Pantoprazole

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking pantoprazole,

• tell your doctor and pharmacist if you are allergic to pantoprazole, dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid), 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 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 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: certain antibiotics, including ampicillin , anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven), atazanavir (Reyataz), digoxin (Lanoxin), diuretics ('water pills'), iron supplements, ketoconazole (Nizoral), methotrexate (Trexall), and nelfinavir (Viracept). 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 or if you tested positive for the bacteria H. pylori.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pantoprazole, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment, especially if you have severe diarrhea.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking pantoprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Protonix^®

Pantoprazole is in a class of drugs called proton pump inhibitors (PPIs), which block the production of acid by the stomach. Other drugs in the same class include lansoprazole (Prevacid), omeprazole (Prilosec) and rabeprazole (Aciphex). Proton pump inhibitors are used for the treatment of conditions such as ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome that are caused by stomach acid.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Pantoprazole there are no specific foods that you must exclude from your diet when receiving Pantoprazole.

• Take pantoprazole exactly as prescribed by your doctor.
• Do not change your dose or stop pantoprazole without talking to your doctor.
• If you forget to take a dose of pantoprazole, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses to try to make up for a missed dose.

Tablets:

• You can take pantoprazole tablets with food or on an empty stomach.
• Swallow pantoprazole tablets whole.
• If you have trouble swallowing a pantoprazole 40 mg tablet, you can take two 20 mg tablets instead.
• Do not split, chew, or crush pantoprazole sodium tablets.

Oral Suspension:

• Pantoprazole oral suspension should only be taken with applesauce or apple juice 30 minutes before a meal.
• Pantoprazole should not be taken in or with water or other liquids, or with other foods other than those described below.
• Pantoprazole oral suspension should not be chewed or crushed.
• Pantoprazole oral suspension packet should not be divided to make a smaller dose.

Directions for use with applesauce:

• Open packet.
• Sprinkle granules on one teaspoonful of applesauce. Do not use any other foods. Do not crush or chew the granules.
• Take within 10 minutes of putting the granules into the teaspoon of applesauce.
• Take sips of water to make sure the granules are washed down into the stomach. Repeat water sips as necessary.

Directions for use with apple juice:

• Open packet.
• Empty granules into a small cup or teaspoon with one teaspoonful of apple juice.
• Stir the mix for 5 seconds (granules will not break up) and swallow it right away.
• To make sure that the entire dose is taken, rinse the container once or twice with apple juice to get out any leftover granules. Swallow the apple juice right away.

Nasogastric Tube or Gastrostomy Tube Administration

For people who have a nasogastric (NG) tube or gastrostomy tube in place, pantoprazole oral suspension can be given as follows:

• Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Throw away the plunger.
• Connect the catheter tip of the syringe to a 16 French (or larger) tube.
• Hold the syringe attached to the tubing as high as possible while giving pantoprazole oral suspension to prevent any bending of the tubing.
• Empty the contents of the packet into the barrel of the syringe.
• Add 10 mL (2 teaspoonfuls) of apple juice and gently tap or shake the barrel of the syringe to help empty the syringe.
• Do this again at least two more times using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should be left in the syringe.

Injection:

• This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you take too much pantoprazole sodium, call your doctor right away.

Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Pantoprazole sodium delayed-release tablets  and instructions for preventing or managing them.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
Table 4: Clinically relevant Interactions Affecting Drugs Co-Administered with Pantoprazole sodium and Interaction with Diagnostics

• Pantoprazole Magnesium
• Pantoprazole Sodium

Proton pump inhibitor, suppresses gastric acid secretion by inhibiting the parietal cell H+/K+ ATP pump

Absorption

Rapid, well absorbed

Distribution

Vd:

Children and Adolescents (Kearns 2008): IV (2 to 16 years of age): 0.22 ± 0.14 L/kg; Oral (5 to 16 years of age): 0.24 ± 0.09 L/kg

Adults: 11 to 24 L

Metabolism

Extensively hepatic; CYP2C19 (demethylation), CYP3A4; no evidence that metabolites have pharmacologic activity

Excretion

Urine (71% as metabolites); feces (18%); pantoprazole clearance increased with weight and age (Peterson, 2009)

Onset of action: Acid secretion: Oral: 2.5 hours; IV: 15 to 30 minutes

Maximum effect: IV: 2 hours

Time to Peak

Children and Adolescents (Kearns 2008): IV (2 to 16 years of age): 0.34 ± 0.12 hours; Oral (5 to 16 years of age): 2.54 ± 0.72 hours

Adults: Oral: 2.5 hours

Hypersensitivity (eg, anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria) to pantoprazole, other substituted benzimidazole proton pump inhibitors, or any component of the formulation

Amphetamine: Proton Pump Inhibitors may increase the absorption of Amphetamine. Monitor therapy

Atazanavir: Proton Pump Inhibitors may decrease the serum concentration of Atazanavir. Management: See full drug interaction monograph for details. Consider therapy modification

Bisphosphonate Derivatives: Proton Pump Inhibitors may diminish the therapeutic effect of Bisphosphonate Derivatives. Monitor therapy

Bosutinib: Proton Pump Inhibitors may decrease the serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors, such as antacids or H2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Consider therapy modification

Capecitabine: Proton Pump Inhibitors may diminish the therapeutic effect of Capecitabine. Monitor therapy

