Dexilant 60mg Takeda medicine for gastroesophageal reflux disease (2 blisters x 7 tablets)
Dosage form Box of 2 blisters x 7 tablets
Specifications Dexlansoprazole
Ingredient
| Composition information | Content |
| Dexlansoprazole | 60mg |
Uses
Indications
Dexilant drugs are indicated in the following cases:
The effect of Dexilant capsules 60mg (n = 20) or Lansoprazol 30mg (n = 23) 1 time/day for 5 days on the pH in the stomach 24 hours has been assessed in healthy subjects in a cross -dose, multi -dose study. The results are summarized in Table 1.
Table 1: The pH effect on the stomach for 24 hours on the 5th after using Dexilant or Lansoprazol.
Dexilant capsules 60mg
lansoprazol 30mg
4,55
4.13
71 (17 hours)
60 (14 hours)
The effect of dexansoprazol on serum gastrin has been assessed in about 3460 patients in clinical trials up to 8 weeks and in 1023 patients up to 6-12 months. The average gastrin concentration increases compared to the original while treating with Dexilant cysts 30mg and 60mg. In patients treated for more than 6 months, the average serum gastrin level increased in the first 3 months of treatment and stability during the remaining treatment. The average serum gastrin concentration returns to the level before treatment within a month after stopping treatment.
Gastrin increases can cause increased chromium cells (ECL) cells and increased serum CGA levels. Increased CGA levels can cause false positive results in the diagnosis of endocrine nerve tumors.
Effects on cells like chrom cells (ECL)
There is no report on the hyperlage of the chrom cells of the intestine (ECL) in the gastric biopsy sample obtained from 653 patients treated with slow Dexilant release capsules 30mg, 60mg or 90mg to 12 months. In rats, the daily dose of Lansoprazols is up to 150mg/kg/day during the time of life, observing a significant increase in blood galastin, followed by the proliferation of chrom cells of the intestine and forming a carcinoid tumor, especially in Cai mice. Heart physiological: At the dose 5 times higher than the maximum recommended dose, dexansoprazol does not extend the QT range to any related clinical scale.
pharmacokinetic pharmacokinetics
Double -slow release formula of Dexilant capsule leads to the path of dexansoprazol concentration in plasma over time with two separate vertices, the first peak occurs 1-2 hours after the drug, then the second peak within 4-5 hours (see Figure 1). Dexlansoprazol is eliminated with the sale time of about 1-2 hours in healthy subjects and in patients with gastroesophageal reflux disease (GERD) symptoms. There is no dexansoprazol accumulation after using many doses of Dexilant cysts 30mg or 60mg, 1 time/day although AUCT values (area under the curve) and CMAX (the highest concentration in plasma) of dexansoprazol are slightly higher (less than 10%) on the 5th day compared to day 1.
Figure 1: Sugar of concentration of dexansoprazole in plasma over time after taking 30mg capsules or 60mg of Dexilant, 1 time/day for 5 days in healthy objects.
Dex dynamic pharmacokinetics of dexansoprazol changes, with percentage of variable coefficient value (CV%) for CMAX, AUC and Cl/F greater than 30% (see Table 2).
Table 2: Average pharmacokinetic parameters (variable coefficient (CV%) for subjects on the 5th after using Dexilant
Dosage Mg
cmax ng/ml
auc ng/h/ml
Cl/F liter/hour
30
658 (40%)
n = 44
3275 (47%)
n = 43
11.4 (48%)
n = 43
60
1397 (51%)
n = 79
6529 (60%)
n = 73
11.6 (46%)
n = 41
After using Dexilant 30mg capsules or 60mg oral for healthy subjects and patients with gastroesophageal reflux disease (GERD) symptoms, the average CMAX and AUC values of dexansoprazol increases proportional to the dose.
When Dexilant 60mg capsule particles are blended with water and the dose is used through the nasal -stomach catheter or taken through the cylinder, bioavailability (CMAX and AUC) of dexansoprazol is similar to when Dexilant 60mg is used in the form of an intact capsule.
Effects of food: In studies on the effects of food on healthy subjects using Dexilant capsules under different eating conditions compared to the time of hunger, increasing CMAX in the range of 12% to 55%, increasing the AUC in the range of 9% to 37% and the TMAX varies (in the range from 0.7 hours to an increase of 3 hours).
Distribution
The cohesion with the plasma protein of dexansoprazol is between 96% to 99% in healthy objects and does not depend on the concentration of 0.01 - 20mcg/ml. The distribution volume (VZ/F) after many doses in patients with gastroesophageal reflux disease, esophagus (GERD) symptoms of 40 liters.
