Augmentin powder 500mg/62.5mg GSK Treatment of infection (12 packs)
Dosage form 12 package box
Specifications Amoxicillin, clavulanic acid
Ingredient Tonsillitis, sore throat, sinusitis, acute bronchitis, chronic bronchitis, pneumonia
Ingredient
| Composition information | Content |
| Amoxicillin | 500mg |
| Clavulanic Acid | 62.5mg |
Uses
Indications
Should use Augmentin 500 under the instructions of the official antibiotic prescription and data on sensitivity of local bacteria.
Augmentin 500mg is indicated for short -term treatment of bacterial infections caused by bacteria sensitive to amoxicillin - Clavulanate, in the following positions:
The sensitivity of bacteria with Augmentin 500mg will vary by geography and time. It is advisable to consult the sensitivity of local bacteria if available, and conduct microorganisms and tests for sensitivity if needed.
Infections caused by amoxicillin sensitive strains can be treated by augmentin 500mg thanks to amoxicillin ingredients. The mixed infection caused by amoxicillin sensitive strains combined with the Beta - Lactamase strain sensitive to Amoxicillin - Clavulanate can be treated with augmentin.
Pharmacokology
Mechanism of action
Amoxicillin is a semi -synthetic antibiotic with wide antibacterial spectrum against many Gram -positive and gram -negative bacteria. However, Amoxicillin is easily decomposed by beta - lactamase, and therefore the effect of Amoxicillin used alone does not include these bacteria.
Clavulanic acid is a beta - lactam, structurally related to penicillin, which is capable of inactivating many types of beta - lactamase, commonly found in resistant bacteria with penicillin and cephalosporin. In particular, Clavulanic Acid works well against beta - lactamase specified by the clinical important plasmid that is often responsible for the resistance of drugs spread. Clavulanic acid often affects the Beta - Lactamase type 1 specified by chromosomes.
The presence of clavulanic acid in augmentin protects amoxicillin from decomposition by beta - lactamase, and effective expansion of amoxicillin antibacterial spectrum includes many common bacteria to resist amoxicillin and penicillin and other cephalosporins. Therefore, Augmentin has a special characteristic of a broad -spectrum antibiotic and a beta - lactamase inhibitor.
Pharmacological effects
In the list below, bacteria are classified based on in vitro sensitivity to augmentin.
In vitro sensitivity of bacteria with augmentin.
Star mark (*) indicates the clinical effect of Amoxicillin - Clavulanate has been proven in clinical trials.
Beta -lactamase bacteria are marked (sign †). An amoxicillin sensitive isolation sample can be considered as sensitive to augmentin.
Common sensitive bacteria
Aerobic grams:
Aerobic grams:
Aerobic grams:
Aerobic grams:
Two components of Augmentin 500mg, amoxicillin and clavulanic acid are completely dissociated in water solutions in physiological pH. Both ingredients are well absorbed and fast when used orally. Augmentin absorption is optimized when taking the drug at the beginning of the meal.
Amoxicillin concentration in serum achieved when using augmentin is similar to when taking amoxicillin separately with the same dose.
Distribution
After intravenous medication, the treatment concentration of both amoxicillin and clavulanic acid in tissue and interstitial fluid. The treatment concentration of both substances is found in the gallbladder, skin, fat and muscle tissue. Treatment concentration can be achieved in epidemics, peritoneal, bile and latex. Both amoxicillin and clavulanic acid are not much associated with protein, studies show that about 25% of clavulanic acid and 18% amoxicillin of the entire drug in plasma are associated with protein.
From animal studies there is no evidence that these two components have accumulated at the body in the body.
Like other penicillins, amoxicillin can be detected in breast milk. Clavulanate is also detected in milk in the form of traces. In addition to the risk of sensitivity related to this excretion, it is not known which adverse effect for breastfeeding.
Studies on animal fertility have shown that both amoxicillin and clavulanic acid are absorbed through the placenta. However, evidence has not been detected about harmful effects on fertility or embryos.
Metabolism
Amoxicillin is partially excreted in the urine in the form of penicilloic acid inactivation with an equivalent of 10-25% of the starting dose. In humans, Clavulanic Acid is converted mainly to 2.5-dihydro-4- (2-hyperroxyethyl) -5-OxO-1 H-Pyrroole-3-Carboxylic Acid and 1-AMINO-4-Hydroxy -over-2-One, and are eliminated in urine, feces and carbon dioxide in breathing gas.
Elimination
Like other penicillins, amoxicillin is excreted mainly through the kidneys, while clavulanate eliminates both the kidneys and does not pass through the kidneys.
