Kapidex Delayed-Release Capsules
Kapidex Delayed-Release Capsules Uses, Dosage, Side Effects, Food Interaction and all others data.
Kapidex Delayed-Release Capsules belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase, at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.
Kapidex Delayed-Release Capsules is a proton pump inhibitor (PPI) and is included in the drug class of antisecretory compounds. It blocks the final step of gastric acid secretion by specific inhibition of the (H+, K+)-ATPase at the secretory surface of the parietal cells on gastric mucosa.
Trade Name | Kapidex Delayed-Release Capsules |
Availability | Prescription only |
Generic | Dexlansoprazole |
Dexlansoprazole Other Names | Dexlansoprazole |
Related Drugs | omeprazole, famotidine, pantoprazole, Nexium, Pepcid, Protonix, esomeprazole, Prilosec |
Type | |
Formula | C16H14F3N3O2S |
Weight | Average: 369.36 Monoisotopic: 369.075882366 |
Protein binding | Plasma protein binding of dexlansoprazole ranged from 96% to 99% in healthy subjects and was independent of concentration from 0.01 to 20 mcg/mL . |
Groups | Approved, Investigational |
Therapeutic Class | Proton Pump Inhibitor |
Manufacturer | |
Available Country | USA |
Last Updated: | September 19, 2023 at 7:00 am |
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Uses
Healing of erosive esophagitis, maintenance of healed erosive esophagitis & symptomatic non-erosive GERD (NERD).
Kapidex Delayed-Release Capsules is also used to associated treatment for these conditions: Erosive Esophagitis, Heartburn, Healed erosive esophagitis, Symptomatic non-erosive gastroesphageal reflux disease
How Kapidex Delayed-Release Capsules works
Kapidex Delayed-Release Capsules inhibits the H/K ATPase enzyme, which is involved in the secretion of hydrochloric acid, hydrolyzing ATP and exchanging H+ ions from the cytoplasm for K+ ions in the secretory canaliculus, which results in HCl secretion into the gastric lumen. Kapidex Delayed-Release Capsules inhibits this effect of H/K ATPase by demonstrating a high degree of activation in the acidic environment. After passing through the liver and reaching the gastric parietal cells activated by a meal, PPIs undergo protonation in the acidic pH environment, followed by conversion to sulphenamide which represents the active form of the drug. Sulphenamide inhibits the activity of the proton pump and hence the transport of hydrogen ions into the gastric lumen via covalent binding to the SH groups of the cysteine residues of H/K ATPase . The delivery technology of dexlansoprazole MR is designed to release the drug in two separate pH-dependent phases, the first in the proximal duodenum (25% of total drug dose) and the second (75% of total drug dose) in the more distal small intestine. Kapidex Delayed-Release Capsules reduces both basal and stimulated gastric acid secretion.
Dosage
Kapidex Delayed-Release Capsules dosage
Healing of erosive esophagitis: 60 mg once daily for up to 8 week
Maintenance of healed erosive esophagitis & relief of heartburn: 30 mg once daily
Symptomatic non-erosive GERD (NERD): 30 mg once daily for 4 week
Side Effects
Diarrhea, abdominal pain, nausea, upper resp tract infection, vomiting, flatulence.
Toxicity
Oral LD50 value in mice, rats and dogs is > 5,000 mg/kg. Most commonly reported adverse reactions are diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. There are no reports of significant overdose but serious adverse events of hypertension have been reported in association with twice daily doses of DEXILANT 60 mg. Nonclicnial toxicology of dexlansopraole was assessed using lansoprazole studies. In two 24-month carcinogenicity studies involving rats, lansoprazole induced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids and increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes of rats. Kapidex Delayed-Release Capsules is expected to have no effect on fertility and the reproductive system.
Precaution
Hepatic impairment. Gastric malignancy should be ruled out. Pregnancy and lactation. Not known whether distributed into breast milk; discontinue nursing or drug
Interaction
Drugs with pH-dependent absorption. Increased risk of hypomagnesaemia with diuretics and digoxin. May decrease plasma concentration of erlotinib, dasatinib and lapatinib. May decrease the bioavailability of itraconazole and ketoconazole. May increase plasma concentration of cilostazol and methotrexate. Reduced bioavailability with antacids and sucralfate.
