Efodyl 500mg Treatment of sugar infection (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Cefuroxim

Ingredient

Composition information	Content
Cefuroxim	500mg

Uses

Indications

cefuroxime are indicated for the treatment of infections below in adults and children from 3 months of age:

tonsillitis and sore throat

Cefuroxime is indicated for the treatment of tonsillitis and mild pharyngitis to fit by sensitive strains of Streptococcus Pyogenes.

acute sinusitis caused by bacteria

Cefuroxime is indicated for treatment of mild acute sinusitis just caused by sensitive strains of streptococcus pneumoniae or haemophilus influenzae (Beta-lactamase strains).

The effect of Cefuroxime in the treatment of acute sinusitis caused by the beta-lactamase strains of Streptococcus pneumoniae or Haemophilus influenzae has not been set.

acute otitis media

Cefuroxime is indicated for acute otitis media caused by sensitive strains of Streptococ-Cus Pneumonia, Haemophilus Influenzae (including beta-lactamase strains), Moraxella Catatrhalis (including beta-lactamase strains) or Streptococcus pyogenes.

Exacection of chronic bronchitis

cefuroxime is indicated for medium-sized treatment for chronic bronchitis caused by sensitive strains of streptococcus pneumonia, Haemophilus influenzae (Beta-lacta-mase-free strains) or Haemophilus parainfluenzae (Beta-lactamase strains).

Skin infections and soft tissue infections

Cefuroxime is indicated for treating skin and soft tissue infections caused by sensitive strains of Staphylococcus aureus (including beta-lactamase strains) or Streptococ-Cus Pyogenes.

Urinary tract infections are uncomplicated

Cefuroxime is indicated for uncomplicated urinary tract treatments caused by sensitive strains of Escherichia Coli or Klebsiella Pneumonia.

Gonorrhea is uncomplicated

cefuroxime is indicated for treating uncomplicated gonorrhea in the urethra, cervical internal caused by penicillinase sensitive strains or non -birth penicillinase of Neisseria gonorrhoeae, treating non -complicated gonorrhea in rectal causes by non -birth sensitive strains of Neisseria Gonorrhoeae.

Lyme disease early (the erythematon moves)

cefuroxime is indicated for early lympha treatment caused by sensitive strains of Borrelia Burgdorferi.

Pharmacology

cefuroxim acetyl has bactericidal effect in vivo is from Cefuroxim -based compound.

Cefuroxim is an effective antibacterial agent with broad spectral activity, bactericidal effects on many common pathogenic bacteria, including beta -lactamase strains.

Cefuroxim is highly sustainable with bacterial beta-lactamase and thus works with many ampicillin-resistant strains or amoxicillin resistance.

Cefuroxim's bactericidal effect is due to synthetic inhibition of cell walls by connecting with the main target proteins.

Sensitive bacteria strains:

Gas -positive gram -positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis (including parameters penicillinase but except methicillin strain), Streptococcus pyogenes and streptococcus soluble beta, streptococcus pneumoniae, streptoccus group b group b group b group b group b group b group b group b group b group b group b group (Streptococcus agalactiae).

Gas -negative gram -negative bacteria: Haemophilus influenzae (including ampiclin), Haemophilus parainfluenzae, Moraxella (Branhamella) Catatrhalis, Neisseria Gonorrheaa (including strains and non -birth penicillinase), E.coli, Klebsiela SPPLLA SPPLLA SPL. Mirabilis, Providencia spp., Proteus Retigeri.

Anaerobic bacteria: Gram -positive and gram -negative bacteria (including peptococcus and peptostreptococcus); Propionibacterium spp.

Other bacteria: Borrelia Burgdorferi.

Unpake strains:

Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calecoaceticus, Listeria monocytogenes. Methicillin resistance strains of Staphylococcus aureus and Staphylococcus epidermidis, Legionella spp.

A few strains of the following species are not sensitive to cefuroxim:

Enterococcus (Streptococcus) Faecalis, Morganella Morganii, Proteus Vulgaris, Entobacter spp; Citrobacter spp; Serratia spp; Bacteroides fragilis.

Mechanism of action:

Cefuroxim is an antibiotic cephalosporin, semi -synthetic, 2nd generation. The injection form is sodium salt, oral drug is Cefuroxim's acetyloxyethyl ester. Cefuroxim acetyl is a precursor, has no antibacterial effect, into the body hydrolyzed under the effect of the enzyme esterase to cefuroxim to work.

