DEXLANSOPRAZOLE

DEXLANSOPRAZOLE
DEXLANSOPRAZOLE

DEXLANSOPRAZOLE

Overview & uses

Dexlansoprazole is the dextra isomer of lansoprazole. It is a drug used to reduce the amount of acid secreted in the stomach.

Indication (uses)

  • For the healing of Erosive Esophagitis.
  • For the maintenance of the healed Erosive esophagitis.
  • For the treatment of symptoms of non-erosive Gastroesophageal reflux disease (GERD).

Pharmacological classification

Proton pump inhibitor for the reduction of gastric acid secretion

Brand names

Dexilant, Dexilant solutab

Dosage form

  • Delayed release capsules in strengths of 30 mg and 60 mg for oral use.
  • Delayed release orally disintegrating tablets (solutab) for oral use in strengths of 10 mg, 20 mg and 40 mg.

Mechanism of action

All proton pump inhibitors are inactive at neutral pH. But, as soon as pH drops below 5, the drug rearranges into two positively charged ions and binds with H+K+ATPase enzyme by forming a covalent bond and inactivates the enzyme. It also inhibits the mucosal carbonic anhydrase enzyme.

How to take Dexlansoprazole tablets (solutab) or capsules?

  • Dexlansoprazole capsules can be taken without any regard to food.
  • Dexlansoprazole tablets (solutab) should be taken 30 minutes before meals.
  • Dexlansoprazole tablets (solutab) and capsules should be swallowed whole and should not be chewed, crushed or spit.

Dosage

For patients with 12 years or more of age (for capsules)

  • For healing of erosive esophagitis:
    • 60 mg capsule once a day for up to 8 weeks.
  • Maintenance of healed erosive esophagitis and relief of heartburn:
    • 30 mg capsule once a day.
  • For the treatment of symptoms of non-erosive Gastroesophageal reflux disease (GERD):
    • 30 mg capsule once a day.

For patients with 12 years or more of age (for tablets)

    • Maintenance of healed erosive esophagitis and relief of heartburn:
      • 30 mg tablet once a day.
    • For the treatment of symptoms of non-erosive Gastroesophageal reflux disease (GERD):
      • 30 mg tablet once a day for up to 4 weeks.

GERIATRIC DOSE ADJUSTMENT

  • No adjustments needed.

RENAL DOSE ADJUSTMENTS

  • No adjustments needed.

HEPATIC DOSE ADJUSTMENT

  • For patients with Child-Pugh score B, the dose is 30 mg capsule or tablet once a day for up to 8 weeks.
  • For Child-Pugh score C – Dexlansoprazole is not recommended.

OVERDOSAGE

  • Severe hypertension has been reported for 60 mg twice a day dose of Dexlansoprazole.
    • Consult your doctor as soon as possible.
  • Symptoms of overdose include reduced motor activity, tremor, ataxia, reduced respiratory frequency and intermittent clonic convulsions.
  • Confusion, oropharyngeal pain, and weight loss were also reported.
  • No specific antidote is known.
  • Dialysis does not aid in excess drug removal as Dexlansoprazole is extensively protein bound.
  • Supportive treatment should be given as and when required.
  • Contact the emergency department of your local hospital in cases of overdose or suspected overdose.