Cefditoren: Proton Pump Inhibitors may decrease the serum concentration of Cefditoren. Management: If possible, avoid use of cefditoren with proton pump inhibitors (PPIs). Consider alternative methods to minimize/control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of PPIs can not be avoided. Consider therapy modification

Clopidogrel: Pantoprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Management: Due to the possible risk for impaired clopidogrel effectiveness, clinicians should carefully consider the need for proton pump inhibitor therapy in patients receiving clopidogrel. Other acid-lowering therapies do not appear to share this interaction. Consider therapy modification

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Cysteamine (Systemic): Proton Pump Inhibitors may diminish the therapeutic effect of Cysteamine (Systemic). Monitor therapy

Dabigatran Etexilate: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates. Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dabrafenib: Proton Pump Inhibitors may decrease the serum concentration of Dabrafenib. Dabrafenib may decrease the serum concentration of Proton Pump Inhibitors. Management: Seek alternatives to the proton pump inhibitor when possible. If concomitant therapy cannot be avoided, monitor for diminished effects of both drugs. Consider therapy modification

Dasatinib: Proton Pump Inhibitors may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of the proton pump inhibitor if some acid-reducing therapy is needed. Avoid combination

Delavirdine: Proton Pump Inhibitors may decrease the serum concentration of Delavirdine. Management: Chronic therapy with proton pump inhibitors (PPIs) should be avoided in patients treated with delavirdine. The clinical significance of short-term PPI therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Avoid combination

Dexmethylphenidate: Proton Pump Inhibitors may increase the absorption of Dexmethylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Dextroamphetamine: Proton Pump Inhibitors may increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates. Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Consider therapy modification

Erlotinib: Proton Pump Inhibitors may decrease the serum concentration of Erlotinib. Avoid combination

Fluconazole: May increase the serum concentration of Proton Pump Inhibitors. Monitor therapy

Gefitinib: Proton Pump Inhibitors may decrease the serum concentration of Gefitinib. Management: Avoid use of proton pump inhibitors (PPIs) with gefitinib when possible. If required, administer gefitinib 12 hours after administration of the PPI or 12 hours before the next dose of the PPI. Consider therapy modification

Indinavir: Proton Pump Inhibitors may decrease the serum concentration of Indinavir. Monitor therapy

Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Monitor therapy

Itraconazole: Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Consider therapy modification

Ketoconazole (Systemic): Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Proton Pump Inhibitors. Consider therapy modification

Ledipasvir: Proton Pump Inhibitors may decrease the serum concentration of Ledipasvir. Management: PPI doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Administration with higher doses of PPIs, 2 hours after a PPI, or in combination with food and PPIs may reduce ledipasvir bioavailability. Consider therapy modification

Lumacaftor: May decrease the serum concentration of CYP2C19 Substrates. Monitor therapy

Mesalamine: Proton Pump Inhibitors may diminish the therapeutic effect of Mesalamine. Proton pump inhibitor-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose proton pump inhibitors (PPIs) with sustained-release mesalamine products. Consider therapy modification

Methotrexate: Proton Pump Inhibitors may increase the serum concentration of Methotrexate. Monitor therapy

Methylphenidate: Proton Pump Inhibitors may increase the absorption of Methylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Proton Pump Inhibitors may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Monitor therapy

Mycophenolate: Proton Pump Inhibitors may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Monitor therapy

Nelfinavir: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Proton Pump Inhibitors may decrease the serum concentration of Nelfinavir. Avoid combination

Neratinib: Proton Pump Inhibitors may decrease the serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Avoid combination

Nilotinib: Proton Pump Inhibitors may decrease the serum concentration of Nilotinib. Management: Avoid this combination when possible since separation of doses is not likely to be an adequate method of minimizing the interaction. Consider therapy modification

PAZOPanib: Proton Pump Inhibitors may decrease the serum concentration of PAZOPanib. Avoid combination

Posaconazole: Proton Pump Inhibitors may decrease the serum concentration of Posaconazole. Consider therapy modification

Raltegravir: Proton Pump Inhibitors may increase the serum concentration of Raltegravir. Monitor therapy

Rilpivirine: Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine. Avoid combination

Riociguat: Proton Pump Inhibitors may decrease the serum concentration of Riociguat. Monitor therapy

Risedronate: Proton Pump Inhibitors may diminish the therapeutic effect of Risedronate. Proton Pump Inhibitors may increase the serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Avoid combination

Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Monitor therapy

Secretin: Proton Pump Inhibitors may diminish the diagnostic effect of Secretin. Specifically, use of PPIs may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of proton pump inhibitors (PPIs) and secretin, and discontinue PPIs several weeks prior to secretin administration, with the duration of separation determined by the specific PPI. See full monograph for details. Consider therapy modification

Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. Monitor therapy

Velpatasvir: Proton Pump Inhibitors may decrease the serum concentration of Velpatasvir. Avoid combination

Voriconazole: May increase the serum concentration of Proton Pump Inhibitors. Proton Pump Inhibitors may increase the serum concentration of Voriconazole. Management: In patients receiving omeprazole 40 mg/day or greater, reduce omeprazole dose by half when initiating voriconazole. Monitor therapy

Hypersecretory disorders: Acid output measurements, target level <10 mEq/hour (<5 mEq/hour if prior gastric acid-reducing surgery)