Refix - 550 ATRA treatment of irritable bowel treatment with diarrhea (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Rifaximin
Ingredient
| Composition information | Content |
| Rifaximin | 550mg |
Uses
indications
Refix - 550 drugs are indicated in the following cases:
Rifaximin is applied by attaching to the Beta subunit of the bacterial RNA polymerase of the bacterial DNA, leading to inhibition of bacterial synthesis.
Rifaximin has wide antibacterial spectrum resistant to most gram -positive and gram -negative bacteria, aerobic and anaerobic bacteria.
Because the drug is very poorly absorbed from the intestinal tract, Rifaximin has the effect on the intestinal spot and has no effect against invasive pathogens even sensitive bacteria oninin Vitro.
In the treatment of prevention of recurrence of hepatic brain disease, Rifaximin is thought to be effective on intestinal bacteria.
resistance mechanism
Rifaximin resistance development is mainly due to chromosomal recovery, a change in the gene RNA RNA polymerase encoding of bacteria.
Clinical studies studying changes in the sensitivity of the intestinal bacteria of patients with diarrhea when traveling were unable to detect the appearance of gram -positive bacteria (such as Enterococci) and Gram Yin (E. Coli) during three days of treatment with Rifaximin.
The development of the normal intestinal bacteria has been repeated, high doses of Rifaximin in healthy volunteers and intestinal inflammation patients. The resistance to Rifaximin develops, but is not stable and does not reside in the gastrointestinal tract or replaces sensitive rifaximin strains. When stopping treatment, the anti -drug strain quickly disappeared.
Experimental and clinical data suggests that Rifaximin treatment in patients hidden Mycobacterium tuberculosis or Neisseria meningitidis will not choose resistance to rifampicin.
Pharmacokinetics
absorption
Dynamic pharmacokinetic studies on rats, dogs and people determine that after taking Rifaximin in the α -form form is not absorbed (less than 1%). After using Rifaximin 550 mg single and multi -dose in healthy people, the average time to reach the peak concentration in plasma is about 1 hour. Pharmacokinetic parameters (PK) change a lot and the accumulation rate on AUC is 1.37.
After taking the dose of rifaximin repeated in healthy volunteers and patients with boweled mucosa (bowel inflammation), rifaximin levels in plasma are negligible (less than 10 ng/ml). An increase in the absorption of rifaximin body is not correlated in terms of clinically recorded when using rifaximin within 30 minutes after a high -fat meal.
In patients with hepatic brain disease, the peak concentration of rifaximin in plasma is 13.5 ng/ml after using Rifaximin 800 mg x 3 times/day for 7 days. The amount of drug found after 7 days below 0.1% of the dose.
Patient's pharmacokinetics parameters with a history of hepatic brain disease are evaluated after using Rifaximin 550 mg 2 times/day. Mobile pharmacokinetic parameters change and exposure to the average Rifaximin (AUCτ) in patients with a history of hepatic brain disease (147 ng.He/ml) about 12 times higher than healthy volunteers after using the regimen with the same dose (12.3 people/ml). When the pharmacokinetics parameters are analyzed based on the classification of Child - Pugh A and B, AUCτ is 10 times higher than the corresponding and 13 times compared to healthy objects.
Distribution
Rifaximin is mounted on average to the plasma protein in humans. In Vivo, the average protein ratio is 67.5% in healthy subjects and 62% in patients with liver failure when using Rifaximin 550 mg.
Metabolism
Research on the balance of the block on healthy volunteers suggest that the amount of Rifaximin has been absorbed through the metabolism process with the minimum amount of elimination through the kidneys in the form of constant drugs. The enzyme is mainly responsible for unknown rifaximin transformation.
Elimination
Rifaximin is almost excreted in feces.
In a block of block balancing, after taking 400 mg of rifaximin attached 14C in healthy volunteers, out of 96.94% of the drug is rediscovered, 96.62% of radioactive drugs are rediscovered in the fertilizer mainly in the form of constant drug and 0.32% of the drug found in urine is mostly metabolites with 0.03% in the form of unchanged drugs. Rifaximin accounts for 18% of the radioactive activity in plasma.
Before taking Refix - 550 ATRA treatment of irritable bowel treatment with diarrhea (3 blisters x 10 tablets)
How to use
Take oral use. Drink with water with or not with food.
