OPXIL SA 500 Imexpharm treats infections caused by sensitive bacteria (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Cephalexin

Ingredient

Composition information	Content
Cephalexin	500mg

Uses

indications

OPXIL® SA 500 drug is indicated in the treatment of infections caused by sensitive bacteria in the following diseases:

Respiratory infections;

otitis media; Birth of Cephalosporin generation I.

ATC code: J01DB01.

Cephalexin is a semi -oral synthetic antibiotic, belonging to the generation cephalosporin group I. The bactericidal effect of the drug is due to inhibition of bacterial cell synthesis.

The drug is attached to one or more penicillin -mounted proteins (PBP) inhibiting peptidoglycan synthesis in bacterial cell walls, thus inhibiting biosynthesis. The bacteria are destroyed by the effects of self -eliminating enzymes (Autolysin and Murein Hydrolase), while assembling cells into cells.

Cephalexin is an antibiotic oral. Like the IPHalosporin I (Cefadroxil, Cefazolin), Cephalexin has in vitro activity on many Gram -positive aura bridges, but the limited effect on gram -negative bacteria.

Antibacterial spectrum:

cephalexin has in vitro activity against the following bacteria:

Streptococci blood -soluble beta; Mirabilis;

klebsiella spp.;

Haemophilus Influenzae;

Cephalexin is not active against most of the Entobacter spp., Morganella Morganii and PR. Vulgaris. Cephalexin has no activity against pseudomonas or Herellea spp. or acinetobacter calecoaceticus.

Streptococcus pneumoniae resistant penicillin is often crossed with beta-lactam antibiotics. When tested by in vitro, Staphylococci shows the cross resistance between cephalexin and methicillin antibiotics.

pharmacokinetics

cephalexin is quickly absorbed after oral use. When using a dose of 500 mg, the average peak concentration in serum is approximately 18 mg/l after 1 hour. The concentration of cephalexin in serum is still detected after 6 hours of medication. Cephalexin is eliminated in urine through glomerular filtration and renal tubules. Studies show that more than 90% of drugs are eliminated in the form of unchanged urine within 8 hours. During the process, the concentration of the peak in the urine when used a dose of 500 mg is approximately 2,200 mg/l.

Cephalexin is absorbed almost entirely in the digestive tract, 75 - 100% quickly eliminated in the activity form in urine absorbed mitigation when using the drug with food. The sale time is about 60 minutes in patients with normal renal function. Hemolysis and abdominal dung can eliminate cephalexin from the blood.

The peak concentration in the blood is achieved after 1 hour after taking the drug, the concentration of treatment is maintained from 6 to 8 hours. About 80% of active drugs are eliminated in urine within 6 hours. There is no accumulation at a larger dose than the maximum treatment dose (4 g/day).

Semi -selling time may increase in newborns due to the incomplete renal function, no accumulation when using the dose up to 50 mg/kg/day.

Before taking OPXIL SA 500 Imexpharm treats infections caused by sensitive bacteria (10 blisters x 10 tablets)

How to use

oral tablets. Because food can slow down the absorption rate of the drug, you should drink when hungry, preferably about 1 hour before eating.

Dosage

Dosage in case of treatment:

Adults:

Common dose: 1- 4 g/day divided into several doses; Most types of infections respond to a dose of 500 mg every 8 hours. If the daily dose is required over 4 g, it is necessary to consider using cephalosporin injecting. The dose should be reduced if the renal function is significantly reduced. Dosage shall not exceed 500 mg/day if glomerular filtration level Children:

The daily dosage daily: 25 - 50 mg/kg is divided into several doses. Clinical studies show that the dose of 75 - 100 mg/kg/day is divided into 4 times used in the treatment of otitis media. For doses less than 500 mg/time, other products should be used with lower cephalexin content.

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?

Handling:

In case of serious overdose, clinical monitoring should be closely monitored and in hematological laboratory, liver, kidney function and blood clotting until the patient is stable. Forced urinary tract, abdominal dung, hemolysis, use of activated carbon, blood transfusion is not helpful when overdose Cephalexin. These methods are hardly indicated. In this case, supportive treatment is needed and often does not leave sequelae.