Metabolism
dexansoprazol is strongly metabolized in the liver by oxidation, reduction and the next formation of sulfate, glucuronid and glutathion complex substances with non -activity metabolites. Oxidation metabolites formed by the cytochrom P450 enzyme (CYP) include hydroxy -meters mainly by CYP2C19 and oxidation into sulfon by CYP3A4.
CYP2C19 is a polymorphic liver enzyme that shows 3 phenotypes in the metabolism of CYP2C19; The normal metabolic person (*1/*1), the intermediate transformer (*1/mutations) and poor metabolic (mutations/mutations). Dexlansoprazol is a mainly circulating component in plasma regardless of the metabolic condition of CYP2C19. In intermediate metabolic and normal metabolic people of CYP2C19, the main metabolites in plasma are 5 - hydroxy dexansoprazol and its glucuronid complex while in poor metabolic people of CYP2C19, dexansoprazol sulfon are the main metabolites in plasma.
Elimination
After using Dexilant capsules, there is no dexansoprazol in the unchanged form excreted in the urine. After using [14C] dexansoprazol for 6 healthy men, about 50.7% (standard deviation (SD): 9.0%) radioactive radioactive was used in urine and 47.6% (SD: 7.3%) in the fertilizer. Expression clearance (Cl/F) in healthy objects is 11.4 - 11.6 liters/hour in the corresponding appropriate, after 5 days use 30mg or 60mg, 1 time/day.
Before taking Dexilant 60mg Takeda medicine for gastroesophageal reflux disease (2 blisters x 7 tablets)
How to use
Dexilant capsule: Use not related to food. Swallowing the whole tablet, not chewed. For patients with difficulty swallowing capsules, it is possible to open Dexilant capsules and drink with apple sauce as follows: Put a tablespoon of apple sauce in a clean container. Open capsules. Sprinkle intact seeds on apple sauce. Swallowing apple sauce and seeds immediately. Do not chew the seeds. Do not store apple and seeds to use later.
In addition, capsules can drink with water through an oral cylinder or nasal-stomach catheter: Use with water contained in an oral cylinder (Oral Syringe).
Open the capsule and pour the seeds into a clean container of 20ml of water. Draw all the mixture into a cylinder. Shake the cylinder gently to keep the particles from settling. Put the mixture in the mouth immediately. Do not store water and seed mixture to use later. Fill the cylinder with 10ml of water, shake gently and drink. Fill the cylinder again with 10ml of water, shake gently and drink.
Use with water through a nasal -stomach catheter (size ≥ 16 French): Open capsules and pour particles into a clean container of 20ml of water. Draw all the mixture into a cylinder with a catheter. Shake the cylinder gently to keep the particles from settling down and pump the mixture immediately through the nasal - stomach catheter into the stomach. Do not store water and seed mixture to use later. Fill the cylinder again with 10ml of water, shake gently and wash the catheter. Fill the cylinder again with 10ml of water, shake gently and use.
Dosage
recommended dose in adults
Indications
Recommended dose regimen
1 capsule 60mg 1 time/day to 8 weeks
1 capsule 30mg 1 time/day*
1 capsules 30mg 1 time/day for 4 weeks
Dosage in children
Safety and effectiveness of Dexilant in children has not been determined.
It is not recommended to use Dexilant for GERD symptoms for children under 1 year of age because research on this drug group has not proven effective.
Used in the elderly
Not observing the overall difference in safety or effectiveness between elderly patients and younger patients but cannot eliminate higher sensitivity in some elderly people.
kidney failure
Unnecessary adjustment of Dexilant dose in kidney failure patients.
Hepatic failure
Unsurprisingly adjust the doses of Dexilant for patients with mild liver failure (type A). For patients with average liver failure (type B child-pugh), the recommended dose of Dexilant capsules for healing corrosive esophagitis is 30mg once a day to 8 weeks.
No studies have been conducted in patients with severe hepatic impairment (type C); It is not recommended to use Dexilant capsules for these patients.
What to do when overdose? The doses of Dexilant 120mg and a single dose of Dexilant 300mg did not lead to death or other unwanted reactions. However, there has been an unexpected response reporting serious hypertension related to Dexilant doses 60mg, 2 times/day. The non -serious undesirable reactions have been observed with the dose of Dexilant 60mg, 2 times/day including hot bursting, touching, sore throat and weight loss.
dexlansoprazol is not expected to be excluded from circulatory due to hemolysis. If overdose occurs, symptomatic treatment should be treated and supported.
