Doxirazol 30 mg 14 capsules

Doxirazol 30 mg 14 capsules

Composition:

Each capsule contains: Dexlansoprazole 30 mg (as dexlansoprazole modified-release).

Product Description:

Doxirazol is a modified-release proton pump inhibitor (PPI) containing dexlansoprazole, the R-enantiomer of lansoprazole.
The product features a Dual Delayed Release technology that provides two consecutive releases of the active substance: the first shortly after administration, and the second a few hours later.
This dual-release profile provides prolonged acid suppression and consistent 24-hour symptom relief by inhibiting the final step of acid production in gastric parietal cells.

Indications for Use:

Doxirazol is indicated for use in adults and pediatric patients aged 12 years and older:
Treatment of Erosive Esophagitis (EE): For healing of all grades of erosive esophagitis (up to 8 weeks).
Maintenance Therapy of Healed EE and Relief of Heartburn: Up to 6 months in adults, and up to 16 weeks in adolescents 12–17 years of age.
Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD): A 4-week course for the relief of heartburn and other reflux symptoms.

Method of Administration and Dosage:

• Administered orally, regardless of meals:
  Treatment of Erosive Esophagitis: 60 mg once daily for up to 8 weeks.
  Maintenance of Healed Erosive Esophagitis: 30 mg once daily.
  Symptomatic Non-Erosive GERD: 30 mg once daily for 4 weeks.
• Special Populations: For patients with moderate hepatic impairment (Child-Pugh Class B), the maximum daily dose should not exceed 30 mg.
• Not recommended for patients with severe hepatic impairment (Child-Pugh Class C).
• Administration Method: Capsules should be swallowed whole.
• If swallowing difficulties occur, the capsule can be opened, the granules sprinkled onto a tablespoon of applesauce, and swallowed immediately without chewing.

Contraindications:

Known hypersensitivity or allergy to dexlansoprazole, other substituted benzimidazoles, or any component of the formulation.
Co-administration with rilpivirine-containing products (due to the risk of loss of antiretroviral therapeutic efficacy).

Precautions:

• Long-term PPI therapy may increase the risk of bone fractures (hip, wrist, spine) and hypomagnesemia (regular monitoring of serum magnesium levels is recommended).
• Associated with an increased risk of Clostridium difficile-associated diarrhea and vitamin B12 deficiency during prolonged treatment.
• Symptomatic response to PPI therapy does not preclude the presence of gastric malignancy.
• Exercise caution when co-administered with warfarin, digoxin, or methotrexate.
• Potential for altered absorption of pH-dependent medications (e.g., atazanavir, erlotinib, ketoconazole).

Adverse Reactions / Side Effects:

Common Reactions (≥2%):
Diarrhea, nausea, vomiting, abdominal pain, flatulence, upper respiratory tract infections, and headache.
Rare / Serious Reactions:
Acute interstitial nephritis, hypomagnesemia (seizures, arrhythmias, tetany), cutaneous and systemic lupus erythematosus, severe hypersensitivity reactions, and anaphylaxis.

Pregnancy and Lactation:

• Pregnancy:
  FDA Pregnancy Category B.
  Animal reproduction studies do not indicate direct harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women.
  Use during pregnancy only if clearly needed and clinical benefits outweigh potential risks.
• Lactation: 
  It is unknown whether dexlansoprazole is excreted in human milk.
  Exercise caution when administering to nursing mothers, weighing the benefits of breastfeeding against the clinical need for therapy.

Storage Conditions:

Store at temperatures below 30°C in a dry place, protected from direct light and moisture.
Keep out of reach of children.

Packaging:

Cardboard box containing 1 blister with 14 modified-release capsules and instructions for use.