Meiact 50mg Meiji oral epidemic treatment for otitis media, sinusitis, tonsillitis (21 packs)

Dosage form Box of 21 packs
Specifications Cefditoren

Ingredient

Composition information	Content
Cefditoren	50mg

Uses

Indications

Meiact Fine Granules is indicated for the treatment of the following infections in children causing sensitive bacteria:

otitis media .

Sinusitis .

Acute tonsillitis in children over 6 months of age (including inflammation around tonsils and abscesses around the tonsils).

Pharmacy

antibacterial activity

During the absorption process in the intestinal wall of Cefditoren Pivoxil converted into cefditoren is an antibacterial substance.

Cefditoren has wide antibacterial antibacterial spectrum including gram -positive and gram -negative bacteria. Especially, the drug has a strong antibacterial effect on Gram -positive bacteria such as Sfaphylococcus sp. Influenzae and anaerobic bacteria such as peptostreptococcus sp., propionibacterium acnes, bacteroides sp. and Prevotella Sp. Cefditor also has antibacterial effects on Haemophilus influenzae ampicillin resistant to ß - lactamase (Blnar).

Vitro's trial shows that CEFDitoren is durable with ß - lactamase produced by different bacteria and has a strong antibacterial effect on the ß - lactamase strains.

Mechanism of action

cefditoren inhibits the synthesis of bacterial cell walls. The drug has high affinity with proteins capable of connecting penicillin in different bacteria (Pbps) so it has bactericidal effects.

Effective treatment of experimental infections

Cefditoren Pivoxil is effective for experimental infections in mice caused by Staphylococcus aureus, Streptococcus Pneumoniae, Escherichia Coli, Klebsiella Pneumoniae and Proteus SP.

pharmacokinetic pharmacokinetics

absorption and distribution

blood concentration in blood:

Cefditoren's serum concentration with a single dose of 3 mg/kg or 6 mg/kg after meals in children with normal kidney function ranges from 1.45 - 2.8 µg/ml. There is a dependence on the dose.

The drug distributed into phlegm, tissue tissue, mucous membrane of the upper jaw sinus, skin tissue, wounds after teeth, etc.

Protein cohesion:

The ratio of cohesion with serum protein is determined by the super filter method of 91.5% with a concentration of 25 µg/ml (in vitro).

In the process of absorption of Cefditoren Pivoxil, converted and converted into cefditoren with antibacterial and pivalic acid activity.

Pivalic acid forms a form of carnitin and is excreted in the urine in the form of PivaloL carnitin. Cefditoren is not metabolized and excreted mainly through urine and bile. Cefditoren's urine excretion (0 - 8 hours) with a dose of 3 and 6 mg/kg after meals in children with normal kidney function is 20% and 17% respectively.

Serum and urine concentration (reference of Meiact 100 tablet data with patients with kidney dysfunction):

Dosage of 200 mg after meals with patients with kidney or dialysis dysfunction shows that the drug concentration is high in all cases, T1/2 varies depending on the degree of kidney dysfunction.

The rate of drug excretion through urine decreases with the degree of kidney dysfunction.

Some of the guidelines for the dose proposal are as follows:

CCR ≥ 50: Normal dose.

Before taking Meiact 50mg Meiji oral epidemic treatment for otitis media, sinusitis, tonsillitis (21 packs)

How to use

Meiact Fine Granules taken orally, taken after meals.

Mix the drug in the package corresponding to a dose of Meiact Fine Granules with a small amount of water. Use the drug chaos immediately after mixing.

Dosage

Children

For children, the usual oral dosage of Cefditoren Pivoxil is 3 mg (activity)/kg, 3 times daily, after meals. The dose can be increased to 6 mg (activity)/kg if necessary but not more than 600 mg (activity) per day.

The dose can be adjusted on the patient's weight and the severity of the disease.

Weight

The dose of 3 mg/kg

About 6 mg/kg 2 Package

11 kg 50 mg (Active)/0.5 g x 1 pack 30 mg (Active)/0.3 g x 2 pack

12 kg 50 mg (Active)/0.5 g x 1 pack

13 kg 50 mg (Active)/0.5 g x 1 pack 30 mg (Active)/0.3 g x 1 pack and 50 mg (Active)/0.5 g x 1 pack

14 kg

50 mg (Active) g x 1 pack and 50 mg (activated)/0.5 g x 1 pack

15 kg 50 mg (Active)/0.5 g x 1 pack 30 mg (Active)/0.3 g x 3 pack

16 kg

Mg (Active)/0.3 g x 3 packs Calculate)/0.5 g x 2 packs Package 30 mg (Active)/0.3 g x4 Package mg (activated)/0.3 g x 1 pack and
50 mg (activity)/0.5 g x 1 pack 30 mg (Active)/0.3 g x 1 pack and
50 mg (Activated)/0.5 g x 2 pack Package 30 mg (activated)/0.3 g x 1 pack and
50 mg (activity)/0.5 g x 2 pack 24 kg 30 mg (Active)/0.3 g x 1 pack and
50 mg (activated)/0.5 g x 1 pack (Active)/0.5 g x 1 pack 1 pack and
50 mg (Active)/0.5 g x 1 pack 50 mg (Active)/0.5 g x 3 Package