About 60 - 70% amoxicillin and about 40 - 65% Clavulanic acid are excreted in the form of unchanged urine within the first 6 hours after taking single tablets 250/125mg or 500/125mg.
Used in combination with probenecid to slow down amoxicillin elimination but do not slow down the renal excretion of clavulanic acid (see interaction).
Augmentin (Beta-lactam antibiotic penicillin group combined with beta-lactamase inhibitors) is an antibiotic with wide antibacterial spectrum, especially against common bacteria in the community and hospitals. Clavulanate's beta-lactamase enzyme inhibitors expand Amoxicillin's antibacterial spectrum, including many strains that have been resistant to other beta-lactam antibiotics.
Before taking Augmentin powder 500mg/62.5mg GSK Treatment of infection (12 packs)
How to use
Mix powder in water before drinking.
Children: When children under 2 years of age, water can be used to dilute Amoxicillin-clavulanate mixture to 2 times.
Take the medicine at the beginning of the meal to minimize the ability to intolerine through the gastrointestinal tract.
Augmentin 500mg's absorption is optimal when taking the drug at the beginning of the meal.
Dosage
Dosage depends on the age, weight and kidney function of the patient and the severity of the infection.
Dosage is expressed in both amoxicillin - Clavulanate except when it is stated according to the dose of each separate ingredient.
Do not treat more than 14 days without checking again.
can start treatment with infusion and follow oral continuation.
Adults
Mild infections to medium
1000/125mg x 2 times/day.
Severe infections (including recurrent and chronic urinary tract infections, lower respiratory tract infections)
1000/125mg x 3 times/day.
Children
Dosage is shown by the age of the child or in the form of mg/kg/day (use 2 or 3 times daily).
Children weighing 40kg or more should be prescribed as recommended for adults.
Children under 12 years old
recommended dose
40mg/5mg/kg/day to 80mg/10mg/kg/day (no more than 3000mg/375mg daily) divided 3 times, depending on the severity of the infection.
The treatment time depends on the response of the patient. Some types of infections (such as osteomyelitis) need longer treatment time.
premature babies
There is no recommended dose for premature babies.
Old people
No dose adjustment, dose as adults. If there are signs of renal failure, the dose should be adjusted by patients with renal impairment.
kidney failure
No dose adjustment in patients with creatinine clearance (CrCl) is greater than 30ml/min.
In patients with creatinine clearance below 30ml/minute, it is not recommended to use Augmentin 500mg with amoxicillin and clavulanic acid ratio of 8: 1, due to no recommendations to adjust the dose.
Hemolygenic: Augmentin package 500mg/62.5mg The form of oral powder should only be used for patients with creatinine clearance higher than 30ml/min.
liver failure
Be cautious when prescribing should periodically check the liver function.
Not enough data to give recommended dose.
What to do when overdose?
Symptoms and signs
Symptoms on the gastrointestinal tract and electrolyte water balance disorders may be an expression of overdose. Observed the amoxicillin crystal, in some cases, the kidney failure (see warning and caution).
Treatment
can treat symptoms for gastrointestinal manifestations with a note of water and electrolyte balance. Augmentin 500mg can be removed from the circulatory cycle with hemolysis.
Children
A study overtime over 51 children at a anti -toxic center showed an overdose of less than 250mg/kg amoxicillin without significant clinical symptoms and no need to clean the stomach.
What to do when forgetting the dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
Data from large clinical trials have been used to determine the frequency of unwanted effects from very popular to rare. The frequency of prescribed for all other unwanted effects (for example, appears below 1/10,000) is determined mainly from the figures after the drug circulates and to refer to the reporting rate rather than the actual frequency.
The following convention is used to classify the frequency:
Very popular> 1/10.
Popular> 1/100 and
Not popular> 1/1000 and
rarely> 1/10,000 and
Very rare
Infections and parasites
Popular: Candida infection on the skin and mucosa.
Disorders of blood systems and lymph
Rare: Reducing leukemia (including neutropen leukopenia) and platelets.
Very rare: Hydronuclia has recovered and hemolytic anemia. Extend bleeding time and prothrombin time.
immune system disorders
Very rare: Neurology, anaphylaxis, serum, hypersensitivity syndrome.
Nervous system disorders
Unknown: dizziness headache.
Very rare hyperactivity with recovery and convulsions. Convulsions may appear in patients with impaired renal function or high doses.
Gastrointestinal disorders
Adults:
Popular: diarrhea, nausea, vomiting.
All subjects: Nausea often appear more when taking high doses. If there are signs of reactions on the gastrointestinal tract, Augmentin can be taken at the beginning of the meal to quickly reduce this reaction.
