Binozt drink powder 200mg/5ml Sandoz treats infections, acute sinusitis (15ml)
Dosage form Box x 15ml
Specifications Azithromycin
Ingredient Sandoz
Ingredient
Thành phần cho 5ml
| Composition information | Content |
| Azithromycin | 200mg |
Uses
indications
Binozt medicine is indicated in the following cases:
azithromycin is used to treat the following infections, caused by bacteria sensitive to azithromycin (see caution and special warning when used and pharmacological):
Pharmacokology
General characteristics
Pharmacological treatment group: antibiotic effects on the body; belong to the macrolid group.
ATC code: J01FA10.
Mechanism of action
Azithromycin is a Azalid, a subgroup of macrolid antibiotics. By cohesion to the subunit of 50S ribosom, azithromycin prevents the transformation of peptid chains from one side of ribosom. The result is inhibition of protein biosynthesis based on RNA in sensitive bacteria.
Pharmacokinetic and pharmacokinetic correlation
The ratio between AUC (area under the concentration - time curve) and mic (minimum inhibitory concentration) is the main correlation parameters between pharmacokinetics and pharmacokinetics that have the most influence on the efficiency of azithromycin.
Medicinal resistance mechanism
resistance to azithromycin may be spontaneous or suffering. There are 3 main resistance mechanisms in bacteria: change the destination position, change the transport of antibiotics and the change of antibiotics.
There is a completely cross resistance between streptococcus pneumoniae, streptococcus group A blood resolution Beta, Enterococcus Faecalis and Staphylococcus aureus, including S. Aureus Methicillin resistance (MRSA) for erythromycin, Azithromycin, other Malrilid Lincosamid.
The level of threshold
According to CLSI (Institute of Clinical and Testing Standards), the following levels have been determined for azithromycin:
Sensitivity
The ratio of resistance may vary in terms of geographic and time for selected bacteria and information about local resistance is necessary, especially when treating severe bacterial infections. When necessary, experts should be asked when the local resistance rate is a useful factor, at least for some suspicious infections.
Studies conducted in Vietnam show that Gram -positive bacteria such as Streptococcus, Pneumococcus, Staphylococcus Aureus are resistant to macrolid groups at about 40%; So partly the ability to use azithromycin is more or less limited. Some other bacteria strains are also very sensitive to azithromycin such as: corynebacterium diphtheriae, Clostridium perfringens, peptostreptoccus and propionibacterium acnes. Always remember that erythromycin -resistant microorganisms may also be resistant to azithromycin as Gram -positive strains, including Enterococcus species and most staphylococcus strains of methicilin are completely resistant to azithromycin.
azithromycin works well in Gram -negative bacteria such as: Haemophilus influenzae, parainfluenzae, and Ducreyi, Moraxella CatVrhalis, Acinetobacter, Yersinia, Legionella Pneumophilia, Bordetella Pertussis, and Parapertussis; Neisseria gonorrhoeae and campylobacter sp. Pneumoniae, Treponema Pallidum and Borrelia Burgdorferi.
Azithromycin has a moderate effect on Gram -negative bacteria such as E. Coli, Salmonella Enteritis and Salmonella Typhi, Entobacter, Acromonas Hydrophilia, Klebsiella.
The strains of Azithromycin -resistant Grams are Proteus, Serratia, Pseudomonas Aeruginosa and Morganella. Overall, Azithromycin acts slightly weaker on Gram -positive bacteria than erythromycin, but stronger on some Gram -negative bacteria including Haemophilus. pharmacokinetics
absorption
Bioarization of azithromycin after taking the drug is approximately 37%. Peak concentrations in plasma are achieved after 2-3 hours of medication.
Distribution After drinking, Azithromycin is widely distributed throughout the body. Dynamic studies have clearly shown azithromycin concentration in higher tissues in plasma (up to 50 times the maximum concentration in plasma). This indicates that the active ingredient is connected in tissues in significant quantities.
concentration in lung, tonsils and prostate tissue is higher than the mic 90 value for the most common pathogenic bacteria after a single dose of 500 mg.