28 kg 30 mg (Active)/0.3 g x 3 pack 30 mg (Active)/0.3 g x 2 packs and
50 mg (Active)/0.5 g x 2 packs Calculate)/0.3 g x 4 packs and
50 mg (Active)/0.5 g x 1 pack

Package 30 mg (activated)/0.3 g x 6 packs

32 kg 50 mg (Active)/0.5 g x 2 packs 30 mg (Active)/0.3 g x 3 packs and
50 mg (activated)/0.5 g x 2 pack Mg (activated)/0.5 g x 2 pack 30 mg (Active)/0.3 g x 3 packs and
50 mg (Active)/0.5 g x 2 packs G x 4 Package 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

is a common symptom for cephem antibiotics: vomiting, nausea, epigastric pain, black tongue, loose stool, diarrhea.

Serious fake colitis may occur in some cases.

Common symptoms include riot diarrhea accompanied by fever, abdominal pain, leukemia, stools mixed with mucus and blood, granulocytes, eosinophilia, hemolytic anemia, leukopenia, jaundice, SGOT/SGPT/ALP, rash, jute, itching, tendency to bleed, renal disorders.

There may be consciousness disorders, epilepsy, increased reflexes, hemolytic anemia, leukemia, thrombocytopenia, especially for patients with heart failure or kidney failure to overdose these drugs.

Treatment

Cephem antibiotics are very safe and selective drugs. Therefore, only measures 2) and 3) The following is necessary unless the overdose has a particularly large level:

gastric lavage (applied when exclusive overdose, within 2 hours after taking the drug). Add vitamin B vitamins and vitamin K.
Symptomatic treatment:

seizure: Diazepam or Phenobarbital injection.

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

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 Meiact Fine Granules , you may experience unwanted effects (ADR).

The ratio of adverse reactions as follows:

The adverse reaction occurs in 19 (4.17%) out of 456 monitoring patients. (1/222) and ALT (GPT) increased by 0.90% (2/222), and hematological changes such as eosinocytes like EOSIN 1.97% (5/254).

The adverse reaction appears in 136 patients (2.34%) with 146 description types. The common adverse reaction is digestive disorders (diarrhea, loose stool, etc.) in 121 patients (2.08%) and extra and skin disorders (rash, urticaria) in 10 patients (0.17%).

According to the results of clinical research using drugs for pediatric patients pneumonia , otitis media and sinusitis with a dose of 6 mg (activity)/kg 3 times daily, adverse reactions occur at 36 (31.3%) out of 115 patients assessed for safety.

The main adverse reaction is diarrhea, loose stool in 28 (24.3%) of patients. The abnormal test values observed in 7 (6.2%) out of 113 patients who have performed tests and are worth the safety, including platelets.

Clinical significant adverse reactions:

Shocking or anaphylactic reaction (

Severe colitis with bloody external external inflammation like fake colitis (0.1%). Monitor patients closely, stop taking drugs and timely intervention if abdominal pain or diarrhea many times.

Stevens - Johnson syndrome or Lyell syndrome (

interstitial pneumonia, PIE syndrome (

Liver dysfunction (

Severe renal dysfunction such as acute renal failure (

Autrax (

Extended antibiotic use with a pivoxil group that reduces blood glucose accompanied by a decrease in blood carnitin (unknown ratio) in children. Stop taking the drug and have timely intervention if there are symptoms of blood sugar reduction such as convulsions or conscious disorders.

Other adverse reactions:

5%> ADR> 0.1%

Hypersensitivity (1): rash.

Hematology (2): Eosin hypernagus.

liver (3): AST (GOT) increases, ALT (GPT) increases.

digestive: diarrhea, nausea, abdominal discomfort, abdominal pain.

ADR

Too hypersensitivity (note 1): urticaria, erythema, itching, fever, swollen lymphadenopathy, lymphatic, joint pain.

Hematology (Note 2): Granulocytian blood reduction, platelet reduction

Liver (note 3): AI - P, jaundice. Kidney: Bun increases, plasma creatinine increases, proteinuria.

digestive: Feeling of stomach, nausea, vomiting.

Then microbiology: stomatitis, fungus candidia .

Vitamin deficiency: Symptoms of vitamin K deficiency (decreased blood prothrombin, risk of bleeding, etc.), lack of vitamin B mixture (tongue, stomatitis, anorexia, neuritis, etc.).

Other: headache, dizziness, edema, paralysis.

(Note 1): Stop taking medicine and timely intervention if symptoms appear.

(Note 2): Monitor patients closely. There is timely intervention if there are abnormal signs such as stopping the drug.

(Note 3): Monitoring by periodic testing.

