Canalia (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).
Composition:
Canalia-30 Capsule: Each capsule contains Dexlansoprazole INN 30 mg as
enteric coated pellets.
Canalia-60 Capsule: Each capsule contains Dexlansoprazole INN 60 mg as
enteric coated pellets.
Canalia Capsule is indicated for
a) Treating heartburn associated with symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
b) Healing of all grades of Erosive Esophagitis (EE)
c) Maintaining healing of EE and relief of heartburn
Canalia (Dexlansoprazole) capsule is administered orally before or after food.
The recommended doses of Dexlansoprazole for adults are as follows:
| Indication | Recommended Dose | Dose Frequency |
| Symptomatic Non-Erosive GERD | 30 mg | Once daily for 4 weeks |
| Healing of EE | 60 mg | Once daily for up to 8 weeks |
| Maintenance of Healed EE and relief of heartburn | 30 mg | Once daily for up to six months |
Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
Most commonly reported adverse reactions are diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting etc.
No dosage adjustment is necessary for patients with mild hepatic impairment. A maximum daily dose of 30 mg for patients with moderate hepatic impairment
can be considered. No studies have been conducted in patients with severe hepatic impairment.
No dosage adjustment is necessary in patients with renal impairment.
Dexlansoprazole may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g. Atazanavir, Warfarin, Tacrolimus, Ampicillin Esters, Digoxin, Iron salts, Methotrexate, Ketoconazole).
Use in Pregnancy & Lactation: There are no adequate and well-controlled studies with Dexlansoprazole in pregnant women. Dexlansoprazole should be
used during pregnancy only if clearly needed. It is not known whether Dexlansoprazole is excreted in human milk, so it may be taken cautiously.
Use in Children: Dexlansoprazole in patients under the age of 12 years has not been studied.
Use in Geriatric Patients: No dosage adjustment is needed in geriatric patients.
Canalia-30 Capsule: Each box contains 60 Capsules in alu-alu blister pack.
Canalia-60 Capsule: Each box contains 30 Capsules in alu-alu blister pack.
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