Omeprazole and sodium bicarbonate

Name: Omeprazole and sodium bicarbonate

How should I take omeprazole and sodium bicarbonate?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine on an empty stomach, at least 1 hour before eating a meal. If this medicine is given to a person who is fed through a nasogastric (NG) tube, the feeding should be stopped at least 3 hours before giving the medicine. Do not restart nasogastric feeding for at least 1 hour after giving omeprazole and sodium bicarbonate.

Take the omeprazole and sodium bicarbonate capsule with a full glass of water. Do not use any other type of liquid or food.

Do not open the capsule or empty the medicine powder from it. Swallow the capsule whole.

To use the powder form, open a packet and pour all of the powder into a small cup with 1 or 2 tablespoons of water. Do not use any other type of liquid. Stir the mixture and drink it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

The 20-mg and the 40-mg forms of this medicine contain the same strength of sodium bicarbonate. Do not use two 20-mg capsules to equal one 40-mg capsule. Do not use two 20-mg powder packets to equal one 40-mg powder packet. If you do not use the exact capsule or powder packet your doctor has prescribed, you may receive too much sodium bicarbonate.

If you use omeprazole and sodium bicarbonate for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Store at room temperature away from moisture and heat.

Before Using omeprazole and sodium bicarbonate

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 omeprazole and sodium bicarbonate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to omeprazole and sodium bicarbonate 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.

Pediatric

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.

Geriatric

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 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.

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.

Interactions with 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 omeprazole and sodium bicarbonate, 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 omeprazole and sodium bicarbonate 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 omeprazole and sodium bicarbonate 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.

  • Amphetamine
  • Atazanavir
  • Bendamustine
  • Benzphetamine
  • Bosutinib
  • Cilostazol
  • Citalopram
  • Clopidogrel
  • Clorazepate
  • Conivaptan
  • Dasabuvir
  • Dasatinib
  • Delavirdine
  • Dextroamphetamine
  • Digoxin
  • Elvitegravir
  • Erlotinib
  • Escitalopram
  • Eslicarbazepine Acetate
  • Gefitinib
  • Indinavir
  • Ketoconazole
  • Ledipasvir
  • Lisdexamfetamine
  • Mefenamic Acid
  • Memantine
  • Methamphetamine
  • Methotrexate
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Netupitant
  • Nilotinib
  • Ombitasvir
  • Paritaprevir
  • Pazopanib
  • Ritonavir
  • Saquinavir
  • Tacrolimus
  • Velpatasvir
  • Vismodegib
  • Voriconazole

Using omeprazole and sodium bicarbonate 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
  • Dasatinib
  • Digoxin
  • Disulfiram
  • Fluconazole
  • Ginkgo Biloba
  • Iron
  • Levothyroxine
  • Raltegravir
  • St John's Wort
  • Tipranavir
  • Triazolam
  • Warfarin

Interactions with Food/Tobacco/Alcohol

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 omeprazole and sodium bicarbonate 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 omeprazole and sodium bicarbonate, 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 omeprazole and sodium bicarbonate. 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.

omeprazole and sodium bicarbonate 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 omeprazole and sodium bicarbonate 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.

PRINCIPAL DISPLAY PANEL – 40 MG POUCH

OMEPRAZOLE/SODIUM BICARBONATE 
Omeprazole and Sodium Bicarbonate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-269
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 40 mg
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1680 mg
Inactive Ingredients
Ingredient Name Strength
XYLITOL  
XANTHAN GUM  
SUCRALOSE  
PEACH  
SUCROSE  
PEPPERMINT  
Packaging
# Item Code Package Description
1 NDC:49884-269-11 30 PACKET in 1 CARTON
1 NDC:49884-269-52 1 POWDER, FOR SUSPENSION in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079182 07/18/2016
OMEPRAZOLE/SODIUM BICARBONATE 
Omeprazole and Sodium Bicarbonate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-268
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 20 mg
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1680 mg
Inactive Ingredients
Ingredient Name Strength
XYLITOL  
XANTHAN GUM  
SUCRALOSE  
PEACH  
SUCROSE  
PEPPERMINT  
Packaging
# Item Code Package Description
1 NDC:49884-268-11 30 PACKET in 1 CARTON
1 NDC:49884-268-52 1 POWDER, FOR SUSPENSION in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079182 07/18/2016
Labeler - Par Pharmaceutical, Inc. (092733690)
Revised: 06/2017   Par Pharmaceutical, Inc.

Index Terms

  • Omeprazole/Sodium Bicarbonate
  • Sodium Bicarbonate and Omeprazole

Contraindications

Hypersensitivity (eg, anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria) to omeprazole, other substituted benzimidazole proton pump inhibitors, or any component of the formulation

Administration

Note: Both strengths of Zegerid capsule and powder for oral suspension have identical sodium bicarbonate content, respectively. Do not substitute two 20 mg capsules/packets for one 40 mg dose.

Capsule: Should be swallowed whole with water (do not use other liquids); do not chew or crush. Capsules should not be opened, sprinkled on food, or administered via NG. Best if taken at least 1 hour before breakfast.

Powder for oral suspension:

Oral: Administer 1 hour before a meal. Mix with 15 to 30 mL of water; stir well and drink immediately. Rinse cup with water and drink. Do not use other liquids or sprinkle on food.

Nasogastric/orogastric tube: Mix well with 20 mL of water (do not use other liquids) and administer immediately; flush tube with an additional 20 mL of water. Suspend enteral feeding for 3 hours before and 1 hour after administering.

Test Interactions

Omeprazole may falsely elevate serum chromogranin A (CgA) levels. The increased CgA level may cause false-positive results in the diagnosis of a neuroendocrine tumor. Temporarily stop omeprazole ≥14 days prior to assessing CgA level; repeat test if CgA level is initially elevated; use the same laboratory for all testing of CgA levels.

Pregnancy Risk Factor C Pregnancy Considerations

Adverse events have been observed in animal reproduction studies with omeprazole. Refer to individual agents.

In Summary

More frequently reported side effects include: congenital anomalies and abdominal pain. See below for a comprehensive list of adverse effects.

Renal Dose Adjustments

No adjustment recommended.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

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