Ceclor 125mg Menarini oral powder for infection treatment (30ml)

Dosage form Bottle x 30ml
Specifications Cefaclor
Ingredient Tonsillitis, pharyngitis, otitis media, sinusitis, urinary tract infections, chronic bronchitis, pneumonia, skin infections

Ingredient

Thành phần cho 5ml

Composition information	Content
Cefaclor	125mg

Uses

indications

Ceclor SUS 125mg/30ml drug is indicated in the following cases:

Cefaclor is indicated for infections caused by the following sensitive bacteria:

Middle otitis media caused by s.pneumoniae, hinfluenzae, staphylococcus, s.pyogenes, (streptococcus B hemolytic group A) and M.Chalrhalis.

Lower respiratory infections, including pneumonia, caused by s.pneumoniae, H.influenzae, s.pyogenes (streptococcus β hemolytic).

Infection of the upper respiratory tract, including sore throat and tonsillitis caused by spyogenes (streptococcus β hemolytic group A) and M.Catrhalis.

Urinary infections include pyelonephritis and cystitis caused by E.coli, P.Mirabilis, Klebsiella spp, and negative staphylococcus aureus (Cefaclor is effective in urinary and chronic infections).

Skin infection and skin structure caused by S.Aureus and S Pyogenes (Streptococcus β Hemolytic Group A).

sinusitis.

Urethritis due to gonorrhea.

Pharmacology

In vitro tests show that cephalosporin has bactericidal effects due to inhibiting cell wall synthesis.

While In vitro tests have proven the sensitivity of the majority of the following bacteria strains with cefaclor:

Aerobic, gram -positive bacteria: Staphylococcus, including penicillinase enzymes, positive coagulase, negative coagulase (when tested in vitro), showing cross -proof signs between cefaclor and methicillin. Streptococcus pneumoniae, Streptococcus pyogenes.

Aerobic bacteria, Gram negative: Citrobacter Diversus, Escherichia Coli, Haemophilus Influenzae, including B-Lactamase enamel strains, ampicillin resistance. Klebsiella spp, Moraxella (Branhamella) Catnrhalis, Neisseria Gonorrhoeae, Proteus Mirabilis.

Anaerobic bacteria: Bacteroides spp (except bacteroides fragilis), peptococcus niger, peptostreptoccus spp, propionibacteria acnes.

Note: Staphylococcus resistant to methicillin and most of Enterococcus strains (Enterococcus feacalis previously called Streptococcus Feacalis and Enterococcus Faecium [formerly called Streptoccus Faecium]) resistant to CEFACLOR and other CEFACLOR. Cefaclor does not act on most of the Entobacter spp, Serratia spp, Morganella Morganii, Proteus Vulgaris and Providencia Rettgeri. Cefaclor does not act on Pseudomonas spp or Acinetobacter spp.

Pharmacokinetics

absorption

Cefaclor is very well absorbed when taken in hunger. The total number of drugs is absorbed the same whether the patient is used when hungry or full; However, when used with food concentration, only 50% -75% compared to the peak concentration when the patient fasted and achieved more slowly about 45 -60 minutes. After orally oral doses of 250 mg, 500 mg, 1 g, in hunger, the average peak concentration in serum corresponds to 7.13, and 23 mg/l, achieved after 30-60 minutes.

Elimination

About 60 -85% of the drug is eliminated in the form of unchanged urine within 8 hours, a large part of the drug is eliminated in the first 2 hours. In this 8 hours, the peak concentration in the urine corresponds to 250 mg, 500 mg, 1g is 600, 900, and 1900 mg/l. The average half -life in the serum in normal people is about 1 hour (from 0.6 to 0.9).

In patients with impaired renal function, the half -life is often slightly longer. In people who completely decrease the kidney function, the semi -cancellation time in the plasma of the original drug is 2.3 to 2.8 hours. Drug elimination sugar in patients with severe renal impairment has not been determined. Dialysis reduces the half -life of drugs by about 25-30%.

Before taking Ceclor 125mg Menarini oral powder for infection treatment (30ml)

How to use

Take oral use.

Dosage

Adults

The usual dose is 250 mg every 8 hours.

For pneumonia and bronchitis, use 250 mg, 3 times daily.

For sinusitis, use 250 mg, 3 times daily for 10 days.

For more serious infections (such as pneumonia) or infections due to other less sensitive bacteria, can double dose. The dose of 4G/day has been safely used for normal people within 28 days, but the total daily dose should not exceed this amount.

To treat acute urethritis due to gonorrhea in men and women, taking a single 3G dose, combined with 1g of probenecid.

Children

The usual dose is 20 mg/kg/day, divided into every 8 hours.

For bronchitis and pneumonia, dose of 20 mg/kg/day, divided into 3 times. For more serious infections, otitis media, and bacterial infections are less sensitive, the dose of 40 mg/kg/day is divided into several times. The maximum dose is 1 g/day.

Treatment of otitis media and sore throat, total daily dose can be divided into 2 times, 12 hours/time. Cefaclor can be used for patients with renal impairment, in this case, there is no need to adjust the dose.

In case of severe renal failure, the dose adjustment is as follows: If the clearinine clearance is 10 - 50 ml/min, use 50% of the common dose; If creatinine clearance is less than 10 ml/min, use 25% of the usual doses. In the treatment of infections caused by streptococcus β hemolysis, it is recommended to use Cefaclor for at least 10 days.

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?

Signs and symptoms

Symptoms of poisoning when using Cefaclor may include: nausea, vomiting, epigastric pain, diarrhea. The level of epigastric pain and diarrhea depends on the dose. If there are other symptoms, it may be due to the secondary reaction of a hidden disease, an allergic reaction or other poisoning effects.

Treatment

To treat overdose, it is necessary to consider the overdose of many drugs, interact between drugs, abnormal pharmacokinetics of the patient.

Except for the case of taking 5 times the dose of normal, it is not necessary to apply gastric lavage. Protect patient respiratory tract, support ventilation and infusion. Careful monitoring and maintaining the survival signs of patients, blood gas, electrolytes in serum, etc. Can reduce the absorption of drugs in the digestive tract by activated carbon.

In many cases, this measure is more effective than causing vomiting or gastric lavage. Consider whether to use activated carbon instead of gastric lavage or must combine both. Using many consecutive doses of activated carbon can increase the elimination of absorbed drugs. It is necessary to protect the respiratory tract of patients when applying the method of gastric lavage or activated carbon.

Other measures such as strong diuretics, peritoneal fertilizer, dialysis, hemolytic jasmine with activated carbon, have not been determined to be effective in the treatment of cefaclor overdose.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Ceclor SUS 125mg/30ml you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive system: diarrhea, nausea, vomiting.

Blood: Easine hypernagus.

Uncommon, 1/1000

Genital system: itching, vaginitis.

Rare, ADR

Blood: platelets.

kidney: interstitial nephritis.

Unknown frequency

Liver: slightly increase AST (SGOT), ALT (SGPT) or alkaline phosphatase.

kidney: slightly increased bun or serum creatinine. nerve: hyperactivity, anxiety, stress, insomnia, confusion, muscle tone, dizziness, hallucinations, chicken sleep. blood: Hypergly increased blood cells, temporary leukemia, hemolytic anemia, aquatic anemia, granulocytes, neutropenia.

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

Ceclor SUS 125mg/30ml contraindicated drug in cases where patients have a history of hypersensitivity to antibiotics belonging to the cefalosporin group.

Be cautious when using

using long -term cefaclor can cause excessive development of non -sensitive strains. Need to monitor patients carefully. If superinfected, appropriate treatment should be taken.

There has been a report that the direct positive Coombs reaction may occur during treatment with cephalosporin antibiotics. It should be known that positive results may be due to drugs, for example, in hematology studies or in cross -reaction tests when blood transfusion is needed to use antiglobulin in secondary positions, or apply Coombs test on infants whose mothers use previous cephalosporin antibiotics.

Be careful when using Cefaclor for patients with severe renal function. Because the half -life of Cefaclor in patients with anuria is 2.3 -2.8 hours, it is often not adjusted for patients with severe or medium renal impairment. Because there is not much clinical experience in using Cefaclor for these cases, clinical monitoring and test results are very careful.

Be cautious when prescribing antibiotics, including cephalosporin for patients with gastrointestinal diseases, especially colitis.

Patients using Cefaclor may have false positive for urine glucose tests when tested with Benedict and Fehling solutions, clinitest tablets. (Glucose enzymatic test strip, USP).

There are several reports that show increased anticoagulant effects when using Cefaclor and oral anticoagulant. Like other beta lactam antibiotics, probenecid inhibits the excretion of cefaclor.

There are no studies to determine cancer and mutations. Studies on fertility show that there is no evidence of signs of fertility.

The ability to drive and operate machinery

No report.

Pregnancy

Studies on reproductive production in Chi Nhat and rats with 12 times the dose of humans and in ferrets at 3 times the maximum dose for people who do not see signs of reproductive or hazardous fetus caused by Cefaclor. However, strict research works on pregnant women are incomplete. Because studies on animals do not always predict the response of humans, should only use this drug on pregnant women if necessary.

breastfeeding period

Small amount of cefaclor is found in breast milk after taking the drug at a dose of 500mg. The average concentration in milk is 0.18, 0.20, 0.21, 0.16mg/l corresponding to the time 2,3,4, and 5 hours. After 1 hour the concentration in the milk is very small, only in the form of marks. The effects on breastfed babies are not known. Be careful when using Cefaclor in breastfeeding mothers.

Drug interaction

Cefaclor's absorption level decreases when used with antacids containing hydroxide magnesium or aluminum ingredients after an hour; H2 inhibitors, do not change the speed as well as the absorption level of Cefaclor.

As well as other beta lactam antibiotics, Probenecid inhibits the excretion of cefaclor. No other outstanding interactions are recorded through clinical trials.

Patients using Cefaclor may have a false positive for glucose testing in urine. This phenomenon occurs when patients use antibiotics cephalosporin test with Benedict and Fehling solutions, as well as with clinitest tablets.

Storage

Store drugs at room temperature 15 ° - 30 ° C.

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