NexCap Capsule Delayed 40mg

Product Information

NEXCAP

NexCap®(Esomeprazole)

Presentation

NexCap-20 capsule: Opaque purple cap with two golden ring and opaque purple body imprinted with ‘NexCap 20 mg’ capsule; each

delayed-release capsule contains Esomeprazole 20 mg present as Esomeprazole Magnesium Trihydrate INN in the form of enteric-coated

pellets.

NexCap-40 capsule: Opaque purple cap with three golden ring and opaque purple body imprinted with ‘NexCap 40 mg’ capsule; each

delayed-release capsule contains Esomeprazole 40 mg present as Esomeprazole Magnesium Trihydrate INN in the form of enteric-coated

pellets.

Indications

Gastroesophageal reflux disease (GERD)

-Healing of erosive esophagitis

-Maintenance of healing of erosive esophagitis

-Symptomatic gastroesophageal reflux disease

Risk reduction of NSAID-associated gastric ulcer

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Peptic ulcer

Dosage and administration

Gastroesophageal reflux disease (GERD)

Healing of erosive esophagitis: Esomeprazole 20 mg (one NexCap-20 capsule) or Esomeprazole 40 mg (one NexCap-40 capsule) once

daily for 4 to 8 weeks. (The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an

additional 4-8 weeks of treatment may be considered).

Maintenance of healing of erosive esophagitis: Esomeprazole 20 mg (one NexCap- 20 capsule) once daily is recommended. (Controlled

studies did not extend beyond six months).

Symptomatic gastroesophageal reflux disease: Esomeprazole 20 mg (one NexCap- 20 capsule) once daily for 4 weeks. (If symptoms do

not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered).

Risk reduction of NSAID-associated gastric ulcer: Esomeprazole 20 mg (one NexCap-20 capsule) or Esomeprazole 40 mg (one NexCap-40

capsule) once daily for up to 6 months. (Controlled studies did not extend beyond six months).

H. pylori. eradication to reduce the risk of duodenal ulcer recurrence: Triple therapy: Esomeprazole 20 mg (one NexCap-20 capsule)

twice daily, Clarithromycin 500 mg twice daily and Amoxicillin 1 g or Metronidazole 400 mg twice daily for 7 days.

Peptic ulcer: Esomeprazole 20 mg (one NexCap-20 capsule) twice daily or Esomeprazole 40 mg (one NexCap-40 capsule) once daily for

8 weeks.

Contra-indications, warnings, etc.

Contra-indication: Esomeprazole is contra-indicated in patients with known hypersensitivity to esomeprazole.

Precautions: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy. Atrophic

gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which

esomeprazole is an enantiomer. Esomeprazole should be taken at least one hour before meals. The capsules should not be chewed or

crushed

.

Use in pregnancy and lactation: Esomeprazole should be used during pregnancy only if clearly needed. The excretion of esomeprazole

in milk has not been studied. However, omeprazole concentrations have been measured in breast milk of a woman following oral

administration of 20 mg. Because esomeprazole is likely to be excreted in human milk, because of the potential for serious adverse

reactions in nursing infants from esomeprazole, and because of the potential for tumorigenicity shown for omeprazole in rat

carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account

the importance of

the drug to the mother.

Use in pediatric patients: Safety and effectiveness in pediatric patients have not been established. Use in geriatric patients: No

overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical

experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some

older individuals cannot be ruled out. Use in patients with renal insufficiency- No dose adjustment is necessary.

Use in patients with hepatic insufficiency: No dose adjustment is necessary in patients with mild to moderate liver impairment.

For patients with severe Iiver impairment a dose of 20 mg of esomeprazole should not be exceeded.

Drug interactions: Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absorption of

drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine did not seem to change the pharmacokinetic profile of

esomeprazole. Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increase in the plasma level of

esomeprazole and 14-hydroxyclarithromycin.

Adverse reactions: The most frequently occurring adverse events are headache and diarrhea. Nausea, flatulence, abdominal pain,

constipation, and dry mouth occurred at similar rates among patients taking esomeprazole or omeprazole.

Overdosage: There have been no reports of overdose with esomeprazole. No specific antidote for esomeprazole is known. Since

esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment

should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be

considered.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

NexCap-20 capsule: Cartons of 56 capsules in alu-alu blister.

NexCap-40 capsule: Cartons of 28 capsules in alu-alu blister.