Food Interaction
- Avoid St. John's Wort. This may induce the CYP3A4 metabolism of dexlansoprazole, which may cause reduced efficacy.
- Take with or without food. Kapidex Delayed-Release Capsules's dual delayed release formulation allows it to be taken without regard to food in contrast to other PPIs.
Kapidex Delayed-Release Capsules Drug Interaction
Moderate: levothyroxineMinor: aspirin, duloxetine, linaclotide, clopidogrel, cyanocobalaminUnknown: ubiquinone, rosuvastatin, cyclobenzaprine, fluticasone nasal, atorvastatin, metoprolol, metoprolol, omega-3 polyunsaturated fatty acids, bifidobacterium infantis / lactobacillus acidophilus, pantoprazole, acetaminophen, ascorbic acid, cholecalciferol, alprazolam
Kapidex Delayed-Release Capsules Disease Interaction
Major: C. diffModerate: liver disease, bone fractures, hypomagnesemia
Volume of Distribution
The apparent volume of distribution after multiple doses in symptomatic GERD patients was 40.3 L .
Elimination Route
After oral administration, the peak plasma concentration increases approximately dose proportionally. The dual delayed release formulation achieves two plasma concentration peaks, where the first peak occurs one to two hours after administration, followed by a second peak within four to five hours. The delivery technology of dexlansoprazole MR is designed to release the drug in two separate pH-dependent phases, the first in the proximal duodenum (25% of total drug dose) and the second (75% of total drug dose) in the more distal small intestine. The median time (Tmax) to peak plasma concentrations (Cmax) of 30 mg dexlansoprazole was 4 hours and ranged from 1 to 6 hours with the Cmax value of 688 ng/mL. AUC was found to be 3275 (ng∙h/mL).
Half Life
Kapidex Delayed-Release Capsules is eliminated with a half-life of approximately one to two hours in healthy subjects and in patients with symptomatic GERD.
Clearance
Apparent clearance (CL/F) in healthy subjects was 11.4 to 11.6 L/hour, respectively, after five days of 30 or 60 mg once daily administration.
Elimination Route
Kapidex Delayed-Release Capsules is cleared from the body by either fecal excretion (50.7%) or renal excretion (47.6%) following oral ingestion, with no unchanged drug detected in the urine.
Pregnancy & Breastfeeding use
Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Contraindication
Kapidex Delayed-Release Capsules is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions, including anaphylaxis have been reported. Acute interstitial nephritis (AIN) has been reported with other proton pump inhibitors (PPIs), including lansoprazole of which dexlansoprazole is the R-enantiomer. Kapidex Delayed-Release Capsules isalso contraindicated with rilpivirine-containing products.
Innovators Monograph
You find simplified version here Kapidex Delayed-Release Capsules
Kapidex Delayed-Release Capsules contains Dexlansoprazole see full prescribing information from innovator Kapidex Delayed-Release Capsules Monograph, Kapidex Delayed-Release Capsules MSDS, Kapidex Delayed-Release Capsules FDA label
FAQ
What is the Kapidex Delayed-Release Capsules used for?
Kapidex Delayed-Release Capsules is a medication which reduces stomach acid. It is used to treat gastroesophageal reflux disease. Kapidex Delayed-Release Capsules is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus.
How safe is Kapidex Delayed-Release Capsules?
It has a good safety profile and carries a low risk of adverse interactions with other drugs. Kapidex Delayed-Release Capsules may increase your risk of having fractures of the hip, wrist, and spine.
How does Kapidex Delayed-Release Capsules work?
Kapidex Delayed-Release Capsules works by decreasing the amount of acid made in the stomach.
What are the common side effects of Kapidex Delayed-Release Capsules?
Common side effects of Kapidex Delayed-Release Capsules are include:
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain, discomfort, tightness, or heaviness
- confusion
- continuing stomach pain
- diarrhea
- difficult or labored breathing
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- headache
- incoherent speech
- joint pain, stiffness, or swelling
- lightheadedness, dizziness, or fainting
- muscle pain, cramps, or weakness
- nausea
- numbness or tingling in the hands, feet, or lips
- pain or discomfort in the arms, jaw, leg, back, or neck
- pounding in the ears
- rash, hives
- shakiness in the legs, arms, hands, or feet
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- unusual bleeding or bruising
- vomiting
- vomiting of blood or material that looks like coffee grounds
- watery or bloody diarrhea
Can I take Kapidex Delayed-Release Capsules while pregnant?
