Cubabute 200mg Hataphar medicine for treatment of mild to medium infections, bronchitis (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Ceftibuten
Ingredient Ha Tay Pharmaceutical Joint Stock Company - Vietnam

Ingredient

Composition information	Content
Ceftibuten	200mg

Uses

indications

CubeTo drugs are indicated in the following cases:

The drug is indicated to treat mild to medium infections due to sensitive bacteria strains such as:

The acute phase of chronic bronchitis caused by Haemophilus Influenzae (including B -Lactamase seminarians), Moraxella Catatrhalis (including seminarians - lactamase) or Streptococcus pneumoniae (indicated strains sensitive to penicillin).

Chronic in clinical trials, where Moraxella Catrhalis is isolated from infected phlegm at the beginning, CEFTIBUTEN's clinical effect is 22% lower than the level of control.

Acute otitis media caused by bacteria caused by Haemophilus influenzae (including B-Lactamase seminarians), Moraxella CatVrhalis (including B-Lactamase strains) or Streptococcus Pyogenes. The middle of acute in clinical/ microbiological, effective anti -Streptococcus pneumoniae decreased by 23% compared to the level of control. Therefore, Cevtibuten should only be experimented when there is sufficient evidence of the anti -Streptococcus pneumoniae effect of Cevtibuten.

Sore throat and tonsillitis due to streptococcus pyogenes. CEFTIBUTEN is often effective in killing streptococcus pyogenes from the pharyngeal area, but there is no data on the effectiveness of CEFTIBUTEN in the prevention of acute rheumatism.

Pharmacokinetics

ATC code: J01DD14.

ceftibuten is an antibiotic of semi -synthetic cephalosporin groups, third generation, orally. The bactericidal effect of Ceftibuten is due to inhibition of bacterial cell walls by attaching to the target protein. CEFTIBUTEN is sustainable with penicillinase and cephalosporinase. Many Beta-lactamase bacteria are resistant to penicillin, which may be sensitive to ceftibuten.

CEFTIBUTEN has been shown in vitro and clinically acting on most of the following bacteria strains:

Gram-positive aerobic bacteria: Streptococcus pneumoniae (except for penicillin resistance lines), Streptococcus pyogenes. Klebsiella sp., Salmonella sp., Shigella sp. Pneumoniae and Pyogenes).

CEFTIBUTEN has a weak printing effect on anaerobic bacteria, including the majority of Bacteroides.

Anti -drug information:

CEFTIBUTEN is sustainable with most beta-lactamase through plasmid intermediaries but is not sustainable with cephalosporinase through chromosomes in bacteria such as Bacteroides, Citrobacter, Entobacter, Morganella and Serratia. Like other beta-lactam, CEFTIBUTEN should not be used for beta-lactam resistance strains with conventional mechanisms such as changes in penicillin-mounted protein changes like S. Pneumoniae resistant penicillin.

The index of the characteristics of the physical and pharmacokinetics (PK/PD):

CEFTIBUTEN is an antibiotic belonging to the B-Lactam group (time-dependent antibacterial antibiotic), has a PK/PD index T> M mic, meaning that the time of antibiotic concentration is higher than the mic. CEFTIBUTEN as well as other antibiotics of this group achieve the highest therapeutic effect when reaching a concentration of over 4 times mic. Higher concentration than this value will not increase bactericidal ability. Therefore, T> MIC is the optimal indicator to evaluate the effectiveness of CEFTIBUTEN treatment. With Ceftibuten as well as with most B-Lactam, T> Mic reaches> 40-50% compared to the dosage range is considered to be effective treatment.

pharmacokinetics

absorption:

Ceftibuten is quickly absorbed after drinking. CEFTIBUTEN concentration in plasma into the pharmacokinetics parameters of cevtibuten after taking a single dose of 400 mg Ceftibuten on 12 male mature male volunteers (20 - 39 years old) is shown in Table 1. Plasma is about 20%.

