Rivomoxi 400mg Hanoi Pharma Treatment of infection (1 blister x 5 tablets)
Dosage form Box of 1 blister x 5 tablets
Specifications Moxifloxacin
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Moxifloxacin | 400mg |
Uses
indications
Rivomoxi is indicated to treat bacterial diseases in people 18 years old or older due to moxifloxacin sensitive bacteria. Moxifloxacin should be used in case of failure with other common antibiotics:
Pneumonia is suffering from the community, except for severity.
Mild to medium pelvic pelvic inflammatory (such as the above genital tract infections including fallopian tube inflammation and endometritis) not accompanied by fallopian tubes, ovaries or pelvic abscesses.
moxifloxacin is not recommended for the use of monomers in mild to medium pelvic inflammatory disease, need to be combined with other appropriate antibiotics (cephalosporin) caused by Neisseria gonorrhoeae to increase Gonorrhoea resistance to increase moxifloxacin resistance unless Neisseria gonorrhoeae anti -Moxifloxacin resistance minus.
Provincial sinusitis caused by bacteria (fully diagnosed).
Acute bacterial infections of chronic bronchitis (full diagnosis).
Due to the Fluoroquinolon antibiotic, including moxifloxacin related to serious harmful fertilizers (see the item cautious when taking the drug) and the acute bacterial infection of chronic bronchitis, acute sinusitis for bacteria that some patients can go away on their own, only moxinoxacin should be used for patients without other treatment options. The drug can be used to complete the treatment process in patients who have improved when initial treatment with moxifloxacin injected in the following indications:
Pharmacokology
Pharmacological group: Fluoroquinolon antibiotics
ATC code: J01MA14
Mechanism of action:
moxifloxacin has a Vitro effect on both gram-negative and gram-positive bacteria, inhibit the Topoisomerase enzyme type II of bacteria (DNA Gyrase and Topoisomer-ASE IV) is the enzyme necessary for bacterial copy, code and DNA repair process. Napthyridin of moxifloxacin has groups 8 - methoxy and 7 - diazabicyclononyl increases antibiotic effects and reduces the selection of anti -drug mutants of gram -positive bacteria.
Pharmacological studies prove that moxifloxacin has the ability to kill bacteria depending on the concentration. The minimum bactericidal concentration (MBC) is found within the minimum inhibitory concentration range (MIC).
affect the intestinal microbiological system in humans:
The following changes in the intestinal microflora are discovered in healthy volunteers after taking moxifloxacin: Escherichia coli, Bacillus spp., Enterococcus spp. And Klebsiella spp. Decreased, as well as anaerobic bacteria, Vulgatus, Bifidobacterium spp., Eubacterium spp. and peptostreptococcus spp. There is an increase in bacteroides fragilis. Normal changes within two weeks.
Resistance mechanism:
The mechanism of resistance to penicillin, cephalosporins, aminoglycosides, macrolid and tetracyclin does not affect the antibacterial activity of moxifloxacin. Other resistance mechanisms such as absorbent reduction (common in Pseudomonas Aeruginosa) and push pumps can affect moxifloxacin sensitivity.
On vitro bacteria resistant to moxifloxacin slowly develops slowly through many mutant steps at the destination of both Topoisomerase Type II enzymes of bacteria, DNA Gyrase and Topoisomerase IV. Moxifloxacin is less affected by the pump mechanism in Gram -positive bacteria.
There was a cross -resistance between moxifloxacin and other fluoroquinolones. However, Gram -positive bacteria resistant to other fluoroquinolones may still be sensitive to moxifloxacin.
pharmacokinetics
absorption and bioavailability:
moxifloxacin absorbs quickly and almost completely through the gastrointestinal tract when taken. Absolute bioavailability of about 91%. The pharmacokinetics of linear moxifloxacin in the range of 50 - 800 mg at a single dose or a dose of 600 mg/day/day for 10 days. After taking the dose of 400 mg, the concentration is at 3.1 mg/l achieved in 0.5 - 4 hours. The highest and lowest concentration in plasma in a stable state (when taking 1 dose of 400 mg/day), respectively, 3.2 and 0.6 mg/l. In a stable state, the degree of contact within the dose distance is about 30% higher than the first dose.
