Oral Pharbaren 500mg treatment of sore throat, tonsillitis, otitis media, acute sinusitis (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Cefprozil

Ingredient

Composition information	Content
Cefprozil	500mg

Uses

indications

Pharbaren drugs indicated treatment in cases of mild infections that have been caused by sensitive bacteria:

Sore throat and tonsillitis caused by Streptococcus Pyogenes. B-Lactamase production line). Pneumoniae, Proteus Mirabilis.

Pharmacokic

cefprozil is a cephalosporin antibiotic semi -synthetic spectrum. Cefprozil has the effect of printing in vitro on the broad spectrum of Gram -positive and gram -negative bacteria. Cefprozil has the effect of bactericidal by inhibiting the synthesis of cell walls.

Cefprozil is more sustainable than Cefaclor under the hydrolysis of beta lactamase due to penicillinase coding plasmid including stamps and S. aureus enzymes as well as IA, IB, IC and ID enzymes. Cefprozil is not active on methicillin staphylococci, Enerobacter, Morganella Morganii, Enterococcus Faecium, most acinetobacter, Proteus vulgaris, Providencia, Pseudomonas and Serratia.

pharmacokinetics

cefprozil is well absorbed when drinking, regardless of the meal. Oral bioavailability of Cefprozil is about 90%. Cefprozil's pharmacokinetics are not affected by food or antacids used simultaneously. The average medical concentration in plasma after using the drug is stated in the following table.

Dosage

Cefprozil concentration in plasma* (McG/ml)

peak ≈ 1.5 hours

4 hours Mg 6.1 1,7 Mg 10.5 3,2

0.4 62% The average value from 12 young volunteers.

In the first 4 hours after taking the medication, the average Cefprozil concentration in the urine is approximately 170 mcg/ml, 450 mcg/ml, 600 mcg/ml, respectively corresponding to the dose of 250 mg, 500 mg, 1 g. The average discharge time of the drug in plasma is 1.3 hours. The ratio attached to plasma proteins is 36% and does not depend on the drug concentration of about 2 mcg/ml to 20 mcg/ml.

There is no evidence of cefprozil accumulation in plasma in people with normal kidney function using repeated oral dose up to 1 g every 8 hours in 10 days.

For patients with renal failure

The time to sell drugs in plasma may be extended up to 5.2 hours, depending on the degree of renal failure. In patients that the kidneys are completely inactive, the average selling time reaches 5.9 hours. In the process of hemorrhage, the sale time of the drug is reduced to 2.1 hours.

For patients with liver failure

There is no difference in pharmacokinetics of drugs in patients with liver failure compared to patients with normal liver function.

For an elderly patient

After using 1 dose of 1 g of Cefprozil, AUC in the elderly ≥ 65 years old) is approximately 35 - 60% higher than the AUC in young adults and the average AUC in women is approximately 15 - 22% higher than the AUC in men. With this degree of pharmacokinetics, it is not necessary to adjust the dose in the elderly.

For children

Pharmacokinetics in pediatric patients (6 months - 12 years old) are not different from adults. The maximum concentration of the drug in plasma is achieved after 1-2 hours of taking the drug. The time to sell drugs in plasma is approximately 1.5 hours. AUC in children used dose 7.5, 15, 30 mg/kg respectively equivalent to AUC in adults using the dose 250, 500, 1000 mg.

Before taking Oral Pharbaren 500mg treatment of sore throat, tonsillitis, otitis media, acute sinusitis (1 blister x 10 tablets)

How to use

oral drugs, regardless of meals.

Dosage

Adults and children aged 13 and older:

Sore throat and tonsillitis: take a dose of 500 mg/24h. No complications: dose of 500 mg/24h.

Children from 2 years old to 12 years old:

Inhabited skin and structural infections: Topic dose of 20 mg/kg/24h.

otitis media: dose of 15 mg/kg/12h.

The treatment time usually lasts from 10 to 15 days, is decided based on the patient's clinical condition and microbiological response. For acute cystitis without complications, the treatment time usually lasts 7 days.

In the treatment of infections caused by Streptococcus Pyogenes, the treatment time takes at least 10 days.

kidney failure

No need to adjust the dose in patients with renal impairment has creatinine clearance> 30 ml/min.

For patients with renal impairment with creatinine clearance

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 do

do when using overdose? Animal toxicity research shows a single dose of up to 5000 mg/kg, which does not cause serious effects or death.

Cefprozil is first eliminated by the kidneys. In the case of serious overdose, especially in patients with kidney function damage, hemolytic refinement will help remove Cefprozil from the body.

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

What to do when you forget 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

Unwanted effects encountered when using Cefprozil is similar to when using other oral cephalosporins. About 2% of patients have to stop using Cefprozil due to unwanted effects.

The most common unwanted effects when using Cefprozil include:

digestive: diarrhea (2.9%), nausea (3.5%), vomiting (1%) and abdominal pain (1%). Similar to some other penicillin and other cephalosporins, there have been reports on rare cases of cholestasis. These unwanted effects are more common in children than adults. Signs and symptoms usually appear after the first few days of the treatment and disappear in a few days after stopping the use of the drug.

