Protonix IV (Intravenous)

Pantoprazole injection is used to treat certain conditions where there is too much acid in the stomach. It is used for a short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) with a history of erosive esophagitis. GERD is a condition where stomach acid flows back into the esophagus. This medicine may also be used to treat Zollinger-Ellison syndrome or other conditions (for example, cancer) where the stomach produces too much acid.

Pantoprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid the stomach makes.

This medicine is given only by or under the direct supervision of your doctor.

It is important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects. If your condition does not improve, or if it worsens, consult your doctor.

You should not receive pantoprazole with medicines containing rilpivirine (e.g., Complera®, Edurant®, Odefsey®). Using these medicines together may lead to unwanted side effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Inform your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.

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). Consult your doctor immediately if you experience 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 cause an injection site reaction called thrombophlebitis. Consult your doctor right away if you notice any of these side effects at the injection site: changes in skin color, pain, tenderness, or swelling of the foot or leg.

Consult your doctor immediately if you have a change in frequency or amount of urination, blood in the urine, fever, joint pain, loss of appetite, nausea, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be signs of a serious kidney problem called acute tubulointerstitial nephritis.

Serious stomach conditions may occur while taking this medicine. Consult your doctor immediately if you or your child has stomach cramps, a bloated feeling, watery and severe diarrhea that may be bloody, fever, nausea or vomiting, or unusual tiredness or weakness.

Pantoprazole injection may increase your risk of fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age or older, if you receive high doses of this medicine, or if you use it for one year or more. Call your doctor right away if you have severe bone pain or cannot walk or sit normally.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to happen if you use this medicine for more than 1 year, or if you take it along with digoxin (Lanoxin®) or certain diuretics (water pills). Consult your doctor immediately if you have convulsions (seizures), a fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Cutaneous or systemic lupus erythematosus may occur or worsen 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 worsens when exposed to the sun.

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 taking this medicine for more than 1 year. Discuss any concerns with your doctor.

Make sure any doctor or dentist treating you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription (e.g., atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Appropriate studies have not been done to determine how pantoprazole injection affects children. Safety and effectiveness have not been established.

Geriatric

Studies to date have not shown any specific problems in older adults that would limit the usefulness of pantoprazole injection. However, older patients may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the risks before using this medication while breastfeeding.

Interactions with Medicines

While some medicines should never be used together, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose, or other precautions may be needed. When you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen for their potential importance and may not include all possible interactions.

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 are taking.

• Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acalabrutinib
• Amphetamine
• Atazanavir
• Atezolizumab
• Belumosudil
• Benzphetamine
• Bosutinib
• Capecitabine
• Cefuroxime Axetil
• Cilostazol
• Dabrafenib
• Dacomitinib
• Dasatinib
• Dextroamphetamine
• Erlotinib
• Eslicarbazepine Acetate
• Fedratinib
• Fluconazole
• Gefitinib
• Infigratinib
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Lisdexamfetamine
• Mavacamten
• Methamphetamine
• Methotrexate
• Methylphenidate
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Nilotinib
• Octreotide
• Palbociclib
• Pazopanib
• Pexidartinib
• Phenobarbital
• Primidone
• Saquinavir
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• Sunitinib
• Tocilizumab
• Velpatasvir
• Vismodegib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Levothyroxine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been chosen for their potential significance and may not include all possible interactions.

Using this medicine with any of the following may increase the risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Cranberry

Other Medical Problems

Other medical problems may affect how this medicine works. Make sure you inform your doctor if you have any other medical issues, especially:

• Diarrhea or
• Hypomagnesemia (low magnesium in the blood), history of or
• Kidney disease or
• Osteoporosis (thinning of the bones) or
• Systemic lupus erythematosus (SLE) or
• Zinc deficiency—Use with caution. May worsen these conditions.

• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

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 or nurse immediately if any of the following side effects occur:

Less common

• Accumulation of pus
• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Changes in skin color
• Fever
• Pain, tenderness, or swelling of the foot or leg
• Stomach pain
• Swollen, red, tender area of infection

Rare

• Drowsiness
• Loss of appetite
• Mood or mental changes
• Muscle spasms (tetany) or twitching
• Nausea
• Seizures
• Trembling
• Unusual tiredness or weakness
• Vomiting

Incidence not known

• Absence of or decrease in body movement
• Black, tarry stools
• Blindness
• Blistering, peeling, or loosening of the skin
• Bloating of the stomach
• Bloody or cloudy urine
• Bloody, black, or tarry stools
• Blurred vision
• Chest pain or tightness
• Chills
• Confusion
• Constipation
• Continuing ringing or buzzing or other unexplained noise in the ears
• Cough
• Dark urine
• Decreased urine output
• Decreased vision
• Diarrhea
• Difficulty with speaking
• Difficulty with swallowing
• Dizziness or lightheadedness
• Dry mouth
• Fast heartbeat
• Feeling of constant movement of self or surroundings
• Greatly decreased frequency of urination or amount of urine
• Hearing loss
• Hives, itching, or rash
• Increased thirst
• Increased watering of the mouth
• Indigestion
• Joint or muscle pain
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Light-colored stools
• Muscle cramps, pain, or stiffness
• Numbness and tingling around the mouth, fingertips, or feet
• Painful or difficult urination
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Pale skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Sensation of spinning
• Severe stomach cramps or pain
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stomach cramps or tenderness
• Swelling of the feet or lower legs
• Swollen glands
• Trouble breathing
• Unexplained bleeding or bruising
• Watery and severe diarrhea, which may also be bloody
• Yellow eyes or skin

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:

More common

• Headache

Less common

• Belching
• Excess air or gas in the stomach or bowels
• Full feeling
• Passing gas

Incidence not known

• Decreased interest in sexual intercourse
• Inability to have or keep an erection
• Loss in sexual ability, desire, drive, or performance

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.

In the U.S.

• Protonix
• Protonix IV

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

It may take several days before this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with pantoprazole, unless your doctor tells you otherwise.

Tell your doctor if you have had problems with your zinc levels in your body. Your doctor may want you to take zinc supplements.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

• Pantoprazole vs. omeprazole: What's the difference between them?
• Can you take pantoprazole 40 mg twice a day?
• How long can I take pantoprazole?
• Does pantoprazole cause bloating?
• When should you take pantoprazole?
• Can pantoprazole cause anxiety?

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