All subjects: Signs and symptoms often appear in or immediately after treatment but some cases may not become clear until several weeks after stopping the drug. These events often recover. The events on the liver may be severe and in some extremely rare cases, there have been death reports. Most of these cases often occur in patients with severe serious illnesses or taking knowing drugs that can affect the liver.
Skin and tissue disorders
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Augmentin 500mg contraindications in the following cases:
Be cautious when using
should carefully ask a history of hypersensitivity reactions to penicillin, cephalosporin or other allergens before starting treatment with augmentin.
There have been severe hypersensitivity reactions (anaphylaxis) and sometimes fatal in patients treated with penicillin. These reactions are more common in patients with a history of hypersensitivity to penicillin. If the allergic reaction occurs, augmentin should be stopped and replaced with appropriate treatment. The serious anaphylactic reaction should be immediately rescued with Adrenalin. Oxygen, intravenous steroids and airways, including intubation may also be necessary.
Avoid using augmentin if suspected of mononucleemocal hypernage due to the appearance of measles rash related to this condition after using amoxicillin.
For prolonged use can sometimes cause an increase in non -sensitive bacteria. Fake colitis has been reported when using antibiotics and with mild to life -threatening severity. Therefore, this diagnostic consideration is very important in patients with diarrhea during or after antibiotics. If diarrhea or prolonged or patients with abdominal cramps, should stop treatment immediately and check the patient more.
Overall, Augmentin tolerates well and has a characteristic low toxicity of penicillin group antibiotics. It is recommended to regularly check the function of the organs, including the liver, kidneys and hematopoietic function when prolonged treatment.
Rarely have abnormal prolonged reporting of prothrombin time (Inr) in patients using augmentin and oral anticoagulants. Should follow appropriately when anticoagulants are prescribed simultaneously. The dose of anticoagulant drugs may be needed to maintain the desired anticoagulant level.
Should be cautious when using augmentin in patients with signs of liver function decline.
In patients with renal impairment, the dose should be adjusted according to the degree of renal failure (see dosage and usage - renal failure).
Observed the urinary crystal in patients who reduce urine secretion but very rare, mainly when patients use infusion. It is recommended that patients drink enough water to maintain the amount of urine excreted during the time of using high -dose amoxicillin to reduce the possibility of the occurrence of amoxicillin crystals (see overdose).
Augmentin 500mg pack, containing aspartame, is a source of phenylalanine and thus should be used carefully in patients with phenylceton.
The ability to drive and operate machinery
has not conducted research on influence on driving or operating machinery. However, unwanted effects may occur (such as allergic reactions, dizziness), affecting the ability to drive and operate machinery (see unwanted effects).
Pregnancy
Studies on fertility on animals (rats and rats with a dose of up to 10 times higher doses for human) when using oral Augmentin and infusion does not show the effect of monitoring. In a single study in premature women due to early rupture of amniotic fluid (PPROM), a report on prophylaxis with Augmentin may be associated with an increase in the risk of necrotizing bowelectitis in infants. Like all other medications, avoiding medications during pregnancy, unless the doctor thinks it is necessary.
Breastfeeding period
can use Augmentin 500mg during breastfeeding. Except for the risk of sensitivity, related to the drug is excreted a very small amount of breast milk, not knowing which adverse effects for breastfeeding babies.
Drug interaction
No recommendations to simultaneously use with Probenecid. Probenecid reduces amoxicillin secretion through the renal tubules. Simultaneous use with augmentin can cause increased and prolonged the concentration of amoxicillin in the blood but does not affect clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin may cause an increase in the likelihood of allergic reactions on the skin. There is no data on using augmentin combination with allopurinol.
Like other antibiotics, Augmentin 500mg can affect the intestinal bacteria that leads to reducing the reabsorption of estrogen and reducing the effectiveness of oral contraceptives.
In the literature, rarely Inr (International Normalise Ratio) cases in patients undergoing treatment with acenocoumarol or warfarin and are prescribed an amoxicillin batch. If necessary to prescribe simultaneously, carefully monitor prothrombin or INR time when using or stop using amoxicillin.
In patients who are taking Mycophenolate Mofetil, there has been a report on the decrease in the concentration of metabolites with mycophenolic acid activity (MPA) in the previous dose of about 50% after starting oral amoxicillin combined with clavulanic acid. The previous change change may not exactly show changes in the overall MPa exposure level.
penicillins may reduce methotrexate excretion leading to increased toxicity.
Storage
Store Augmentin 500mg in closed packaging, in a dry place, less than 30 ° C.
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