Meiact 200mg Treatment of tonsillitis, acute pharyngitis, jaw bone sinusitis (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Cefditoren

Ingredient

Composition informationContent
Cefditoren200mg

Uses

indications

The drug is indicated for the treatment of infections caused by sensitive bacteria strains (see the summary of the characteristics):

  • Tonsillitis, acute pharyngitis;
  • About the upper sinusitis;
  • The exacerbation of chronic bronchitis;
  • Pneumonia has a community from mild to medium;
  • Uncount skin and skin structure infections such as cellular inflammation, wound infections, folliculitis, impetigo and boils.
  • Should pay attention to the official instructions on the appropriate use of antibacterial agents.

    Pharmacokology

    Mechanism of action

    cefditoren causes antibacterial effects by inhibiting the synthesis of bacterial cell walls due to affinity with penicillin -mounted proteins.

    The relationship between pharmacokinetics and pharmacokinetics

    With a dose of 200mg twice daily, plasma concentrations exceed the minimum inhibitory concentration (Mic 90) for Moraxella Catatrhalis, Haemophilus Influenzaet Streptococcus paogenes and Streptococcus pneumoniae sensitive to penicillin with at least 50% time between two doses.

    The dose of 400mg twice daily, also provides a period of time on the minimum inhibitory concentration that is enough to exceed the MIC 90 of Streptococcus Pneumoniae resistance to penicillin.

    resistance mechanism

    Bacterial resistance with cefditoren may be due to one or the following mechanisms:

  • hydrolyzed by beta - lactamase. Cefditoren can be resolved by Beta - Lactamase broad spectroscopy (ESBLS) and by chromosomal encoding enzymes (AMPC) that can cause or lose stability in some aerobic Gram -negative bacteria strains.

  • Reduce the affection of penicillin -mounted proteins for cefditor.
  • The waterproof of the external membrane limits the contact of cefditoren with penicillin -mounted protein in Gram -negative bacteria strains.

  • Increase the activity of transportation pumps.
  • More than one of these resistance mechanisms can exist simultaneously in single bacterial cells.

    Depending on the presence mechanism, bacteria may show cross -resistance to many or all beta - lactam and/or antibacterial substances of the same group.

    Gram -negative bacteria contain beta - lactamase encoding chromosomes like Entobacter spp,. Serratia spp,. Citrobacter spp,. and providentia spp,. It is advisable to pay attention to the resistance for Cefditoren Pivoxil, although it may be clearly sensitive on in vitro.

    Disconnect points

    The minimum inhibitory concentration of cefditoren, which allows sensitive strains to distinguish from intermediate sensitive strains, and intermediate sensitive strains compared to resistance strains are: sensitive ≤ 0.5μg/ml, resistance ≥ 2μg/ml (or> 1μg/ml according to recent criteria).

    This parameter is based on the evaluation of bacterial strains isolated from clinical. The common condition of the resistance may vary according to the geographical location and time for the options and local information about resistance, especially when treating serious infections.

    When necessary, it is advisable to find professional advice when the common resistance in the locality is the benefits of the substance used in at least the cases of infection.

    Clinical strains of bacteria are clinically distributed

    Mic (PG/mL)

    Explanation

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

    streptococcus pneumonie*

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

    streptococcus pyogenes*

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

    ≤ 0.5

    ≥ 2

    sensitive

    resistance

  • Gram -positive aerobic bacteria:
  • Enterococcus spp;
  • Staphylococcus aureus resistant to methicillin (MRSA)*.
  • Acinetobacter baurmann;
  • pseudomonas aeruginosa.
  • Bacteroides Fragilis Group;
  • Clostridium difficile.
  • chlamydia spp;
  • Mycoplasma spp;
  • Legionella spp.

    After drinking, Cefditoren Pivoxil is absorbed in the digestive tract and is hydrolyzed into cefditoren by the effect of esterase. The absolute bioavailability of Cefditoren uses oral about 15-20% (report number: 823/7).

    The presence of food in the gastrointestinal tract increases the absorption of Cefditoren Pivoxil, with CMAX and AUC higher than 50% and 70% higher than when hungry (reports: 823/2).

    The dose of 200mg oral at a average CMAX meal is 2.6μg/ml after about 2> 5 hours, while the average dose of 400mg for CMAX is 4.1μg/ml with the same time period (report number: 823/7).

    Distribution

    plasma protein associated with cefditoren is 88% (report number: CEF - 97 - 0i7).

    The distribution volume (V/F) in a stable state is not significantly different from the distribution integral after the single dose and relatively independent of the dose (40 - 65 liters) (Report number: 823/1 and Me101).

    After using a single dose of 400mg, the penetration of the drug into the bronchial mucosa and the secretion of the bronchi are 60% and 20% of the plasma concentration (report number: ME105). After using the same dose, the concentration of cefditoren in the inflated skin fluid is 40% and 56% compared to plasma AUC after 8 and 12 hours, respectively (Report: CEF - 98 - 024).

    Metabolism/excretion

    After using multiple doses, the parameters of pharmacokinetics are similar to that when using the single dose, and there is no accumulation.