What to do when forgetting the dose? However, if near the next dose schedule, do not use the forgotten dose and take the next dose on time. Do not use two doses at the same time to compensate for the forgotten dose.
Side Effects
The following unwanted effects are described below and the other parts of the instructions for use: interstitial inflammation, cyanocobalamin deficiency (vitamin B12), diarrhea associated with clostridium difficile, fracture, blood magnesium.
Experience from clinical trials
Due to the various conditions for clinical trials, the percentage of side effects observed in the clinical trials of a drug cannot be compared directly to the ratio in the clinical trials of another drug and may not reflect the observation ratio in reality.
The safety of Dexilant capsules is evaluated in 4548 patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least 6 months and 203 patients treated for a year. Patients aged 18-90 years old (average 48 years old) with 54% of women, 85% of whites, 8% of black people, 4% of Asians and 3% of other races. 6 Random clinical trials with control have been conducted to treat corrosive esophagitis (EE), maintain corrosive esophagitis and gastroesophageal reflux disease (GERD) symptoms, including 896 patients using placebo, 455 patients using Dexilant cysts 30mg, 2218 patients using Dexilant capsules 60mg and 1363 patients using 30mg, 1 -day/pp.
Unjust unwanted reactions: The most common undesirable reactions (> 2%) have occurred at a higher percentage for Dexilant capsules compared to placebo in control studies presented in Table 8.
Table 8: Unwanted reaction rate in control studies.
Unwanted reaction
Parentary (n = 896%)
Dexilant
(n = 455)
%
Dexilant
(n = 2218)
%
Dexilant
(n = 2611)
%
Lansoprazol
30mg
(n = 1363
%)
diarrhea
Abdominal pain
Nausea
Above respiratory infection
vomit
flatulence
2.9
3.5
2.6
0.8
0.8
0.6
5,1
3.5
3.3
2.9
2.2
2.6
4.7
4.0
2.8
1.7
1.4
1.4
4.8
4.0
2.9
1.9
1.6
1.6
3,2
2.6
1.8
0.8
1.1
1,2
Unwanted reactions lead to stopping treatment: In control clinical studies, the most unwanted reaction leads to Dexilant's stop treatment is diarrhea (0.7%).
Unexpected reactions are less common
Other undesirable reactions have been reported in controlled studies at less than 2%, listed below by body system:
See the full prescription information of Lansoprazol on unwanted effects not observed with Dexilant.
After -sales experience
The following unwanted reactions have been determined during the process after Dexilant was approved in the US. Because these reactions are voluntarily reported from an unknown scale population group, it is not always possible to always be reliable about the frequency of these reactions or establish a causal relationship with drug use.
Warnings
Contraindicated
Contraindicated use of Dexilant in patients who know how to be too hypersensitivity to any component of the drug. Hypersensitivity reactions, including anaphylactic shock that have been reported (see adverse effects). Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIS), including Lansoprazols that dexansoprazol is optical isomers.
PPIs, including Dexilant contraindicated with drugs containing ripivirin.
Be cautious when taking drugs
The presence of stomach malignancy: response to symptoms with Dexilant does not prevent the presence of malignant stomach disease.
Acute interstitial nephritis: Acute interstitial nephritis has been observed in patients using ppi including Lansoprazol. Interstitial nephritis can occur at any time during PPI treatment and usually due to an idiopathic hypersensitivity reaction. Stop using Dexilant if acute interstitial nephritis develops.
Lack of cyanocobalamine (vitamin B12): Daily treatment with any acid inhibitors for a long time (for example, longer than 3 years) can lead to poorly absorbent cyanocobalamin (vitamin B12) due to little or reduced stomach acid secretion. Rarely reports on cyanocobalamin deficiency occurred when treated with acid inhibitors reported in literature. This diagnosis should be considered if clinical symptoms are suitable for cyanocobalamin deficiency observed in patients treated with Dexilant.
diarrhea associated with Clostridium difficile: Observated studies have published showing treatment with Proton pump inhibitors (PPI) such as Dexilant may come with an increase in the risk of diarrhea related to Clostridium difficile, especially in hospital patients. This diagnostic diagnosis is needed for diarrhea that does not improve. PPIs treated with PPI should use the lowest dose and in the shortest time suitable for the condition of being treated.
