Dexlansoprazole (MR) (30mg) 

Dexlansoprazole is a proton pump inhibitor used to treat erosive esophagitis, heartburn, and gastroesophageal reflux disease (GERD). It works by blocking H+/K+-ATPase in the parietal cells of the stomach.

LANSOSTRUM 30 contains Dexlansoprazole, which is the R-enantiomer of Lansoprazole, which is composed of a racemic mixture of the R- and S-enantiomers. This means LANSOSTRUM 30 contains only the more pharmacologically active form of the drug, providing enhanced efficacy.

Dexlansoprazole was approved for medical use in the United States in 2009. Since then, it has become a preferred choice for managing acid-related disorders due to its unique formulation and extended duration of action.

What Makes Dexlansoprazole Different?

Dexlansoprazole is the first PPI with a dual delayed release formulation designed to provide 2 separate releases of medication to extend the duration of effective plasma drug concentration.

This innovative approach addresses many limitations of conventional PPIs, making LANSOSTRUM 30 a superior choice for patients requiring reliable acid suppression.

Brand Names Around the World

Dexlansoprazole is marketed globally under various brand names including Dexilant (formerly Kapidex) in the United States, and as LANSOSTRUM 30 in India among other brand names.

How Does LANSOSTRUM 30 Work? (Mechanism of Action)

Understanding how LANSOSTRUM 30 works helps patients appreciate its effectiveness in controlling gastric acid production.

Primary Mechanism

Dexlansoprazole is a proton pump inhibitor (PPI) that suppresses both basal and stimulated gastric acid secretion.

Dexlansoprazole inhibits the final step in gastric acid production by blocking the (H+, K+)-ATPase enzyme.

Like lansoprazole, dexlansoprazole permanently binds to the proton pump and blocks it, preventing the formation of gastric acid.

Step-by-Step Process

1. Absorption: After oral administration, the drug is absorbed in the gastrointestinal tract
2. Activation: Dexlansoprazole is converted to its active form in the acidic environment of parietal cells
3. Binding: The active drug binds irreversibly to the H+/K+-ATPase enzyme (proton pump)
4. Inhibition: This binding blocks the final step of acid production
5. Result: Gastric acid secretion is significantly reduced

Why Proton Pump Inhibition is Effective

The proton pump is the final common pathway for gastric acid secretion. By blocking this pump, LANSOSTRUM 30 provides more complete and longer-lasting acid suppression compared to other acid-reducing medications like H2 blockers.

The Revolutionary Dual Delayed Release Technology

One of the most significant features of LANSOSTRUM 30 is its innovative Dual Delayed Release (DDR) technology.

How DDR Technology Works

The Takeda drug has a dual release pharmaceutical formulation, with two types of granules of dexlansoprazole, each with a coating that dissolves at a different pH level.

With its dual release pharmaceutical formulation, the first quick release produces a plasma peak concentration about one hour after application, with a second delayed release producing another peak about four hours later.

The Two-Peak Advantage

Dexlansoprazole MR, a proton pump inhibitor that uses Dual Delayed Release technology, produced a pharmacokinetic profile with a plasma concentration-time curve characterized by two distinct peaks and an extended duration of pharmacologically active dexlansoprazole concentration in plasma.

Advantages Over Conventional PPIs

Compared to the older generation of PPIs, dexlansoprazole has a unique pharmacokinetic profile due to its delayed-release and dual-delivery release system: This aims to address some limitations of the older-generation PPIs, such as short plasma half-life and the need for meal-associated dosing.

Clinical Uses and Indications

LANSOSTRUM 30 is prescribed for a variety of acid-related gastrointestinal conditions.

Approved Indications

Presently, dexlansoprazole MR is indicated for the healing of erosive esophagitis (60 mg qd) for up to 8 weeks, maintenance of erosive esophagitis healing (30 mg qd) for up to 6 months and relief of symptoms of NERD patients (30 mg qd) for up to 4 weeks.

Dexlansoprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD) in adults and children 12 years of age and older. It is also used to treat esophagitis (swelling that may damage tissues of the esophagus) and for the maintenance treatment of esophagitis and healing in adults and children 12 years of age and older.

