Bamalite

Bamalite Uses, Dosage, Side Effects, Food Interaction and all others data.

Bamalite 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.

Bamalite 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 Bamalite
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 Spain,
Last Updated: September 19, 2023 at 7:00 am
Bamalite
Bamalite

Uses

Healing of erosive esophagitis, maintenance of healed erosive esophagitis & symptomatic non-erosive GERD (NERD).

Bamalite is also used to associated treatment for these conditions: Erosive Esophagitis, Heartburn, Healed erosive esophagitis, Symptomatic non-erosive gastroesphageal reflux disease

How Bamalite works

Bamalite 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. Bamalite 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. Bamalite reduces both basal and stimulated gastric acid secretion.

Dosage

Bamalite 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. Bamalite 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. Bamalite's dual delayed release formulation allows it to be taken without regard to food in contrast to other PPIs.

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

Bamalite 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

Bamalite 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

Bamalite 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. Bamalite isalso contraindicated with rilpivirine-containing products.

Innovators Monograph

You find simplified version here Bamalite

Bamalite contains Dexlansoprazole see full prescribing information from innovator Bamalite Monograph, Bamalite MSDS, Bamalite FDA label

FAQ

What is the Bamalite used for?

Bamalite is a medication which reduces stomach acid. It is used to treat gastroesophageal reflux disease. Bamalite 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 Bamalite?

It has a good safety profile and carries a low risk of adverse interactions with other drugs. Bamalite may increase your risk of having fractures of the hip, wrist, and spine.

How does Bamalite work?

Bamalite works by decreasing the amount of acid made in the stomach.

What are the common side effects of Bamalite?

Common side effects of Bamalite 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 Bamalite while pregnant?

This Bamalite 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 Bamalite safe during breastfeeding?

No information is available on the use of Bamalite or lansoprazole during breastfeeding. However, lansoprazole has been used safely in newborn infants, so it is unlikely that the amount of Bamalite in breastmilk would be harmful.

Can I drink alcohol with Bamalite?

Bamalite orally disintegrating tablets should not be taken with alcohol. Alcohol may may affect how Bamalite orally disintegrating tablets works.

Can I take Bamalite on an empty stomach?

Bamalite may be taken with or without food. Take at around the same time every day.

How many time can I take Bamalite daily?

Bamalite is usually taken once a day.

How much Bamalite can I take daily?

The usual dosage of Bamalite for gastroesophageal reflux (GERD) is 30 mg once daily. You'll likely take this dosage for 4 weeks.

How long does Bamalite take to work?

Bamalite 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 Bamalite?

The elimination half-life of Bamalite 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 Bamalite?

Bamalite shouldn't be used for more than 8 weeks.

Is Bamalite safe for long-term use?

Taking Bamalite long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk. If you use Bamalite 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 Bamalite?

You should not take this medicine if you are allergic to Bamalite, 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 Bamalite?

If you take too much Bamalite call your healthcare provider or local Poison Control Center or seek emergency medical attention right away. If Bamalite is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur.

Does Bamalite cause heart problems?

Bamalite 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 Bamalite cause kidney?

Bamalite can cause kidney problems. Long-term use of Bamalite 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 Bamalite cause liver problems?

Bamalite 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 Bamalite.

Can Bamalite increase blood pressure?

Bamalite may cause high blood pressure. In clinical studies, less than 2% of people taking Bamalite had high blood pressure.

*** Taking medicines without doctor's advice can cause long-term problems.
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