Dafrazol Traphaco treatment and prevention of peptic ulcer, reflux esophagitis (14 tablets)
Dosage form Box of 14 tablets
Specifications Omeprazole
Ingredient
| Composition information | Content |
| Omeprazole |
Uses
Indications
Dafrazol is indicated in the following cases:
For people:
For children from 2 years and older and weighs over 20kg:
For children over 4 years old and weighs over 30kg:
Combined with antibiotics to treat peptic ulcer caused by H. pylori.
Pharmacokology
omeprazol is an inhibitor of the acid secretion of the stomach due to inhibiting the enzyme system hydrogen/potassium adenosin triphosphatase (H+/K+ ATPase), also known as the proton pump in the stomach cell wall. Take a single dose of 20mg of omeprazole to create a strong and effective gastric acid excretion inhibition. The maximum effect is achieved after 4 days of treatment. In patients with duodenal ulcer, it is possible to maintain a 80% reduction in gastric acid in 24 hours.
Omeprazole can inhibit Helicobacter pylori bacteria in patients with colitis or reflux esophagitis infected with this bacterium. Combining omeprazol with some antibiotics (such as Clarithromycin, amoxicilin) can eradicate H. pylori attached to ulcers and remission for a long time.
pharmacokinetics
The drug is formulated in the form of small particles in the intestine, quickly absorbed and reached the peak concentration in plasma after 1-2 hours. The drug is completely absorbed in the small intestine after drinking for 3 to 6 hours. Food does not affect the absorption of the drug. Oral bioavailability at a single dose of about 40% and increased by about 60% when used repeated daily.
The apparent distribution of the drug is about 0.3L/kg of weight. The drug is attached to about 97% to plasma proteins.
After absorbing omeprazol is almost completely transformed in the liver by the cytochrom P450 enzyme system. The metabolites are not active and are excreted mainly through urine (about 80%) and partially in the feces. Although Omeprazol has half a lifetime in plasma shorter than 1 hour, the drug has a long effect (due to the prolonged attachment of the drug to H+/ K+ ATPASE). So it is possible to use the drug only one day. Omeprazol is completely eliminated from blood between the doses and does not tend to accumulate during drug use.
People with impaired liver function: The metabolism of omeprazol is impaired, leading to bioavailability, but not accumulating drugs and chemicals in the body.
Persons impaired renal function: bioavailability and unchanged excretion speed.
Elderly: Metabolic speed is somewhat impaired in the elderly (from 75 - 79 years old).
Children: During treatment with recommendations for children from 1 year of age, the concentration of drugs in plasma is similar to adults. In young children under 6 months, the clearance of omeprazol is low due to low metabolism.
Before taking Dafrazol Traphaco treatment and prevention of peptic ulcer, reflux esophagitis (14 tablets)
How to use
Oral drugs.
Should drink in the morning, best not used with food, swallowing the whole tablet with half a glass of water. Do not chew or crush capsules.
For patients with difficulty swallowing and children, it is possible to open the capsule, mix the drug seeds with water or juice then swallow with half a glass of water, pay attention to use immediately (or within 30 minutes) and not chew the drug seeds.
Dosage
with adults
Treatment of stomach ulcers
Take 1 capsule/day for 4 weeks. Continue for 4 weeks if not completely healed. For patients with poor response: Take 2 capsules/day for 8 weeks.
Treatment of duodenal ulcer
Take 1 capsule/day for 2 weeks. Continue for 2 weeks if not completely healed. For patients with poor response, take 2 capsules/day for 4 weeks.
Prevention of recurrence of stomach ulcers - duodenum
Take 1 tablet/day (may increase to 2 tablets/day if necessary).
Coordinate with antibiotics to eradicate H. pylori in stomach - duodenal ulcer.
Coordinate with antibiotics in the treatment regimen, of which the dose of the drug is: Take 2 tablets/day divided into 1-2 times. These ways for 1 week.
If the patient is still positive for H. pylori. Repeat treatment regimen.
Treatment and prevention of stomach - duodenal ulcer due to nonsteroidal anti -inflammatory drugs
Treatment: Take 1 tablet/day for 4 weeks. If not completely healed, continue treating for another 4 weeks.
Prevention: Take 1 capsule/day.
Treatment of reflux esophagitis
Take 1 capsule/day for 4 weeks. Longer treatment if not completely healed.
Case of serious illness: Take 2 capsules/day for 8 weeks.
Treatment of symptoms of gastroesophageal reflux disease
Treatment: Take 1 tablet/day. Need to monitor if the symptoms have not been controlled after 4 weeks.
Treatment of Zollinger - Ellison syndrome
Starting dose: 3 tablets/day. Adjust the dose if necessary but with a dose of over 80mg (4 tablets) must be divided into 2 times/day.
with children 2 years and older and weighs over 20kg
Treatment of reflux esophagitis
Take 1 tablet/day, may increase to 2 capsules/day if necessary.