Primary Indications

A. Gastroesophageal Reflux Disease (GERD)

GERD occurs when stomach acid frequently flows back into the esophagus, causing heartburn and other symptoms. LANSOSTRUM 30 effectively reduces acid production, providing relief from:

• Heartburn
• Acid regurgitation
• Chest pain related to acid reflux
• Difficulty swallowing

B. Erosive Esophagitis

Erosive esophagitis is damage to the esophagus caused by stomach acid. LANSOSTRUM 30 helps:

• Heal existing damage to the esophageal lining
• Prevent further erosion
• Maintain healed tissue

C. Non-Erosive Reflux Disease (NERD)

For patients with GERD symptoms but no visible esophageal damage, LANSOSTRUM 30 provides effective symptom relief.

Additional Benefits

Dexlansoprazole MR has also been shown to be beneficial in patients with nocturnal GERD-related symptoms, sleep disturbances due to GERD, acid regurgitation, eradication of H. pylori and heartburn relief in obese patients.

Dosage and Administration Guidelines

Administration Instructions

It is usually taken once a day. Dexlansoprazole may be taken with or without food.

Dexlansoprazole MR can be administered without regard to food or the timing of food in most patients.

Swallow the delayed-release capsules whole; do not chew or crush them. If you have difficulty swallowing capsules, you may open the capsule, sprinkle the contents on 1 tablespoon of applesauce, and swallow immediately without chewing.

Alternative Administration Methods

For patients who have difficulty swallowing capsules:

1. Applesauce Method: Open capsule and sprinkle contents on 1 tablespoon of applesauce; swallow immediately
2. Water Dispersion: Contents can be mixed with water for administration via oral syringe or nasogastric tube
3. Do NOT crush or chew the granules as this will destroy the delayed-release mechanism

Treatment Duration

To heal erosive esophagitis and relieve heartburn, dexlansoprazole is usually given for up to 6 months in adults, and for 4 to 16 weeks in children ages 12 through 17.

Missed Dose

If you miss a dose of LANSOSTRUM 30, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Pharmacokinetics: How the Body Processes LANSOSTRUM 30

Understanding the pharmacokinetics of LANSOSTRUM 30 explains its superior clinical performance.

Absorption

The dual delayed release formulation creates two distinct absorption phases, ensuring extended drug availability.

Distribution

Plasma protein binding of dexlansoprazole ranged from 96 to 99% in healthy subjects and was independent of concentration.

Metabolism

Dexlansoprazole is extensively metabolized in the liver, primarily through the cytochrome P450 enzyme system, particularly CYP2C19 and CYP3A4.

Extended Duration

Dexlansoprazole MR (30–120 mg qd for 5 days) has demonstrated a longer mean residence time (MRT) than lansoprazole following oral administration (5.5–6.4 hours versus 2.8–3 hours, respectively).

Acid Suppression Efficacy

The percent of time pH > 4 over 24 h values were 59.2% and 66.7% for dexlansoprazole MR 30 and 90 mg, respectively.

Clinical Efficacy and Research Evidence

LANSOSTRUM 30 has been extensively studied in clinical trials demonstrating its effectiveness.

Healing of Erosive Esophagitis

Dexlansoprazole MR 60 mg demonstrated similar efficacy for healing of erosive esophagitis at 8 weeks compared with lansoprazole 30 mg, and dexlansoprazole MR 30 mg was superior to placebo for maintenance of healed erosive esophagitis at 6 months with 99% of nights and 96% of days heartburn-free over 6 months.

Life table analysis in the intention-to-treat population indicated that dexlansoprazole MR healed 92%–95% of patients versus 86%–92% healed by lansoprazole.

GERD Symptom Relief

Dexlansoprazole outperformed the placebo and other PPIs in the resolution of heartburn and reflux symptoms in patients with GERD, with benefits during and after treatment, especially in those with moderate and severe symptoms.

Nocturnal Symptom Control

Dexlansoprazole MR 30 mg was better than placebo for relieving nighttime heartburn and GERD-related sleep disturbances in symptomatic GERD patients without erosive esophagitis.

 

Benefits of LANSOSTRUM 30

1. Extended Acid Suppression

The dual delayed release technology provides longer-lasting acid control compared to conventional PPIs.

2. Flexible Dosing

Dexlansoprazole MR can be administered without regard to food or the timing of food in most patients.

This flexibility makes it easier for patients to adhere to their treatment regimen.

3. Superior Healing Rates

Clinical studies demonstrate higher healing rates for erosive esophagitis compared to older PPIs.

4. Excellent Nighttime Control

Particularly beneficial for patients with nocturnal symptoms and sleep disturbances due to GERD.

