Mesulpine 20mg Yooyoung tablets treat gastroesophageal reflux disease (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Rabeprazole

Ingredient

Composition information	Content
Rabeprazole	20mg

Uses

indicated

Mesulpine Tab 20 is indicated in the following cases:

Treatment gastroesophageal reflux disease , gastrointestinal ulcers, duodenum and Zollinger - Ellison syndrome.

ATC code: A02BC04.

rabeprazol is a benzimidazole conductor, which inhibits proton pumps, belonging to a group of compounds that reduce gastric acid secretion. Rabeprazole has the effect of inhibiting basic gastric secretion and in stimulating state, without acetylcholin resistant properties or H2 h2, H+/K+ - Atpase - Atpase in the cells of the stomach mucosa. This enzyme is considered an acid, hydrogen or proton pump in the cell so Rabeprazol is considered a proton pump inhibitor.

rabeprazol is attached to this enzyme to prevent the final stage of gastric secretion. In Rabeprazol stomach walls are protonized and converted into active sulfenamid and then attach to the cysteine of the proton pump that makes this enzyme inactivated.

After taking 20 mg of sodium Rabeprazol, the effect of inhibiting gastric acid secretion will appear within 1 hour, maximum effect within 2-4 hours. The ratio of basic acid secretion and acid secretion due to food stimulating at 23 hours after taking the first dose is 69% and 82% respectively. Inhibiting time can last up to 48 hours. The effect of inhibiting acid secretion increases slightly at a daily dose once and reaches a stable level after 3 days of medication.

Acid secretion returns to normal after 2-3 days of stopping the drug. Acid reduction due to any cause, including rabeprazol, will lead to increased normal bacteria in the stomach - intestines, increasing the risk of gastric - intestinal infections with Salmonella, Campylobacter and Clostridium difficile.

For Helicobacter pylori, Rabeprazole can inhibit this bacteria in people with duodenal ulcer or reflux due to esophagitis when infected, possibly because the drug has been attached to bacteria inhibiting the activity of urease. Rabeprazol combination with 1 or more antibiotics such as clarithromycin, amoxicillin can increase the effectiveness of h. pylori infection.

In patients using Rabeprazol 10 - 20 mg daily for a period of up to 43 months, serum gastrin levels in the first 2-8 weeks show that Rabeprazol has the effect of inhibiting acid secretion and gastrin levels that maintain stable if the treatment continues.

Gastrin levels will return to the value before treatment within 1-2 weeks of using the drug. Gastric pH increases (due to stomach acid secretion inhibitors) increases the production of chromium granulocytes (ECL - Cell). Although the rats have carcinon lesions, people have used Rabeprazol for up to 1 year, so far has not seen adenoma dysplasia.

Dynamic pharmacokinetics

After taking sodium rabeprazol, the blood concentration in the blood is achieved after 2-5 hours, the half -life of plasma cancel from 1-2 hours. The bioavailability of sodium Rabeprazol dose by oral by 52% of intravenous injection. The cohesion ratio of sodium Rabeprazol with plasma protein is about 96.3%. Sodium Rabeprazol is metabolized in the liver by the Cytocrom P450 3A system (for sulfon metabolism) and at Cytocrom P450 2C19 (for Desmethyl Rabeprazol metabolism).

Used by oral about 90% of the drug is eliminated through urine in the form of metabolism of carboxylic acid, glucuronid and mercapturic acid, the metabolic form of sodium rabeprazol is also detected in the feces. No metabolic detection of sodium rabeprazol in urine as well as in stool. There is no evidence of the accumulation of sodium rabeprazol.

In patients with renal impairment such as end -stage renal failure, dialysis patients (Creatinine clearance ≤ 5 ml/min/1.73 m2) or patients with renal impairment do not progress severe when using rabeprazol with doses like healthy people show that AUC and CMAX are lower than the corresponding parameters in healthy volunteers about 35%. The sale time of normal people is 0.82 hours and the patient in dialysis is 0.95 hours during the separation and 3.6 hours after the separation.

In patients with liver failure

After a dose of 20 mg of sodium Rabeprazole for patients with mild to moderate liver failure, AUC doubled and had T1/2 of Rabeprazol increased by 2-3 times higher than healthy volunteers. However, after 7 days at a dose of 20 mg daily, AUC increased by 1.5 times and CMAX increased to 1.2 times and T1/2 of Rabeprazol in these patients was 12.3 hours.

In the elderly

Eliminating Rabeprazol has somewhat decreased in the elderly. After 7 days of taking the drug at a dose of 20 mg of sodium Rabeprazol daily, AUC has nearly doubled, CMAX increased by 60% and T1/2 increased to about 30% compared to healthy volunteers. However, there is no evidence of the accumulation of rabeprazol in this group.

Before taking Mesulpine 20mg Yooyoung tablets treat gastroesophageal reflux disease (2 blisters x 14 tablets)

How to use

oral medication. Use as directed by the treating doctor. Take the drug in the morning, before meals, should take the pills, do not chew or remove the pills.

Dosage

Adults, the elderly

Review esophagus: 20 mg/day, used for 4 - 8 weeks.

Gastric ulcer, duodenum: 20 mg/day, used for 4 weeks.

Zollinger - Ellison syndrome: 60 mg/day, adjust the dose depending on the pathology.