The cohesion of azithromycin with serum protein is variable and different, depending on the serum concentration from 52% at 0.05 mg/l to 12% at 0.5 mg/l. The distribution volume reaches the status of 31.1 I/kg.
Elimination
The last half -life of relaxation reflects close to the semi -exhaust time in tissue is about 2 to 4 days.
About 12% of azithromycin intravenous dose, excreted in the urine within 3 days, in a constant form, high concentration of azithromycin is unchanged found in bile. In particular, 10 metabolites have been discovered (formed by methyl reduction at N-O-, by the hydroxylation of the desosamin and the Aglycon ring and by the assembly separation of Cladinose skin fungus). Compare microbiological quantification methods and liquid chromatography shows that metabolites have no microbiological activity.
In animal studies, high concentrations of azithromycin are found in macrophages. In experiments of higher concentration of azithromycin, it is also released when there is more active phagger than not stimulated. This process contributes to the accumulation of azithromycin in infection tissue.
pharmacokinetics in special patient groups
kidney failure
After a single dose of Azithromycin 1 g, the average CMAX and AUC0-120 value increased by 5.1% and 4.2% respectively in patients with mild to medium to medium kidney (glomerular filtration speed of 10 - 80 ml/min) compared to those with normal renal function (glomerular filtration speed> 80 ml/minute). For people with severe renal failure, CMAX and AUC0-12 average increased by 61% and 35% respectively compared to ordinary people.
Liver failure
In patients with mild to moderate liver failure, there is no evidence of a significant pharmacokinetic change of azithromycin compared to people with normal kidney function. In these patients, the degree of finding azithromycin in the urine seems to rise, probably due to clearing with a decrease in the clearance in the liver.
Children and adolescents Pharmacokinetics has so far been studied in children 4 months to 15 years old using capsules, powder or chaos. At the concentration of 10 mg/kg on the 1st day then about 5 mg/kg on Monday to Thursday to Thursday, CMAX achieved slightly lower than adults with CMAX is 224 μg/l in children from 0.6 - 5 years old and after 3 days of drug use and 383 μg/l in children from 6 to 15 years old. T1/2 is 36 hours in older children within the scope of predictions for adults.
Before taking Binozt drink powder 200mg/5ml Sandoz treats infections, acute sinusitis (15ml)
How to use
take medicine once a day. Can use medicine with food.
Can avoid the bitter taste after taking the medication by taking juice shortly thereafter.
How to mix the epidemic
Shake the bottle of powder without opening.
Add 7.5 ml of cold water to the bottle by using a pump to measure.
Close the lid and shake well until the mixture is homogeneous, the color from white to white.
Shake the vial before each use.
How to measure the dose
A 10 ml pump pump is marked every 0.25 ml is provided with the drug box. This syringe comes with a part that fits the bottle. To measure the dose:
Dosage
Adults
For urinary tract infections and cervix caused by Chlamydia trachomatis oral 1 dose 1000 mg.
For other indications of a total dose of 1500 mg, taking 500 mg/day for 3 consecutive days. Or the total dose (1500 mg) can be used for 5 days with 500 mg of the first day and 250 mg from Monday to Thursday.
