CELE-PANTOZOLE 40MG

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.

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.

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.

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.