Cefuroxim has the effect of killing bacteria in the stage of growth and division by inhibiting synthesis of bacterial cells. The drug is attached to proteins associated with penicillin (penicillin binding protein, PBP), which are proteins involved in the composition of bacterial cell membrane structure, acting as a catalytic enzyme for the final stage of cell synthesis.

As a result, the synthetic cell wall will be weakened and unstable under the impact of osmotic pressure. The affinity of Cefuroxim with PBP of different types will determine the effect of the drug.

As well as other beta-lactam antibiotics, the bactericidal effect of cefuroxim depends on time. Therefore, the goal of the dose regime is to optimize the exposure period of bacteria with the drug.

Time of blood concentration in blood is greater than the minimum inhibitory concentration of antibiotics with isolated bacteria (T> MIC) is a pharmacokinetic/pharmacokinetic parameters that are closely related to the treatment effect of Cefuroxim. T> Mic needs to reach at least 40 - 50% of the distance between the two giving drugs.

pharmacokinetics

After drinking, Cefuroxim Acetil is slowly absorbed from the digestive tract and is quickly hydrolyzed in the intestinal and blood mucosa to release Cefuroxim into the circulatory system.

The best absorbed drug when taken immediately after eating.

The peak concentration of cefuroxim in plasma varies depending on the form of tablets or chaos. The drug reaches a maximum concentration of 4-6 mg/liter for a dose of 250 mg, 5-8 mg/liter for a dose of 500 mg and 9-14 mg/liter for 1g dose of about 2-3 hours after taking the drug after meals.

Cefuroxim is widely distributed throughout the body, including pleural fluid, phlegm, bone, fluid and aquatic fluid. The apparent distribution volume in healthy adults ranges from 9.3 - 15.8 liters/1.73 m2. Cefuroxim passes through the bloody barrier when the meninges are inflamed. Medicine through placenta and excretion through breast milk.

Cefuroxim is not metabolized and eliminated in the form of unchanged, about 50% through glomerular filtration and about 50% through excretion in the renal tubules. The drug is high in urine. After the injection, most of the doses of use excreted within 24 hours, mostly excreted within 6 hours. Probenecid inhibits cefuroxim excretion through the renal tubules, causing the cefuroxim concentration in plasma to rise and last longer. Cefuroxim only excreted in bile with very small amounts.

The concentration of cefuroxim in serum is reduced when it is separated.

Before taking Efodyl 500mg Treatment of sugar infection (2 blisters x 10 tablets)

How to use

Use oral.

Should be used after meals to best absorb the drug. Because the Efodyl tablet breaks when breaking has a bitter taste, should not break, grind or chew. For children who cannot swallow the whole tablet, should use the form of efodyl phase nuggets.

Dosage

A regular treatment is 7 days (maybe from 5 to 10 days).

adults and children (from 40 kg or more)

Dosage of Efodyl tablets in adults and children (from 40 kg or more)

tonsillitis, sore throat, acute sinusitis caused by bacteria: 250 mg x 2 times/day.

Acute otitis media: 500 mg x 2 times/day.

Exacerbats of chronic bronchitis: 500 mg x 2 times/day.

Urinary tract infections: 250 mg x 2 times/day.

Skin infections and soft tissue inferiority: 250 mg x 2 times/day.

Inhabulating gonorrhea: The only dose 1000 mg.

Lyme disease early: 500 mg x 2 times/day for 14 days (possibly from 10 to 21 days).

Dosage of Efodyl tablets in children (from 40 kg or less)

tonsillitis, sore throat, acute sinusitis caused by bacteria: 10 mg/kg body weight 2 times/day, up to 125 mg 2 times/day.

Children 2 years of age and older sufferer from otitis media or more serious infections: 5 mg/kg body weight twice a day, up to 250 mg x 2 times/day.

Urinary tract infections: 15 mg/kg body weight 2 times/day, up to 250 mg 2 times/day.

Skin infections and soft tissue infections: 15 mg/kg body weight 2 times/day, up to 250 mg 2 times/day.

Lyme disease in the early stage: 15 mg/kg body weight 2 times/day, up to 250 mg 2 times/day for 14 days (possibly from 10 to 21 days).

