MECEFIX-B.E 150mg Merap Treatment of urinary tract infections, otitis media (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Cefixim

Ingredient

Composition information	Content
Cefixim	150mg

Uses

indications

MECEFIX - B.E 150 mg are indicated for treatment of infections caused by sensitive bacteria in adults and children aged 6 months and older include:

Uncontrolled urinary tract infections caused by Escherichia Coli and Proteus Mirabills.

otitis media caused by Haemophilus Influenzae, Moraxella CatVrhalis and Streptococcus pyogenes (treatment effects on otitis media caused by streptococcus pyogenes are studied less than 10 cases).

Sore throat and tonsillitis caused by Streptococcus Pyogenes (Note: Penicillin is a drug often chosen in the treatment of infections caused by Streptococcus pyogenes. Cefixime is often effective in eliminating streptococcus pyogenes in the palate; joint).

The play of chronic bronchitis caused by Streptococcus Pneumoniae and Haemophilus Influenzae.

Invalid gonorrhea (cervical/urethra) caused by neisseria gonorrhoeae (penicillinase seminarians and non -birth penicillinase).

Pharmacokology

Mechanism of action

Like other cephalosporins, the bactericidal effect of cefixime is due to inhibition of cell wall synthesis. Cefixime stabilizes high in the presence of many beta-lactamase enzymes. Therefore, many penicillin-resistant bacteria and some cephalosporin thanks to the presence of beta-lactamase may be sensitive to cefixime.

Drug resistance

Cefixime resistance of Haemophilus Influenzae and Neisseria Gonorrhoeae is often associated with changes in proteins associated with penicillin (PBPS). Cefixime may have a limited activity for the Beta-Lactamase spectrum bacteria (ESBLS). Pseudomonas, Enterococcus, strains of group D, Listeria monocytogenes, most staphical strains (including methicillin strains), bacteroides fragilis strains, and most strains of Enentobacter, Clostridium are resistant to cefixime.

antibacterial spectrum

cefixime has been indicated that there is activity for most strains of the following bacteria on both in vitro and clinical infections.

Gram -positive bacteria: Streptococcus pneumonia, Streptococcus pyogenes. Mirabilis. However, the effectiveness of Cefixime in the treatment of clinical infections caused by these bacteria has not been set up by adequate and well -controlled clinical trials.

Gram -positive bacteria: Streptococcus agalactiae. Vulgaris, Serratia Marcescens, Providencia, Salmonella, Shigella.

400 mg capsules and 400 mg of Cefixime tablets are equivalent to biological when taking the drug in hunger. Peak concentration in plasma reaches 2 PG/ml (1 - 4 PG/ml) and reaches 3.7 PG/ml (1.3 - 7.7 PG/m) after taking a single dose of 200 and 400 mg tablets about 2 - 6 hours. When taking medicine in full state, food reduces the absorption, manifests itself through a 15% reduction in the area under the curve and 25% of the peak concentration in the plasma of the drug.

distribution

About 65% Cefixime in the blood is attached to plasma proteins and this cohesion does not depend on concentration.

metabolism and elimination

About 50% of the absorption dose of the drug is eliminated in urine in the form of constant for 24 hours. In animal studies, over 10% of Cefixime dose is also eliminated through the bile. Cefixime's exhaust time in healthy people does not depend on the form of preparation and the average is from 3 to 4 hours, but can be up to 9 hours in some ordinary volunteers.

Special subjects

Elderly

The area under the average curve at a stable state in elderly patients is about 40% higher than adults. The pharmacokinetic parameters between 12 young subjects and 12 elderly subjects have the same dose of Cefixime 400 mg/day for 5 days with statistical differences. However, this difference is not significant clinically.

kidney failure

In patients with medium impaired renal function (Creatinin clearance 20 - 40 ml/minute), the average selling time of cefìxime lasts up to 6.4 hours. When the renal failure is severe (creatinine clearance 5 - 20 ml/minute), the average selling time increases to 11.5 hours. Hematomopiaiasis and peritoneal fertilizer are not eliminated a significant amount of drugs from the blood. However, a study showed that at a dose of 400 mg, pharmacokinetics parameters in patients were ruling as much as in people with creatinine clearance from 21 to 60 ml/min.