Parameters CEFTIBUTEN concentration in plasma (µgg/ml) after taking a single dose of 400 mg ceftibuten and pharmacokinetic parameters (± 1 sd) (n = 12 healthy adult men) Now 6.1 (5.1)

1.5 hours 9.9 (5.9)

2.0 hours 11.3 (5.2) (3,0)

4.0 hours 11.2 (2.9) 6.0 hours 5.8 (1.6) Now 1,1 (0.4)

cmax, µg/ml 15.0 (3,3) TMAX, hour 2.6 (0.9) auc, µg. > Ceftibuten concentration in plasma in children is proportional to the dose of Ceftibuten 200 mg and 400 mg.

distribution:

The average distribution volume (V/F) of Cevtibuten in 6 adults is 0.21 1/kg (± 1 sd = 0.03 1/kg).

Links to protein: 65% CEFTIBUTEN is linked to plasma proteins. The ratio of binding with protein does not depend on the concentration of ceftibuten in plasma.

tissue penetration:

Bronchial secretion: In a study of over 15 adults, a single dose of 400 mg of ceftibuten and is expected to undergo bronchodoscopes, the average concentration in the epithelium and bronchodilator epidemic is 15% and 37% of plasma concentrations. In a study of 24 adults using CEFTIBUTEN 200 mg or 400 mg once a day, the average cmax in phlegm is 1.5 Ug/ml at 2 hours after oral and medium cmax in plasma 17 ng/ml in after 2 hours after taken. MEF on average is about 70% AUC in plasma. In the same study, CMAX value is 14.3 ± 2.7 kg/ml in MEF at 4 hours after taking the drug and 14.5 ± 3.7 Ug/ml in plasma at 2 hours after taking the drug. ready.

Metabolism:

A study with Ceftibuten on 6 healthy male volunteers proves that CIS -ceftibuten is the main component in both total blood and urine. About 10% of Ceftibuten is transformed into a page isomer, this substance is active in about 1/8 of the activity of CIS isomers.

excretion:

Cevtibuten's waste time in plasma is about 2.0 to 2,344, and lasts longer in patients with renal failure. A significant amount of drugs are removed from the body by hemolysis.

CEFTIBUTEN is excreted in urine, 95% of the used ceftibuten has been restored in urine or in feces. Of the six healthy male volunteers, about 56% of the dosage of Ceftibuten has been restored from urine and 39% from stool within 24 hours. Because the excretion through the kidney is a significant removal path of CEFTIBUTEN, patients with kidney dysfunction and dialysis patients need to be adjusted.

The effect of food:

The effect of food on biochemical biochemistry of Cevtibuten is considered over 26 healthy male volunteers to drink 400 mg of Ceftibuten after waking up or right after the standard breakfast. The results showed that the food slowed down the time to reach CMAX 1.75 hours, reduced CMAX to 18% and reduced the absorption (AUC) to 8%.

pharmacokinetics in some special patients:

Elderly patients

CEFTIBUTEN pharmacokinetics have been studied in the elderly (≥ 65 years old) with the number of male (n = 8) and women (n = 4). Each volunteer is taken for Ceftibuten 200 mg twice a day for 3 days. The average CMAX is 17.5 (3.7 ng/ml after 3 days compared to 12.9 (2.1) ng/ml) after the first dose; The accumulation of ceftibeten in a stable state in plasma is 40%. Information about the kidney function of these volunteers is not available, so the importance of this finding for the use of CEFTIBUTEN cysts clinically on elderly patients is not clear. It may be necessary to adjust the doses of ceftibuten in elderly patients.