Distribution:
moxifloxacin is quickly distributed to extracellular compartments. After taking the dose of 400 mg, the scope reached 35 M.GH/L. The distribution volume at a stable state (VSS) is approximately 2.0 /kg. In In vitro and EX Vivo studies, about 40 - 42% moxifloxacin binds to protein, regardless of the concentration of the drug. Moxifloxacin is linked mainly with plasma albumin.
Metabolism:
moxifloxacin undergo a biological metabolism ||, eliminated through the kidneys and bile in the form of non -team and sulpho complexes (M1) and glucuronid (m2). M1 and M2 are metabolites that are meaningful to humans, both are inactive bacterial substances. The clinical phase of phase I and in vitro research shows that there is no pharmacokinetic interaction with other drugs transformed through phase 1 related to the Cytochrom P450 system. There are no signs of oxidative metabolism.
Era:
The semi -canceled time is approximately 12 hours. With a dose of 400 mg, the average total clearance is about 179-246 ml/min. The clearance of the kidney is about 24 - 53 ml/min, showing that the drug can be partially reabsorbed in the renal tubules.
The drug is eliminated in the urine (about 19% in the form of changing, 2.5% m1, 14% m2) and fertilizer (about 25% in the form of changing, 36% m1, no m2) nearly 96% after using a dose of 400 mg.
Simultaneously used with ranitidin and probenecid does not change the kidney clearance of the drug.
Elderly and light weight:
Moxifloxacin concentration in plasma is higher in the elderly and lightweight people.
kidney failure:
Moxifloxacin pharmacokinetics parameters are not affected in people with renal failure (including creatinine clearance> 20 ml/min/1.73m2). When renal function decreases, the concentration of metabolites m2 (glucuronid) increases to the ratio of 2.5 (with creatinine clearance
Hepatic failure:
On the basis of pharmacological studies have been conducted so far, in patients with liver failure (Group A, B according to the classification of Child Pugh), cannot identify any differences compared to healthy volunteers.
The decline in liver function is more related to the transformation into M1 in plasma, when comparing the liver failure with a healthy volunteer and using the drug. There is still not enough data on the use of moxifloxacin in clinical liver functional impaired patients.
Before taking Rivomoxi 400mg Hanoi Pharma Treatment of infection (1 blister x 5 tablets)
How to use
swallow the whole pill with a sufficient amount of water, can take medicine without meals. Treatment time:
Dosage
Common dose in adults: 400mg 1 time/day.
Renal failure, liver failure: No need to adjust the dose for patients with severe to severe kidney failure or artificial dialysis patients such as absorbing color or even peritoneal fertilizer. There is not enough data in patients with impaired liver function.
Lightweight people, the elderly: No need to change the dose with the elderly and lightweight people.
Children and adolescents: Contraindicated using moxifloxacin in children and adolescents (under 18 years old). Safety and efficiency for this age has not been determined.
Treatment time:
Pneumonia is suffering from the community for 10 days.
Mild pelvic inflammatory for 14 days.
Acute sinusitis caused by bacteria 7 days.
Acute bacterial infections of chronic bronchitis 5 - 10 days.
In clinical trials, most patients shift from intravenous injection to orally for 4 days (for pneumonia in the community) or 6 days (for complicated skin infections and skin structure). The total time of oral use and intravenous injection is 7-14 days for the acquired pneumonia in the community and 7 - 21 days for skin infections and complex skin structure.
Do not overdose (400 mg/time/day) and extend the recommended treatment time.
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 do
do when overdose? Tracking the electrocardiogram should be done because it may extend the QT range. Use activated carbon early to reduce the absorption of drugs, avoid over -increasing the body contact with the drug, because activated carbon reduces the bioavailability of moxifloxacin by more than 80% when used combined.
In an 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 dose to compensate for missed dose.
Side Effects
Unwanted effects are recorded by clinical frequency and after the drug is circulated with moxifloxacin 400 mg/day listed after 923 in addition to nausea and diarrhea, other side effects have a frequency of less than 3%. In each frequency group, the unwanted effect shows the degree of severity.