Kidney: Bun increases (0.1%) and plasma creatinine (0.1%). form, fever, stevens-johnson syndrome, platelet reduction.

Some unwanted effects are reported in patients with antibiotics of cephalosporin groups: anemia, hemolytic anemia, hemorrhagic, kidney dysfunction, poisoned epidermal necrosis, kidney toxicity, prolonged prothrombin time, positive coombs reaction, hyperlike, neutrophils decreased, granular hypercellation.

Warnings

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

Contraindicated

Pharbaren drug is contraindicated in the following cases:

allergies to antibiotics Cephalosporin or any ingredients of the drug.

Be cautious when using

hypersensitivity and allergies

Before starting treatment with Cefprozil, it is necessary to determine if the patient has a hypersensitivity reaction to Cefprozil, Cephalosporin, Penicilin, or other drugs. Be careful if using this drug in patients sensitive to penicillin by cross sensitivity between beta-lactam antibiotics has been recorded and may appear over 10% of patients with a history of allergies to penicillin.

When the allergic reaction appears, it is necessary to stop using the drug immediately. Drug allergies may need epinephrin and other emergency measures including oxygen, infusion, antihistamine, corticosteroids, and airways support.

Stomach - guts

diarrhea caused by Clostridium difficile (CDAD) is reported when using antibiotics, including Cefprozil. Diarrhea may manifest from mild to severe, even leading to death from colitis. Therefore, this diagnosis should be considered in patients after using antibiotics with symptoms of diarrhea, colitis, fake colitis, acute poisoning colitis, perforation. There have been reports on the case of CDAD more than 2 months after using antibiotics.

Antibiotic therapy may not be effective when treating severe CDAD. After diagnosing CDAD, it is necessary to immediately conduct appropriate treatments. Mild CDAD often responds to the discontinuation of non -direct antibiotic use C. difficile. In the case of a patient with a severe, severe and electrolyte control, protein supplementation, effective antibiotic treatment on C. difficile, even surgery when necessary.

Hematopoeia anemia

There have been reports on intermediate immunity anemia in patients using cephalosporin antibiotics. If the patient has anemia during treatment or after using Cefprozil for 2 to 3 weeks, it is necessary to consider diagnosing anemia related to cephalosporin, stop using the drug and continue monitoring anemia to take appropriate treatment.

Do not use cefprozil in patients with a history of hemolytic anemia related to cephalosporin because of hemolytic anemia if relapse is much worse.

General recommendation

It is necessary to assess the patient's kidney condition before and during treatment, especially in serious patients. For patients who have been diagnosed or suspected of renal failure, clinical monitoring and clinical testing closely before and during treatment with Cefprozil. Cefprozil's daily daily dose is needed in patients with creatinine clearance

There was a report on the coombs directly positive during the treatment of cephalosporin group antibiotics. Precautions when using drugs in patients with a history of stomach - intestinal diseases, especially colitis.

Children

The use of Cefprozil in the treatment of acute sinusitis in this patient's subject is based on evidence of research on adults and pharmacokinetics in children.

Safety and effectiveness of drugs in children less than 6 months old has not been established. There has been a report on the accumulation of other cephalosporin antibiotics in newborns (caused by prolonged semi -emissions in this age group).

Elderly

There is no study using Cefprozil in the elderly with chronic diseases. In the elderly, excretion of the drug through the kidneys is impaired even when the serum creatinine clearance is normal.

Can be indicated to reduce the dose or reduce the frequency of drug use in this patient object.

Use drugs for women during pregnancy and lactation

Pregnant women

Research on reproductive function has been conducted on mice, rats and rabbits at a dose of 14, 7 and 0.7 times compared to the maximum daily dose in humans (1000 mg) in mg/m2, and no evidence of Cefprozil's harmful effects on the fetus. There is no complete research on pregnant women, only drugs should be used if the benefits are superior to the risk.

breastfeeding women

less than 1% of the drug on the mother is excreted in milk. Be cautious when using medication in breastfeeding women. Can consider stopping the medication temporarily.

The effect of drugs on driving, operating machinery

because the drug can cause dizziness and drowsiness, should not use the drug when driving and operating machinery.

Drug interaction

Kidney toxicity has been reported when using the aminoglycosides and antibiotics of cephalosporin groups.

Simultaneous use with probenecid doubled the area under the curve (AUC) of Cefprozil.

Interactive drug/experiment:

Cephalosporin antibiotics may cause a false positive reaction to the urine with the test of copper elimination (Benedict or Fehling solution or with clinitest tablets), but does not affect the enzyme test (glucose oxidase) for glucose urine.

The false negative reaction may appear in the ferricyanid test for blood sugar. The presence of Cefprozil in the blood does not affect the quantitative creatinine in urine or serum by alkaline picrat.

Storage

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

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