Before taking MECEFIX-B.E 150mg Merap Treatment of urinary tract infections, otitis media (2 blisters x 10 tablets)

How to use

oral medication.

Dosage

Adults

Cefixime's recommended dose is 400 mg/day, using a single dose or divided into 2 times, 12 hours apart.

In the treatment of cervical/urethra, uncomplicated urethra, a single dose of 400 mg is recommended. The drug can be taken regardless of the time of the meal.

In the treatment of streptococcus pyogenes infections, the treatment time with Cefixime is at least 10 days.

Children

Children from 6 months of age: recommended doses are 8 mg/kg/day, use a single dose or divided into 2 times, 4 mg/kg every 12 hours.

Dosage recommended in children can be determined with each weight according to Table 1 below.

Table 1. Cefixime's recommended dose on children's objects according to weight

The weight of children (kg) Dosage/day (mg)

5 - 7.5*

12.5 100 40 300 ml.

Dosage for children from over 45 kg or over 12 years of age is recommended in adults.

Treatment of otitis media should use the form of phlegm. Clinical trials on the treatment of otitis media show that pharmaceutical concentration in the blood when using the mixture is higher than when using the tablet form on the same dose.

Patients with renal failure

For patients with creatinine clearance of 60 ml/min, no dose adjustment. For patients with renal impairment, the dose adjustment should be adjusted according to Table 2. Hematoma and peritoneal jurisdiction do not remove a significant amount of drugs from the blood.

Table 2. Dosage on patients with kidney failure

Creatinine clearance (ml/minute) Dosage/day (mg)

from over 60 The usual dosage Or constant peritoneal fertilizer 172

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?

Symptoms of overdose

When cefixime overdose may have symptoms of convulsions. Unwanted effects on a small number of healthy volunteers when taking only 2 g cefixime dose are no different from patients treated at the recommended dose.

Overdose

Because there is no specific treatment, it is mainly symptomatic treatment. Stop the medication immediately and handle as follows: Gastric lavage, anti -convulsions may be used if clinical indications. Because Cefixime is not removed from the circulating a significant amount of hemorrhage or peritoneal fertilizer, it does not take these measures.

What to do when you forget 1 dose? However, if it is almost the next dose, skip the forgotten dose. Do not use double dose to compensate for the forgotten dose.

Side Effects

When using MECEFIX - B.E 150 mg, you may experience unwanted effects (ADR).

Information from clinical trials

Common, ADR> 1/100

Digestive system: diarrhea, loose or regular stools, abdominal pain, nausea, indigestion, bloating .

Information from circulation

The rate of encounter: ADR

Digestive system: abdominal pain, indigestion, flatulence, diarrhea, nausea and vomiting.

The immune system, skin and subcutaneous tissue: Anaphylaxis reactions (including shock and death), skin rash, urticaria, drugs caused by drugs, itching, genitals, vaginitis , joint pain, angio, face edema. Diversified persimmons, Stevens-Johnson syndrome, poisoned epidermal necrosis (Lyell syndrome) and serum resembling reactions were reported. liver: hepatitis, jaundice.

Infections and parasites: Some cases of fake colitis have been detected in clinical trials. The onset symptoms of fake colitis may appear during or after treatment. Candida fungus. kidney: Acute renal failure including interstitial renal tubular inflammation is the basic condition.

Central nervous system: headache, dizziness, convulsions.

Respiratory, chest and mediastinum: Difficulty breathing.

Blood and lymphatic system: A decrease in platelets, leukopenia, neutropenia, prolonging prothrombin, hyperglycemia, reduced hemorrhage, granulocytopenia, and hyperpses, platelets, hemolytic anemia.

Extraordinary test: Hyperburin hyperkemis, temporary increase in blood urea or creatinine, temporary increase SGPT, SGOT and alkaline phosphatase.

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

MECEFIX - B.E 150 mg Contraindications in the following cases:

Used for patients with hypersensitivity to any component of the drug and patients allergies to any other beta-lactam antibiotic.