No experience using cefuroxime in children under 3 months old.

For children who cannot swallow the tablet, should use the form of Efodyl mixed nuggets.

Cefuroxime acetyl and nuggets of Cefuroxime acetyl oral phase nuggets are not equivalent to biological, so it cannot be replaced on the basis of mg/mg.

Patients with impaired renal function

Safety and effectiveness of Cefuroxime in patients with renal failure has not been set. For patients with renal impairment with creatinine clearance below 30 ml/min, it is necessary to adjust the time between doses caused by cefuroxime excreted by the kidneys. Cefuroxime is effectively eliminated by hemolysis.

Dosage of Efodyl tablets in patients with renal function impairment

Creatinin clearance

t1/2 (hours)

Dosage recommended

1,4 - 2.4

No need to adjust the dose (see standard dose at adults and children (from 40 kg or more)).

4,6

A standard dose (see the standard dose at adults and children (from 40 kg or more) every 24 hours.

16,8

A standard dose (see the standard dose at adults and children (from 40 kg or more)) every 48 hours.

2 - 4

Should use an additional standard dose (see the standard dose at adults and children (from 40 kg or more)) at the end of each hemolysis.

There is no data on patients with liver failure. Because Cefuroxime is excreted by the kidneys, the liver function impairment is expected not to affect the pharmaceutical dynamics of Cefuroxime.

What to do when overdose?

The concentration of cefuroxim in serum can be reduced by hemolytic and abdominal separation.

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 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

When using Efodyl 500mg, you may experience unwanted effects (ADR).

The most common unwanted effect is the excessive growth of candidiasis, eosinophilia, headache, dizziness, gastrointestinal disorders and liver enzymes.

The unwanted effects are listed below by the organ system, the frequency of encounter and the severity of the seriousness, with the conventional frequency of meetings: very common: ≥ 1/10; Common: ≥ 1/100; Not common: ≥ 1/1000 to

Infections and parasites

Common: Excessive growth of candidiasis.

Unknown: excessive growth of Clostridium difficile bacteria.

Blood disorders and lymphatic systems

Common

: Nothing.

Uncommon: False positive, plateletic, leukocytes (sometimes severely reduced).

Unknown: hemolytic anemia.

Cephalosporin tends to be adsorbed on the surface of red blood cell membranes and reacts directly to antibodies, causing a false positive cooom and very rare hemolytic anemia.

immune system disorders

Unknown: Drug fever, serum, anaphylactic reaction, Jarisch-HERX-HEIMER reaction.

Nervous system disorders

Common: headache, dizziness.

digestive disorders

Common: Gastrointestinal disorders include diarrhea, nausea, abdominal pain.

Less: vomiting.

Not known: fake colitis (see the cautious part when taking the drug).

Disorders of the liver system

Common: temporary liver enzyme.

Not known: jaundice (mainly due to cholestasis), hepatitis.

Temporary liver enzymes in plasma are recorded as reversed.

Skin disorders and subcutaneous tissues

Uncommon: skin rash.

Unknown: urticaria, itching, diverse erythema, Stevens-Johnson syndrome, poisoned epidermal necrosis, nerve angio.

How to handle ADR:

Notify the doctor the unwanted effects when using the drug.

Stop using Cefuroxim; In case of allergies or serious hypersensitivity reactions, it is necessary to conduct supportive treatment (maintain ventilation, use adrenalin, oxygen, corticosteroid intravenous injection).

When a mild mild fake colitis, usually just stop the drug. In medium and severe cases, it is necessary to infusion and electrolytes, protein supplementation and antibiotic treatment with antibiotic effect Clostridium difficile (Metronidazol or oral vancomycin). It is necessary to be careful to check the history of using drugs in the case of suspected fake colitis because the disease may appear late after 2 months, even later after stopping antibiotic treatment regimen.

Warnings

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

Contraindicated

Hypersensitivity to cefuroxime or any ingredients of the drug.

Precautions when using

Elderly people

The clinical experience is reported that there is no difference in response between the elderly and the younger adult. However, it is not possible to eliminate higher sensitivity levels in some elderly patients.

cefuroxime is excreted by the kidneys and the risk of unwanted effects may be higher in patients with renal impairment. Because the elderly may have renal function impairment, caution needs to be used in dosage options, can monitor kidney function if needed.

