Zegerid

Name: Zegerid

Warnings

Contraindications  

Hypersensitivity drugs or components of the formulation

Cautions  

Atrophic gastritis reported with long term use

PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve

Contains sodium bicarbonate; use with caution in patients with Bartter’s syndrome

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4- 12 weeks; serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations

Use with caution in patients with respiratory alkalosis due to the presence of sodium bicarbonate

May require dosage reduction with liver disease

Bioavailability may be increased in the elderly

Use caution in patients with hypokalemia or hypocalcemia; contains sodium bicarbonate

Shown to cause gastric carcinoid tumors in rats with increased doses, but risk in humans unconfirmed

Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (>1 year), high-dose therapy

Hypomagnesemia may occur with prolonged use (>1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued; consider monitoring magnesium levels prior to initiation of PPI treatment and periodically

Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI

Inhibits hepatic isoenzyme CYP2C19 and may alter metabolism of drugs that are CYP2C19 substrates

Proton pump inhibitors may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite Gastric atrophy reported with long term use

Relief of symptoms does not eliminate the possibility of a gastric malignancy

Therapy increases risk of salmonella, campylobacter and other infections

May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered oncomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy therapy with high dose methotrexate administration

What Is Omeprazole Sodium Bicarbonate?

Omeprazole is a proton pump inhibitor that decreases the amount of acid your stomach produces. Sodium bicarbonate is an antacid that raises the pH in your stomach to keep the omeprazole from breaking down in stomach acid.

Omeprazole and sodium bicarbonate is a combination medicine used to treat heartburn and other symptoms of gastroesophageal reflux disease (GERD). This medicine is also used to treat ulcers and other conditions involving excessive stomach acid production.

Omeprazole and sodium bicarbonate is not for immediate relief of heartburn symptoms.

Omeprazole and sodium bicarbonate may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not take this medicine if you are allergic to omeprazole or sodium bicarbonate.

This medicine contains sodium bicarbonate, a form of salt. Each capsule contains the equivalent of 300 mg of sodium. Each packet of powder contains the equivalent of 460 mg of sodium. If you are on a low-salt or low-sodium diet, you may not be able to use omeprazole and sodium bicarbonate. Talk with your doctor.

Ask a doctor or pharmacist if it is safe for you to use omeprazole and sodium bicarbonate if you have other medical conditions, especially:

  • kidney or liver disease;
  • heart disease;
  • metabolic or respiratory alkalosis (usually after prolonged illness); or
  • low levels of calcium, magnesium, or potassium levels in your blood.

Taking a proton pump inhibitor such as omeprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older. It is not clear whether omeprazole is the actual cause of an increased risk of fracture.

Some conditions are treated with a combination of antibiotics with omeprazole and sodium bicarbonate. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Omeprazole and sodium bicarbonate can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Omeprazole and sodium bicarbonate is not approved for use by anyone younger than 18 years old.

  • Heartburn

Pregnancy

Information about this omeprazole-and-sodium-bicarbonate-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Manufacturer

  • MSD Consumer Care, Inc.

  • Santarus, Incorporated

  • Stat Rx Usa Llc

What is omeprazole and sodium bicarbonate?

Omeprazole is a proton pump inhibitor that decreases the amount of acid your stomach produces. Sodium bicarbonate is an antacid that raises the pH in your stomach to keep the omeprazole from breaking down in stomach acid.

Omeprazole and sodium bicarbonate is a combination medicine used to treat heartburn and other symptoms of gastroesophageal reflux disease (GERD). This medicine is also used to treat ulcers and other conditions involving excessive stomach acid production.

Omeprazole and sodium bicarbonate is not for immediate relief of heartburn symptoms.

Omeprazole and sodium bicarbonate may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before taking omeprazole and sodium bicarbonate?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not take this medicine if you are allergic to omeprazole or sodium bicarbonate.

This medicine contains sodium bicarbonate, a form of salt. Each capsule contains the equivalent of 300 mg of sodium. Each packet of powder contains the equivalent of 460 mg of sodium. If you are on a low-salt or low-sodium diet, you may not be able to use omeprazole and sodium bicarbonate. Talk with your doctor.

Ask a doctor or pharmacist if it is safe for you to use omeprazole and sodium bicarbonate if you have other medical conditions, especially:

  • a rare kidney disorder called Bartter's syndrome;

  • liver disease;

  • any allergies;

  • heart disease; or

  • low levels of calcium, magnesium, or potassium levels in your blood.

Taking a proton pump inhibitor such as omeprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older.

Some conditions are treated with a combination of antibiotics with omeprazole and sodium bicarbonate. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Omeprazole and sodium bicarbonate can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Omeprazole and sodium bicarbonate is not approved for use by anyone younger than 18 years old.

Uses For Zegerid

Omeprazole and sodium bicarbonate combination is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. Sometimes this medicine is used in combination with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers associated with infection caused by the H. pylori bacteria (germ).

Omeprazole and sodium bicarbonate combination is used to prevent upper gastrointestinal tract bleeding in seriously ill patients.

Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

Sodium bicarbonate, also known as baking soda, is an antacid. It works by neutralizing the excess acid in the stomach.