    About 18% of Cefditoren dose was detected in the country without metabolic (reports: CEF - 97 - 001 and 823/1, 823/3 and Me 101). The semi -discharged time in the plasma of Cefditoren is about 1 - 1.5 hours. The total clearance is adjusted by bioavailability of about 25 - 30L/hour, while the renal clearance is about 80 - 90ml/min (report number: CEF - 97 - 001 and 823/3).

    Studies with Cefditoren are marked in healthy volunteers showing that non -absorbing parts are excreted in feces, while the majority of Cefditoren used appears in the form of non -active metabolites.

    There is no detection of cefditoren pivoxil in feces or urine (reports: CEF - 97 - 014). The pivalate section is excreted through the kidneys in the form of Pivalolcarnitine (report number: CEF - 99 - 032).

    Special population

  • Sex.
  • The pharmacokinetics of Cefditoren Pivoxil does not see a significant difference between men and women.
  • Elderly.

  • Cefditoren concentration in plasma in the elderly (over 65 years old) shows that CMAX and AUC are 26% and 33% higher than young people. However, it is not necessary to adjust the dose except for liver and/or renal renal energy (report number: CEF - 97 - 016).
  • Renal disabilities.

  • After taking multiple doses of Cefditoren Pivoxil 400mg in patients with average to severe renal impairment, 2 times higher cmax and 2.5 to 3 times higher than AUC than normal volunteers (see the dose and usage). There is no data for the prime patient (report number: CEF - 97 - 017 and Me 106).
  • Liver energy.

    In case of mild liver disability (Child - PUGH A) to medium liver underlying (Child - PUGH B), using multiple doses of Cefditoren Pivoxil 400mg increases slightly pharmacokinetic parameters compared to normal people. There is no data in serious liver disabled patients (Child - Pugh C).

    Before taking Meiact 200mg Treatment of tonsillitis, acute pharyngitis, jaw bone sinusitis (2 blisters x 10 tablets)

    How to use

    should swallow the whole tablet with a sufficient amount of water. Drugs should be taken at meals.

    Dosage

    Dosage used depends on the severity of infection, patient condition and bacterial strain.

    Dosage Meiact 200mg:

    Adults and teenagers (over 12 years old):

  • Acute tonsillitis: 200mg Cefditoren every 12 hours in 10 days.
  • Sinusitis of the upper jaw bone: 200mg Cefditoren every 12 hours in 10 days.
  • Severe exacerbations of chronic bronchitis: 200mg Cefditoren every 12 hours in 5 days.
  • Pneumonia has a community:
  • Mild case: 200mg Cefditoren every 12 hours in 14 days.
  • Average case: 400mg Cefditoren every 12 in 14 days.
  • Skin and uncomplicated skin infections: 200mg Cefditoren every 12 hours in 10 days.
  • Children under 12 years old

  • For children under 12 years old, recommend using Meiact Eine Granules.
  • Elderly people

  • It is not necessary to adjust the dose in the elderly, except for severe liver or kidney failure.
  • In case of kidney disability

  • No need to adjust the dose in patients with mild renal failure. In medium patients with medium renal absence (dialysis of Creatinin 30 - 50ml/minute), the total daily dose does not pass 200mg Cefditoren every 12 hours.
  • In severe patients with severe renal absence (creatinine purification
  • There is no recommendation for dialysis patients (see more vigilance, caution and pharmacokinetic properties).
  • In case of liver disability

  • No need to adjust the dose in mild liver disabled patients (ChiID - PUGH A), average liver disability (Child - Pugh B).
  • In case of severe liver defect (Child - PUGH C), there is no available data to allow the recommended dose setup.
  • 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 using overdose?

    Symptoms of overdose of cephalosporin antibiotics are brain agitation leading to convulsions. In case of overdose, gastrointestinal should be washed.

    should monitor patients carefully, treat symptoms and support treatment. Cefditoren Pivoxil can eliminate each partially through hemorrhage.

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

    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 dose to compensate for missed dose.

    Side Effects

    When using the drug, you may experience unwanted effects (ADR).

    About 6000 patients taking Cefditoren at a dose of 200mg or 400mg twice daily for 14 days in clinical trials. About 24% of patients are reported to have at least one side effect, when stopping treatment, side effects occur in 2.6% in patients.

    Most of the digestive side effects. In most studies, diarrhea occurs more than 10% of patients and usually at a dose of 400mg rather than a dose of 200mg twice daily. The side effects are observed, reported in clinical trials or after being marketed as follows:

    In each group, side effects are shown in the order of severity of severity

    Agency

    Very common side effects (≥ 1/10)

    Common side effects (≥ 1/100,

    Not common side effects (≥ 1/1,000,

    Rare side effects (≥ 1/10,000,

    Unknown (unpredictable from available figures)

    Prolonged blood coagulation time, increase AST, increase alkaline phosphate, albuminuria, reduce thromboplastin time, increase LDH and increase creatinin

