Ceclor 125mg Menarini oral powder for infection treatment (60ml)

Dosage form Bottle x 60ml
Specifications Cefaclor
Ingredient Otitis media, urinary tract infections and soft tissues, gonorrhea infections, respiratory infections

Ingredient

Thành phần cho 5ml

Composition information	Content
Cefaclor	125mg

Uses

indications

Ceclor SUS drugs are indicated in the following cases:

otitis media caused by s.pneumoniae, H.influenzae, Staphylococcus, S.Pyogenes, (Streptococcus B Hemolytic Group A) and M.Catatrhalis. S.Pyogenes (Streptococcus B Hemolyte Group A) and M.CatVrhalis. P.Mirabilis, Klebsiella spp, and staphylococcus aureus.

Note: Cefaclor is effective in urinary infections including acute and chronic.

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

Sinusitis.

Should culture and make antibiotics to determine the sensitivity of pathogenic bacteria with Cefaclor.

Pharmacological

In vitro tests show that cephalosporin has a bactericidal effect due to inhibiting cell synthesis. While In Vitro tests have proven the sensitivity of the majority of the following bacteria strains with Cefaclor, clinical effects for strains are not mentioned in the specified section and unknown uses.

Aerobic, gram -positive bacteria

Staphylococcus, including penicillinase enzymes, positive coagulase, negative coagulase (when tested in vitro), shows the cross resistance between cefaclor and methicillin. pyogenes.

Aerobic bacteria, gram sound

citrobacter diversus.

Escherichia coli. CatVrhalis.

Neisseria gonorrhoeae.

Bacteroides spp (except Bacteroides fragilis).

peptococcus niger. Enterococcus (Enterococcus Feacalis [formerly called Streptococcus Feacalis] and Enterococcus Faecium [formerly called Streptococcus Faecium]) resistant to Cefaclor and other cephalosporins. 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.

Dynamic pharmacokinetics

cefaclor is absorbed very well when drinking 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, the peak concentration is only 50% - 75% compared to the peak concentration when the patient is fasting and achieves more slowly about 45 -60 minutes.

After taking oral doses of 250 mg, 500 mg, 1 g, in hunger, the average peak concentration in serum is 7, 13, and 23 mg/l, achieved after 30-60 minutes. About 65 - 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, 1 g achieved of 600, 900, and 1,900 mg/l. The average half -life in normal serum 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 (60ml)

How to use

cefaclor is used by oral.

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

To treat acute urethritis due to gonorrhea in men and women: use a single dose of 3 g, combined with 1 g of problemecid.

Children

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

For bronchitis and pneumonia: take a 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.

dose of 20 mg/kg/day (Note: teaspoon (mcf)).

Weight 9 kg: Type 125 mg/5 ml: 1/2 mcf, 3 times/day.

Weight of 18 kg:

Type 125 mg/5 ml: 1 mcf, 3 times/day; 2 mcf, 3 times/day.

type 250 mg/5 ml: 1/2 mcf, 3 times/day.

Weight 9 kg:

Type 125 mg/5 ml: 1 mcf, 2 times/day.

Type 250 mg/5 ml: 2 mcf, 2 times/day.

Treatment of otitis media and sore throat: Total daily dose can be divided into 2 times, 12 hours/time.

Cefaclor may be used for patients with renal failure, in this case, do not 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 below 10 ml/min, use 25% of the common doses.

In the treatment of infections caused by streptococcus B hemolytic, 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.

How to treat

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 5 times the dose of normal, no need to apply gastrointestinal measures.

Protects the patient's respiratory tract, supports ventilation and infusion. Careful monitoring and maintenance of the patient's survival signs, blood gas, electrolytes in serum. 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 wash. 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.

Need to protect the respiratory tract of patients when applying stomach lavage or activated carbon. Other measures such as strong diuretics, peritoneal fertilizer, dialysis, hemolytic jurgle with activated carbon, have not been determined to be effective in the treatment of Cefaclor overdose.

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

When using Ceclor Sus, you may experience unwanted effects (ADR).

Hypersensitivity reactions have been reported in about 1.5% of patients, in the form of measles rash (1/100 cases). Itching, urticaria, positive Coombs reaction occurs at a lower rate of less than 1/200 cases for each type. Cases of serum -like reactions have been reported in some cases of using Cefaclor. The characteristics of this reaction include diverse roses, rash and other skin manifestations that come with arthritis (joint pain, fever or no fever.

These reactions are different from classical serum disease in that it is rarely accompanied by lymph nodes and proteinuria, no immune complex in the blood, and leaving no sequelae. Sometimes there may be individual symptoms, but it is not a manifestation of a serum like a reaction. While additional studies are being conducted, serum -like reactions seem to be due to hypersensitivity reactions, and often occur more during and after the second Cefaclor treatment (or later).

