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Omeprazole and sodium bicarbonate (Oral route)

Pronunciation:

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

Brand Names:

  • Zegerid

Dosage Forms:

  • Packet
  • Capsule

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 (e.g., 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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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.

  • Atazanavir
  • Bendamustine
  • Bosutinib
  • Citalopram
  • Clopidogrel
  • Clorazepate
  • Clozapine
  • Dabrafenib
  • Dasatinib
  • Delavirdine
  • Elvitegravir
  • Erlotinib
  • Eslicarbazepine Acetate
  • Indinavir
  • Ketoconazole
  • Methotrexate
  • Mycophenolate Mofetil
  • Nelfinavir
  • Nilotinib
  • Pazopanib
  • Ponatinib
  • Saquinavir
  • Tacrolimus
  • Vismodegib

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
  • Cholic Acid
  • Cilostazol
  • Cranberry
  • Dasatinib
  • Digoxin
  • Disulfiram
  • Fluconazole
  • Ginkgo Biloba
  • Iron
  • Raltegravir
  • St John's Wort
  • Tipranavir
  • Triazolam
  • Voriconazole
  • Warfarin

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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
  • 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—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 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 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 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 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.

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—

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

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.

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 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.

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.

Atrophic gastritis (inflammation in the stomach) may occur, especially if you take this medicine for a long time. Talk with your doctor if you have concerns about this.

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

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". Stop using this medicine and 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.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking this medicine.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal 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
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
mood or mental changes
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
shortness of breath
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
wheezing
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
high blood pressure
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
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
skin rash
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
anxiety
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
sleeplessness
sugar in the urine
swelling of the breasts or breast soreness in both females and males
swelling or inflammation of the mouth
trouble sleeping
unable to sleep
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.


Last Updated: 4/4/2014

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