Fracture: Some observed studies have published showing that PPI treatment may be accompanied by an increase in the risk of hip, wrist or spine fractures associated with osteoporosis. The risk of increased fractures in patients with high doses is defined as treatment with a daily and long -term doses of proton pumps (one year or longer). PPIs treated with PPI should use the lowest dose and in the shortest time suitable for the condition of being treated. Patients who are at risk of fractures related to osteoporosis should be treated under the established treatment instructions.
Magnesium reduction:
Magnetic, symptomatic and asymptomatic magnesia, which has been reported rare in patients treated with PPI for at least three months, in most cases after one year of treatment. Serious side effects include muscle spasm, arrhythmia and seizures. In most patients, the treatment of blood magnesium reduces requires magnesium supplements and stopped using proton pump inhibitors.
For patients expected to treat prolonged treatment or users of proton pump inhibitors with drugs such as digoxin or drugs that can cause loss of blood magnesium (eg diuretics), medical staff may need to consider monitoring magnesium levels before starting treatment with Proton pump inhibitors and periodic monitoring.
Interaction with determining endocrine nerve tumors:
Chromographin A (CGA) concentration increases in the decrease in the concentration of drugs induced in stomach acid. Increased CGA levels can cause false positive results in diagnosis to identify endocrine nerve tumors. Medical staff should temporarily suspend the treatment of dexlansoprazol for at least 14 days before evaluating CGA concentration and reviewing the tests if the CGA concentration is high.
If tests are conducted in series (for example, for monitoring), similar commercial laboratories should be used for testing, because the scope of reference between tests may vary.
Concomitance of Dexilant with Methotrexate: Y Literature shows that the simultaneous use of ppi with methotrexate (mainly at high doses, seeing the prescription information of methotrexate) can increase and prolong its concentration of methotrexate and/or metabolites in the serum, which can lead to methotrexate poisoning. When using high doses of methotrexate, temporary suspension of proton pump inhibitors in some patients.
affects the ability to drive and operate machinery
dexansoprazol is expected to not adversely affect the ability to drive or operate machinery.
Pregnancy and lactation
Pregnancy
There is no research on using dexansoprazol in pregnant women to show a risk of drug -related. In animal reproductive studies, there is no effect on the development of embryos - fetuses while using dexansoprazol oral oral for rabbits during the formation of the organ at the dose up to 9 times the maximum dose recommended for humans (MRHD) (based on the surface area of the body) or the rabbit and mouse to drink Lansoprazols with the corresponding doses of up to 40 and 16 times MRHD (based on the surface of the body). Dexlansoprazol should only be used carefully for pregnant women and only when necessary.
Breastfeeding period
There is no information related to the presence of dexansoprazol in human milk. However, Lansoprazol and its metabolites are present in mouse milk. The health and growth benefits of breastfeeding should be considered with a clinical need for the mother's Dexilant and with any unwanted effects from Dexilant that may occur in a breastfeeding or from the potential condition of the mother.
Special patient groups
Age (elderly): Dexlansoprazol's last phase selling time increases significantly in elderly subjects compared to younger subjects (in order of 2.2 hours and 1.5 hours). Dexlansoprazol shows that the whole body concentration (AUC) is higher in the elderly (34.5%higher) than the younger subjects.
Sex: In a study of 12 male and 12 healthy female subjects, taking the Dexilant 60mg capsule doses, women exposed to the whole body (AUC) higher (43%higher) than men. The difference in exposure between men and women does not show a significant concern about safety.
Renal failure: dexansoprazol is strongly metabolized in the liver into non -active metabolites and no initial drugs in the urine after a dose of dexansoprazol oral. Therefore, the pharmacokinetics of dexansoprazol are not expected to change in patients with renal failure and no studies have been conducted in renal failure subjects. In addition, the pharmacokinetics of Lansoprazol are not clinically different in patients with mild, medium or severe renal failure compared to healthy objects with normal kidney function.
Hepatic failure: In a study in 12 patients with average liver impairment (Child - PUGH type B) Take a single dose of 60mg of Dexilant capsules of systemic exposure (AUC) of dexansoprazol cohesion and no cohesion with protein about 2 times higher than people with normal liver function. The difference in exposure is not due to the difference in protein cohesion. There is no study conducted in patients with severe liver failure (Child - PUGH type C) (see dosage and usage).
Drug interactions
Clinically related interactions affect drugs simultaneously with Dexilant and interact with diagnostics
antiviral drugs:
The impact of ppis on Retro virus anti -virus drugs is very different. Clinically importance and mechanism behind these interactions are not always known.
