S O M A T E C

About Us

SOMATEC PHARMACEUTICALS LTD. is a fast growing pharmaceutical company in Bangladesh.

Contact Info

28/B, Segun Bagicha, Dhaka-1000, Bangladesh.

+880-02-9337667

+880-02-9357827

+880-02-8391480

info@somatecpharmabd.com

X Lan

X Lan 30: Each capsule contains Dexlansoprazole INN 30 mg in enteric coated pellets.
X Lan 60: Each capsule contains Dexlansoprazole INN 60 mg in enteric coated pellets.

Brand Name

: X Lan

Generic Name

: Dexlansoprazole INN

Therapeutic Class

: Antiulcerants

Strength

:
30mg 60mg

Indications

X Lan is a proton pump inhibitor (PPI) used to treat-
· Relief of heartburn
· Healing of all grades of Erosive Esophagitis
· Maintenance of healed Erosive Esophagitis
· Symptomatic Non-Erosive Gastro-Esophageal Reflux Disease (GERD)

Pharmacology

X Lan (Dexlansoprazole) delayed release capsule has been characterized as a gastric proton pump inhibitor (PPI) that blocks the final step of gastric acid production. It is the R-enantiomer of Lansoprazole (a racemic mixture of the R- and S-enantiomers). Dexlansoprazole capsule contains enteric coated pellets with different pH- dependent dissolution profiles.

The formulation of Dexransoprazole utilizes Dual Delayed Release (DDR) technology which results in plasma concentration- time profile with two distinct peak; the first peak occurs within 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. No accumulation of Dexlansoprazole occurs after multiple once daily doses of X Lan 30 mg or 60 mg.

Dosage

The recommended doses of Dexlansoprazole for adults are as follows:
Relief of heartburn: 30 mg once daily for up to 6 months
Healing of Erosive Esophagitis (EE): 60 mg once daily for up to 8 weeks
Maintenance of Healed EE and relief of heartburn: 30 mg once daily for 6 months
Symptomatic Non-Erosive GERD: 60 mg once daily for 4 weeks

Interaction

With Medicine: Dexlansoprazole may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., Ampicillin esters, Digoxin, Iron salts, Ketoconazole).
With Food & others: Dexlansoprazole can be taken without regard to food.

Contraindications

Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Side Effects

Diarrhea, abdominal pain, nausea, vomiting, flatulence etc.

Pregnancy & Lactation

Dexlansoprazole is considered a US FDA Pregnancy Category B drug. This means that Dexlansoprazole is probably safe for use during pregnancy, although the full risks are currently unknown.
Use in children & adolescent (<18 years of age)
Safety and effectiveness of in pediatric patients have not been established.
 

Precautions & Warnings

Patients taking concomitant warfarin may require monitoring for increased lnternational Normalized Ratio (lNR) and prothrombin time. lncreased INR and prothrombin time may lead to abnormal bleeding and even death.

Overdose Effects

There have been no reports of significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in any severe adverse events.

Storage Conditions

· Store in cool & dry place, protected from light.
· Keep out of reach of children.

Indications

X Lan is a proton pump inhibitor (PPI) used to treat-
· Relief of heartburn
· Healing of all grades of Erosive Esophagitis
· Maintenance of healed Erosive Esophagitis
· Symptomatic Non-Erosive Gastro-Esophageal Reflux Disease (GERD)

Pharmacology

X Lan (Dexlansoprazole) delayed release capsule has been characterized as a gastric proton pump inhibitor (PPI) that blocks the final step of gastric acid production. It is the R-enantiomer of Lansoprazole (a racemic mixture of the R- and S-enantiomers). Dexlansoprazole capsule contains enteric coated pellets with different pH- dependent dissolution profiles.

The formulation of Dexransoprazole utilizes Dual Delayed Release (DDR) technology which results in plasma concentration- time profile with two distinct peak; the first peak occurs within 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. No accumulation of Dexlansoprazole occurs after multiple once daily doses of X Lan 30 mg or 60 mg.

Dosage

The recommended doses of Dexlansoprazole for adults are as follows:
Relief of heartburn: 30 mg once daily for up to 6 months
Healing of Erosive Esophagitis (EE): 60 mg once daily for up to 8 weeks
Maintenance of Healed EE and relief of heartburn: 30 mg once daily for 6 months
Symptomatic Non-Erosive GERD: 60 mg once daily for 4 weeks

Interaction

With Medicine: Dexlansoprazole may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., Ampicillin esters, Digoxin, Iron salts, Ketoconazole).
With Food & others: Dexlansoprazole can be taken without regard to food.

Contraindications

Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Side Effects

Diarrhea, abdominal pain, nausea, vomiting, flatulence etc.

Pregnancy & Lactation

Dexlansoprazole is considered a US FDA Pregnancy Category B drug. This means that Dexlansoprazole is probably safe for use during pregnancy, although the full risks are currently unknown.
Use in children & adolescent (<18 years of age)
Safety and effectiveness of in pediatric patients have not been established.
 

Precautions & Warnings

Patients taking concomitant warfarin may require monitoring for increased lnternational Normalized Ratio (lNR) and prothrombin time. lncreased INR and prothrombin time may lead to abnormal bleeding and even death.

Overdose Effects

There have been no reports of significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in any severe adverse events.

Storage Conditions

· Store in cool & dry place, protected from light.
· Keep out of reach of children.

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