Augmentin powder 250mg/31.25mg GSK Treatment of infection (12 packs)

Dosage form 12 package box
Specifications Amoxicillin, clavulanic acid
Ingredient Tonsillitis, sore throat, sinusitis, urinary tract infections, acute bronchitis, chronic bronchitis, pneumonia

Ingredient

Composition informationContent
Amoxicillin250mg
Clavulanic Acid31.25mg

Uses

Indications

Should use Augmentin 250mg under the instructions of the official antibiotic prescription and data on sensitivity of local antibiotics.

Augmentin 250mg is indicated for short-term treatment of bacterial infections caused by bacteria sensitive to amoxicillin-clavulanate, in the following positions:

Upper respiratory infection (including ear-mosaic) such as tonsillitis recurrence of sinusitis, otitis media, typically caused by Streptococcus Pneumoniae, Haemophilus Influenzae*, Moraxella Catarrhalis* and Streptococcus Pyogenes.

Lower respiratory infections such as acute bronchitis, lobe pneumonia and bronchitis, typically caused by Streptococcus Pneumoniae, Haemophilus Influenzae* and Moraxella CatVhalis*.

Urinary, genital infections such as cystitis, urethritis, nephritis, pyelonephritis, female genital infections, typically caused by Enterobacteriaceae (mainly Escherichia Coli), Staphylococcus Saprophyticus and Enterococcus Species and gonorrhea caused by Neisseria Gonorrhoeae.

Typical skin and soft tissue infections caused by Staphylococcus aureus, Streptococcus Pyogenes and Bacteroides Species.

Bone and joint infections such as osteomyelitis, typically caused by Staphylococcus aureus, often required for prolonged treatment.

Other bacterial infections such as infections/miscarriage, postpartum infections, abdominal infections.

* Some bacteria belong to these species born beta-lactamase, making them not sensitive to Amoxicillin.

The sensitivity of bacteria with Augmentin 250mg 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 250mg thanks to amoxicillin composition. The mixed infection caused by amoxicillin sensitive strains combined with the beta-lactamase seminarians sensitive to Amoxicillin-clavulanate can be treated with augmentin.

Pharmacokology

Mechanism of action

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) inhibits one or more yeast (often called penicillin binding proteins, PBP) in bacterial peptidoglycan biosynthesis, this is an indispensable component in the structure of bacterial cell walls. The inhibition of peptidoglycan biosynthesis leads to weakened cell walls, which often lead to cell decomposition and death.

Amoxicillin is easily decomposed by beta-lactamase generated by anti-drug bacteria and therefore the effect of Amoxicillin used alone does not include these bacteria.

Clavulanic is a structural beta-lactam related to penicillin. It is inactivated the beta-lactamase enzymes thus prevents Amoxicillin inactivity. Clavulanic acid alone does not give clinically useful antibacterial effects.

The presence of clavulanic acid in Augmentin formulas to protect amoxicillin from decomposition by beta-lactamase, and wide tissue has the antibacterial spectrum of amoxicillin including many common bacteria with amoxicillin and penicillin and 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 with Augmentin 250mg.

In vitro sensitivity of bacteria with Augmentin 250mg: Beta-lactamase bacteria are not marked (marked +). A sample sensitive to Amoxicillin can be considered sensitive to augmentin.

Common sensitive bacteria

Aerobic grams:

Bacillus anthracis.

Enterococcus Faecalis.

listeria monocytogenes.

nocardia asteroides.

streptococcus pyogenes*+.

streptococcus agalactiae*+.

Streptococcus spp. (other β hemolytic bacteria)*+.

Staphylococcus aureus (methicillin sensitive)*.

Staphylococcus saprophyticus (sensitive to methicillin).

Staphylococcus aureus without coagulase (methicillin sensitive).

Aerobic grams:

bordetella pertussis.

haemophilus influenzae*.

Haemophilus parainfluenzae.

helicobacter pylon.

Moraxella catrhalis*.

neisseria gonorrhoeae.

Pasteurella Multocida.

Vibrio Cholera.

Other:

Borrelia Burgdorferi.

leptospira icterohaemorrhagiae.

treponema pallidum.

anaerobic grams:

Clostridium spp.

peptococcus niger.

peptostreptococcus magnesium.

peptostreptococcus micros.

peptostreptococcus spp.

Aerobic grams:

bacteroides fragilis.

bacteroides spp.

capnocytophaga spp.

Eikenella Corrodens.

fusobacterium nucleatum.

fusobacterium spp.

porphyromonas spp.

Bacteria whose drug resistance may be a problem

Aerobic grams:

Escherichia coli*.

klebsiella oxytoca.

klebsiella pneumoniae*.

klebsiella spp.

proteus mirabilis.

proteus vulgaris.

proteus spp.

salmonella spp.

shigella spp.

Aerobic grams:

corynebacterium spp.

Enterococcus fast.

streptococcus pneumoniae*+.

Viridians streptococcus.

