PRODUCTS

OMECARBO PS 20

OMECARBO PS 20

INDICATIONS

Duodenal Ulcer
Gastric Ulcer
Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
Erosive Esophagitis
Maintenance of Healing of Erosive Esophagitis


INDICATIONS

Duodenal Ulcer

OMECARBO (omeprazole/sodium bicarbonate) is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

Gastric Ulcer

OMECARBO  is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer.

Treatment of Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD

OMECARBO is indicated for the treatment of heartburn and other symptoms associated with GERD.

Erosive Esophagitis
OMECARBO is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.
The efficacy of OMECARBO used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it
may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of OMECARBO may be considered.

Maintenance of Healing of Erosive Esophagitis

OMECARBO is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months.

DOSAGE AND ADMINISTRATION

DOSAGE

OMECARBO (omeprazole/sodium bicarbonate) is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. Directions for use for each indication are summarized in Table 11. All recommended doses throughout the labeling are based upon omeprazole.

Since both the 20 mg and 40 mg oral suspension packets contain the same
amount of sodium bicarbonate (1680 mg), two packets of 20 mg are not
equivalent to one packet of OMECARBO 40 mg; therefore, two 20 mg packets
of OMECARBO should not be substituted for one packet of OMECARBO 40 mg.

OMECARBO should be taken on an empty stomach at least one hour before a
meal.

For patients receiving continuous Nasogastric (NG)/ Orogastric (OG) tube
feeding, enteral feeding should be suspended approximately 3 hours before
and 1 hour after administration of OMECARBO Powder for Oral Suspension.

Table 11: Recommended Doses of OMECARBO by Indication for Adults 18 Years and Older

 

Short-Term Treatment of
Active Duodenal Ulcer
20 mg Once daily for 4 weeks
Benign Gastric Ulcer 40 mg Once daily for 4-8
weeks
Gastroesophageal Reflux
Disease (GERD)
Symptomatic GERD (with
no esophageal erosions)
Erosive Esophagitis
20 mg
20 mg
Once daily for up to 4
weeks
Once daily for 4-8 weeks
Maintenance of Healing of
Erosive Esophagitis
20 mg Once daily

 

Special Populations
Hepatic Insufficiency
Consider dose reduction, particularly for maintenance of healing of erosive esophagitis.

ADMINISTRATION

OMECARBO Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.

SẢN PHẨM CHIẾN LƯỢC