About PTRIC 40

PANTOPRAZOLE

What is pantoprazole?

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

Pantoprazole is used to treat erosive esophagitis (damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or GERD) in adults and children who are at least 5 years old. Pantoprazole is usually given for up to 8 weeks at a time while your esophagus heals.

Pantoprazole is also used to treat Zollinger-Ellison syndrome and other conditions involving excess stomach acid.

Warnings

Pantoprazole is not for the immediate relief of heartburn symptoms.

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.

Long-term treatment with pantoprazole may also make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. Talk with your doctor if you need long-term pantoprazole treatment and you have concerns about vitamin B-12 deficiency.

Pantoprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Pantoprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

Before taking this medicine

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

You should not use this medicine if:

• you also take medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey);

• if you had breathing problems, kidney problems, or a severe allergic reaction after taking pantoprazole in the past; or

• you are allergic to pantoprazole or similar medicines (lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, and others).

Tell your doctor if you have ever had:

• low levels of magnesium in your blood;

• lupus; or

• osteoporosis or low bone mineral density.

You may be more likely to have a broken bone while using pantoprazole long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy, especially if you are an adult over 50.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using this medicine.

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

Pantoprazole pregnancy and breastfeeding warnings (more detail)

How should I use pantoprazole?

Take pantoprazole exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Use the lowest dose for the shortest amount of time needed to treat your condition.

Pantoprazole is taken by mouth (oral) or given as an infusion into a vein (injection). A healthcare provider may teach you how to properly use the injection by yourself.

Pantoprazole tablets are taken by mouth, with or without food. The 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 and given either by mouth or through a nasogastric (NG) tube.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have any questions.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

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

Pantoprazole can cause false results with certain medical tests. Tell the doctor or laboratory staff that you are using this medicine.

Pantoprazole may also affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use this medicine.

Store this medicine at room temperature away from moisture, heat, and light.

Dosing information

Usual Adult Dose for Erosive Esophagitis:

Treatment of Erosive Esophagitis:
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:
40 mg orally once a day. Controlled studies have been limited to 12 months of pantoprazole therapy.

Usual Adult Dose for Gastroesophageal Reflux Disease:

Parenteral: 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: 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:

Study (n=54)
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:

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:

Study (n=242) - Triple therapy:
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 pantoprazole orally once daily until day 28. Triple therapy has resulted in eradication rates of greater than 95%.

The QUADRATE Study (n=405) - Quadruple therapy:
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: 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: 40 mg twice daily, to a maximum of 240 mg per day. Some patients have received treatment with pantoprazole for more than 2 years.

Usual Adult Dose for Stress Ulcer Prophylaxis:

Study (n=21) - Stress Ulcer bleeding prophylaxis in the Critical Care Setting:
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.

Study (n=20 ) - Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting:
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:

Study (n=21) - Stress Ulcer bleeding prophylaxis in the Critical Care Setting:
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.

Study (n=20 ) - Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting:
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.

Detailed Pantoprazole dosage information

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using pantoprazole?

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Pantoprazole side effects

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

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• sudden pain or trouble moving your hip, wrist, or back;

• bruising or swelling where intravenous pantoprazole was injected;

• kidney problems - fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;

• low magnesium - dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

• new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking pantoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use pantoprazole 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.

Common pantoprazole side effects may include:

• headache, dizziness;

• stomach pain, gas, nausea, vomiting, diarrhea;

• joint pain; or

• fever, rash, or cold symptoms (most common in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pantoprazole side effects (more detail)

What other drugs will affect pantoprazole?

Tell your doctor about all your other medicines. Some may interact with pantoprazole, especially:

• digoxin;

• methotrexate; or

• a diuretic or "water pill."

This list is not complete. Other drugs may affect pantoprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here