Pronunciation:

oh-MEP-ra-zole, SOE-dee-um bye-KAR-bo-nate

Brand Names:

• Zegerid

Dosage Forms:

• Capsule
• Packet
• Powder for Suspension

Classifications:

Therapeutic—

Gastric Acid Secretion Inhibitor

Pharmacologic—

Proton Pump Inhibitor

Uses of This Medicine:

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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of omeprazole and sodium bicarbonate combination in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omeprazole and sodium bicarbonate combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Acalabrutinib
• Amphetamine
• Atazanavir
• Atezolizumab
• Belumosudil
• Belzutifan
• Benzphetamine
• Bosutinib
• Cabotegravir
• Capecitabine
• Cefuroxime Axetil
• Cilostazol
• Citalopram
• Clopidogrel
• Clorazepate
• Conivaptan
• Dabrafenib
• Dacomitinib
• Darunavir
• Dasabuvir
• Dasatinib
• Delavirdine
• Dextroamphetamine
• Diazepam
• Digoxin
• Elagolix
• Erdafitinib
• Erlotinib
• Escitalopram
• Eslicarbazepine Acetate
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Fosphenytoin
• Gefitinib
• Indinavir
• Infigratinib
• Itraconazole
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Lisdexamfetamine
• Mavacamten
• Mefenamic Acid
• Memantine
• Methamphetamine
• Methotrexate
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Netupitant
• Nilotinib
• Octreotide
• Olanzapine
• Omaveloxolone
• Ombitasvir
• Palbociclib
• Paritaprevir
• Pazopanib
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pirtobrutinib
• Primidone
• Rifampin
• Rilpivirine
• Ritonavir
• Saquinavir
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• St John's Wort
• Sunitinib
• Tacrolimus
• Tocilizumab
• Velpatasvir
• Vismodegib
• Voriconazole
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Armodafinil
• Carbamazepine
• Chloroquine
• Cyanocobalamin
• Disulfiram
• Ginkgo Biloba
• Iron
• Levothyroxine
• Raltegravir
• Tipranavir
• Triazolam

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bartter's syndrome (rare kidney problem) or
• Diarrhea or
• Hypocalcemia (low calcium in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood), history of or
• Osteoporosis (bone problem) or
• Respiratory alkalosis (low levels of carbon dioxide in the blood) or
• Seizures, history of or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Liver disease—You may need a dose adjustment. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking this medicine if your doctor told you to take it for a specific amount of time, even if you feel better.

This medicine comes with a Medication Guide or a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine contains sodium (salt). Talk to your doctor before using this medicine if you are on a low-sodium (low-salt) diet or if you have or are at risk for congestive heart failure.

Tell your doctor if you are taking calcium supplements on a regular basis.

Both 20 and 40 milligrams oral suspension packets or capsules contain the same amount of sodium bicarbonate. Do not substitute two 20 milligrams (mg) oral suspension packets or capsules with one 40 mg oral suspension packets or capsules. Talk to your doctor if you have any questions.

Take this medicine on an empty stomach at least 1 hour before a meal. For patients receiving continuous feeding through a tube, feeding should be temporarily stopped about 3 hours before and 1 hour after administration of Konvomep™ oral suspension or Zegerid® powder for oral suspension.

Swallow the capsules whole with water. Do not take it with other liquids. Do not break, crush, or chew it. Do not open the capsule and sprinkle the contents into food.

To use the Konvomep™ oral suspension: Shake the bottle before each use. Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.

If you are using the Konvomep™ oral suspension with a nasogastric or orogastric tube:

• Shake well and draw up 20 mL of the medicine into a catheter-tipped or oral syringe.
• Give the medicine through the nasogastric or orogastric tube into the stomach right away.
• Refill the syringe with 20 mL of water.
• Flush any remaining contents from the nasogastric or orogastric tube into the stomach.

To use the Zegerid® powder for oral suspension:

• Empty packet of powder into a small cup containing 1 to 2 tablespoons of water.
• Do not use other liquids or foods.
• Stir well and drink immediately.
• Refill cup with water and drink.

If you are using the Zegerid® powder for oral suspension with a nasogastric or orogastric tube:

• Mix the packet of powder with approximately 20 mL of water.
• Stir well and draw up into appropriately sized syringe.
• Give the medicine through the nasogastric or orogastric tube into the stomach right away.
• Refill the syringe with an equal amount of water.
• Shake and flush any remaining contents from the nasogastric or orogastric tube into the stomach.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or powder for suspension):
  • To treat duodenal ulcers, erosive esophagitis, and GERD:
    • Adults—20 milligrams (mg) once a day at least 1 hour before a meal. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • To treat gastric ulcers:
    • Adults—40 milligrams (mg) once a day at least 1 hour before a meal. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (powder for suspension):
  • To prevent upper gastrointestinal tract bleeding in seriously ill patients:
    • Adults—The first day: 40 milligrams (mg) for the first dose, then after 6 to 8 hours, a second 40 mg dose. After the first day: 40 mg once a day for up to 14 days.
    • Children—Use and dose must be determined by your doctor.
  • To treat gastric ulcers:
    • Adults—40 milligrams (mg) once a day for 4 to 8 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the Konvomep™ oral suspension in the refrigerator for up to 30 days.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, check with your doctor.

Do not use this medicine if you are also taking rilpivirine (Edurant®) or products containing rilpivirine (eg, Complera®). Using these medicines together may cause serious side effects.

Tell your doctor if you have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine to treat erosive esophagitis.

This medicine is sometimes given together with other medicines to treat ulcers. Be sure you understand about the risks and proper use of any other medicine your doctor gives you together with omeprazole and sodium bicarbonate combination.

Check with your doctor right away if you have a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be symptoms of acute tubulointerstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

Serious stomach conditions may occur while taking this medicine alone or together with antibiotics. Check with your doctor immediately if you have stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea, vomiting, or unusual tiredness or weakness.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely are 50 years of age and older, if you receive high doses of this medicine or use it for one year or more.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Side Effects of This Medicine:

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 or tightness

confusion

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, cramps, spasms, 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

trembling

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Bladder pain

blue lips, fingernails, or skin

bone pain

chest discomfort

cloudy urine

coma

decreased urine output

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

stomach cramps or pain

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

mood or mental changes

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 interest in sexual intercourse

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

inability to have or keep an erection

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

loss in sexual ability, desire, drive, or performance

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.