ZEGERID: Package Insert and Label Information

ZEGERID- omeprazole and sodium bicarbonate powder, for suspension
ZEGERID- omeprazole and sodium bicarbonate capsule
Santarus, Inc..

1 INDICATIONS AND USAGE

ZEGERID for oral suspension and ZEGERID capsules are indicated in adults for the:

short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
short-term treatment (4 to 8 weeks) of active benign gastric ulcer.
treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
o
The efficacy of ZEGERID used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of ZEGERID may be considered.
maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.

ZEGERID for oral suspension is indicated in adults for the:

reduction of risk of upper GI bleeding in critically ill adult patients.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

ZEGERID (omeprazole and 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. All recommended doses throughout the labeling are based upon omeprazole.
The sodium content of ZEGERID capsules and ZEGERID for oral suspension should be taken into consideration when prescribing this product [see Warnings and Precautions (5.3)]:
o
ZEGERID capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg.
o
ZEGERID for oral suspension: each 20 mg and 40 mg packet of contains 1,680 mg (20 mEq) of sodium bicarbonate. The total content of sodium in each packet is 460 mg.
Due to the sodium bicarbonate content of ZEGERID:
Two packets of 20 mg ZEGERID for oral suspension are not interchangeable with one packet of 40 mg ZEGERID for oral suspension.
Two 20 mg ZEGERID capsules are not interchangeable with one 40 mg ZEGERID capsule.

2.2 Dosage Regimen

The recommended dosage regimen by indication in adults of ZEGERID for oral suspension and ZEGERID capsules is summarized in Table 1. Only 40 mg ZEGERID for oral suspension is indicated for the reduction of risk of upper GI bleeding in critically ill adult patients and the dosage regimen is summarized in Table 2. All recommended dosages are based upon omeprazole content.

Table 1: Recommended Dosage Regimen of ZEGERID for Oral Suspension and ZEGERID Capsules in Adults by Indication
*
Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy [see Clinical Studies (14.1)].
The efficacy of ZEGERID used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of ZEGERID may be considered.

Indication

Dosage of

ZEGERID for oral suspension or ZEGERID capsules

Treatment Duration

Treatment of Active Duodenal Ulcer

20 mg once daily

4 weeks *

Treatment of Active Benign Gastric Ulcer

40 mg once daily

4 to 8 weeks

Treatment of Symptomatic GERD

20 mg once daily

Up to 4 weeks

Treatment of EE due to Acid-Mediated GERD

20 mg once daily

4 to 8 weeks

Maintenance of Healing of EE due to Acid-Mediated GERD

20 mg once daily

Controlled studies do not extend beyond 12 months.

Table 2: Recommended Dosage Regimen of 40 mg ZEGERID for Oral Suspension in Adults by Indication

Indication

Dosage of

40 mg ZEGERID for oral suspension

Treatment Duration

Reduction of Risk of Upper GI Bleeding in Critically Ill Patients

40 mg initially; followed by 40 mg 6 to 8 hours later; and40 mg once daily thereafter

14 days

2.3 Preparation and Administration

ZEGERID Capsules

Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water.
Take on an empty stomach at least one hour before a meal [see Clinical Pharmacology (12.3)].

ZEGERID for Oral Suspension

ZEGERID for oral suspension is intended to be mixed with water and administered orally or via a nasogastric (NG) or orogastric (OG) tube.
If administered orally, take on an empty stomach at least one hour before a meal.
If administered via NG or OG tube, suspend enteral feeding approximately 3 hours before and 1 hour after administration of ZEGERID for oral suspension.

Oral Administration

o
Empty the contents of a packet into a small cup containing 5 to 10 mL of water. Do not mix with liquids or foods other than water.
o
Stir well and drink immediately.
o
Refill cup with water and drink immediately.

Nasogastric (NG) or Orogastric (OG) Tube Administration

o
Add 20 mL of water to a catheter tipped syringe and then add the contents of a packet. Use an appropriately-sized catheter tipped syringe. Do not mix with liquids or foods other than water.
o
Shake the syringe to dissolve the powder.
o
Administer through the NG or orogastric tube into the stomach right away.
o
Refill the syringe with an equal amount of water.
o
Shake and flush any remaining contents from the NG tube or orogastric tube into the stomach.

3 DOSAGE FORMS AND STRENGTHS

ZEGERID is available as:

Capsules

20 mg: Each opaque, hard gelatin, white capsule, imprinted with the Santarus logo and “20”, contains 20 mg omeprazole and 1,100 mg sodium bicarbonate.
40 mg: Each opaque, hard gelatin, colored dark blue and white capsule, imprinted with the Santarus logo and “40”, contains 40 mg omeprazole and 1,100 mg sodium bicarbonate.

For Oral Suspension

20 mg: white, flavored powder packaged in unit-dose packets. Each packet contains 20 mg omeprazole and 1,680 mg sodium bicarbonate.
40 mg: white, flavored powder packaged in unit-dose packets. Each packet contains 40 mg omeprazole and 1,680 mg sodium bicarbonate.

4 CONTRAINDICATIONS

ZEGERID is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)].

Proton pump inhibitors (PPIs), including ZEGERID, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with ZEGERID does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy.

5.2 Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea and anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).

Discontinue ZEGERID and evaluate patients with suspected acute TIN [see Contraindications (4)].

5.3 Sodium Bicarbonate Buffer Content

Each 20 mg and 40 mg ZEGERID capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg.

Each 20 mg and 40 mg packet of ZEGERID for oral suspension contains 1,680 mg (20 mEq) of sodium bicarbonate. The total content of sodium in each packet is 460 mg.

Chronic administration of bicarbonate with calcium or milk can cause milk-alkali syndrome. Chronic use of sodium bicarbonate may lead to systemic alkalosis, and increased sodium intake can produce edema and weight gain.

The sodium content of ZEGERID products should be taken into consideration when administering to patients on a sodium-restricted diet or those at risk for developing congestive heart failure.

Avoid ZEGERID in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance.

5.4 Clostridium difficile -Associated Diarrhea

Published observational studies suggest that PPI therapy like ZEGERID may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

5.5 Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines [see Dosage and Administration (2.2) and Adverse Reactions (6.2)].

5.6 Severe Cutaneous Adverse Reactions

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs [ see Adverse Reactions (6.2) ]. Discontinue ZEGERID at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

5.7 Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving ZEGERID, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

5.8 Interaction with Clopidogrel

Avoid concomitant use of ZEGERID with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity. Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using ZEGERID, consider alternative antiplatelet therapy [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

5.9 Cyanocobalamin (Vitamin B-12) Deficiency

Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with ZEGERID.

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