Common (1/100 nervous system disorders headache. Eyes, dizziness sensory disorders, taste buds (in case of loss of taste rarely occur). Confusion and disorientation. Sleep disorders (Love owner is insomnia). Run. Sleeping dizziness Instructions on how to handle ADR: Stop moxifloxacin immediately when there is any sign of hypersensitivity reactions, side effects on nerves (convulsions, depression, confusion, hallucinations, tremor, suicide thoughts); Pain, inflammation or sprain. Manifestations of digestive disorders such as nausea, vomiting, abdominal pain, taste disorders are often mild without treatment intervention. If there are signs of fake colitis, it is necessary to monitor the degree of diarrhea, if severe must be treated with other antibiotics appropriately.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Rivomoxi is contraindicated in the following cases:
In clinical and clinical trials, there has been a change of electrocardiogram, the length of QT after using moxifloxacin. To use safe drugs, indicated using moxifloxacin in the following cases:
Be cautious when using
serious harmful reactions are the ability to not recover and cause disabilities, including tendonitis, tendon rupture, peripheral neuropathy and adverse effects on the central nervous system.
Fluoroquinolon antibiotics are associated with serious harmful reactions that can cause disabilities and non -recovery on different organs of the body. These reactions may appear simultaneously on the same patient. Harmful reactions are often recorded including tendonitis, tendon, joint pain, muscle pain, peripheral neuropathy and adverse effects on the central nervous system, anxiety, depression, insomnia, severe headaches and confusion). These reactions may occur within hours to a few weeks after using the drug. Patients at any age or no risk factors that exist before may have these harmful reactions.
Stop using the drug as soon as there are signs or first symptoms of any serious harmful reactions. In addition, avoid using Fluoroquinolon antibiotics for patients who have had serious reactions related to fluoroquinolon.
The benefits of moxifloxacin treatment especially infections with low severity should be considered the information in this section.
extends the QTC range and the risk of extending QTC:
moxifloxacin has shown the ability to extend the QTC range on the electrocardiogram in some patients. In ECG analysis on clinical trial with moxifloxacin, QTC lasts 6 + 26 milliseconds, 1.4% compared to the original. Women tend to extend QTC than men and may be more sensitive to the drug that lasts the QTC. Elderly people may also be more sensitive to the effects of drugs related to QT.
The drug can reduce potassium levels, so it must be used cautiously in patients using moxifloxacin.
Caution for patients with arrhythmia (especially elderly and women), such as acute myocardial ischemia or extended the QT period because it can lead to an increase in the risk of ventricular arrhythmia (torsion) and cardiac arrest. The QT range lasts longer when the drug concentration is higher, so the overdose should not be used.
If signs of arrhythmia occur when treated with moxifloxacin, stop taking medication and electrocardiogram.
Hypersensitivity/allergic reaction:
There have been hypersensitivity reports and allergic reactions of fluoroquinolones include moxifloxacin after the first dose. Anaphylaxis can progress to life -threatening shock, even after the first dose. In these cases, moxifloxacin should be stopped and implemented appropriate treatment (such as shock treatment).
Severe liver disorders:
Acute hepatitis cases can lead to liver failure (including death) that have been reported when using moxifloxacin. Patients should contact the doctor before continuing to treat if there are signs and symptoms of acute liver disease that progresses rapidly such as jaundice, dark urine, bleeding or brain disease - liver. Must test liver function in case of signs of disorder occurs.
The bullous reaction on the skin:
Cases of skin bulling reactions such as Stevens - Johnson syndrome or poisoned epithelial necrosis have been reported when using moxifloxacin. Patients need a doctor immediately before continuing treatment if skin reaction or mucosa occurs.
Patients are at risk of menstruation:
Quinolones are known to cause epilepsy. Caution should be used in patients with central neurological disorders or other risk factors that can lead to seizures or reduced seizures. In case of epilepsy, moxifloxacin should be stopped and implemented appropriate treatments.
Peripheral nerve:
Cases of multi -neuritis sensation or motor nerves lead to abnormalities, tactile reduction, sensory disorders that have been reported in patients using quinolon including moxifloxacin. Patients treated with moxifloxacin should notify the doctor before continuing to treat if the symptoms of neuropathy such as pain, burning, tingling, throbbing nerve pain, numbness or weak limb.