Reducing the exposure of some antiviral drugs (e.g. Rilpivirin, Atazanavir, and Nelfinavir) when concurrent use with dexansoprazol can reduce anti -viral effects and promote drug development.
Increasing exposure of other antiviral drugs (eg Saquinavir) when used simultaneously with dexansoprazol may increase the toxicity of antiviral drugs.
There are other antiviral drugs that do not have clinical interactions associated with dexansoprazol.
Medicines containing Rilpivirin: Contraindicated use with Dexilant. View prescribed information.
nelfinavir: Avoid simultaneous use with Dexilant. View prescribed information of antacids for retrovirus for more information.
warfarin:
Inreat Inr and prothrombin time in patients using PPI drugs with Warfarin. Incrowing the Inr and prothrombin time can lead to abnormal bleeding and even death.
Monitor the INR index and prothrombin time. Warfarin dose may be adjusted to maintain the target INR range. View prescribed information of warfarin.
Clopidogrel: Concomitance dexansoprazol and clopidogrel in healthy objects that do not affect clinical significant effects on the concentration of the active metabolites of clopidogrel or platelogram inhibitors due to clopidogrel (see pharmacological). It is not necessary to adjust the clopidogrel dose when used for the approved Dexilant dose.
methotrexate:
Concentrated use of ppi drugs with methotrexate (mainly at high doses) may increase and prolong the concentration of methotrexate and/or hydrogen metabolites in serum, which can lead to methotrexate poisoning. No official drug interaction studies between high doses of methotrexate and ppi drugs are conducted.
Can consider suspension of using Dexilant for patients who are taking high doses of methotrexate.
digoxin:
There is a possibility of increased exposure of digoxin. Monitor Digoxin concentration. Digoxin dose may be needed to maintain medication concentration. View prescription information of digoxin.
Absorbing pharmacokinetic drug depends on gastric pH (for example, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazo l /iTraconazol).
dexlansoprazol may reduce the absorption of other drugs due to the effect of reducing the acidity in its stomach.
Mycophenolat Mofetil (MMF): Concentrated use of PPIs on healthy patients and organ transplant patients using MMF has been reported to reduce exposure to active metabolites, mycophenolic acid (MPa), may be due to reduced mmf solubility at the increased gastric pH level. Clinically related to MPA exposure reduction in transplant waste has not been determined in organ transplant patients using Dexilant and MMF. Be careful when using Dexilant for organ transplant patients being treated with MMF. View prescribed information of the absorption drugs dependent on the stomach pH.
tacrolimus:
There is the ability to increase the exposure of Tacrolimus, especially in organ transplant patients, but the poor metabolize CYP2C19 or medium. Monitor the body blood concentration of Tacrolimus. Tacrolimus's dose may be needed to maintain the concentration of treatment. View prescribed information of tacrolimus.
Interaction with determining endocrine nerve tumors:
Chromographin A (CGA) concentration increases in the decrease in the concentration of drugs induced in stomach acid. Increased CGA levels can cause false positive results in diagnostic identification of endocrine nerve tumors.
Health staff should temporarily suspend the treatment of dexansoprazol for at least 14 days before evaluating CGA concentration and consider repeating tests if the original CGA level is high. If tests are conducted in series (for example, to monitor), similar commercial laboratories should be used for testing, because the scope of reference between tests may be different.
Interaction with stimulating hormone tests:
Increase the gastrin excretion reaction in the hormone stimulation test reaction, giving fake Gastrinoma results.
Temporarily stop treatment with Dexilant at least 30 days before evaluating to give Gastrin's concentration back to the original time.
Fake positive urine test with THC:
There have been reports on fake positive urine screening tests with tetrahydrocannabinol (THC) in patients being treated with PPIs. A replacement method should be considered to verify positive results.
Clinically related interactions affect Dexilant when used simultaneously with other drugs.
CYP2C19 and CYP3A4 induction substances:
Dexlansoprazol's exposure reduction when used simultaneously with strong St. John’s World, Rifampicin: Avoid simultaneous use with Dexilant. Products containing ritonavir: see prescribed information.
CYP2C19 and CYP3A4 inhibitors:
Expected exposure to exposure of dexansoprazol when concurrent with strong inhibitors. Voriconazole: See prescribed information.
Storage
Storage below 30 degrees C. Expiry date: 36 months from the date of manufacture.
Manufacturer: Takeda Pharmaceutical Company Ltd. (Japan).
Registered: Takeda Pharmaceuticals (Asia Pacific) PTE., Ltd.
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