneumoniae penicillin resistance.

The drug can cause seizures in patients with impaired renal function or patients with high doses.

Avoid using amoxicillin/clavulanic acid if suspected of being infected with monon cells due to the appearance of measles rash related to this condition when using amoxicillin.

Simultaneous use of Allopurinol while treating amoxicillin may increase the risk of allergic reactions on the skin.

For a long time can sometimes cause an increase in non -sensitive bacteria strains.

The appearance of a whole body stain with a fever with pustules at the beginning of treatment may be a sign of the acute all -body pustules syndrome (AGEP). AUGMEX should be stopped and contraindicated to use amoxicillin afterwards.

Be cautious when using amoxicillin/clavulanic acid in patients with liver failure.

There have been reports on liver harms mainly in men and the elderly and is related to the treatment for a long time. It is rare for liver harmful reports in children. In all patients, signs and symptoms often occur during treatment or right after the end of treatment but in some cases, there is no clear manifestation until the end of the treatment. The liver condition can recover later. Harms on the liver can be serious and extremely rare reports on death. These harmful effects often occur in patients who are seriously ill or are taking simultaneously drugs known to have harmful effects on the liver.

Inflammation is associated with antibiotic use that has been reported on most antibiotics including amoxicillin and severe severity from life -threatening risks. Therefore, it is necessary to diagnose patients with diarrhea during or after treatment. If bowelitis occurs, amoxicillin/clavulanic acid should be stopped immediately, consult a doctor to conduct appropriate treatment. Contraindicated drugs reduce bowel motility in this case.

When treatment is prolonged, periodic assessments of organs include liver and kidney function and hematopoietic function.

Rarely reports on the extension of prothrombin in patients using amoxicillin/clavulanic acid. Should be monitored appropriately when used with anticoagulant drugs. It may be necessary to adjust the dose of oral anticoagulants to maintain the desired anticoagulant level.

Observed the urinary crystal in patients with reduced urine secretion but very rare, mainly occurring in patients treated with infusion. When using high doses of amoxicillin, it is necessary to maintain enough water and eliminate pepper water to reduce the likelihood of causing amoxicillin urine. For patients who place the bladder catheter, regularly check the smooth condition of the tube.

While treating with amoxicillin, the glucose oxidase enzyme should be used for testing in the urine because fake positive results may occur with non -enzyme method.

Clavulanic acid in Augmex can cause nonsense cohesion of red blood cell membranes with IgG and albumin, causing fake positive results for the COOMB’s test.

There have been a positive report when using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients with amoxicillin/clavulanic acid but later confirmed that they are not infected with Aspergillus. There has been a report on the cross-reaction of polyfuranoses and polysaccharides non-Aspergillus mushrooms with Bio-Rad Laboratories Platelia Aspergillus EIA test. Therefore, positive results in patients using amoxicillin/clavulanic acid should be confirmed by other diagnostic methods.

The ability to drive and operate machinery

There are no studies on the impact of the drug on the ability to drive and operate machinery. However, unwanted effects (hypersensitivity, dizziness, convulsions) can occur, affecting the ability to drive and operate machinery.

Pregnancy

Animal studies do not show direct or indirect harm to the process of pregnancy, the development of embryo/fetal embryos, birth or the development of young children after birth. The limited data of the use of amoxicillin/clavulanic acid during pregnancy does not show the risk of birth defects. In a study on premature women due to the rupture of amniotic fluid before the period, there was a report that the use of amoxicillin/clavulanic acid so that infection prevention may be associated with increased risk of necrotizing bowelitis in infants. Therefore, avoiding drugs during pregnancy, except for the doctor is necessary.

Breastfeeding period

Both active ingredients are secreted in breast milk (unknown effects of clavulanic acid on breastfed babies). As a result, diarrhea and mucous mucous fungal infection may occur in breastfed babies, so it may be necessary to stop breastfeeding. It is also necessary to consider the risk of drug sensitivity. Amoxicillin/clavulanic acid should only be used after breastfeeding after considering the benefits and risks of treatment.

Drug interaction

Oral anticoagulant drugs

Periferous anticoagulants and penicillin antibiotics are widely used in practice without reporting on drug interaction. However, there have been articles on cases of Inr international normalization index in patients maintained with acenocoumarol or warfarin and undergo a treatment with amoxicillin. If you have to share these two drugs, prothrombin should be carefully monitored or internationalized index when starting to use additional or stopping amoxicillin. In addition, it may be necessary to adjust the dose of oral anticoagulants.

methotrexate

Penicillin can reduce methotrexate secretion that increases the risk of drug poisoning.

Probenecid

There is no recommendation to use drugs with probenecid. Probenecid reduces amoxicillin elimination at the renal tubules. Used with probenecid may increase and prolong Amoxicillin levels but do not affect clavulanic acid.

mycophenolat mofetil

In patients with Mycophenolat Mofetil, there has been a report on the reduction of about 50% of the next dose of the metabolic substance with mycophenolic acid activity (MPA) after starting to use amoxicillin and oral clavulanic acid. The change in concentration level before the next dose may not accurately reflect the amount of MPA drugs on the body. Therefore, it is not necessary to adjust the dose of Mycophenolat Mofetil if there is no abnormalities of transplant function. However, clinical monitoring should be monitored during combined and short -term treatment after antibiotic treatment.

Storage

In closed packaging, avoid light and avoid moisture. At room temperature no more than 30 ° C.

Expiry date: 24 months from the date of manufacture. Do not use overdue drugs on the box.

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