Mental reaction:
Psychiatric reactions can occur even after the first quinolon. In a few cases, depression or mental reactions progress to the intention of suicide and self -injuries. In the case of patients with these reactions, moxifloxacin should be stopped and appropriate measures should be taken. It is recommended not to use moxifloxacin in mental patients or in patients with a history of mental illness.
diarrhea due to antibiotics, colitis:
antibiotic diarrhea (AAD) and antibiotic colitis (AAC), including fake colitis and diarrhea caused by Clostridium difficile, has been reported when using a combination of broad antibiotics including moxifloxacin, which can fluctuate from mild diarrhea to fatal colitis. Therefore, patients with diarrhea must be carefully evaluated after using moxifloxacin. If diarrhea or colitis is suspected of antibiotic treatment, including moxifloxacin, it is advisable to stop taking the drug and taking appropriate treatment. In addition, there must be appropriate measures to control infections to reduce the risk of transmission. Popular inhibitors are contraindicated in patients with severe diarrhea.
Patients with myasthenia gravis:
moxifloxacin should be used carefully in patients with myasthenia gravis because symptoms may be more serious.
tendonitis, tendon:
Inflammation and tendon rupture (especially heel tendon) can occur when using quinolon, including moxifloxacin, may occur within 48 hours after starting and lasting up to several months after stopping treatment. The risk of tendon and tendonitis increases in older patients and those who treat simultaneously with corticosteroids. When the first sign of the disease, patients should stop treating with moxifloxacin, damaged limbs need to rest and consult a doctor for treatment (such as no movement).
Patients with renal failure:
Elderly patients with kidney disorders should use moxifloxacin cautiously if they cannot maintain adequate drinking water, because dehydration can increase the risk of kidney failure.
visual disorders:
If the vision is weakened or has any effect on the eye, it is necessary to consult the doctor immediately.
Blood disorders:
Like other fluoroquinolones, moxifloxacin also causes blood sugar disorders including hypercasses and hypoglycemia. Hemodiac disorders are mainly seen in elderly patients with diabetes in combination with moxifloxacin with oral hypoglycemic drugs (such as sulfonylurea) or insulin. Therefore, careful monitoring of blood glucose in diabetes patients.
Avoid light sensitive reactions:
Quinolon has been shown to cause light sensitivity reactions in patients, studies have shown that moxifloxacin is at a lower risk. However, patients should avoid exposure to strong UV or light during treatment with moxifloxacin.
Patients with glucose deficiency - 6 - Phosphate dehydrogenase:
Patients with a family history of glucose deficiency - 6 - Phosphate dehydrogenase phosphate are prone to hemolytic reaction when treated with quinolon. Therefore, caution should be used with moxifloxacin carefully in these patients.
Patients with skin infections, complicated subcutaneously (CSSSI):
Clinically effective of moxifloxacin in the treatment of severe infections, cauliflasses, foot infections in patients with diabetes with bone marrow failure have not been set.
Patients with pelvic inflammatory disease:
For patients with complex pelvic inflammatory infections (related to fallopian tubes, ovaries or pelvic abscesses), should be treated with intravenously, should not be used for this form of dosage. Pelvic inflammatory disease can be caused by Neisseria Gonorrhoeae Fluoroquinolon. cause. Therefore, in these cases, moxifloxacin should be coordinated with another appropriate antibiotic (such as cephalosporin) unless neisseria gonorrhoeeae resistant moxifloxacin is excluded. If the clinical improvement is ineffective after 3 days of treatment, this therapy should be reviewed.
Biological tests:
Moxifloxacin treatment may affect mycobacterium spp bacteria. Check by inhibiting the growth of tuberculosis bacteria for negative results in samples taken from patients currently using moxifloxacin.
Patients infected with Staphylococcus aureus Methicillin resistance (MRSA):
moxifloxacin is not recommended to treat MRSA infections. In case of suspected infections caused by MRSA, it is recommended to start treatment with appropriate antibiotics.