5. Once-Daily Convenience

Single daily dosing improves patient compliance and treatment outcomes.

6. Well-Established Safety Profile

The safety profile of dexlansoprazole 30–90 mg has been shown to be similar to that of lansoprazole. There were no significant differences between dexlansoprazole and placebo or lansoprazole for most of the common treatment-emergent AEs.

7. Consistent Drug Delivery

The modified release formulation ensures consistent drug levels throughout the day.

Side Effects

Like all medications, LANSOSTRUM 30 may cause side effects in some patients.

Common Side Effects

Dexlansoprazole (Dexilant) doesn't cause many side effects, but some of the more common ones include diarrhea, nausea, and stomach pain.

System	Common Side Effects
Gastrointestinal	Diarrhea, nausea, abdominal pain, flatulence, constipation
Nervous System	Headache, dizziness
Respiratory	Upper respiratory tract infection
General	Fatigue

Less Common Side Effects

• Vomiting
• Dry mouth
• Taste disturbances
• Skin rash
• Joint pain

Serious Side Effects (Rare)

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

Long-Term Use Concerns

Taking dexlansoprazole long-term may cause you to develop stomach growths called fundic gland polyps. If you use dexlansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency.

Dexlansoprazole can cause low magnesium levels, also known as hypomagnesemia, which can be serious. Decreased magnesium levels can cause seizures or heart rhythm problems.

When to Seek Medical Attention

Contact your healthcare provider immediately if you experience:

• Severe diarrhea with watery stools
• Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
• Symptoms of low magnesium (muscle spasms, irregular heartbeat, seizures)
• Signs of lupus (joint pain, rash on cheeks or arms)
• Severe stomach pain

Precautions and Warnings

Fracture Risk

Dexlansoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

Clostridium difficile Infection

Patients taking PPIs may have an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients.

Vitamin and Mineral Deficiencies

Long-term PPI use may lead to:

• Vitamin B-12 deficiency (after 3+ years of use)
• Magnesium deficiency
• Calcium absorption issues

Fundic Gland Polyps

Extended use may increase the risk of stomach polyps, particularly if used for more than one year.

Lupus-Like Reactions

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs.

Masking of Serious Conditions

PPIs may mask symptoms of gastric cancer. Consider endoscopy in patients with persistent symptoms despite treatment.

Contraindications

LANSOSTRUM 30 should NOT be used in the following situations:

Relative Contraindication

• Severe liver impairment (use with caution)
• Known osteoporosis or fracture risk
• History of hypomagnesemia

Drug Interactions

LANSOSTRUM 30 can interact with several medications. Always inform your healthcare provider about all medications you are taking.

Drugs Metabolized by CYP2C19

Dexlansoprazole may affect the metabolism of drugs processed by the CYP2C19 enzyme system.

Minimal Interaction Profile

Coadministration of dexlansoprazole MR with diazepam, phenytoin or theophylline did not affect the pharmacokinetics of these drugs.

Methotrexate Interaction

PPIs may increase serum levels of methotrexate. Consider temporary discontinuation of LANSOSTRUM 30 in patients receiving high-dose methotrexate.

Warfarin Interaction

Monitor INR and prothrombin time when dexlansoprazole is used with warfarin, as increased bleeding may occur.

Tacrolimus Interaction

PPIs may increase tacrolimus levels, especially in transplant patients who are CYP2C19 intermediate or poor metabolizers.

Food and Alcohol Interactions

Food Interactions

One of the significant advantages of LANSOSTRUM 30 is its flexibility with food:

Dexlansoprazole MR can be administered without regard to food or the timing of food in most patients.

Unlike some older PPIs that require administration before meals, LANSOSTRUM 30 can be taken at any time of day, with or without food.

Alcohol

While there is no direct interaction between dexlansoprazole and alcohol, patients with GERD should limit alcohol consumption as it can:

• Worsen acid reflux symptoms
• Irritate the esophageal lining
• Reduce lower esophageal sphincter pressure

Special Populations

Pregnancy

LANSOSTRUM 30 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data are available on the use of dexlansoprazole in pregnant women.

Breastfeeding

It is not known whether dexlansoprazole is excreted in human breast milk. Caution should be exercised when LANSOSTRUM 30 is administered to nursing mothers.