This Kapidex Delayed-Release Capsules should be used during pregnancy only if clearly needed. US FDA pregnancy category: Not assigned. Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Is Kapidex Delayed-Release Capsules safe during breastfeeding?
No information is available on the use of Kapidex Delayed-Release Capsules or lansoprazole during breastfeeding. However, lansoprazole has been used safely in newborn infants, so it is unlikely that the amount of Kapidex Delayed-Release Capsules in breastmilk would be harmful.
Can I drink alcohol with Kapidex Delayed-Release Capsules?
Kapidex Delayed-Release Capsules orally disintegrating tablets should not be taken with alcohol. Alcohol may may affect how Kapidex Delayed-Release Capsules orally disintegrating tablets works.
Can I take Kapidex Delayed-Release Capsules on an empty stomach?
Kapidex Delayed-Release Capsules may be taken with or without food. Take at around the same time every day.
How many time can I take Kapidex Delayed-Release Capsules daily?
Kapidex Delayed-Release Capsules is usually taken once a day.
How much Kapidex Delayed-Release Capsules can I take daily?
The usual dosage of Kapidex Delayed-Release Capsules for gastroesophageal reflux (GERD) is 30 mg once daily. You'll likely take this dosage for 4 weeks.
How long does Kapidex Delayed-Release Capsules take to work?
Kapidex Delayed-Release Capsules will start working within a few days. In a clinical study, 38% of people were heartburn-free after taking Dexilant for 3 days.
What is the half life of Kapidex Delayed-Release Capsules?
The elimination half-life of Kapidex Delayed-Release Capsules is approximately 1–2 hours in healthy subjects and in patients with symptomatic GERD; this is similar to other PPI.
How long can I take Kapidex Delayed-Release Capsules?
Kapidex Delayed-Release Capsules shouldn't be used for more than 8 weeks.
Is Kapidex Delayed-Release Capsules safe for long-term use?
Taking Kapidex Delayed-Release Capsules long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk. If you use Kapidex Delayed-Release Capsules for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.
Who should not take Kapidex Delayed-Release Capsules?
You should not take this medicine if you are allergic to Kapidex Delayed-Release Capsules, or if: you had breathing problems, kidney problems, or a severe allergic reaction after taking this medicine in the past; or you also take a medicine that contains rilpivirine (Complera, Edurant, Odefsey).
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Can I overdose on Kapidex Delayed-Release Capsules?
If you take too much Kapidex Delayed-Release Capsules call your healthcare provider or local Poison Control Center or seek emergency medical attention right away. If Kapidex Delayed-Release Capsules is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur.
Does Kapidex Delayed-Release Capsules cause heart problems?
Kapidex Delayed-Release Capsules may cause a low level of magnesium in your blood. And if it isn't treated, this condition can lead to serious heart problems, such as an abnormal heart rhythm.
Can Kapidex Delayed-Release Capsules cause kidney?
Kapidex Delayed-Release Capsules can cause kidney problems. Long-term use of Kapidex Delayed-Release Capsules or other PPIs may increase the risk of a serious kidney injury called acute interstitial nephritis (AIN). AIN is defined by inflammation in the tissue of the kidney. It can often be treated if caught early, but in rare cases it can cause permanent damage.
Can Kapidex Delayed-Release Capsules cause liver problems?
Kapidex Delayed-Release Capsules may also cause lupus, this is an autoimmune disease that results in pain and inflammation throughout the body. And some people with lupus experience heart- or liver-related problems. Other heart- and liver-related problems were also reported as rare side effects in studies of Kapidex Delayed-Release Capsules.
Can Kapidex Delayed-Release Capsules increase blood pressure?
Kapidex Delayed-Release Capsules may cause high blood pressure. In clinical studies, less than 2% of people taking Kapidex Delayed-Release Capsules had high blood pressure.