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 doses to compensate for missed dose.

Side Effects

The unwanted reaction rate is about 3% - 6% of the entire patient.

When using OPXIL® SA 500 drugs often experience unwanted effects (ADR) such as:

Common (ADR> 1/100):

Digestive: diarrhea, nausea.

Blood: Eosinemia increases eosin.

Skin: rash, urticaria, itching.

Systemic: headache, dizziness, anaphylactic reaction, fatigue Hepatitis, jaundice, hypertension, increase AST.

stop cephalexin. If allergies or hypersensitivity are serious, need to conduct supportive treatment (ensure ventilation and use epinephrine, oxygen, intravenous corticosteroid injection). Difficile.

Warnings

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

Contraindicated

OPXIL® SA 500 drug is contraindicated in the following cases:

Patients with antibiotics of cephalosporin groups.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Before treatment with cephalexin, pay attention to find out if the patient has an overcurrent response to cephalosporin, penicillin or other drugs. Caution should be used when using cephalexin for patients allergic to penicillin. There have been clinical evidence and in the lab in cross allergy between penicillin and cephalosporin. There have been cases where patients with severe reactions (including anaphylaxis) with both drugs. Therefore, it is necessary to consider these diagnosis in patients with diarrhea related to antibiotic use. The degree of colitis from mild to life -threatening. It is possible to overcome cases of mild fake colitis by stopping the drug. Cases from moderate to severe, appropriate measures should be applied. Need to monitor patients carefully. If the superinfection occurs during treatment, it is necessary to apply appropriate measures. It is necessary to carefully study clinically and in the laboratory because the safety dose may be lower than the recommended dose.

affects the test:

positive for direct Coombs has been reported during treatment with cephalosporin antibiotics. For hematological tests, or during blood transfusion when the globulin tests are performed in small groups, or in the Coombs test for infants whose mothers use antibiotics cephalosporin before birth, positive results may be due to drugs. But with enzyme tests, it is not affected.

The effect of the drug on driving and operating machinery

There is no evidence of the effect of the drug on the ability to drive and operate machinery.

Using drugs for women during pregnancy

pregnancy

Although studies in the laboratory and clinical room have not yet been evidence about the use of teratogenic drugs. However, be cautious when indicating cephalexin for pregnant women.

Breastfeeding period

Cephalexin content is excreted in breast milk increasing for 4 hours after taking a dose of 500 mg. Cephalexin reaches a maximum concentration of 4 micrograms/ml, then gradually decreases until 8 hours of medication. Be careful when using cephalexin for breastfeeding women.

Drug interaction

like other beta-lactam antibiotics, Probenecid prevents the excretion of Cephalexin's kidneys, thus increasing serum levels and increasing the sale time of cephalexin.

In a single study in 12 healthy subjects using the dose of 500 mg Cephalexin and Metformin, CMAX and AUC Metformin in plasma increased average, equivalent to 34%and 24%, metformin clearance through the renal decrease average 14%. There is no side effects reported in 12 healthy subjects in this experiment. There is no information on drug interactions between cephalexin and metformin when using multi -dose. The clinical significance of this study is unclear, especially there is no case of "lactic acidosis" (lactic acidosis) is reported regarding the treatment of coordination of metformin and cephalexin.

Hypotension can occur in patients with leukemia using cell poison simultaneously with Gentamicin and Cephalexin.

High -dose cephalosporin use with other poisonous drugs such as aminoglycosides or strong diuretics (e.g. Furosemid, ethacrynic acid and piretanid) can adversely affect kidney function. Clinical experience shows no problem with Cephalexin at the recommended dose.

There have been notifications about cephalexin reducing the effects of estrogen in oral contraceptives.

cholestyramin attached to cephalexin in the intestine slows down their absorption.

The effect of cephalexin may increase when used with ureteric agents.

Cephalexin can reduce the effectiveness of typhoid vaccine.

Storage

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

To be out of reach of children, read the instructions carefully before use.

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