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

Meiact Fine Granules contraindicated in the following cases:

Meiact Fine Granules Contraindicated for patients with a history of hypersensitivity to any component of the drug.

Relatively contraindications: According to the general principle, Meiact Fine Granules is contraindicated for patients who are sensitive to one of the ingredients of the drug or with other antibiotics of the Cephem group, in case the use is necessary, it can be used carefully.

cefditoren pivoxil is contraindicated in cases of primary carnitin or congenital metabolic disorders leading to clinical cartinin deficiency.

Warning

The general principle is to minimize the use of drugs in treatment based on the patient's condition, after identifying drugs that are sensitive to drugs to prevent the appearance of anti -drug bacteria strains.

In the case of patients with severe renal failure, it should be extended between the drug's taken.

Precautions when using

Hypersensitivity reaction to penicillin antibiotics.

yourself or family with a history of allergies such as bronchial asthma, rash, or urticaria.

Severe kidney dysfunction.

Poor food absorption or being nourished in the gastrointestinal tract, elderly or weak health (need to be closely monitored because of the symptoms of vitamin K deficiency).

The drug contains aspartam. Aspartam is completely hydrolyzed in the gastrointestinal tract when taken. The main hydrolysis product includes phenylalanin. Therefore the drug can be harmful to patients with phenylketo urinary disease (phenylalanin metabolic disorders).

This drug contains sucrose. Therefore, drugs should be used in patients with rare genetic problems such as fructose intolerance, glucose - galactose or deficiency - Isomaltase.

particularly cautious

may be shocked, need to monitor closely.

Using antibiotics with Pivoxil group (including this drug, Cefcapen Pivoxil Hydrochloride Hydrate, Cefteram Pivoxil and Tebipenem Pivoxil) reduce carnitin levels in plasma due to the metabolism/secretion of pivalic acid (metabolites of antibiotics with pivoxil groups).The use of antibiotics with pivoxil groups may cause hypoglycemia and hypoglycin carnitine in children (especially, in infants and young children). Therefore, when using antibiotics with Pivoxil group, patients must be closely monitored, paying special attention to carnitin reduction.

When using this drug for children under 3 years old at a dose of 6 mg (activity)/kg 3 times daily, diarrhea, loose stools occur with high frequency. If these symptoms appear, appropriate symptomatic treatment should be taken.

Precautions for storage

Store pills to avoid light and moisture. Only open the package right before use.

Using drugs in the elderly

The rate of gums in the elderly is no different from adults. However, in the elderly, there is often a decline in the physiological function, so it is necessary to closely monitor when using the drug based on the following two points, adjust the dose and the distance between the drug use.

Slow elimination in patients with renal failure. Therefore, the concentration of drugs in the blood may increase.

The risk of bleeding due to vitamin K deficiency in the elderly when taking similar drugs.

The ability to drive and operate machinery

because the drug can cause side effects such as headache, dizziness, so it can affect the ability to drive or operate machinery. Therefore, do not drive or operate machinery when you feel unwell.

Pregnancy and nursing mothers

only use this drug for pregnant women or intend to get pregnant when the benefits of using drugs greater than the risk may occur during treatment. The safety of the drug for pregnant women has not been announced. In addition, decreased blood carnitin in women using antibiotics containing pivoxil groups in the last three months of pregnancy has been reported, as well as in newborns of these mothers.

used for children

The safety of the drug for infants who are underweight and underweight children have not been announced.

When using this drug for children under 3 years old at a dose of 6 mg (activity)/kg 3 times daily, diarrhea/loose stool can occur with high frequency, need to be cautious.

Drug interaction

antacids.

Simultaneous use of antacids containing magnesium and aluminum hydroxide and cefditoren pivoxil at the same time with food reduces CMAX and AUC of Cefditoren. Although there is no clinical evidence, it is not advisable to use cefditoren and antacid.

H2 antagonistic drugs

Simultaneous use of intravenously and cefditor pivoxil is used to reduce CMAX and AUC of Cefditoren. Although there is no clinical evidence, Cefditoren Pivoxil should not be used simultaneously with H2 antagonistic drugs.

Probenecid

As other antibiotics j - lactam, copper using probenecid with cefditoren pivoxil can increase the level of cefditoren in plasma, increase CMAX, AUC levels and increase the semi -waste time.

birth control pills

Using Cefditoren Pivoxil does not change the pharmacokinetic properties of Ethinyl Estradiol contraceptive pills. Cefditoren Pivoxil can be used simultaneously with Ethinyl estradiol contraceptive pills.

Interaction with test reactions

cephalosporin can be false positive for the COooms test, which can hinder the cross combination of blood.

A false positive reaction to the urine can occur with copper tests but does not occur with enzyme tests.

The false negative reaction can occur with the ferricyanid test when determining sugar in plasma or blood, for both Hexokinase or oxidase glucose methods used to determine blood sugar/plasma concentrations in patients using CEFDITOREN PIVOXIL.

Storage

Temperature below 30 ° C

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