Patients with renal failure

CEFTIBUTEN pharmacokinetics have been studied in adult patients with renal dysfunction. Cevtibuten's plasma waste time increases and the total clearance (CI/F) decreases corresponding to the level of increased renal dysfunction. Of the 6 patients with moderate kidney dysfunction (30 to 49 ml/minute creatinine clearance), cevtibuten plasma waste time increased to 7.1 hours and CI/F decreased to 30 ml/min. Of the 6 patients with severe renal dysfunction (creatinine clearance from 5 to 29 ml/minute), the selling time increased to 13.4 hours and CI/F decreased to 16 ml/min. Among 6 kidney patients with creatinine clearance

Before taking Cubabute 200mg Hataphar medicine for treatment of mild to medium infections, bronchitis (2 blisters x 10 tablets)

How to use

oral medication, take medicine for 1 hour before eating or 2 hours after eating.

Dosage

Adults and children aged 12 and older: 400mg (2 capsules)/time/day x 10 days.

Children under 12 years of age: Use other forms of preparation appropriately.

Children weight> 45kg: use the dose like adults.

Patients with adult kidney failure:

Creatinin clearance> 50ml/minute: No dose reduction. Or 400mg (2 capsules)/time/2 days. Or 400mg/time/4 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?

How to handle: Anti -seizure treatment. Remove ceftibuten by gastrointestinal hemolysis. The effectiveness has not been determined to eliminate the drug from the peritoneal fertilizer.

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 doses to compensate for missed dose.

Side Effects

When using the drug often has unwanted effects (ADR) such as:

Unwanted effects in clinical trials

In clinical trials, 1728 adult patients (USA and 636 international) were treated with the recommended dose of Ceftibuten (400 mg daily). There is no death or permanent defect due to drug poisoning in any patient in these studies. 36/1728 (2%) Patients stop taking the drug due to investigators that may, perhaps, or almost certainly related to the toxicity of the drug. The causes of drug stops are mainly due to digestive disorders, usually diarrhea, vomiting or nausea. 6/1728 (0.3%) Patients stop taking drugs due to rash or itching because they think about the use of ceftibuten.

In the US tests, the following adverse reactions are considered by investigators as possible, or almost certainly related to the use of CEFTIBUTEN capsules in multi -dose clinical trials (n = 1092 patients treated with CEFTIBUTEN).

CEFTIBUTEN's adverse reactions in tablets in clinical trials in adult patients (n = 1092)

Headache

diarrhea

Difficulty breathing

Dizziness

Abdominal pain

Vomiting

The rate> 0.1% and anorexia, constipation, dry mouth, difficulty breathing, difficulty, belching, fatigue, flatulence, loose stool, monilia disease, nasal congestion, rash, drowsiness, taste disorders, hives, vaginitis.

Eosin eosinophilia

Hemoglobin reduction

Increase ALT (SGPT)

Increase bilirubin

Increase creatinine

platelet increase

platelet reduction

leukopenia

Increase AST (SGOT)

Unwanted effect after bringing the drug to the market

The following adverse reactions have been reported during the process of bringing the drug to the market: language loss, jaundice, black stool, mental disorders, the reaction is like serum, whistling, Stevens-Johnson syndrome, and poisoned epidermal necrosis.

Unwanted effects of the cephalosporin group

In addition to the above -mentioned adverse reactions listed above have been observed in patients treated with CEFTIBUTEN tablets, the following unwanted effects and laboratory testing have been reported to cephalosporin antibiotics:

Allergic reactions, anaphylaxis, drug fever, Stevens-Johnson syndrome, kidney dysfunction, kidney poison, bile stasis, anemia, hemolytic anemia, hemorrhagic, false positive with sugar test in urine, leukemia, all bloody reduction and grain leukemia. Palf inflammation, onset of symptoms that may occur during or after antibiotic treatment.

Most unwanted effects respond to symptomatic or loss of medication. If convulsions occur related to drug treatment, stop the drug and use anti -convulsions if clinical indications.

Warnings

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

Contraindicated

CubeT medicine is indicated in the following cases:

Patients with allergies to cephalosporin antibiotic groups or any ingredients of the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Be careful when using cephalosporin antibiotics for patients suspected or know if they are allergic to penicillin. About 10% of patients with a history of allergies to penicillin reacts with cephalosporin. The severe hypersensitivity reaction (anaphylaxis) has also been reported in patients using penicillin and cephalosporin and the hypersensitivity reaction to anaphylaxis also appeared. If anaphylactic reaction appears with ceftibuten, stop the drug and use appropriate therapies. Severe anaphylaxis should take appropriate emergency measures such as epinephrin, for oxygen breathing, antihistamine, corticosteroids, hypertension amines and careful monitoring.