    Serum cargo reduction

    cardiovascular disorders

    Eosin leukemia, platelets, hemolytic anemia, lymphadenopathy

    A blood cell loss

    Agreement, dizziness, insomnia, sleep, sleep disorders

    forgotten, coordinated disorders, tone of tone, meningitis, run

    Asthma

    Eosin -loving pneumonia, interstitial pneumonia

    diarrhea

    Nausea, abdominal pain, digestive disorders

    Constipation, flatulence, vomiting, Candida fungus in the mouth, belching, dry mouth, taste disorder

    Oral stomatitis, mouth ulcers, bowelitis, bowel ulcer, gastrointestinal ulcers, gastrointestinal bleeding, tongue, hiccups, tongue to change color

    Acute renal failure

    Acne, hair loss, eczema, dermatitis, peeling, herpes simplex, sensitive reaction to light

    Stevens - Johnson syndrome, diverse erythema, epidermal necrosis

    dehydration, hyperglycemia, hypokalemia, hypoglycemia

    Fungal infections

    Urinary tract infection, clostridium diffcile

    The body smells, chills

    bilirubin blood

    Liver damage, hepatitis

    Breast pain, menstrual disorders, uterine hemorrhage, Disorder Disorders

    Warnings

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

    Contraindicated

    Contraindications in the following cases:

  • Hypersensitivity to the main active ingredient cefditoren, as well as with other cephalosporins or any excipients. For patients with hypersensitivity to casein, it is recommended that this patient contains sodium caseinate.
  • There is a history of severe hypersensitivity reactions or/and average with penicillin or with other beta - lactam types.
  • as well as the producing Pivalate, Cefditoren Pivoxil contraindicated in cases of primary carnitine.
  • Precautions when using

    before conducting treatment with cefditoren, ask the patient carefully to determine if the patient has a history of hypersensitivity to ceditoren cephalosporin, penicilin or other beta - lactam substances.

    Use Cefditoren cautiously in patients with any hypersensitivity reactions to penicillin or any beta - lactam.

    diarrhea when using antibiotics, colonitis, fake colonitis has been reported when using cefditor.

    Note these diagnosis in short -term diarrhea diseases after treatment. Cefditoren should be stopped if diarrhea is seriously diarrhea and/or blood during treatment and appropriate treatment.

    Cefditoren should be used carefully in individuals with a history of gastrointestinal disease, especially colitis.

    Patients with medium to severe renal failure, this ratio will increase when increased use with cefditoren (see pharmacokinetic properties). For this reason, the total daily dose should be reduced when using ceditoren in patients with average to severe, chronic and chronic kidney disabled to avoid clinical consequences such as seizures.

    Cephalosporin antibiotics should be used with caution in patients who use the kidney toxins simultaneously such as Aminoglycosid antibiotics or diuretics (such as Furosemid) because these combinations create unwanted reactions on kidney function and related to toxicity on hearing.

    Extending the use of cefditoren can lead to excessive increase in sensitive strains such as Enterococci and Candida spp.

    While treating with cephalosporin, prothrombin activity may decrease.

    Therefore, prothrombin should be monitored in patients at risk such as kidney or liver disabled patients or patients treated with anticoagulants.

    Using pivalate precursors can lead to reduced carnitine levels in plasma. However, clinical researchers concluded that there was no clinical impact of carnitine reduction but related to the use of cefditoren pivoxil.

    The ability to drive and operate machinery

    Medicines have medium and light -moving effects on the ability to drive and operate machinery. Cefditoren Pivoxil can cause dizziness and drowsiness.

    Pregnancy and nursing mothers

    Pregnant women

    Animal studies do not show direct or indirect harm to pregnancy, pregnancy development, development during reproduction and after birth (see section 5.3).

    There is no enough data for the use of Cefditoren Pivoxil in pregnant women.

    breastfeeding women

    There is no sufficient data on the appearance of cefditoren in breast milk. Therefore, it is not recommended to use Meiact during breastfeeding.

    Drug interaction

    antacids

    Concomitance antacids containing magnesium and aluminum hydroxide and cefditoren pivoxil at the same time with food reduces CMAX and AUC of Cefditoren 14% and 11% respectively.

    Should use antacids and cefditor pivoxil two hours apart.

    H2 antagonistic drugs

    Simultaneous use of intravenous hyotidine and cefditoren pivoxil oral use reduces CMAX and AUC of Cefditoren 27% and 22% respectively. Therefore, it is not advisable to simultaneously use Cefditoren Pivoxil with H2 antagonistic drugs.

    Probenecid

    Simultaneous use of Probenecid with Cefditoren Pivoxil reduces the excretion of Cefditoren, resulting in an increase in 49%CMAX, an increase of 122%AUC and an increase of 53%waste.

    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.

    Interaction with test reactions

  • cephalosporin can cause false positive with the COooms test, which can hinder the cross combination of blood.
  • A false positive reaction to the urine can occur with tests with copper but does not occur with testing with enzymes.

    False negative reactions that occur with Ferricyanid test when determining the sugar in plasma or blood, exchange with both Hexokinase or oxidase glucose methods used to determine blood sugar/plasma concentrations in patients using CEFDITOREN PIVOXIL.

    Storage

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

    To be out of reach of children.

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