Be cautious when using

Children

Safety and effectiveness of Cefixime over 6 months of age has not been set up.

The rate of unwanted effects on digestive, including diarrhea and loose stools, in children using the same mixture as the ratio in adults using tablets.

Elderly

Clinical experience is not determined to have a difference between elderly patients and young patients, which are not necessary to adjust the dose in the elderly.

kidney failure

Cefixime dose must be adjusted in patients with renal failure, as well as continuous peritoneals and hemorrhage. Patients during hemolysis should be monitored and need kidneys when using cefixime.

Hypersensitivity reaction

Anaphylactic reactions (including shock and death) have been reported when using Cefixime.

Before starting treatment with cefixime, it is necessary to determine if the patient has a history of hypersensitivity to cephalosporin, penicillin or other drugs. If this drug is used for patients sensitive to penicillin, be cautious because of the diagonal hypersensitivity between beta-lactam antibiotics has been recorded and may occur over 10% of patients with a history of penicillin allergies. If the allergic reaction occurs with Cefixime, stop the drug.

diarrhea caused by Clostridium difficile

diarrhea caused by Clostridium Difficile (CDAD) has been reported to most antibiotics, including Cefixime, with severity from mild diarrhea to death colitis. The treatment with antibiotics changes the normal bacterial system in the colon, leading to the overgrowth of C. Difficile.

C. Difficile toxin A and B, contributing to CDAD development. C. Difficile's high toxin strains increase disease and death because these strains may be resistant to antibiotics and may need surgery to remove the colon. CDAD must be considered in all patients with diarrhea after using antibiotics. Careful evaluation is necessary because CDAD has been reported after more than two months of using antibiotics.

If suspected or confirming CDAD, stop using antibiotics does not work directly with C. Difficile. Water and electrolyte compensation, protein supplementation, antibiotic treatment work with C. Difficile, and surgical evaluation should be conducted in accordance with clinical indications.

affect blood clotting

Cephalosporin, including cefixime, can reduce prothrombin activity. The risk group includes patients with liver or renal failure, poor nutritional condition, patients using prolonged antibiotics, and the previous patient has stabilized anti -coagulation therapy. Prothrombin time must be monitored in patients at risk and use vitamin K as prescribed.

Development of anti -drug bacteria

Cefixime prescription when there is no clear suspicion or bacterial infection that has been shown to bring benefits to patients and increase the risk of developing anti -drug bacteria.

Be cautious of the excipients used

Lactose -containing drugs: Be cautious when used in people who do not tolerate some sugar. Patients with rare genetic problems such as galactose intolerance, lactase lactase deficiency or malposive glucose-galactose should not use this drug.

The ability to drive and operate machinery

There is no report showing that Cefixime has the ability to drive and operate machinery. However, unwanted effects have been reported by Cefixime such as headaches, dizziness can affect the ability to drive and operate machinery.

Pregnancy

There are no good and complete studies in pregnant women. Only use this drug during pregnancy when really necessary.

Breastfeeding period

Do not know if Cefixime is excreted through breast milk or not, need to consider temporarily stop breastfeeding when treated with this medicine.

Drug interaction

carbamazepine

Increased carbamazepine concentration when used simultaneously with Cefixime has been reported. Quantifying drugs can support detection of carbamazepine changes in plasma.

warfarin and anticoagulants

Increase prothrombin time, with or without bleeding, which has been reported when used simultaneously with cefixime.

Testing

A false positive reaction to the ureter may occur during a nitroprussid test, but does not occur when using nitroferricyanid.

The use of cefixime can lead to a false positive reaction with glucose in urine when using clinitest® **, benedict or fehling solution. Glucose tests are based on the glucose oxidase enzyme reaction (such as Clinistix® ** or Testape® **) recommended to be used. False positive coombs test has been reported when treated with other cephalosporins. Therefore, it is necessary to recognize the positive Coombs test may be due to the drug.

(**) Clinitest® and Clinistix® are brands registered by Ames Division, Miles Laboratories Inc.; TestAme® is a brand registered by Eli Lilly and Company.

Storage

Store in closed packaging, dry place, below 30 ° C, avoid direct light.

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