Children and teenagers ( The total dose in children from 1 year of age is 30 mg/kg orally 10 mg/kg once a day for 3 days, or for 5 days with a single dose of 10 mg/kg on the first day, the next dose of 5 mg/kg daily for the next 4 days, according to the table below. Restricted data for children under 1 year of age. weight 3 -day regimen 5 -day regimen 10 mg/kg/day Day 1 10 mg/kg/day day 2 - 5 5 mg/kg/day 10 kg 2.5 ml 2.5 ml 1.25 ml 12 kg 3 ml 3 ml 1.5 ml 14 kg 3.5 ml 3.5 ml 1.75 ml 16kg 4 ml 4 ml 2 ml 17 - 25 kg 5 ml 5 ml 2.5 ml 26 - 35 kg 7.5 ml 7.5 ml 3.75 ml 36 - 45 kg 10 ml 10 ml 5 ml 45 kg 12.5 ml 12.5 ml 6.25 ml In patients with renal failure No need to adjust the dose in patients with mild to moderate renal failure (GFR 10 - 80 ml/min) (see caution and special warning when used). In patients with liver failure No need to adjust the dose in patients with mild to moderate liver function (see caution and special warning when used). Elderly Use the dose like adults. Because elderly patients may be accompanied by a progressive defhancine condition, they should be cautious with these patients due to the risk of arrhythmia and torsion. 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? The typical symptoms of macrolid antibiotic overdose include non -recovery, severe nausea, vomiting and diarrhea. In case of overdose, active carbon and symptomatic treatments should be indicated and general support when necessary. In case of emergency, call the 115 emergency center immediately or go to the nearest local health station. 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:
The table below lists adverse effects according to the organ system and the frequency is determined in clinical trials and monitoring after bringing the drug to the market. The frequency of groups is defined according to the following convention:
Popular (≥ 1/10); Common (≥ 1/100 to In each frequency group, the adverse effect is presented in the order that gradually decreases the severity.
The adverse reactions may or may be related to azithromycin based on clinical trials and monitoring after bringing the drug to the market.
Infections and parasites
Gastrointestinal disorders
Metabolic and nutrition disorders
Nervous system disorders
Gastrointestinal disorders
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Binozt medicine is contraindicated in the following cases:
Be cautious when using
similar to erythromycin and other macrolid antibiotics, serious reactions rarely occur, including angioedema and anaphylactic shock (rarely leading to death). Some of these reactions with azithromycin have caused recurrent symptoms and need longer monitoring and treatment time.
Because the liver is the main excretion of azithromycin, it is cautious when using azithromycin for patients with severe liver disease. Cases of acute hepatitis can lead to life -threatening liver failure recorded with azithromycin (see unwanted effect). Some patients may have a history of liver disease or may have used other liver toxic drugs.
In case of signs and symptoms of liver dysfunction, such as rapid progression of liver failure related to jaundice, dark urine, risk of bleeding or liver brain disease, should immediately do liver function tests. Azithromycin should be stopped if there is liver dysfunction.
In patients using chicken spurs derivatives, alcaloids of chicken spurs derivative can be accumulated causing poisoning when used simultaneously with macrolide antibiotics. There are no data related to the ability to interact between the derivatives of the chicken spurs and azithromycin. However, the theory due to the risk of poisoning the alcaloids of the aforementioned mushrooms may occur, should not be used simultaneously azithromycin with the derivatives of chicken spurs.
Similarly when preparing any antibiotics, it is recommended to observe signs of superinfection with unsure microorganisms, including fungi.
diarrhea caused by Clostridium difficile (CDAD) has been recorded when using most antibiotics, including azithromycin, and the severity may range from mild diarrhea to death colitis. Treatment with antibiotics changes the normal microbiological system in the intestinal tract leading to excessive development C. Difficile. C. Difficile produces toxins A and B causing diarrhea caused by C. Difficile. Highly toxic substances produced by C. Difficile strains increase the incidence of disease and mortality due to these infections that can be resistant to antibiotics and may need to remove the colon. The ability to diarrhea caused by C. difficile needs to be considered in all patients with diarrhea after antibiotics. It is necessary to carefully consider the previous medications for notes diarrhea due to C. different appeared more than 2 months after antibiotics.
In patients with severe renal impairment (glomerular filtration level
Extreme heart muscle and prolonged QT interval leads to an increase in the risk of arrhythmia and torsion, which has been recorded when using macrolid antibiotics including azithromycin (see unwanted effect). Therefore, the following conditions can lead to an increased risk of ventricular arrhythmia (including peaks) that can lead to cardiac arrest, so cautious when using azithromycin for patients who are showing signs of arrhythmia (especially women and elderly patients) such as:
Outbreaks of severe myasthenia gravis and the onset of myastheniastaric syndrome have been recorded in patients using azithromycin (see unwanted effect section).
Safety and effectiveness in prevention and treatment of Mycobacterium avium complex in children have not been set.