Side effects or unwanted effects

  • The most common adverse reaction is diarrhea.
    • Consult your doctor as soon as possible. This may require discontinuation of the treatment with dexlansoprazole.
  • Acute intestinal nephritis.
    • Fever, nausea, vomiting, skin rash, confusion, fatigue, exhaustion and blood in the urine are some of the symptoms. Consult your doctor as soon as possible.
  • Longtime treatment with dexlansoprazole may lead to vitamin B12 deficiency.
  • Increased serum chromogranin A levels.
  • Treatment with proton pump inhibitor may be associated with an increased risk of Clostridium difficile associated diarrhea, particularly in hospitalized patients.
  • Longtime treatment with Omeprazole may increase the risk of osteoporosis-related fractures of hip, wrist or spine.
  • Change of taste or a bad taste, acne, back pain and drowsiness was reported by patients taking dexlansoprazole for a long period of time.
    • Ask your pharmacist to recommend a suitable medicine and consult your doctor.
  • Hypomagnesemia in patients taking proton pump inhibitors for over a year, characterized by arrhythmias, seizures and tetany.
    • Consult your doctor as soon as possible. This may require magnesium supplement and discontinuation of the proton pump inhibitor.
  • May give false positive urine test for tetrahydrocannabinol in patients on proton pump inhibitor treatment.

WARNINGS

  • Treatment with proton pump inhibitor may be associated with an increased risk of Clostridium difficile associated diarrhea, particularly in hospitalized patients.
  • Longtime treatment with Omeprazole may increase the risk of osteoporosis-related fractures of hip, wrist or spine.
  • Contraindicated in patients with a known hypersensitivity to dexlansoprazole, lansoprazole or any of the content of the formulation.

Pregnancy and breastfeeding

Pregnancy

Category B, which means that Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

  • No sufficient human studies have been conducted regarding the use of dexlansoprazole in pregnant women.
  • Animal studies have shown no effects on embryo-fetal development.

Nursing

  • Data not available.
  • Caution should be exercised while administering dexlansoprazole to a nursing mother as many drugs are secreted in milk.
  • Caution should be exercised as many drugs are found to be secreted in human milk which causes unwanted exposure of the drug to infant and potential for side effects associated with that drug.

Interactions

Drug interactions

  • Dexlansoprazole decreases gastric pH. Any drug, whose absorption is dependent on gastric pH, affects the absorption of that drug when co-administered with Dexlansoprazole.
    • Absorption of Ketoconazole, Atazanavir, Erlotinib, iron salts and mycophenolate mofetil is decreased while absorption of digoxin in increased.
  • Dexlansoprazole increases the concentration of Saquinavir.
  • Dexlansoprazole decreases the concentrations of Rilpivirine, Atazanavir and Nelfinavir.
    • Concomitant use of Dexlansoprazole with above-mentioned drugs is contraindicated as such combination would decrease the efficacy of anti-HIV treatment and may pose a risk of viral resistance.
  • Concomitant use of Dexlansoprazole and warfarin should be done under strict monitoring, particularly for the increases in INR and prothrombin time.
  • Voriconazole increases the concentration of Dexlansoprazole by more than double.
  • Concomitant administration of Dexlansoprazole, clarithromycin and amoxicillin increases the plasma levels of Dexlansoprazole.
  • Concomitant use of Dexlansoprazole and methotrexate may lead to increased and prolonged plasma concentration of methotrexate and/or its metabolite hydromethotrexate.
  • Concomitant use of Dexlansoprazole and Tacrolimus may increase the concentration of Tacrolimus.
  • Dexlansoprazole may increase the exposure of digoxin.
  • Dexlansoprazole decreases gastric pH. Any drug, whose absorption is dependent on gastric pH, affects the absorption of that drug when co-administered with Dexlansoprazole.
    • Absorption of Ketoconazole, Atazanavir, Erlotinib, iron salts and mycophenolate mofetil is decreased while absorption of digoxin in increased.
  • Concomitant use of St. john’s wart and Rifampin should be avoided.

Drug-food interactions

  • Dexlansoprazole should be taken on an empty stomach, at least 1 hour before meals.
  • Avoid alcohol with solutab as it may reduce the efficacy of dexlansoprazole.
  • A capsule of Dexlansoprazole can be taken without any regard to food.
  • Solutab tablet of Dexlansoprazole should be taken 30 minutes before meals.

Note: The sole purpose of every information shared on this article is to bring awareness. Do not use this information as aa piece of medical adviceor prescription advice or as a tool for the treatment, diagnosis or prevention of the disease.