These reactions are commonly reported in children than adults, with the ratio from 1/200 (0.5%) in a centralized test to 2/8,346 (0.024%) in all clinical trials (the ratio in children in clinical trials is 0.055%) to 1/38,000 (0.003%) in random reports.

Signs and symptoms usually occur a few days after the beginning of treatment and decrease in a few days after stopping the drug. There are also cases where patients have to be hospitalized because of these reactions but the hospital stay is usually short (average from 2 to 3 days, according to the report of the monitoring studies after bringing the drug to the market). In patients who need to be hospitalized, symptoms may from mild to severe, most of the severe symptoms occur in children. Antihistamine and Glucocorticoid drugs help reduce these signs and symptoms. There is no report on serious sequelae.

Hypersensitivity reactions, including Stevens - Johnson syndrome, poisoned epidermal necrosis and anaphylactic reaction, rarely occur. Symptoms like anaphylaxis can be manifested by individual reactions including angels, fatigue, edema (facial edema and limb), shortness of breath, abnormalities, fainting, or vasodilation. Anaphylaxis may occur more commonly in patients with a history of penicillin allergies. Hypersensitivity reactions may last for several months but very rare.

Gastrointestinal symptoms occur in about 2.5% of patients, usually diarrhea (1/70 cases). Palmic colitis may appear both during and after the treatment with antibiotics. Nausea and vomiting rarely occur.

Like some other penicillin and cephalosporin, mild hepatitis and jaundice are also reported very little.

Other effects are considered to be related to antibiotic therapy, including Eosine white blood cells (1/50 patients), genitals, vaginitis, rarely thrombocytopenia and interstitial nephritis have recovered.

Other non -drug -related effects, including:

Central nervous system: Increasing dynamic recovery, anxiety, stress, insomnia, confusion, increasing muscle tone, dizziness, hallucinations, sleeping chicken, having a report but very little.

Temporary abnormalities on clinical tests have also been reported even though the cause has not been clearly defined, they are also stated as the information for the doctor to refer:

Liver: AST (SGOT), ALT (SGPT) or alkaline phosphatase (1/40) hematoma - Like other lactam antibiotics, increased blood cells, temporary leuk cells, and rarer than hemolytic anemia, proliferate anemia, granulocytes, neutrophils can be recovered with clinical recovery. Prothrombin with or without clinical bleeding in patients with simultaneous use of cefaclor and cooumadin.

Some cephalosporin can cause epilepsy, especially in patients with renal impairment when not reduced dose. If the epilepsy appears due to the use of drugs, the drug should be discontinued. Anti -convulsions can be treated if clinical indications.

Instructions on how to handle ADR

Can reduce the side effects of the drug by reducing the dose.

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 drug contraindicated in the following cases:

Do not use drugs for patients with a history of hypersensitivity to antibiotics belonging to cefalosporin group. If CEFACLOR must be used for patients sensitive to penicillin, be careful because there is a cross -allergic reaction that includes anaphylaxis between beta lactam antibiotics. When necessary, patients must be treated with appropriate drugs: vasoconstrictor amines, antihistamine or corticosteroids. Palmic colitis has been reported to most broad -spectrum antibiotics (including macrolids, semi -synthetic penicillin, and cephalosporins). Therefore, the consideration of diagnosing patients with diarrhea when using antibiotics is very important. This colitis can be from mild to severe threatening the patient's life. Lightweight can only be stopped. The average to heavy to need appropriate treatments.

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 hematological studies or in cross -reaction tests when needing blood transfusion uses antiglobulin in secondary positions, or applying Coombs test on infants whose mothers use cephalosporin antibiotics before birth.

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.

The impact of the drug on subclinical tests: Patients with Cefaclor may have false positive for urine glucose tests when tested with Benedict and Fehling solutions, clinitest tablets, but there will be no false positive when using TestaE. (Glucose enzymatic test strip, USP).

There are several reports that show an increase in anticoagulant effect when using Cefaclor and oral anticoagulant.

As well as other Lactam antibiotics, probenecid inhibits the excretion of cefaclor.

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

The ability to drive and operate machinery

The drug hardly affects the ability to drive and operate machinery. However, there are also a few reports on the risk of dizziness, so the doctor may depend on the specific case that is recommended or not recommended for patients to use drugs when driving and operating machinery.

Pregnancy

Studies on reproductive production in mice and rats with 12 times the dose of humans and ferrets in dew 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.

labor and childbirth: The influence of cefaclor on labor and birth has not been known.

Breastfeeding period

Small amount of Cefaclor is found in breast milk after taking the drug at a dose of 500 mg. The average concentration in milk is 0.18, 0.20, 0.21, 0.16 mg/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 is reduced when used in common with antacids containing hydroxide magnesium - or aluminum after an hour; The inhibitor H, does not change the speed and absorption level of Cefaclor. Like other Lactam B 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.

After mixing into a mixture (in use): 14 days (stored at 29-8 ° C).

Do not use the drug when expired printing on the label.

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