Information about some excipients of the drug
Caution in patients with diabetes: 5 ml of the mixture contains 3.7 g of sucrose.
Patients with rare genetic problems such as fructose intolerance, glucose-galactose malabsorption or deficiency of sucrase-isomaltase should not be used because it is high in sucrose.
This drug contains aspartam as precursors of phenylalanin. Should be harmful to people with phenylketouria.
The effect of the drug on the ability to drive and operate machinery
The drug can cause side effects such as headache, dizziness, drowsiness, visual disorders, tinnitus, stress, excitement ... So be careful in using the drug when driving and operating machinery.
Use drugs for women during pregnancy and lactation
Pregnant women
There is no enough data on the use of azithromycin in pregnant women. Azithromycin's animal reproductive toxicity studies show that the drug is given a fence of the placenta, but does not observe the effect of causing the abortion of the drug. The safety of azithromycin when using the drug during pregnancy has not been determined. Therefore, only azithromycin should be used during pregnancy in case of superior benefits.
breastfeeding women
Azithromycin has been excreted in breast milk, but there is no adequate and well -controlled clinical studies in breastfeeding women to describe the pharmacokinetics of azithromycin excreted breast milk on humans. The drug must be used with caution in breastfeeding women.
fertility
In fertility studies performed in mice, reducing the rate of pregnancy has been recorded after using azithromycin. The relationship on this issue is not well known.
Drug interaction
antacids
A pharmacokinetic study of the effect of simultaneous use of antacids with azithromycin shows that antacids do not affect the total bioavailability of azithromycin although the serum peak concentration decreases by about 24%. Patients need to use both azithromycin and antacids should not take these two drugs at the same time.
cetirizin
On healthy volunteers, simultaneous use of azithromycin and cetirizin 20 mg in 5 days in a stable state shows no pharmacokinetic interaction and does not change the meaning of about QT.
didanosin (dideoxyinosin)
Simultaneous use of Azithromycin 1200 mg/day with Didanosin 400 mg/day on 6 HIV patients positive shows that the drug does not affect the pharmacokinetics in the stable state of Didanosin compared to placebo.
Digoxin (substrate of P-GP)
Concomitance macrolid antibiotics, including azithromycin, with substrates of p-glycoprotein, such as digoxin, has been recognized to increase the substrate concentration of p-glycoprotein in serum. Therefore, if simultaneously used azithromycin and substrates of P-GP such as digoxin, it is advisable to consider the possibility of the concentration of these substrates in the serum increases.
zidovudin
Azithromycin single dose 1000 mg and a repeated dose of 1200 mg and 600 mg have little effect on plasma pharmacokinetics and zidovudine urinary excretion or their glucuronic metabolites. However, taking azithromycin increases the concentration of zidovudin phosphorylation, clinical metabolic metabolites, in peripheral blood nuclear cells. It is unclear whether this has a clinical significance, but it may benefit the patient.
Azithromycin does not interact with the significant with the cytochrom P450 system in the liver. The drug is not considered to have pharmacokinetic interactions such as erythromycin and other macrolides. Cytochrom P450 induction in the liver for metabolites through cytochrom does not occur with azithromycin.
The fungal alcaloids
Due to the theory of poisoning of chicken fungus in theory, it is not recommended to simultaneously use azithromycin with chicken spurs derivatives (see special and cautious warnings when used). Mobile pharmacokinetic studies have been conducted with azithromycin and the following drugs have been known as meaningful metabolism through cytochrom P450.
Atorvastatin
Simultaneously used with Atorvastatin (10 mg daily) and azithromycin (500 mg daily) do not change the concentration of serum of Atorvastatin (based on the HMG Coa-Reductase inhibitor test). However, cases of muscle pattern in patients using azithromycin along with the statins have been recorded after bringing the drug to the market.
carbamazepin
In a pharmacokinetic interaction study on healthy volunteers, carbamazepine concentration or active metabolites in plasma are not significant in patients using simultaneously with azithromycin.
cimetidine
A pharmacokinetic study on the effects of a single dose of cimetidin taken for 2 hours before taking azithromycin, showing no change on azithromycin pharmacokinetics.
