A Comprehensive Overview of Protolans (Dexlansoprazole) – Indications, Dosage, Interactions, and Precautions

Protolans, a medication containing dexlansoprazole, is used to manage various gastrointestinal conditions by reducing gastric acid secretion. This article provides an in-depth exploration of Protolans, including its indications, dosage, administration, potential drug interactions, and important precautions.

1. Indications and Usage

Protolans (dexlansoprazole) is a medication with multiple indications for the treatment and management of gastrointestinal disorders:

1.1 Healing of Erosive Esophagitis (EE):
Protolans is indicated for healing all grades of erosive esophagitis for up to eight weeks.

1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn:
Protolans is indicated to maintain the healing of erosive esophagitis and provide relief from heartburn for up to six months.

1.3 Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD):
Protolans is indicated for treating heartburn associated with symptomatic non-erosive GERD for four weeks.

2. Dosage and Administration

Protolans is available as capsules in 30 mg and 60 mg strengths for adult use. The recommended doses for various indications are as follows:

  • Healing of EE: 60 mg once daily for up to 8 weeks
  • Maintenance of Healed EE and relief of heartburn: 30 mg once daily
  • Symptomatic Non-Erosive GERD: 30 mg once daily for 4 weeks

For patients who have difficulty swallowing capsules, alternative administration methods are provided, such as mixing granules with applesauce or water for oral administration.

3. Contraindications and Precautions

Protolans is contraindicated in patients with known hypersensitivity to any component of the formulation. Anaphylaxis and acute interstitial nephritis have been reported with the use of Protolans.

4. Drug Interactions

Protolans may interact with several drugs, including those with pH-dependent kinetics, such as ampicillin esters, ketoconazole, atazanavir, and iron salts. Co-administration of Protolans with warfarin may affect the pharmacokinetics of warfarin and INR. Caution is advised when administering high-dose methotrexate to patients receiving Protolans, as it may elevate and prolong serum levels of methotrexate. Clopidogrel and Protolans should not be used routinely together, as it may lead to decreased effectiveness of clopidogrel.

5. Special Populations

  • Pediatric Use: The pharmacokinetics of dexlansoprazole in patients under 18 years of age have not been studied.
  • Geriatric Use: Geriatric patients may experience an increased terminal elimination half-life of dexlansoprazole compared to younger patients.
  • Renal Impairment: No dosage adjustment is necessary for patients with renal impairment, as dexlansoprazole is extensively metabolized in the liver.
  • Hepatic Impairment: Dosage adjustment may be required for patients with moderate hepatic impairment, and no studies have been conducted in severe hepatic impairment.

5. Adverse Reactions

Commonly reported adverse reactions include diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. Additional adverse reactions encompass a wide range of systems, including cardiac, gastrointestinal, nervous, and skin-related disorders.

Conclusion

Protolans (dexlansoprazole) is a versatile medication indicated for healing erosive esophagitis, maintaining healed esophagitis, and relieving heartburn in patients with gastroesophageal reflux disease. This comprehensive overview highlights its indications, dosages, administration methods, potential drug interactions, and important precautions, providing healthcare professionals with valuable insights into its usage. It is imperative for healthcare providers to consider these factors while prescribing Protolans to ensure safe and effective patient management.


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