Thinkle renal and liver function

No need to adjust the dose in patients with renal and medium and mild liver function.

Use in children

Do not use for children, due to the safety of using sodium rabeprazol for children who have not been determined (there are no complete clinical trials).

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 using overdose? Unwanted effects are usually mild and can stop when stopping the drug. Sodium Rabeprazol is closely linked to plasma, ineffective hemorrhage in the exclusion of sodium rabeprazol.

In case of an overdose, it is necessary to monitor symptomatic and complementary treatment.

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 Mesulpine Tab 20 you may experience some unwanted effects (ADR).

Common, 1/100

Infection and parasitic infection: infection.

Mental: Insomnia.

nerve: headache, dizziness.

Respiratory, mediastinum and chest: cough, sore throat , rhinitis.

digestive: diarrhea, nausea, vomiting, abdominal pain, constipation, flatulence.

Muscle muscle, connective tissue: Non -specific pain, back pain.

Systemic: weakness, influenza syndrome.

Uncommon, 1/1000

Mental: restlessness.

Respiratory, mediastinum and chest: bronchitis , sinusitis.

digestive: indigestion, dry mouth, belching.

Skin and subcutaneous tissue: Red rash.

Muscle muscle, connective tissue: muscle pain, bumping legs, joint pain.

kidney - Urinary tract: Urinary tract infection . Systemic: chest pain, chills, fever.

Testing: increased liver enzymes.

Instructions on how to handle ADR

Unwanted effects such as abdominal pain, diarrhea, headache, fatigue are often over when continuing treatment, rarely have to stop the drug. Other symptoms if prolonged to stop the drug or transfer to other drugs.

Warnings

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

Contraindicated

Mesulpine Tab 20 Contraindications in the following cases:

Patients with sodium rabeprazol or any ingredients of the drug.

Pregnant and lactating women.

Be cautious when using

When suspected stomach ulcers, it is recommended that the possibility of malignant disease because treatment can reduce symptoms and hinder the diagnosis of the disease.

Do not use for children because there is no experience to use.

Be cautious when using rabeprazol because there is a risk of hypersensitivity reactions to other proton pump inhibitors or benzimidazol derivatives when used instead.

Be cautious when indicating Rabeprazol for the first time for patients with severe liver failure due to the lack of clinical data.

Treatment of using proton pump inhibitors, including Rabeprazol, may increase the risk of gastrointestinal infections with Salmonella, Campylobacter and Clostridium difficile.

Do not only combine Sodium Rabeprazol with Atazanavir, do not use Rabeprazol for patients with Galactose intolerance due to genetics, deficiency of lapp lactose or impaired absorption of glucose, galactose.

Observing research that the use of high -dose proton pump inhibitors and for a long time (over 1 year) increases the risk of fractures by 10-40%, so patients at risk of osteoporosis when taking the drug for a long time should supplement calcium, vitamin D and pay attention to activity, exercise to avoid the risk of fracture.

Serious Magnesi has been reported when treated with proton pump inhibitors for 3 months or more with symptoms such as fatigue, dizziness, delusion, convulsions, sometimes ventricular disorders, these symptoms are often overlooked by patients. This condition can be improved when stopped and added Magnesi.

The ability to drive and operate machinery

The unwanted effect of sodium Rabeprazol can cause headaches, weakness, fever. Therefore, if indicated for sodium rabeprazol, patients should avoid driving and operating machinery.

Pregnancy

There is no specific study of Rabeprazol's safety for pregnant women. Animal studies do not see the fetus at the usual doses. However, animal studies cannot predict all the results in humans. Hence contraindicated for pregnant women.

The period of breastfeeding

Contraindications for breastfeeding women because they do not know if Rabeprazol does not know whether or not to excrete in milk. No research has been conducted on nursing mothers. However, rabeprazol is secreted into mouse milk.

Drug interaction

Sodium Rabeprazole inhibits cyclosporin metabolism, resulting in an increase in plasma cyclosporin levels. Research on volunteers shows that cyclosporin levels are higher than normal concentrations after 14 days of use of 20 mg of sodium rabeprazol. Sodium Rabeprazol reduces gastric acid secretion so it will affect the absorption drugs depending on the stomach pH.

When used simultaneously with sodium Rabeprazol, the bioavailability of ketoconazole decreases by about 30%, while the area under the curve (AUC) and the maximum concentration (CMAX) of Digoxin increases by 19%and 29%respectively. Rabeprazole may reduce the absorption of ketoconazole or otraconazole, so if you need to monitor the adjustment of ketoconazole or iTraconazole.

When concurrent use of Atazanavir 300 mg/ritonavir 100 mg along with sodium Rabeprazol single dose only 40 mg/day or Atazanavir 400 mg with a single dose Lansoprazol 60 mg/day on healthy volunteers shows strong reduction in acanavir levels. Although it has not been studied, it is thought that the phenomenon also occurs with other proton pump inhibitors, so it does not simultaneously use proton pump inhibitors, and Rabeprazol with Atazanavir.

There have been reports when using proton pump inhibitors with methotrexate (mainly high doses), which may increase the concentration of methotrexate and/or hydrogen metabolites, increasing the unwanted effect of this drug.

Storage

Store in closed packaging, in a cool, dry place, avoid light, at temperatures below 30 ° C.

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