Oral anticoagulants orally
A pharmacokinetic interactive study showed that azithromycin did not affect the anticoagulant effect of wafarin when using a single dose of 15 mg on a healthy volunteer. There have been reports on anticoagulant effects when simultaneously used azithromycin with
The oral anticoagulant drugs are recorded after bringing the drug to the market. Although the causal relationship has not been established, regular monitoring of prothrombin should be considered when using azithromycin for patients who are taking oral anticoagulant drugs.cyclosporin
A pharmacokinetic study on healthy volunteers oral azithromycin 500 mg/day for 3 days and then using a single dose of Cyclosporin 10 mg/kg orally shows that CMAX and AUC0-5 are significant. Therefore, be cautious when using these drugs at the same time. If it is necessary to use simultaneously, cyclosoprin should be monitored and adjust the dose accordingly.
Efavirenz
Single -dose of Azithromycin 600 mg and Efavirenz 400 mg daily for 7 days does not cause any pharmacokinetic interaction with clinical significance.
fluconazol
Concentrated use of Azithromycin single dose 1200 mg does not change the pharmacokinetics of Fluconazol single dose 800 mg. Azithromycin's total drug and semi -waste time does not change when used simultaneously with fluconazol, however, Azithromycin's CMAX has been recorded by 18%, which has been recorded without clinical significance.
indinavir
Concentrated use of Azithromycin single dose 1200 mg does not affect statistically significant to pharmacokinetics of indinavir 800 mg, used 3 times/day for 5 days.
methylprednisolon
A pharmacokinetic interaction study on healthy volunteers shows that azithromycin does not affect the pharmacokinetics of Methylprednisolon.
Midazolam
On healthy volunteers, simultaneous use of azithromycin 500 mg/day for 3 days does not change the clinical significance of pharmacokinetics and pharmacological force of Midazolam single dose of 15 mg.
nelfinavir
Simultaneous use of azithromycin (1200 mg) and Nelfinavir in a stable state (750 mg 3 times/day) increases azithromycin concentration. Do not record clinical significant adverse reactions and do not need to adjust the dose.
rifabutin
Simultaneous use of azithromycin and rifabutin does not affect the serum concentration of both drugs.
neutropenia has been recorded in patients with simultaneous use of azithromycin and rifabutin. Despite neutrophils related to the use of rifabutin, the causal relationship of coordination with azithromycin has not been established (see unwanted effect section).
terfenadin
Dynamic pharmacokinetic studies do not record interactive evidence between azithromycin and terfenadin. There have been reports on rare cases, in which the ability to interact is not completely excluded; However, there is no concrete evidence that interaction may occur.
Theophyllin
There is no evidence of clinical pharmacokinetics when using simultaneously azithromycin and theophyllin on healthy volunteers.
triazolam
Over 14 healthy volunteers, simultaneous use of Azithromycin 500 mg on the first day and 250 mg on the 2nd day with 0.125 mg triazolam on the 2nd day does not affect the pharmacokinetics of triazolam when compared to the use of triazolam and placebo.
trimethoprim/sulfamethoxazol
Simultaneous use of trimethoprim/sulfamethoxazol (160 mg/800 mg) for 7 days with azithromycin 1200 mg on Saturday does not affect the concentration of the peak of the drugs, the total amount of drugs in the circulation or elimination through urine of trimethoprim or sulfamethoxazol. The serum azithromycin concentration is similar to other studies.
Other antibiotics
Observations may have cross -resistance between macrolid antibiotics and azithromycin (eg erythromycin) as well as lincomycin and clindamycin. Do not recommend the use of antibiotics in the same group.
The drugs have been known to extend the range of qt
azithromycin should not be used in combination with known drugs that can extend the QT range.
Storage
No storage above 30 ° C.
Other drugs
- CHLORPHENAMINE 10MG/ML SOLUTION FOR INJECTION
- FURAMIDE TABLETS
- Opatanol
- PIRACETAM 800MG TABLETS
- SULPIRIDE TABLETS 200MG
- VIRGAN EYE GEL
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions