Dexilant 30mg 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 | 30mg |
Uses
Indications
Dexilant 30mg drug is indicated in the following cases:
The effect of Dexilant 30mg (n = 20) or Lansoprazole 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. Effect on the pH in the stomach 24 hours on Thursday after using Dexilant or Lansoprazole
lansoprazole 30 mg
4,55 4.13
71 (17 hours) 60 (14 hours)
The effect of dexansoprazole 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 beginning during the treatment, Dexilant 30 and 60 mg. 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 time, remaining treatment.
Average serum gastrin levels return to the level before treatment within 1 month after stopping treatment.
Gastrin increases, causing increased chromromaffin, ECL) cells and increases serum CGA levels. Increased CGA levels can cause false positive results in the diagnostic test of endocrine nerve tumors.
Collection on chromium -like cells of the intestine (ECU)
There is no report on hyperlage of chromium and intestinal cells (ECL) in the gastric biopsy sample, obtained from 653 patients treated with Dexilant 30, 60 or 90mg to 12 months.
In mice, the daily dosage of Lansoprazole is up to 150mg/kg/day during the time of life, observing a significant increase in blood galastin, followed by increased chromium -like cells of the intestine and forming a carcinoid tumor, especially in Cai mice.
Heart physiological
At 5 times the dose is 5 times higher than the maximum recommended dose, dexlansoprazole does not extend the QT range at any level of clinical significance.
pharmacokinetics
Dexilant's double changing release formula leads to the path of Dexlansoprazole 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. Dexlansoprazole 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 dexansoprazole accumulation after using doses of Dexilant 30mg or 60mg, 1 time/day although the AUC values (area under the curve) and CMAX (the highest concentration in plasma) of Dexansoprazole are slightly higher (less than 10%) on the 5th day compared to the 1st day.Dexlansoprazole's dynamic pharmacokinetics changes, with percentage of variable coefficient value (CV%) for CMAX, AUC and CL/F greater than 30% (see Table 2).
Table 2. The average pharmacokinetics parameters (variable coefficient (CV)%) for the 5th ivory objects after using Dexilant
cmax (ng/ml)
AUC24 (NG-ML/ML)
Cl/F (liters/hour)
30 658 (40%) 3275 (47%) 11.4 (48%) (n = 43) (n = 43)
60
1397 (51%) 6529 (60%) (n = 73) (n = 41)
After using Dexilant 30mg or 60 mg oral for healthy subjects and patients with symptomatic gastroesophageal reflux disease, the average CMAX and AUC values of dexansoprazole increases proportional to the dose.
When Dexilant 30mg particles are mixed with water and the dose is used through the nasal -stomach catheter or taken through cylinder, bioavailability (CMAX and AUC) of Dexlansoprazole is similar to when Dexilant 30mg is used in the form of an intact capsule.
Effect of food
In studies on the influence of food on healthy subjects using Dexilant in 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 of 0.7 hours by up to 3 hours).
Distribution
The cohesion with the plasma protein of dexansoprazole between 96 to 99% in healthy objects and regardless of the concentration of 0.01 - 20mcg/ml. The distribution volume (Vz/F) after many doses in patients with gastroesophageal reflux disease symptoms is 40L.
Metabolism
dexlansoprazole is strongly metabolized in the liver by oxidation, reduction and then forming sulfate, glucuronide and glutathion complexes with non -active metabolites. Oxidized metabolites formed by the cytochrome P450 (CYP) enzyme system include hydroxy meters mainly by CYP2C19 and oxidation into sulfone by CYP3A4.
CYP2C19 is a polymorphic liver enzyme that shows 3 phenotypes in the metabolism of the substrates of CYP2C19, normal metabolic (*1/*1), intermediate metabolaters (*1/mutations) and poor metabolic (mutations/mutations). Dexlansoprazole 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 dexansoprazole and its glucuronide complex while in poor metabolic people of CYP2C19, dexansoprazole sulfone is the main metabolite in plasma.
Excretion
After using Dexilant, there is no dexansoprazole in the form of unchanged excretion in urine. After using [14C] dexansoprazole 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 -11.6L/hour in the corresponding right, after 5 days of use 30mg or 60mg, 1 time/day.
Special patient groups
Group of children's patients
Dexlansoprazole'spharmacokinetics in patients under 12 years of age has not been studied.
Patients aged 12-17
The pharmacokinetics of Dexlansoprazole have been studied in 36 patients from 12 - 17 years old with symptoms of gastroesophageal reflux disease in a multi -central test. Patients are randomly selected to use Dexilant 30mg or 60mg, 1 time/day for 7 days. The average CMAX and AUC of Dexlansoprazole in patients aged 12-17 in the order of 105 and 88%, compared to adults in a dose of 30mg and in order of 81 and 78%, at a dose of 60mg.
Table 3. The average pharmacokinetics parameters (variable coefficient (CV)%) in patients from 12 - 17 years old with gastroesophageal reflux disease - esophagus symptoms on Saturday after using Dexilant 30mg 1 time/day for 7 days
cmax
(ng/ml)
AUCTAU
(ng-ml)
Cl/F
(liters/hour)
30 mg
(n = 17)
691
(53)
2886
(47)
12,8
(48)
60 mg
(N-18)
1136
(51)
5120
(58)
15,3
(49)
The end phase selling time of dexansoprazole is significant in elderly subjects compared to younger subjects (in order of 2.2 hours and 1.5 hours).
Dexlansoprazole shows systemic concentration (AUC is higher in elderly subjects (34%higher) than younger subjects.
Gender
In a study in 12 men and 12 healthy female subjects taking a dose of Dexilant 30mg, women have a higher body concentration (AUC) (43%higher) than men. The difference in concentration between men and women does not show a significant concern about safety.
kidney failure
Dexlansoprazole is strongly metabolized in the liver into non -active metabolites and no initial drugs are recovered in the urine after a dose of dexansoprazole oral. Therefore, the pharmacokinetics of dexlansoprazole are not expected to change in patients with renal failure and no studies have been conducted in kidney failures. In addition, the pharmacokinetics of Lansoprazole are not clinically different in patients with mild, medium or severe renal failure compared to healthy kidney functions.
Hepatic failure
In a study in 12 patients with medium liver failure (type B child-pugh) oral a single dose of 60mg Dexilant, the body concentration (AUC) of dexlansoprazole in the form of cohesion and no cohesion with protein about 2 times higher than those with normal liver function. The difference in this concentration is not due to the difference in cohesion with protein. There is no study conducted in patients with severe hepatic failure (C).
Before taking Dexilant 30mg Takeda medicine for gastroesophageal reflux disease (2 blisters x 7 tablets)
How to use
Take oral use.
Use is not related to food. Drink whole tablets, do not chew.
For patients who are difficult to take capsules, can open Dexilant capsules and drink with apple sauce as follows:
Use with water through a drink:
Table 4. The recommended dose regimen of the Dexilant capsules as prescribed in patients aged 12 and over
Dose Dexilant
time
1 capsule 60mg, 1 time/day.
up to 8 weeks.
1 capsule 30mg, 1 time/day*.
Refrigated studies have not pulled
for 6 months long in adult patients and 16 weeks in patients from 12 - 17 years old.
1 capsule 30mg, 1 time/ivory
4 weeks.
For average liver dysentery patients (B-Pugh type B), the recommended dose is Dexilant 30mg 1 time/day to eight weeks. It is not recommended to use Dexilant in patients with severe hepatic impairment (type C).
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 using overdose? The doses of Dexilant 120mg and a single dose of Dexilant 300mg did not lead to death or other serious adverse events. However, there has been a report on the disadvantage of serious hypertension related to Dexilant doses 60mg 2 times/day. The non -serious adverse reactions have been observed with the dose of Dexilant 60mg, 2 times/day including hot bursting, touching, sore throat and weight loss. Dexlansoprazole is not expected to be excluded from the circulatory due to hemolysis. In case of overdose, symptomatic treatment and supportive treatment.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
When using Dexilant, you may experience unwanted effects (ADR).
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.
The common undesirable 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 5.
Table 5: 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
Unexpected reactions are less common
Other undesirable reactions have been reported in controlled studies at less than 2%, listed below by body system:
Blood disorders and lymphatic systems: Anemia, lymph nodes.
Heart disorders: angina, arrhythmia, slow heartbeat, chest pain, edema, myocardial infarction, chest drum, tachycardia.
Disorders of ears and mesmerizing: Ear pain, tinnitus, dizziness.
Endocrine disorders: goiter.
Eye disorders: eye irritation, eye swelling.
Gastrointestinal disorders: abdominal discomfort, abdominal pain, abdominal stools, abnormalities in the anus, barrett esophagus, stomach object, abnormal intestine, smell breathing, microscopic colitis, colon polyps, constipation, mouth dryness, colitis, indigestion, difficulty swallowing, bowel inflammation, belching, esophagitis, gastritis, gastritis - Gut, gastroesophageal reflux disease (gerd), ulcers and gastric perforation, vomiting blood, bloody stools, hemorrhoids, reducing stomach empty, irritable bowel syndrome, mucus, mucous membranes of blistering, painful defecation, rectal inflammation, intense mouth, rectal hemorrhage, vomiting.
Systemic disorders and medications: Side reactions of drugs, weakness, chest pain, challenge, abnormal sensation, inflammation, mucositis, lymphadenopathy, fever, fever.
Liver disorders: Abdominal pain caused by bile, gallstones, liver.
immune system disorders: hypersensitivity.
Infection and parasitic infection: Candida fungus, influenza, nasopharyngitis, mouth herpes, sore throat, sinusitis, virus infection, vulva - vaginal infection.
Lesions, poisoning and complications due to procedures: falling, fractures, joint sprains, overdose, pain due to tricks, sunburns.
Test: Increase ALP, increase ALT, increase AST, decrease/increase bilirubin, increase blood creatinine, increase blood ga gademin, hyperkemia, hyperkalemia, liver functional abnormalities, decrease in platelets, increase total protein, gain weight.
Metabolic disorders and nutrition: Change appetite, hypercalcemia, hypokalemia.
Disorders of musculoskeletal and connective tissue: joint pain, arthritis, muscle spasm, musculoskeletal pain, muscle pain.
Nervous system disorders: Change taste, convulsions, dizziness, headache, migraine, memory decrease, paresthesia, increased mental activity, tremor, nerve pain tria.
Mental disorders: abnormal dreams, anxiety, depression, insomnia, sexual desire.
Kidney and urinary disorders: difficulty urinating, urinating.
Disorders of reproductive system and mammary glands: menstrual pain, painful intercourse, multiple menstruation, menstrual disorders.
Respiratory disorders, chest and mediastinum: Choking, asthma, bronchitis, cough, shortness of breath, hiccups, deep breathing, respiratory trails, sore throat.
Skin and subcutaneous tissue disorders: acne, dermatitis, erythema, itching, rash, skin damage, urticaria.
vascular disorders: deep vein thrombosis, hot blood, hypertension.
Unwanted additional reactions have been reported in a long -term non -control study 1) and are considered to be related by treatment doctors, including: Anaphylaxis, Hearing virtual, B lymphoma, hyperactitis, central obesity, acute gallbladder inflammation, water loss, diabetes, difficulty pronunciation, orange bleeding, cystic inflammation, gout, gout (herpes zoster) Armor, neutrophils, reduced concentration of average hemoglobin in red blood cells (MCHC), neutrophils, rectal macadosis, restrediant vacuum syndrome, drowsiness, tonsillitis.
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.
Blood disorders and lymphatic systems: autoimmune hemolytic anemia, spontaneous plateletal hemorrhage.
Disorders and mesmerizing: deaf.
eye disorders: blurred vision.
Digestive disorders: edema, pancreatitis.
Systemic disorders and medications: Face edema.
Liver disorders: drugs caused by drugs.
immune system disorders: Anaphylaxis (requiring emergency intervention), flaking dermatitis, Stevens - Johnson syndrome, poisoned epidermal necrosis (some deaths).
Infection and parasitic infection: diarrhea related to Clostridium difficile.
Metabolic and nutrition disorders: Magneta reduction, hypoglycemia.
Disorders of musculoskeletal and connective tissue: fractures.
Nervous system disorders: stroke, transient ischemia.
Kidney and urinary disorders: Acute renal failure.
Respiratory, chest and mediastinum disorders: throat edema, stuffy throat.
Skin and subcutaneous tissue disorders: Body rash, leukemia.
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
Dexilant 30mg contraindications in the following cases:
Precautions when using
The presence of stomach malignancy
In adults, response to symptoms with treatment with Dexilant 30mg does not rule out the presence of malignancy in the stomach. Consider adding monitoring and diagnostic tests in adult patients who respond below the optimal level or early recurrence of symptoms after completing treatment with Proton pump inhibitors, in elderly patients, more endoscopic review.
Acute interstitial nephritis
The acute interstitial nephritis has been observed in patients using proton pump inhibitors including Lansoprazole. Interstitial nephritis can occur at any time during treatment with proton pump inhibitors and often due to a spontaneous hypersensitivity reaction. Stop using Dexilant 30mg if acute interstitial nephritis develops.diarrhea related to clostridium difficile
Published observations showed that proton pump inhibitors such as Dexilant 30mg may be accompanied by an increase in the risk of diarrhea related to Clostridium difficile, especially in hospital patients, which need to consider this diagnosis for non -improved diarrhea.
Patients with treatment, with, proton pump inhibitors should use the lowest doses and during the most suitable time suitable for the treatment.
fracture
Some observed studies have been published, showing that the treatment of proton pump inhibitors may be accompanied by an increase in the risk of hip, wrist or spine fractures associated with osteoporosis. The risk of fractures increases in patients with high doses, which is defined as treatment with a daily and long -term doses of proton pumps (one year or longer). Patients treated with proton pump inhibitors should use the lowest dose and in the shortest time suitable for treatment.
Patients who are at risk of fractures related to osteoporosis should be treated under the established treatment instructions.
Lupus erythematosus on the skin and lupus erythematosus
Lupus erythematosus (CLE) and systemic lupus (SLE) have been reported in patients taking proton pump inhibitors. These events have occurred in the form of new onset and exacerbation of existing autoimmune disease. Most of the lupus erythematosus cases are caused by proton pump inhibitors, which are lupus erythema in the skin. The most common form of lupus in the skin is reported in patients treated with proton pump inhibitors, which is the red -skinned lupus (SCLE) and occurs within a few weeks to a few years after continuous drug treatment in patients from young to the elderly. In general, historical findings are observed without the participation of the agency.
Systemic lupus (SLE) is less common than the skin lupus (CLE) has been reported in patients, taking proton pump inhibitors. Lupus erythematosus systems, concerned about proton pump inhibitors are usually lighter than the systemic lupus system that is not due to drugs. The onset of lupus erythematosus often occurs within a few days to a few years after the beginning of treatment, mainly in patients from young adults to the elderly. Most patients have rash, but joint pain and blood cells have been reported.
Avoid using proton pump inhibitors longer than medical indications. If the signs or symptoms are suitable for the erythema lupus in the skin or the system lupus, the system is recorded in patients who use Dexilant 30mg to stop taking the drug and transfer the patient to the appropriate specialist. Most patients improve when stopping the proton pump inhibitors for 4 - 12 weeks. Serum tests (for example, antibodies (ANA)) may be positive and increased serum test results may take more time to recover than clinical manifestations. Cyanocobalamin deficiency (vitamin B-12)
Daily treatment with any acid inhibitors for a long time (for example, longer than three years) can lead to poorly absorbent cyanocobaiamine (vitamin B12) due to reduced chlohydric gastric acid or deficiency of gastric chlohydric acid. Rare reports on cyanocobalamin deficiency occur when treated with acid inhibitors that have been reported in the literature. This diagnosis should be considered if clinical symptoms are suitable for cyanocobalamin deficiency observed in patients treated with Dexilant 30mg.
Magnesi blood reduction
Magnesi, symptomatic and asymptomatic magnesia, has been reported rare in patients treated with proton pump inhibitors for at least 3 months, in most cases after 1 year of treatment. Serious adverse reactions include muscle spasm, arrhythmia and seizures, in most patients, the treatment of color reduction requires magnesium supplementation and stop use of Proton pump inhibitors.
For patients expected to treat prolonged treatment or those who use proton inhibitors for drugs such as digoxin or drugs that can cause reduced blood magnesium (eg diuretics), health professionals may need to consider monitor monitoring before starting treatment with proton pump inhibitors and periodic monitoring.
The ability to drive and operate machinery
Dexlansoprazole does not have the effect of driving and operating machinery.
Pregnancy
There has been no study using dexansoprazole in pregnant women to show a risk of drug -related drugs. Dexlansoprazole is the r isomers of Lansoprazole, and in observation studies have been published with Lansoprazole in pregnant women, there is no relationship between side effects on pregnant women and the use of Lansoprazole (see data section).
In animal reproductive studies, oral mice lansoprazole oral during the formation process until breastfeeding at 1.8 times the maximum dose is recommended for humans. Dexlansoprazole reduces weight and femoral length, reduces the length of the head - buttocks, reduces the growth of the thickness of the bone (in male mice) on the 21st day after birth (see the data section).
These effects lead to reducing body weight. Pregnant women should be recommended for potential risks to the fetus. It is unclear that the risk of an estimate of heavy birth defects and miscarriage for the population group is indicated. All pregnant women are at risk of birth defects, miscarriage or other side effects. Among the common US population, the risk of an estimate of severe birth defects and miscarriage in cases of pregnancy is clinically recognized in the order of 2 - 4% and 15-20%.
Data
Data on people
dexlansoprazole is the r isomer R of Lansoprazole. The existing data from observations has been published with Lansoprazole in pregnant women does not show the relationship between side effects on pregnant women and the use of Lansoprazole. The methodology limits of these observation studies certainly cannot be established or excluded any drug -related risk during pregnancy.
In a rescue study conducted by European Network of Teratology Information Services, the results obtained from a group of 62 pregnant women used an average dose of 30 mg Lansoprazole/day compared to a control group of 868 pregnant women who do not use bowls for every ego of Proton pump inhibitors (PPI). There is no difference in the rate of large defects between women who use PPI drugs and controlled groups, corresponding to the relative risk level (RR) = 1.04, [reliability (CL) 95% 0.25-4.21].
In a rescue -based rescue team study on all babies born alive in Denmark from 1996 to 2008, there was no significant increase in large birth defects when checking 794 babies born with mothers using Lansoprazole in the first 3 months of pregnancy. In a comparative analysis of 1,530 pregnant women using ppi drugs at least in the first 3 months of pregnancy, with 133,410 pregnant women who do not use PPI drugs, showing no significant increase in risk of birth defects or spontaneous miscarriage due to PPI medication (for birth defects difference ratio (OR) = 1.12, [Cl 95% 0.45] 95% 0.84 -1.97]).
Animal data
A study of embryo - fetal development has been conducted on rabbits with dexlansoprazole oral doses of up to 30mg/kg/day (about nine times the doses of dexansoprazole are recommended for people on the body surface area) during the formation process that shows no effect on pregnancy due to dexansoprazole. In addition, studies on embryo - fetal development have been conducted on rats with oral lansoprazole dose up to 150mg/kg/day (40 times the dose of Lansoprazole to recommend for people on the basis of body surface area) during the formation of organ and rabbit with the dose of oral Lansoprazole orally up to 30mg/kg/day (16 times the dose In the process of forming the agency, there was no impact on fetus caused by lansoprazole.
A study on toxicity in the process of developing and postpartum development, with additional conclusions to evaluate the development of bone is done with oral lansoprazole from 10 - 100mg/kg/day (0.2 -1.8 times the dexansoprazole 60mg dose is recommended for the AUC -based AUC of Dexansoprazole under the regional hygiene curve) Until breastfeeding. The effect on the mother is observed at a dose of 100mg/kg/day (1.8 times the dexlansoprazole 60mg dose is the maximum dose recommended for the AUC -based AUC of Dexlansoprazole) including extending the time of pregnancy and poor appetite.
Cases of fetal death also increased at this dose may be secondary because the mother is poisoned. The body weight of the child is also reduced at a dose of 100mg/kg/day starting from the 11th after birth. Weight and length of the femur, the length of the head - the buttocks are also reduced at the dose of 100mg/kg/day on the 21st day after birth. The weight of the femorism continues to decrease at a dose of 100mg/kg/ivory in the 17-18 weeks of age. The growth of the thickness of the bone is also reduced at a dose of 100mg/kg/day on the 21st day after birth, and increases in the male mouse at 30 and 100mg/kg/day at 17 - 18 weeks of age. Acting on bone indicators leads to reducing body weight.
Breastfeeding period
There is no information related to the presence of dexansoprazole in breast milk, affecting breastfeeding or affecting milk creation. However, Lansoprazole and its metabolites are present in mouse milk. Benefits of the development and health of breastfeeding with the clinical needs of the mother about Dexilant 30mg and with any adverse effects due to Dexilant 30mg can occur in breastfed babies or due to the potential condition of the mother.
Drug interaction
Table 6 and 7 including drugs with important drug interactions and interactions with diagnosis when used simultaneously with Dexilant 30mg and instructions for prevention or treatment of them.
Refer to the labeling information of simultaneous medications to collect more information about interactive with proton pump inhibitors.
Table 6: Clinical interactions affect drugs simultaneously with Dexilant 30mg and interact with the diagnosis
antiviral drugs Retrovirus
The effect of proton pump inhibitors on Retrovirus anti -Retrovirus drugs is very different. Clinically importance and mechanism behind these interactions are not always known.
- Reducing the concentration of some antiviral drugs (e.g. Rilpivirine, Atazanavir and Nelfinavir) when concurrent use with dexansoprazole can reduce antiviral effects and promote drug resistance.
- Increasing the concentration of other antiviral drugs (for example, saquinavir) when concurrent with dexansoprazole may increase the toxicity of antiviral drugs.
- Other antacidors do not lead to interaction with dexansoprazole clinical significance.
Ripivirine products: contraindicated to simultaneously use with Dexilant 30mg (see contraindicated). View prescribed information.
Nelfinavir: Avoid simultaneous use with Dexilant 30mg. View prescribed information of nelfmavir.
saquinavir: View prescribed information of saquinavir and monitor the hidden toxicity of saquinavir.
Other antacids: See prescribed information.
Warfarin Increase the international standardized ratio (INR) and prothrombin time in patients using proton and warfarin inhibitors. Increasing LNR and prothrombin time can lead to abnormal bleeding and even death. Monitor Inr and prothrombin time. Warfarin dose may be adjusted to maintain the target INR range. View prescribed information of warfarin. Concentric use of proton pump inhibitors with methotrexate (mainly at high doses) can increase and prolong methotrexate levels or hydroxymethotrexate metabolites in serum, which can lead to toxicity of methotrexate. No official drug interaction studies between high doses of methotrexate and proton pump inhibitors are conducted (see warning and caution). Can consider suspension of Dexilant 30mg for patients who are taking high doses of methotrexate.
Digoxin
Possible leads to increased concentration of digoxin.
Monitoring Digoxin concentration. Digoxin dose may be needed to maintain medication concentration. View prescription information of digoxin.
Dexlansoprazole may reduce the absorption of other drugs due to its effects that reduce the acidity in the stomach.
Mycophenolate Mofetil (MMF): Concentrated use of proton pump inhibitors on healthy subjects and organ transplant patients using MMF has been reported to reduce the concentration of active metabolites, mycophenolic acid (MPA), may be due to reducing the solubility of MMF in the gastroentric pH. The clinical significance of mpa concentration for transplantation has not been determined in organ transplant patients using Dexilant 30mg and MMF.
See the prescription information of other drugs that the absorption depends on the stomach pH.
tacrolimus
capable of increasing the concentration of Tacrolimus, especially in organ transplant patients who are intermediate metabolic or poor metabolic people of CYP2C19
Monitor the bottom concentration of Tacrolimus in the whole blood. Tacrolimus's dose may be needed to maintain the concentration of treatment. View prescribed information of tacrolimus.
Chromographin A (CGA) concentration increases in the reduction of thick skin acidity due to Proton pump processing. Increased CGA concentration can cause prosthetic results in the examination of hormonal nerve tumors (see warning and caution, clinical pharmacology).
Temporarily suspended treatment with Dexilant 30mg for at least 14 days before evaluating CGA concentration and reviewing the test if the CGA concentration is high. If mass tests (for example, to monitor), should be used with a commercial laboratory for testing, because the scope of reference between tests may be different.
Increasing the gastrin secretion response to the secretine stimulation test, showing the results of the Gastrin (Gastrinoma).
Temporarily suspended treatment with Dexilant 30mg at least 30 days before evaluating to give the initial gastrin level (see clinical pharmacological)
There have been reports on fake positive urine screening tests with tetrahydrocannabinol (THC) in patients being treated with Proton pump inhibitors.
Should consider an alternative method to verify positive results.
CYP2C19 or CYP3A4 induction drugs
Reduce the concentration of dexansoprazole when used simultaneously with strong induction drugs (see clinical pharmacological).
st. John’s World., Rifampin: Avoid simultaneous use with Dexilant.
Expected to increase the concentration of dexansoprazole when using simultaneously with strong inhibitors (see clinical pharmacological).
voriconazole: See prescribed information.
Storage
In a dry place, avoid light, at temperatures below 30 ° C.
Expiry date: 36 months from the date of manufacture. Do not use overdue drugs stated on the packaging.
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