Bacteria that have been resistant to drugs

Aerobic grams:

acinetobacter spp.

citrobacter Freundii.

Enerobacter spp.

Hafnia Alvei.

Legionella Pneumophila.

Morganella Morganii.

Providencia spp.

pseudomonas spp.

Serratia spp.

stenotrophomas maltophilia.

Yersinia Enterocolitica.

Other:

chlamydia pneumoniae.

chlamydia psittaci.

chlamydia spp.

Coxiella Burnetii

mycoplasma spp.

pharmacokinetic

absorption

Two components of Augmentin 250mg, 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 250mg (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 250mg/31.25mg GSK Treatment of infection (12 packs)

How to use

Mix the powder in the water before drinking. Take the medication at the beginning of the meal to minimize the possibility of intolerance through the gastrointestinal tract. The absorption of Augmentin 250mg is optimal when taking the drug at the beginning of the meal.

Children: When children under 2 years of age, water can be used to dilute Amoxicillin-clavulanate mixture to 2 times.

Dosage

Dosage depends on the age, weight and kidney function of the patient and the severity of the infection.

Do not treat more than 14 days without checking again.

can start treatment with infusion and follow oral continuation.

Adults

Mild infections to medium

Use 1000/125mg x 2 times/day.

Severe infections (including recurrent and chronic urinary tract infections, lower respiratory tract infections)

Use 1000/125mg 3 times/day.

Children

Dosage is shown by the age of the child or in the form of mg/kg/day (dividing 2 or 3 times daily).

Children weighing 40kg or more should be prescribed as recommended for adults.

Children under 12 years old

recommended dose

Use 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.

Patients with renal failure

No dose adjustment in patients with creatinine clearance (CrCl) is greater than 30ml/min.

In patients with creatinine clearance below 30ml/min, it is not recommended to use Augmentin with amoxicillin and clavulanic acid ratio of 8: 1, due to no dose adjustment recommendations.

Hemolygenic: Augmentin package 250mg/31.25mg The form of oral powder should only be used for patients with creatinine clearance higher than 30ml/min.

Be cautious when prescribing, should periodically check the liver function. There is 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 can be removed from the circulatory cycle.

A research study on 51 patients at a toxic anti -toxic center has shown that the overdose is less than 250mg/kg amoxicillin does not come with significant clinical symptoms and does not need to clean the stomach.

Abuse and drug dependence: There is no report on drug dependence, addiction or abuse for this drug.

What to do when forgetting 1 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.

Popular side effects> 1/100 and

Infections and parasites: Candida infection on skin and mucosa.

Gastrointestinal disorders: diarrhea, nausea, vomiting.

Unpopular side effects> 1/1000 and

Nervous disorders: Dizziness headache.

Gastrointestinal disorders: indigestion.

Bile disorders: Unpopular recognition of a moderate increase in AST or ALT in patients treated with beta-lactam antibiotics, but do not know the meaning of these findings.

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

Rare side effects> 1/10,000 and

Blood and lymphatic disorders: Restoration of leukemia (including neutropenia) and thrombocytopenia.

Skin disorders and subcutaneous tissues: Diverse roses.

Very rare side effects

Disorders of blood and lymphatic systems: Local leukemia has recovery and hemolytic anemia. Extend bleeding time and prothrombin time.

Disorders of the immune system: Neurological angio, anaphylaxis, serum disease syndrome, hypersensitivity.

Nervous system disorders: hyperactivity with recovery and convulsions. Convulsions may appear in patients with impaired renal function or high doses.

Gastrointestinal disorders: Antibiotic colitis (including fake colitis and bleeding colitis). (See warning and caution). Black hair tongue, very rare reports on teeth change in children. Good dental hygiene can prevent tooth color change.

Hepatitis bile disorders: Hepatitis and jaundice of these events have been recorded when using other penicillin and cephalosporin. The liver events are mainly reported in men and elderly patients and may be related to prolonged treatment.

Skin and subcutaneous disorders: Stevens-Johnson syndrome, poisoned epidermal necrotic, flake dermatitis and pustules of all over the body (AGEP).

Kidney and urinary disorders: interstitial nephritis, urinary crystals (see overdose).

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

Augmentin 250mg contraindications in the following cases:

In patients with a history of hypersensitivity to beta-lactam, for example penicillin and cephalosporin.

In patients with a history of hypersensitivity to beta-lactam, for example, penicillin and cephalosporin, a history of jaundice/liver dysfunction related to amoxicillin-clavulanate.

Caution when using

Should ask carefully the history of hypersensitivity reactions to penicillin, cephalosporin or other allergens before starting treatment with augmentin 250mg.

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 250mg 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 250mg tolerates well and has low 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 reports of prothrombin (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 250mg in patients with signs of liver function impairment.

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 pack, containing aspartame, is a source of phenylalanin 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 250mg 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 250mg 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 250mg 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 250mg in closed packaging, in a dry place, less than 30 ° C.

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