Children and teenagers:
Due to the adverse effects of moxifloxacin on cartilage in adults. Therefore, contraindicated use of moxifloxacin in children and teenagers under 18 years old.
excipients:
This product contains lactose, so it is necessary to be cautious in patients with rare genetic problems without galactose, lactase deficiency or glucose - galactose.
The effect of drugs on driving and operating machinery
There has been no research on the effect of moxifloxacin on driving and operating machinery. However, fluoroquinolones include moxifloxacin that may cause reactions on the central nervous system (dizziness, transient vision loss), temporary or long -term consciousness (fainting). Patients need advice on the effects of the drug before driving and operating machinery.
Use drugs for women during pregnancy and lactation
pregnancy:
Safety for pregnant women has not been evaluated. Animal research shows that the drug is harmful to the reproductive organs, for people who are not known. Due to the risk of fluoroquinolon causing gravity cartilage degeneration in adult animals and injuries encountered in children using fluoroquinolon, moxifloxacin are not used in pregnant women.
breastfeeding period:
Prelise clinical data shows a small amount of moxifloxacin excreted into milk. Although there is no data on humans, because the risk of fluoroquinolon causes gravity cartilage degeneration in adult animals, so do not use moxifloxacin in nursing women.
Interactive drug
Interaction with other drugs: The effect of the coat extension of Moxifloxacin with some other drugs that can cause extension of QTC, leading to an increased risk of ventricular arrhythmia, including vertices. So contraindicated combination of any of the following drugs with moxifloxacin:
IAA anti -arrhyths (quinidin, hydroquinidin, disopyramid).
Anti -arrhythmia group III (amiodaron, sotalol, dofetilid, ibutilid).
Anti -psychotic drugs (Phenothiazin derivatives, pimozid, Serindol, Haloperidol, SultoPrid).
Three -round antidepressants.
Some antibiotics (Saquinavir, Sparfloxacin, erythromycin V, Pentamidin, anti -malaria drugs, especially halofantrin).
Antihistamine (terfenadin, astemizol, mizolastin).
Other drugs (Cisaprid, Vincamin IV, Bepridil, Diphemanil).
moxifloxacin should be used carefully in patients who are taking drugs that can reduce blood potassium concentration (such as thiazid diuretics and straps, laxative, indented (high -dose), corticosteroids, amphotericin b) or medications that slow down the clinical heart rate slow.
It takes a period of 6 hours between the time of using moxifloxacin and medications containing cation 2 or 3 (antacids containing magnesi or aluminum, didanosin, sucralfate and iron or zinc -containing drugs).
Simultaneously use 400 mg of oral moxifloxacin with activated carbon, drugs - reduce absorption significantly and bioavails decrease by more than 80%. So do not use these two drugs simultaneously.
After taking the drug many times in healthy volunteers, moxifloxacin increases the cmax of Digoxin about 30% without affecting the minimum scope or concentration. Careful when used with digoxin.
In studies conducted in people with diabetes, simultaneous use of oral moxifloxacin with glibenclamid reduces about 21% of the plasma peak concentration of glibenclamid. The combination of glibenclamide and moxifloxacin theoretically can cause mild and transient hyperglycemia. However, the pharmacokinetic changes of glibenclamide do not lead to changes in other parameters (blood sugar, insulin). Therefore, there is no clinical interaction between moxifloxacin and glibenclamide.
Change Inr
In many cases, there is an increase in oral anticoagulant effects in patients with antibiotics, especially fluoroquinolones, macrolid, tetracycline, cotrimoxazol and some cephalosporins. Inflammation and infections, age and general condition of patients are risk factors. In this case, it is difficult to assess the cause of Inr disorders (due to infection or treatment). Prevention should be performed with Inr monitoring, if necessary, adjust the oral anticoagulant dose accordingly. Clinical studies show that there is no interaction after simultaneous use of moxifloxacin with: ranitidin, probenecid, freezing contraceptive pills, functional foods containing calcium, injection morphine, theophylllin, cyclosporin or otraconazole. There is no metabolic interaction via cytochrom P450.
Interaction with food:
There is no interaction between moxifloxacin and food.
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
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