Pediatric Population

LANSOSTRUM 30 is approved for use in adolescents 12-17 years of age for:

• Healing of erosive esophagitis
• Maintenance of healed erosive esophagitis
• Symptomatic GERD

Safety and effectiveness in patients younger than 12 years have not been established.

Elderly Patients

No dosage adjustment is required in elderly patients. However, be aware of increased fracture risk and potential for vitamin/mineral deficiencies with long-term use.

Hepatic Impairment

No dosage adjustment for DEXILANT is necessary for patients with mild hepatic impairment (Child-Pugh Class A). DEXILANT 30 mg should be considered for patients with moderate hepatic impairment (Child-Pugh Class B).

For patients with severe hepatic impairment (Child-Pugh Class C), a maximum dose of 30 mg daily should be considered.

Renal Impairment

No dosage adjustment of DEXILANT is necessary in patients with renal impairment. The pharmacokinetics of dexlansoprazole in patients with renal impairment are not expected to be altered since dexlansoprazole is extensively metabolized in the liver to inactive metabolites.

 

Storage Instructions

Proper storage ensures the medication remains effective:

• Store at room temperature (20-25°C / 68-77°F)
• Protect from moisture
• Keep in original container
• Keep container tightly closed
• Store away from direct light and heat
• Keep out of reach of children
• Do not use after expiration date

Conclusion

LANSOSTRUM 30 (Dexlansoprazole MR 30mg) represents a significant advancement in proton pump inhibitor therapy. Its innovative Dual Delayed Release technology provides extended acid suppression, making it an excellent choice for patients with GERD, erosive esophagitis, and related acid disorders.

The unique pharmacokinetic profile of LANSOSTRUM 30, with its two-peak plasma concentration curve, addresses many limitations of conventional PPIs. The ability to take the medication without regard to food timing improves patient convenience and compliance, while the extended duration of action ensures better symptom control throughout the day and night.

Frequently Asked Questions 

Q1: What is LANSOSTRUM 30 used for?

LANSOSTRUM 30 is used to treat gastroesophageal reflux disease (GERD), heal erosive esophagitis, and maintain healing of the esophagus. It effectively reduces stomach acid production to provide relief from heartburn and acid-related symptoms.

Q2: How should I take LANSOSTRUM 30?

Take LANSOSTRUM 30 once daily, with or without food. Swallow the capsule whole – do not crush or chew. If you have difficulty swallowing, you may open the capsule and sprinkle the contents on applesauce.

Q3: Can I take LANSOSTRUM 30 without food?

Yes. Dexlansoprazole MR can be administered without regard to food or the timing of food in most patients.

Q4: How long does it take for LANSOSTRUM 30 to work?

Many patients experience symptom relief within the first few days of treatment. However, complete healing of erosive esophagitis may take up to 8 weeks.

Q5: Is LANSOSTRUM 30 safe for long-term use?

While LANSOSTRUM 30 is generally safe, long-term use (more than 1 year) may increase risks of bone fractures, vitamin B-12 deficiency, and magnesium deficiency. Discuss the benefits and risks with your doctor for extended treatment.

Q6: Can I take LANSOSTRUM 30 during pregnancy?

LANSOSTRUM 30 should only be used during pregnancy if clearly needed and the benefits outweigh the risks. Consult your healthcare provider before using this medication if you are pregnant or planning to become pregnant.

Q7: What should I avoid while taking LANSOSTRUM 30?

Avoid foods and beverages that trigger your GERD symptoms (spicy foods, caffeine, alcohol, acidic foods). Also avoid taking certain medications like rilpivirine concurrently.

Q8: Is LANSOSTRUM 30 habit-forming?

No, LANSOSTRUM 30 is not habit-forming and does not cause physical dependence.

Q9: Can children take LANSOSTRUM 30?

LANSOSTRUM 30 is approved for adolescents aged 12-17 years. It is not recommended for children under 12 years.

Q10: What makes LANSOSTRUM 30 different from other PPIs?

LANSOSTRUM 30 uses Dual Delayed Release technology, providing two separate releases of medication for extended acid suppression. This unique formulation allows flexible dosing without regard to meals and provides superior 24-hour acid control.

Q11: Can I drink alcohol while taking LANSOSTRUM 30?

While there's no direct drug interaction, alcohol can worsen GERD symptoms and should be limited or avoided.

Q12: What should I do if I miss a dose?

Take the missed dose as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue your regular schedule. Never double dose.