Protonix I.V.

• Antacids
• GERD (Acid Reflux, Heartburn)
• Peptic Ulcer (Stomach Ulcer)
• Reflux Laryngitis

• If you have an allergy to pantoprazole or any other part of Protonix I.V. (pantoprazole injection).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking any of these drugs: Atazanavir, nelfinavir, or rilpivirine.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Protonix I.V. with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Protonix I.V..
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• Call your doctor if you have throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
• Take calcium and vitamin D as you were told by your doctor.
• This medicine may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take Protonix I.V. in high doses or for longer than a year, or if you are older than 50 years old. Talk with your doctor.
• Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. You will need to have your blood work checked if you will be taking this medicine for a long time or if you take certain other drugs like digoxin or water pills. Talk with your doctor.
• Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
• Lupus has happened with Protonix I.V., as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• You may need to take zinc while you take this medicine. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Protonix I.V., call your doctor right away.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Very bad dizziness or passing out.
• Very bad belly pain.
• Bone pain.
• Fever or chills.
• Sore throat.
• A big weight loss.
• Irritation where the shot is given.
• This medicine may raise the chance of a very bad form of diarrhea called Clostridium difficile (C diff)-associated diarrhea. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Loose stools (diarrhea).
• Belly pain.
• Upset stomach or throwing up.
• Gas.
• Dizziness.
• Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Protonix I.V. (pantoprazole injection), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Protonix I.V.. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Protonix I.V..

Review Date: October 4, 2017

Applies to pantoprazole: oral packet, oral tablet, oral tablet enteric coated

Other dosage forms:

• intravenous powder for solution

Along with its needed effects, pantoprazole (the active ingredient contained in Protonix IV) 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 while taking pantoprazole:

• Abdominal or stomach pain
• blurred vision
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• nausea
• sweating
• troubled breathing
• unexplained weight loss
• vomiting

• Absence of or decrease in body movements
• blindness
• blistering, peeling, or loosening of the skin
• bloating
• bloody or cloudy urine
• bloody, black, or tarry stools
• blurred vision
• chills
• clay-colored stools
• constipation
• continuous ringing or buzzing or other unexplained noise in the ears
• cough
• dark-colored urine
• decreased vision
• diarrhea
• difficulty with speaking
• difficulty with swallowing
• dizziness or lightheadedness
• drowsiness
• fast heartbeat
• feeling of constant movement of self or surroundings
• fever
• general feeling of tiredness or weakness
• greatly decreased frequency of urination or amount of urine
• headache
• hearing loss
• high fever
• hives, itching, or skin rash
• indigestion
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• mood or mental changes
• muscle cramps
• muscle pain or stiffness
• muscle spasms (tetany) or twitching
• 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
• seizures
• sensation of spinning
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• swelling of the feet or lower legs
• swollen glands
• tightness in the chest
• trembling
• unexplained bleeding or bruising
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Some side effects of pantoprazole 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:

• Belching
• bloated or full feeling
• excess air or gas in the stomach or intestines
• passing gas
• trouble sleeping

• Increased watering of the mouth

Treatment of Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.

Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome

PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions.

PROTONIX I.V. for Injection may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of PROTONIX I.V. for Injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP. When administered through a Y-site, PROTONIX I.V. for Injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.

Midazolam HCl has been shown to be incompatible with Y-site administration of PROTONIX I.V. for Injection. PROTONIX I.V. for Injection may not be compatible with products containing zinc. When PROTONIX I.V. for Injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.

Treatment with PROTONIX I.V. for Injection should be discontinued as soon as the patient is able to be treated with PROTONIX Delayed-Release Tablets. Also, data on the safe and effective dosing for conditions other than those described in INDICATIONS AND USAGE , such as life-threatening upper gastrointestinal bleeds, are not available. PROTONIX I.V. 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

Parenteral routes of administration other than intravenous are not recommended.

No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Doses higher than 40 mg/day have not been studied in hepatically-impaired patients. No dosage adjustment is necessary in patients undergoing hemodialysis.

Treatment of Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

The recommended adult dose is 40 mg pantoprazole given once daily by intravenous infusion for 7 to 10 days. Safety and efficacy of PROTONIX I.V. for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated (see INDICATIONS AND USAGE ).

Fifteen Minute Infusion

PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, and further diluted (admixed) with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL. The reconstituted solution may be stored for up to 2 hours at room temperature prior to further dilution; the admixed solution may be stored for up to 22 hours at room temperature prior to intravenous infusion. Both the reconstituted solution and the admixed solution do not need to be protected from light.

PROTONIX I.V. for Injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.

Two Minute Infusion

PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 2 hours at room temperature prior to intravenous infusion and does not need to be protected from light. PROTONIX I.V. for Injection should be administered intravenously over a period of at least 2 minutes.

Pathological Hypersecretion Associated withZollinger-Ellison Syndrome

The dosage of PROTONIX I.V. for Injection in patients with pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions varies with individual patients. The recommended adult dosage is 80 mg q12h. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg q8h is expected to maintain acid output below 10 mEq/h. Daily doses higher than 240 mg or administered for more than 6 days have not been studied. (See Clinical Studies section.) Transition from oral to I.V. and from I.V. to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with Zollinger-Ellison Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.

Fifteen Minute Infusion

Each vial of PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be combined and further diluted (admixed) with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL. The reconstituted solution may be stored for up to 2 hours at room temperature prior to further dilution; the admixed solution may be stored for up to 22 hours at room temperature prior to intravenous infusion. Both the reconstituted solution and the admixed solution do not need to be protected from light.

PROTONIX I.V. for Injection should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.

Two Minute Infusion

PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 2 hours at room temperature prior to intravenous infusion and does not need to be protected from light. The total volume from both vials should be administered intravenously over a period of at least 2 minutes.