Treatment time: 4 - 8 weeks.
Treatment of heartburn and acid reflux in gastroesophageal reflux disease
Take 1 tablet/day, may increase to 2 capsules/day if necessary.
Treatment time: 2 - 4 weeks.
Need to monitor if the symptoms are not controlled.
with children over 4 years old and weighs over 30kg
Combined with antibiotics in the treatment of peptic ulcer caused by H. pylori.
Coordinate with antibiotics in the treatment regimen, of which the dose of the drug is: Take 2 tablets/day divided into 2 times. These ways for 1 week.
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? According to the literature, the dose of up to 560mg has been described, and according to some reports received when the dose is up to 2400mg (120 times the treatment dose), symptoms of overdose are: nausea, vomiting, dizziness, abdominal pain, diarrhea and headache, in addition to indifference, depression. confused. Symptoms of fleeting and no serious consequences.
How to treat: Symptomatic treatment if necessary.
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 Dafrazol, you may experience unwanted effects (ADR).
Agency system, frequency meet
Unwanted effects
leukopenia, platelet reduction.
Loss of granulocytes, reducing all blood cells.
immune system disorders Hypersensitivity reactions: fever, angioedema, anaphylactic shock Hemorrhage reduction.
unknown Hypergenia, severe blood magnesium, which can lead to hypocalcemia. Hypergeniasis may also be associated with hypokalemia.
Insomnia.
Anxiety, confusion, depression.
agitated, hallucinations.
Headache.
Dizziness, paresthesia, drowsiness.
Flavor disorders.
blurred vision.
Dizziness.
Bronchospasm. Abdominal pain, constipation. Diarrhea, flatulence. Nausea/ vomiting. dry mouth, stomatitis, gastrointestinal candidiasis.
unknown Micro colitis.
liver enzyme.
Hepatitis with or without jaundice.
Hepatic failure, cerebral disease in people with liver failure.
Dermatitis, back, rash, urticaria. Hair loss, light sensitivity.
Diverse roses, Steven - Johnson syndrome, poisoned epidermal necrosis.
unknown LUPUS Red Red Reds. Broken hip, wrist or spine. joint pain, muscle pain.
weak muscle.
Interstitial nephritis.
Female mammary glands in men.
Fatigue, peripheral edema. Increase sweating.
Notify the doctor with unwanted effects when taking the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Dafrazol drugs are contraindicated in the following cases:
Precautions when using
before taking the drug for people with stomach ulcers, it must eliminate malignant tumors (the drug can cover symptoms, so it is late to diagnose).
Concentrated with Atazanavir is not recommended, but if it is required to use combining, clinical monitoring when increasing the dose of Atazanavir to 400mg with ritonavir 100mg, omeprazol dose should not exceed 20mg (1 tablet).
Use Omeprazol reduces the absorption of vitamin B12 ..
Concentrated use Omeprazol with metabolic drugs through CYP2C19. It is necessary to consider the risk of drug interaction, such as the interaction of omeprazol and clopidogrel.
Severe blood magnesium is reported in patients using proton pump inhibitors such as omeprazol for at least 3 months and many cases in 1 year. Symptoms of blood magnesium such as fatigue, muscle spasm, delirium, convulsions, ventricular rhythm disorders may occur but they catch silent oil and are overlooked. To improve this disorder, need magnesium supplements and stop using proton pump inhibitors.
For patients with prolonged treatment or medication with digoxin or medication that causes blood magnesium, it is advisable to consider due to blood magnesium levels before starting and periodically during treatment.
High doses and prolonged doses (over 1 year), the risk of hip, wrist and spine fractures may be increased, mainly in the elderly or when there are risk factors. Patients at risk of osteoporosis should be concerned and supplemented with vitamin D, calcium.
Proton pump inhibitors are related to the rare case of the expedition of lupus, if the injury occurs, it is necessary to seek medical help and consider stopping the drug.
Stop treatment with omeprazol at least 5 days before measuring Chromographin A (endocrine nerve tumor test) to avoid the effect of test results.
Some children with chronic diseases may need long -term treatment, although this is not recommended.
Omeprazole may increase the risk of gastrointestinal infections.
When using long -term treatment, especially when exceeding 1 year, patients should be monitored regularly.
The drug uses sucrose excipients, therefore, patients with rare genetic problems are free-intolerant, Glucose-Galactose or deficient enzyme Sucrase-isomaltase should not use this drug.
The ability to drive and operate machinery
Omeprazol does not affect the ability to drive or operate machinery. However, the harmful reactions of drugs such as dizziness and visual disorders may occur, then patients should not drive or operate machinery.
Pregnancy
Omeprazol may be used during pregnancy. Results of 3 studies studies (with more than 1,000 exposure results) showed no side effects of omeprazol to pregnancy or to the health of the fetus and babies.
Breastfeeding period
Omeprazol is excreted into breast milk but does not have the ability to affect breastfeeding when using the dose level.
