Dextac 60: A Proton Pump Inhibitor for Acid-Related Disorders

Dextac 60 is a Proton Pump Inhibitor (PPI) that effectively reduces the amount of acid produced in the stomach. It contains Dexlansoprazole, which is the R-enantiomer of lansoprazole, and is formulated as a Dual Delayed Release (DDR) capsule for sustained acid suppression.

How Dextac 60 Works (Pharmacology)

Dextac (Dexlansoprazole) functions by specifically inhibiting the (H+/K+)-ATPase (proton pump) in the gastric parietal cells of the stomach. By blocking this final step in acid production, it significantly reduces gastric acid secretion.

The unique Dual Delayed Release (DDR) formulation in Dextac capsules leads to two distinct peaks in plasma concentration: the first peak occurs 1 to 2 hours post-administration, followed by a second peak within 4 to 5 hours. This dual release mechanism ensures prolonged acid control. Dexlansoprazole undergoes extensive metabolism in the liver and is primarily excreted via urine.

Key Indications & Benefits

Dextac 60 is indicated for the treatment of various acid-related conditions:

• Healing of Erosive Esophagitis (EE): Indicated for healing all grades of EE for up to 8 weeks.
• Maintenance of Healed Erosive Esophagitis: Used to maintain healing of EE and provide relief from heartburn for up to 6 months.
• Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD): Indicated for the treatment of heartburn associated with symptomatic non-erosive GERD for 4 weeks.

Dosage & Administration

Dextac capsules can be taken with or without food and should be swallowed whole.

Alternatively, the capsule can be opened, and the intact granules sprinkled on one tablespoon of food and swallowed immediately. The granules should not be chewed.

If a dose is missed, it should be taken as soon as remembered. However, if it's too close to the time for the next dose, only the regularly scheduled dose should be taken; a double dose should never be taken.

Dosing Recommendations:

• Healing of Erosive Esophagitis:60 mg Once daily for up to 8 weeks.
• Maintenance of Healed Erosive Esophagitis and Relief of Heartburn: 30 mg Once daily (Note: while the 60mg strength is listed, the maintenance dose for Dexlansoprazole is generally 30mg. Always clarify the prescribed strength and dose with your doctor). (For Dexlansoprazole MUPS: 30 mg once daily for 6 months in adults and 16 weeks in patients 12 to 17 years of age.)
• Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks.

Always consult a registered physician for medication use.

Important Considerations & Warnings

It is crucial to discuss your full medical history with your doctor before taking Dextac 60.

Contraindications:

• Patients with known hypersensitivity to any component of the formulation.

Side Effects:

• Common side effects: Diarrhea, abdominal pain, nausea, vomiting, and flatulence.

Interactions:

• Medications: Dextac may interact with Atazanavir, Warfarin, Tacrolimus, Clopidogrel, and Methotrexate. Specific precautions and monitoring may be necessary when co-administered.
• Food & Others: No specific data on interactions with food or other non-medicinal substances is available.

Pregnancy & Lactation:

• Pregnancy Category B. There are no adequate and well-controlled studies with Dexlansoprazole in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
• Lactation: There are no adequate and well-controlled studies with Dexlansoprazole in lactating mothers. Caution should be exercised, and the decision to continue or discontinue nursing or the drug should consider the importance of the drug to the mother.

Precautions & Warnings:

• Gastric Malignancy: PPIs can mask the symptoms of gastric malignancy; therefore, this should be ruled out before starting treatment.
• Clostridium difficile Associated Diarrhea: PPI use may be associated with an increased risk of Clostridium difficile-associated diarrhea.
• Bone Fracture: Long-term and high-dose PPI therapy may increase the risk of bone fractures (e.g., hip, wrist, spine).
• Hypomagnesemia: PPIs, particularly with prolonged use (typically >1 year), can lead to hypomagnesemia (low magnesium levels).
• Concomitant use with Methotrexate: Close monitoring for methotrexate toxicity is recommended if high-dose methotrexate is co-administered with PPIs.

Use in Special Populations:

• Children & Adolescents: Safety and effectiveness in patients below 12 years of age have not been established.
• Geriatric Use: No dose adjustment is necessary for elderly patients.
• Renal Impairment: No dose adjustment is necessary for patients with renal impairment.
• Hepatic Impairment: No dose adjustment is necessary for patients with mild hepatic impairment. A maximum daily dose of 30 mg should be considered for patients with moderate hepatic impairment.

Overdose Effects:

• There have been no reports of significant overdose with Dextac. Multiple doses of 120 mg and a single dose of 300 mg did not result in death or other severe adverse events.

Storage Conditions

Store below 30°C temperature in a dry place, protected from light. Keep all medicines out of reach of children.