Protonix

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Generic Name: Protonix Brand Name(s): Generics only. No brands available.

Uses

What is Protonix® (pantoprazole) used for?

Protonix® is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Protonix® is used to treat erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excess stomach acid such as Zollinger-Ellison syndrome.

Protonix® is not for immediate relief of heartburn symptoms.

How should I take Protonix® (pantoprazole)?

Take Protonix® exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Protonix® tablets can be taken with or without food. Protonix® oral granules should be taken 30 minutes before a meal.

Do not crush, chew, or break the tablet. Swallow it whole.

The oral granules should be mixed with applesauce or apple juice. Do not use any other type of liquid or soft food. Sprinkle the granules directly onto 1 teaspoon of applesauce or apple juice. Stir for 5 seconds and swallow this mixture right away without chewing. Do not save the mixture for later use.

To give Protonix® granules through a nasogastric (NG) feeding tube:

  • Attach a 60-milliliter syringe to the NG tube and remove the plunger. Hold the syringe high enough to prevent any bends in the tube.
  • Empty the Protonix® granules into the syringe barrel and mix in 2 teaspoons of apple juice.
  • Add 2 more teaspoons of apple juice to the syringe to rinse the granules through. Tap or shake the syringe as the juice empties into the tube.
  • Rinse with 2 teaspoons of apple juice at least twice more to make sure there are no granules remaining in the syringe or NG tube.

Take Protonix® for the full prescribed length of time. Your symptoms may improve before the condition is fully treated.

If you use Protonix® 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.

Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine.

If you use Protonix® 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.

This medicine can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking Protonix®.

How do I store Protonix® (pantoprazole)?

Protonix® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Protonix® in the bathroom or the freezer. There may be different brands of Protonix® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Protonix® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Protonix® (pantoprazole)?

Before using this drug, tell your doctor if:

  • You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
  • You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
  • You have allergy with any of active or inactive ingredients of Protonix® or other medications.
  • You have any other illnesses, disorders, or medical conditions.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use Protonix® if you are allergic to medicines such as lansoprazole (Prevacid), esomeprazole (Nexium), omeprazole (Prilosec, Zegerid), or rabeprazole (AcipHex).

Taking a proton pump inhibitor such as pantoprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medicine long term or at high doses, and in those who are age 50 and older. It is not clear whether Protonix® is the actual cause of an increased risk of fracture.

Protonix® is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Pantoprazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Protonix® is not approved for use by anyone younger than 5 years old.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Protonix® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Protonix®. Protonix® is pregnancy risk category B, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown

Side effects

What side effects can occur from Protonix® (pantoprazole)?

Common side effects may include:

  • Headache
  • Fever
  • Cold symptoms such as stuffy nose, sneezing, sore throat
  • Stomach pain, gas, nausea, vomiting
  • Mild diarrhea
  • Joint pain

Call your doctor at once if you have:

  • Severe stomach pain, nausea, vomiting, and weight loss
  • Diarrhea that is watery or bloody
  • Seizure (convulsions)
  • Kidney problems – urinating more or less than usual, blood in your urine, swelling, rapid weight gain
  • Symptoms of low magnesium – dizziness, confusion
  • Fast or uneven heart rate
  • Tremors (shaking) or jerking muscle movements
  • Feeling jittery
  • Muscle cramps, muscle spasms in your hands and feet
  • Cough or choking feeling

Get emergency medical help if you have signs of an allergic reaction to Protonix®: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Protonix® (pantoprazole)?

Protonix® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

  • Ampicillin
  • Ketoconazole
  • Methotrexate
  • Mycophenolate mofetil
  • Warfarin (Coumadin, Jantoven)
  • HIV or AIDS medicine – atazanavir, nelfinavir
  • Iron-containing medicines – ferrous fumarate, ferrous gluconate, ferrous sulfate, and others

Does food or alcohol interact with Protonix® (pantoprazole)?

Protonix® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Protonix® (pantoprazole)?

Protonix® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Health conditions that may interact with this drug are:

  • Severe liver disease
  • Low levels of magnesium in your blood
  • Osteoporosis
  • Low bone mineral density (osteopenia)

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Protonix® (pantoprazole).

What is the dose of Protonix® (pantoprazole) for an adult?

Usual Adult Dose for Erosive Esophagitis:

Treatment of Erosive Esophagitis:

The recommended dose is 40 mg orally once a day for up to 8 weeks; however, an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

Maintenance of Healing of Erosive Esophagitis:

The recommended dose is 40 mg orally once a day. Controlled studies have been limited to 12 months of Protonix® therapy.

Usual Adult Dose for Gastroesophageal Reflux Disease:

Parenteral: The recommended dose is 40 mg once a day for 7 to 10 days, administered via intravenous infusion over a period of 15 minutes. Intravenous therapy should be discontinued as soon as the patient is able to resume oral therapy.

Oral: The recommended dose is 40 mg orally once a day, for short-term administration (up to 8 weeks); however, an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

Usual Adult Dose for Duodenal Ulcer:

The recommended dose is 40 mg orally once a day, dose was increased every 12 weeks by 40 mg increments to a maximum of 120 mg per day, for 28 weeks.

Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete duodenal ulcer healing in up to 87% and 94% of patients after 4 weeks and 8 weeks respectively.

Usual Adult Dose for Gastric Ulcer:

The recommended dose is 40 mg orally once a day. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete gastric ulcer healing in up to 87% and 97% of patients after 4 weeks and 8 weeks respectively.

Usual Adult Dose for Helicobacter pylori Infection:

Triple therapy:

The recommended dose is 40 mg orally twice daily for 7 days, commonly in conjunction with clarithromycin and either amoxicillin or metronidazole to eradicate Helicobacter pylori, followed with 40 mg Protonix® orally once daily until day 28. Triple therapy has resulted in eradication rates of greater than 95%.

Quadruple therapy:

The recommended dose is 40 mg orally twice daily for 7 days, concomitantly with bismuth subcitrate and tetracycline, both four times daily, and metronidazole 200 mg three times daily and 400 mg at bedtime. Helicobacter Pylori eradication was achieved in 82% of patients.

Usual Adult Dose for Zollinger-Ellison Syndrome:

Parenteral: The recommended dose is 80 mg every 12 hours, administered by 15-minute infusion. Daily doses higher than 240 mg administered in equally divided doses by 15-minute infusion, or administered for more than 6 days have not been studied.

Oral: The recommended dose is 40 mg twice daily, to a maximum of 240 mg per day. Some patients have received treatment with Protonix® for more than 2 years.

Usual Adult Dose for Stress Ulcer Prophylaxis:

Stress Ulcer bleeding prophylaxis in the Critical Care Setting:

The recommended dose is 80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

Peptic Ulcer re-bleeding prophylaxis after hemostasis in the Critical Care Setting:

The recommended dose is 80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

Usual Adult Dose for Peptic Ulcer:

Stress Ulcer bleeding prophylaxis in the Critical Care Setting:

The recommended dose is 80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

Peptic Ulcer re-bleeding prophylaxis after hemostasis in the Critical Care Setting:

The recommended dose is 80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

What is the dose of Protonix® (pantoprazole) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Protonix® (pantoprazole) available?

Protonix® is available in the following dosage forms and strengths:

  • Injection, powder, for solution pantoprazole sodium 40mg in 10Ml

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Protonix®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: July 19, 2017 | Last Modified: July 19, 2017

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