Drug interaction
The effect of omeprazol on pharmacokinetics of other active ingredients
The active ingredients absorb depends on the pH
A decrease in stomach acid concentration during treatment with omeprazol may increase or reduce the absorption of the active ingredients that depend on the stomach pH.
nelfinavir, Atazanavir: plasma concentrations of Nelfinavir and Atazanavir decrease when used simultaneously with omeprazol.
Use of omeprazol combination with nelfinavir is contraindicated. The use in combination with omeprazol (40mg once daily) reduces the absorption of Nelfinavir 40% and the absorption of metabolites with M8 75 - 90% activity. This interaction may be related to CYP2C19 inhibition.
It is recommended not to use omeprazol simultaneously and Atazanavir. Simultaneous use Omeprazol (40mg once daily) and Atazanavir 300mg/ritonavir 100mg in volunteer, the result reduces 75% of Atazanavir absorption. Increasing the dose of Atazanavir to 400mg does not compensate for the effects of omeprazol on the absorption of Atazanavir. Simultaneous use of omeprazol (20mg once a day) with Atazanavir 400mg/ritonavir 100mg in healthy volunteers shows a reduction of about 30% of Atazanavir absorption compared to the dose of Atazanavir 300mg/Ritonavir 100mg once daily.
Digoxin: Concomitant treatment with omeprazol (20mg daily) and Digoxin in healthy people increase the bioavailability of 10%Digoxin. The toxicity of digoxin is rarely reported. However, be cautious when using high -dose omeprazol in the elderly. Tracking treatment for digoxin should be strengthened.
Clopidogrel: Research results in healthy people show that pharmacokinetic/pharmacokinetic interaction between clopidogrel (loaded dose of 300mg/maintenance dose 75mg daily) and omeprazol (oral daily dose of 80mg) leads to reduction in the active metabolic exposure of clopidogrel average 46%. and reduce the maximum platelet aggregation inhibition (caused by ADP) on average 16%. Data is inconsistent with the clinical impact of Omeprazol's pharmacokinetics/pharmacokinetics for the main cardiovascular events that have been reported from observation and clinical studies. To prevent, should not be used simultaneously omeprazol and clopidogrel.
Other active ingredients: the absorption of Posaconazole, Erlotinib, Ketoconazole and Itraconazole significantly decreased and therefore clinical effects may be impaired. Avoid simultaneous use with Posaconazol and Erlotinib.
The active ingredients metabolized by CYP2C19
Omeprazol is a medium inhibitor CYP2C19 - the main metabolic enzyme of omeprazol. Therefore, the metabolism of active ingredients used simultaneously metabolized by CYP2C9, may be reduced and the system exposure of these substances increases. Examples of such drugs are R-Warfarin, anti-vitamin K. Cilostazol, Diazepam and Phenytoin.
cilostazol: Omeprazol, used at a dose of 40mg in healthy people in a cross -sectional study, increasing CMAX and AUC of Cilostazol 18% and 26% respectively, and one of the metabolites of 29% and 69%.
Phenytoin: Monitoring phenytoin concentration in plasma recommended in the first 2 weeks after starting treatment with omeprazol, and if adjusting phenytoin dose, monitoring and continuing the dose adjustment will take place until stop treatment with omeprazol.
Cases of unknown mechanisms
Saquinavir: The use of omeprazol combination with saquinavir/ritonavir leads to an increase in plasma saquinavir concentration in approximately 70% related to good tolerance in HIV -infected patients.
tacrolimus: Concomitant use with omeprazol has been reported to increase the concentration of tacrolimus in serum, need to increase monitoring of tacrolimus concentration as well as kidney function (creatinine clearance), and tacrolimus dose is adjusted if necessary.
Methotrexate: When used in combination with proton pump inhibitors, methotrexate levels are reported to increase in some patients. When using high doses of methotrexate, it is necessary to consider stopping the temporary omeprazol.
Effects of other active ingredients on omeprazol pharmacokinetics
CYP2C19 or CYP3A4 inhibitors: Because Omeprazol is metabolized by CYP2C19 and CYP3A4, the active ingredients inhibitors CYP2C19 or CYP3A4 (such as Clarithromycin and Voriconazol) can lead to an increase in the concentration of omeprazol in serums by reducing the speed of Omeprazole transformation. The coordination treatment with voriconazole leads to doubling the level of omeprazol exposure. Measuring high dose Omeprazol is well eliminated, the adjustment of omeprazol dose is unnecessary. However, it is necessary to consider adjusting the dose in patients with severe liver failure and if indicated for long -term treatment.
CYP2C19 or CYP3A4 induction substances: CYP2C19 or CYP3A4 induction substances or both (such as rifampicin and st John’s Wort) can lead to reduced plasma omeprazol levels by increasing the speed of omeprazol metabolism.
Storage
Leave a cool place, avoid light, temperature below 30⁰C
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