1. Product Description
- Name: Dexlansoprazole 30mg & 60mg
- Type: Proton Pump Inhibitor (PPI)
- Form: Oral delayed-release capsule
- Strength: 30 mg and 60 mg per capsule
- Therapeutic Category: Gastrointestinal / Acid Suppression
2. Chemical Information
- Chemical Name: Dexlansoprazole
- Molecular Formula: C16H14F3N3O2S
- Molecular Weight: Approximately 369.36 g/mol
- Active Pharmaceutical Ingredient (API): Dexlansoprazole
3. Indications
- Primary Uses:
- Healing of erosive esophagitis associated with gastroesophageal reflux disease (GERD)
- Maintenance of healing of erosive esophagitis and relief of associated heartburn
- Treatment of heartburn associated with symptomatic non-erosive GERD, where approved
- Management of acid-related gastrointestinal symptoms as directed by a healthcare professional
4. Dosage and Administration
- Dosage Form:
- 30 mg Capsules: Commonly used for maintenance of healing of erosive esophagitis and for symptomatic non-erosive GERD, according to the approved indication.
- 60 mg Capsules: Commonly used for healing of erosive esophagitis, according to the approved indication.
- Typical Dosage Schedule:
- 30 mg: Once daily for the indication and duration specified by the prescribing information.
- 60 mg: Once daily for the treatment period specified for erosive esophagitis.
- Dosage and duration may vary according to the patient’s condition, age, clinical response, and applicable prescribing information.
- Administration:
- Take orally as directed by a healthcare professional.
- Capsules should generally be swallowed whole with water and should not be crushed or chewed.
- Follow the product-specific instructions regarding administration with or without food.
5. Pharmacokinetics
- Absorption: Dexlansoprazole is absorbed following oral administration and undergoes rapid absorption.
- Distribution: It is extensively distributed in the body and is highly bound to plasma proteins.
- Metabolism: Primarily metabolized in the liver through oxidation and reduction pathways, including CYP2C19 and CYP3A4.
- Excretion: Metabolites are eliminated primarily through urine and feces.
6. Side Effects
- Common Side Effects:
- Headache
- Diarrhea
- Abdominal pain
- Nausea
- Upper respiratory tract symptoms
- Serious or Clinically Important Effects:
- Severe allergic or hypersensitivity reactions
- Severe or persistent diarrhea associated with Clostridioides difficile
- Low magnesium levels with prolonged use
- Vitamin B12 deficiency with prolonged treatment
- Kidney inflammation (acute tubulointerstitial nephritis)
- Increased risk of certain fractures with long-term use, particularly in patients with other risk factors
7. Contraindications
- Known Allergies: Hypersensitivity to Dexlansoprazole, substituted benzimidazoles, or any component of the formulation.
- Drug Combinations: Concomitant use with rilpivirine-containing products is contraindicated where specified by applicable prescribing information.
- Other Contraindications: Refer to the approved product information for additional product-specific contraindications.
8. Precautions
- Caution: Use with appropriate medical supervision in patients with liver impairment and in those requiring prolonged acid-suppression therapy.
- Drug Interactions: Dexlansoprazole may interact with medicines whose absorption or metabolism is affected by gastric acidity or CYP-related pathways. Patients should inform their healthcare provider about all medicines and supplements they are taking.
- Monitoring: Long-term treatment may require clinical monitoring based on patient risk factors and duration of therapy.
9. Storage
- Conditions: Store according to the product label, generally at controlled room temperature and protected from excessive heat and moisture.
- Packaging: Available in product-specific blister packs or bottles, depending on the manufacturer’s packaging configuration.
- Keep Out of Reach: Keep the product out of reach of children.
10. Patient Counseling Information
Administration: Take Dexlansoprazole exactly as prescribed by your healthcare professional. Do not alter, crush, or chew the capsule unless the approved product instructions specifically permit an alternative method of administration.
Adherence: Follow the prescribed dose and duration of treatment. Do not discontinue long-term therapy without consulting your healthcare professional.
Report Symptoms: Seek medical attention for signs of a severe allergic reaction, persistent or severe diarrhea, or other unusual or serious symptoms.
Medical Advice: Inform your healthcare professional about existing medical conditions, pregnancy or breastfeeding, and all medicines or supplements being used.