Dosage
Adults
Incarnation syndrome with diarrhea: The recommended dose of Refix 550 takes 1 tablet/time, 3 times a day in 14 days. Patients with recurrent symptoms may continue to treat twice as long as the same dose regimen.
Hepatitis: The recommended dose of Refix 550 takes 1 capsule/time x 2 times/day.
Children
Safety and effectiveness of Refix 550 mg in children (under 18 years old) has not been set up.
Elderly
No need to adjust the dose in the elderly because the safe and effective data of the Refix 550 mg shows no difference between the elderly and young patients.
Hepatic failure
No dose adjustments in patients with hepatic failure.
kidney failure
There is no data on changing the dose in patients with renal failure, need to be cautious when used in patients with renal impairment.
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?
In cases of overdose, recommendations on symptoms and supportive treatment.
In an 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 Refix - 550, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Not common, 1/1000 Difficult, intense urine. Rare, 1/10000 proteinuria. 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
Refix drugs - 550 contraindicated in the following cases:
Be cautious when using
used in children
Safety and effectiveness of rifaximin to prevent recurrence of brain disease has not been set in patients under 18 years old.
Used in the elderly
In control of Rifaximin control in patients with hepatitis, 19.4% of patients aged 65 and older, while 2.3% of patients aged 75 and older. There is no difference in safety and effectiveness recorded between these objects and younger people, and clinical experiences that have not reported the difference in response between the elderly and young people but not eliminating the increased sensitivity in some elderly people.
diarrhea caused by Clostridium difficile
diarrhea caused by Clostridium difficile has been reported when using most antibiotics including rifaximin, the degree of change from mild diarrhea to death. Antibiotic treatment changes the intestinal bacteria and can lead to excessive proliferation of C. Difficile.
c. Difficile produces toxin A and B that contributes to diarrhea caused by C. Difficile. The strains C. Difficile produces excessive toxins that cause increased disease or death from these infections may persist when treated with antibiotics and may need intestinal cutting. Diarrhea due to Clostridium difficile should be considered in all patients with diarrhea after using antibiotics. It is necessary to record the history of diarrhea by C. Difficile that has been reported for more than 2 months after taking antibiotics.
If doubtful or certain diarrhea is caused by C. Difficile, it is necessary to stop using antibiotics that are used and that antibiotic does not have C. Difficile. It is necessary to infusion and electrical explanation, protein supplement, antibiotic treatment C. Difficile and assessment of clinical surgery.
kidney failure
There is no clinical data on the use of Rifaximin in patients with renal failure.
Patients with severe liver failure (Child - Pugh C)
Increased body exposure in patients with liver failure. Clinical trials are limited to patients with MELD score
Development of anti -drug bacteria
Develop anti -drug bacteria including Staphylococcus aureus if the patient is exposed to long -term rifaximin. Rifaximin resistance strains are also resistant to rifampicin. Therefore, it is not recommended to use Rifaximin in patients who are less likely to develop a late -stage liver disease or patients who have a good response to alternative drugs.
The ability to drive and operate machinery
dizziness has been reported in controlled clinical trials. However, Rifaximin has a significant impact on the ability to drive and operate machinery.
Pregnancy
Preceptic research of Rifaximin drug/metabolic substance through the placenta has not been done.
The period of breastfeeding
It is unknown whether Rifaximin/its metabolites are excreted into human milk or not. The risk of children has not been excluded. Should decide to stop breastfeeding or stop rifaximin depending on the benefits of breastfeeding compared to the benefits of treatment for the mother.
Drug interaction
Due to negligible absorption from the digestive tract after taking Rifaximin, the risk of interactive body is low.
In vitro research shows that Rifaximin does not inhibit the iszyme cytochrom P450 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 and CYP3A4 at a concentration of up to 200 ng/ml (at least 10 clinical cmax times). Rifaximin does not inhibit these enzymes when used on clinical use.
In In Vitro research, Rifaximin causes CYP3A4 induction, but in patients with normal liver function, Rifaximin at the recommended dose does not cause CYP3A4 induction. It is not known that Rifaximin has a significant influence on the pharmacokinetics of the substrates of CYP3A4 simultaneously used with rifaximin in patients with impaired liver function whether or not the increase in Rifaximin concentration.
Due to the influence on the intestinal microorganism system, the effectiveness of oral oral contraceptives can be reduced after using rifaximin. However, it is recommended to use additional contraceptives, especially when estrogen content is below 50 mg.
Storage
Store in cool dry places below 30 ℃. Avoid light.
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