Pantoprazole and what it is used for

Pantoprazole is a selective proton pump inhibitor, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine.

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.

Pantoprazole is used to treat adults and adolescents 12 years of age and above for

• Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.

• An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.

• Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.

• Stomach and duodenal ulcers.

Chemistry of Pantoprazole

• Pantoprazole is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2- pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:

• Pantoprazole is supplied as a for delayed-release oral suspension in unit dose packets, available in one strength (40 mg) pantoprazole, (equivalent to 45.1 mg of pantoprazole sodium), and as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium).

• Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.

• The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.

• Pantoprazole For Delayed-Release Oral Suspension contains the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.

• Pantoprazole Delayed-Release Tablets contain the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. Pantoprazole Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Pantoprazole

• If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently, especially when you are taking Pantoprazole as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.

• Taking a proton pump inhibitor like pantoprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

• If you have reduced body stores or risk factors for reduced vitamin B12 and receive long-term treatment with pantoprazole. As with all acid reducing agents, pantoprazole may lead to a reduced absorption of vitamin B12.

• If you are on Pantoprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole that reduces stomach acid.

• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.

• If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazole. Remember to also mention any other ill-effects like pain in your joints.

Special precautions you should follow?

Before taking pantoprazole,

• tell your doctor and pharmacist if you are allergic to pantoprazole, dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, in Zegerid), rabeprazole (AcipHex), any other medications, or any of the ingredients in pantoprazole tablets or granules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven), atazanavir (Reyataz), digoxin (Lanoxicaps, Lanoxin), dasatinib (Sprycel), diuretics ('water pills'), erlotinib (Tarceva), iron supplements, itraconazole (Onmel, Sporonox), ketoconazole (Nizoral), methotrexate (Trexall, Xatmep), mycophenolate mofetil (Cellcept), nelfinavir (Viracept), nilotinib (Tasigna), and saquinavir (Invirase). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had a low level of magnesium in your blood, low levels of vitamin B-12 in your body, osteoporosis, osteoporosis (a condition in which the bones become thin and weak and break easily), or an autoimmune disease (condition in which the body attacks its own organs causing swelling and loss of function) such as systemic lupus erythematosus.

• tell your doctor if you are taking rilpivirine (Edurant, in Complera, Odefsey). Your doctor will probably tell you not to take pantoprazole if you are taking this medication..

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking pantoprazole, call your doctor.

How should you use pantoprazole?

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.

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.

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

The oral granules should be mixed with applesauce or apple juice and given either by mouth or through a nasogastric (NG) tube.

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.

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).

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