As other broad -spectrum antibiotics, prolonged antibiotic treatment can lead to the appearance and development of resistance bacteria, so careful monitoring of patients should be monitored. If there is signs of superinfection, it is necessary to take appropriate treatments.

Ceftibuten dose may need to be adjusted in patients with different levels of renal function, especially in patients with creatinine bars below 50 ml/min or patients with dialysis. Patients with dialysis are carefully monitored and should use CEFTIBUTEN right after dialysis.

Be cautious when using CEFTIBUTEN in people with a history of gastrointestinal diseases, especially colitis.

Palm of the fake colitis has been reported to all broad -spectrum antibiotics including Ceftibuten and the level of mild to life -threatening. Therefore, this diagnosis should be considered in patients with diarrhea after the use of broad -spectrum antibiotics. Treatment with broad -spectrum antibiotics changes the normal bacterial system of the intestinal tract and can cause Clostridia bacteria to overdo it. Studies show that a toxin produced by Clostridium difficile is a main cause of colitis related to antibiotics.

After the diagnosis of fake colitis, appropriate treatment measures should be taken. Cases of fake colitis mild, often from stopping the drug. In the case of medium to severe fake colitis, it is necessary to consider compensation and electrolytes, protein supplements and treatment with antibacterial antibacterial drugs against Clostridium difficile.

Should take the medication for at least 2 hours before eating or at least 1 hour after eating.

In the composition of Aspartam drugs contains a large amount of phenylalanin, which can be harmful to people with urinary phenylceton should be cautious when used.

The effect of drugs on driving and operating machinery

There is no data on the influence of CEFTIBUTEN on driving and operating machinery.

Because the drug can cause headaches, dizziness, dizziness, so be cautious when used while driving or operating machinery.

Using drugs for women during pregnancy and lactation

Using drugs for pregnant women:

Animal studies show that there is no evidence of harmful effects on the fetus. There is no adequate and controlled research in pregnant women. Therefore, the drug should only be used during pregnancy when really necessary.

Use medicine for breastfeeding women:

The safety of Ceftibuten has not been proven, should not be used during breastfeeding.

Interactive drug

Other drugs - other drugs:

Theophylin: 12 healthy male volunteers are used one dose of 200 mg of ceftibuten 2 times/day for 6 days. With the dose of Ceftibuten on the morning of Friday, each volunteer is a single -dose of theophylin dosage (4 mg/kg). The pharmacokinetics of theophylin is not changed. The influence of ceftibuten on the pharmacokinetics of theophylin has not been studied.

anti -acid or receptor antagonists H2: The effect of gastric pH increases on biochemical bioavailability of CEFTIBUTEN is assessed in 18 healthy mature volunteers. Each volunteer is taken for a 400 mg CEFTIBUTEN. A dose of liquid antacids does not affect CMAX or AUC of Cevtibuten. However, when using 150 mg of ranitidin every 12 hours/time in 3 days increases CMAX of ceftibuten to 23% and increasing the AUC of Ceftibuten to 16%. The clinical relevance of these increases is not known.

Drug interaction - Test results:

There is no chemical interaction or test that is recorded with Ceftibuten. The false positive result in the direct Coombs test has been reported during the use of other cephalosporins. However, the test results using healthy red blood cells to test for CEFTIBUTEN have caused reactions with tests Coombs in vitro to prevent positive reactions, even with high concentrations of up to 40 mg/ml.

Medicine - Food:

CEFTIBUTEN's speed and absorption level in the form of an epidemic may be affected when used with food.

The cavalry of the drug:

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Storage

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

To be out of reach of children, read the user manual carefully before use.

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