Renal function impairment

For patients with renal failure with creatinine clearance below 30 ml/min, it is necessary to adjust the time between the doses, Cefuroxime is effectively removed by blood decomposition.

Hypersensitivity reaction

Special care is indicated in patients who have an allergic reaction to penicillin or other beta-lactam antibiotics due to the risk of cross-sensitivity. Like all beta-lactam antibiotics, serious hypersensitivity reactions and sometimes death have been reported. In case of serious hypersensitivity reaction, Cefuroxime must be stopped immediately and take appropriate emergency measures.

Before starting treatment, it is necessary to determine whether the patient has a history of serious hypersensitivity reactions to cefuroxime, other cephalosporins or any other beta-lactam. Be careful when using cefuroxime for patients with a history of hypersensitivity is not serious with other beta-lactam antibiotics.

Jarisch reaction - Herxheimer

Jarisch - Herxheimer reaction has been recorded when using Cefuroxime Acetyl to treat Lyme disease. This is the direct result from the bactericidal activity of Cefuroxime Acetil with Lyme - Borrelia Burgdorferi. Patients need to be reassured that this is a common result when treating Lyme with antibiotics and recovering.

Excessive development of non -sensitive microorganisms

As well as other antibiotics, the use of cefuroxime acetyl can lead to over -growth of candidiasis. Long -term use can also lead to excessive growth of other non -sensitive microorganisms (for example, Enterococci and Clostridium difficile), may need to interrupt the treatment segment.

Colitis and fake colitis are found in most antibiotics including cefuroxime and can fluctuate in mild to life -threatening levels. So consider this diagnosis in diarrhea patients during or after using Cefuroxime is very important. Discontinue treatment with cefuroxime and specific treatment for Clostridium difficile should be considered. Do not use intestinal peristalsis inhibitors

affect diagnostic tests

Palf -positive glucose reactions in urine can occur with a copper reducing reaction (for example, using Benedict or Fehling solution), but does not occur with enzyme tests.

Due to the fake negative result that can occur in a test to determine blood/plasma glucose concentrations using ferricyanide, the method of oxidase or hexokinase glucose is recommended to use in patients using cefuroxime.

The use of cefuroxime can cause a false positive for the Coombs.

The presence of cefuroxime does not affect serum creatinine and urine quantitative results by alkaline picrate.

The ability to drive and operate machinery

There has been no research on the influence of Cefuroxime on driving and operating machinery. However, unwanted effects have been reported by Cefuroxime such as headaches, dizziness can affect the ability to drive and operate machinery.

Pregnancy

There are no complete and well -controlled studies on the use of cefuroxime in pregnant women. Animal studies show that there is no harmful effects on pregnant animals, embryo and fetal development, reproductive process and baby's development after birth. Because animal reproductive studies do not always predict to be met in humans, Cefuroxime should only be used for pregnant women when the benefits are superior to the risk.

Breastfeeding period

Small amount of Cefuroxime is excreted into breast milk. It is expected that there is no unwanted effect at the treatment dose, although it is not possible to rule out the risk of diarrhea or mucous mucous fungal infection. Stop breastfeeding when having these unwanted effects. Cefuroxime should only be used in breastfeeding women when they have evaluated benefits/risks.

Reproductive ability

There is no data on the impact of cefuroxime acetyl on human fertility. Animal reproductive studies show that there is no influence on fertility.

Drug interaction

Oral contraceptives

Cefuroxime can affect intestinal bacteria, resulting in reducing estrogen reabsorption and reducing the effectiveness of oral contraceptives combined with estrogen and progesterone. Should consider using other contraceptive measures during treatment.

Medications that reduce stomach acid

Medications that reduce gastric acid can lead to reduced bioavailability of cefuroxime acetyl compared to hunger conditions and tend to disable the increase in absorption when taking the drug after meals.

Probenecid

Concomitance use Probenecid and Cefuroxime Acetil increases the meaning of the peak concentration, the area under the plasma concentration curve and the semi -waste time of Cefuroxime. Therefore, simultaneous use of Probenecid and Cefuroxime Acetil is not recommended.

anticoagulants

Simultaneous use with oral anticoagulants can cause Inr.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

Other drugs

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