This medicine is available only with your doctor's prescription.

Zegerid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • chest pain
  • confusion
  • convulsions
  • cough
  • decreased urine
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • fainting
  • fast or irregular heartbeat
  • fever or chills
  • headache
  • increased thirst
  • lightheadedness
  • loss of appetite
  • muscle pain or cramps
  • muscle spasms (tetany) or twitching
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid, shallow breathing
  • seizures
  • slow heartbeat
  • sneezing
  • sore throat
  • sweating
  • tightness in the chest
  • trembling
  • troubled breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach cramps or pain
  • bladder pain
  • blue lips, fingernails, or skin
  • bone pain
  • chest discomfort
  • cloudy urine
  • coma
  • decreased urine output
  • difficult or troubled breathing
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • headache
  • irregular, fast or slow, or shallow breathing
  • irritability
  • lower back or side pain
  • muscle cramps in the hands, arms, feet, legs, or face
  • restlessness
  • swelling
  • swelling of the face, feet, lower legs, ankles, or hands
  • weakness or heaviness of the legs
Rare
  • Severe pain in the chest
  • sudden onset of severe breathing difficulty
Incidence not known
  • Arm, back, or jaw pain
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • chest tightness or heaviness
  • constipation
  • cough or hoarseness
  • dark-colored urine
  • diarrhea
  • difficulty with swallowing
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • greatly decreased frequency of urination or amount of urine
  • high fever
  • hives or skin rash
  • indigestion
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • noisy breathing
  • nosebleeds
  • pain with swallowing
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain, continuing
  • sweating
  • swollen glands
  • unexplained bleeding or bruising
  • unusual weight gain or loss
  • weight gain
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Feeling of warmth
  • increased sweating
  • redness of the face, neck, arms, and occasionally, upper chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Agitation
  • cold sweats
  • cool, pale skin
  • depression
  • excess air or gas in the stomach or intestines
  • flushed, dry skin
  • fruit-like breath odor
  • full feeling
  • increased hunger
  • increased thirst
  • increased urination
  • lack or loss of strength
  • nightmares
  • passing gas
  • shakiness
  • slurred speech
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash
Incidence not known
  • Abnormal dreams
  • attack, assault, or force
  • bad, unusual, or unpleasant (after) taste
  • blindness
  • blue-yellow color blindness
  • change in taste
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased vision
  • double vision
  • dry eyes or skin
  • eye pain
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • hair loss or thinning of the hair
  • hearing loss
  • hives or welts
  • increased sensitivity of the skin to sunlight
  • itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use
  • lack of feeling or emotion
  • pain in the testes
  • pinpoint red or purple spots on the skin
  • redness or other discoloration of the skin
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • severe sunburn
  • sleepiness or unusual drowsiness
  • sugar in the urine
  • swelling of the breasts or breast soreness in both females and males
  • swelling or inflammation of the mouth
  • trouble sleeping
  • uncaring

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How Supplied/Storage and Handling

Zegerid 20 mg Capsules: Each opaque, hard gelatin, white capsule, imprinted with the Santarus logo and “20”, contains 20 mg omeprazole and 1100 mg sodium bicarbonate.

  NDC 68012-102-30 Bottles of 30 capsules

Zegerid 40 mg Capsules: Each opaque, hard gelatin, colored dark blue and white capsule, imprinted with the Santarus logo and “40”, contains 40 mg omeprazole and 1100 mg sodium bicarbonate.

  NDC 68012-104-30 Bottles of 30 capsules

Zegerid Powder for Oral Suspension is a white, flavored powder packaged in unit-dose packets. Each packet contains either 20 mg or 40 mg omeprazole and 1680 mg sodium bicarbonate.

  NDC 68012-052-30 Cartons of 30: 20 mg unit-dose packets   NDC 68012-054-30 Cartons of 30: 40 mg unit-dose packets

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep container tightly closed. Protect from light and moisture.

What is Zegerid?

Zegerid contains a combination of omeprazole and sodium bicarbonate. Omeprazole is a proton pump inhibitor that decreases the amount of acid your stomach produces. Sodium bicarbonate is an antacid that raises the pH in your stomach to keep the omeprazole from breaking down in stomach acid.

Zegerid is used to treat heartburn and other symptoms of gastroesophageal reflux disease (GERD). This medicine is also used to treat ulcers and other conditions involving excessive stomach acid production.

Zegerid is not for immediate relief of heartburn symptoms.

Zegerid side effects

Get emergency medical help if you have signs of an allergic reaction to Zegerid: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • diarrhea that is watery or bloody;

  • stomach pain, nausea, vomiting, weight loss;

  • confusion, dizziness, seizure (convulsions);

  • numbness or tingling in your face, arms, or legs;

  • kidney problems - urinating more or less than usual, blood in your urine, swelling, rapid weight gain; or

  • symptoms of low magnesium - dizziness; fast or uneven heart rate; tremors (shaking) or jerking muscle movements; feeling jittery; muscle weakness, muscle cramps, muscle spasms in your hands and feet; cough or choking feeling.

Common Zegerid side effects may include:

  • headache;

  • nausea, vomiting, stomach pain, gas; or

  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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