Pantoprazole

What is Pantoprazole?

• Pantoprazole (Protonix) is a proton pump inhibitor used for the treatment of stomach ulcers, short-term treatment of erosive esophagitis due to gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including Zollinger–Ellison syndrome.

Pantoprazole

Pantoprazole

Pantoprazole Enantiomers Strutural Formulae

What are the uses of this medicine?

Pantoprazole (Protonix) is a prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.

In adults, pantoprazole sodium delayed-release tablets are used for:

• up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 weeks of pantoprazole sodium delayed-release tablets in patients whose EE does not heal.
• maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD. It is not known if pantoprazole sodium delayed-release tablet is safe and effective when used for longer than 12 months for this purpose.
• the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome.

In children 5 years of age and older , pantoprazole sodium delayed-release tablets are used for:

• up to 8 weeks for the healing and symptom relief of EE.

Limitations of use in children:

• It is not known if pantoprazole sodium delayed-release tablets are safe if used longer than 8 weeks in children.
• Pantoprazole sodium delayed-release tablets are not for use in children under 5 years of age.
• It is not known if Pantoprazole sodium delayed-release tablets are safe and effective in children for treatment other than EE.

How does this medicine work?

• Pantoprazole, (pan toe' pra zole) like other PPIs, blocks gastric acid production by binding to and inactivating the H+/K+-ATPase of gastric parietal cells, causing inhibition of the proton pump that transports H+ into the gastric lumen, the final common step in gastric acid production.
• Pantoprazole is a prodrug and is converted to the active form in the acidic secretory canaliculi of parietal cells.
• Because the inhibition is irreversible, acid secretion is suppressed for 24 to 48 hours, until new proton pump molecules have been synthesized and transported to the cell membrane.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• allergic to pantoprazole sodium, any other PPI medicine, or any of the other ingredients in pantoprazole sodium delayed-release tablets.
• taking a medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey) used to treat HIV-1 (Human Immunodeficiency Virus).

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• anticoagulants (blood thinners) such as warfarin (Jantoven), atazanavir (Reyataz, in Evotaz), dasatinib (Sprycel), digoxin (Lanoxin), diuretics ('water pills'), erlotinib (Tarceva), iron supplements, itraconazole (Sporanox, Tolsura), ketoconazole, methotrexate (Trexall, Xatmep), mycophenolate mofetil (Cellcept, Myfortic), nelfinavir (Viracept), nilotinib (Tasigna), saquinavir (Invirase) and rilpivirine (Edurant, in Cabenuva, Complera, Juluca, Odefsey).

Is this medicine FDA approved?

• Study of pantoprazole began in 1985, and it came into medical use in Germany in 1994.
• It is available as a generic medication.
• Pantoprazole was the fourth PPI approved for use in the United States in 2000 and now is in wide use.

How should this medicine be used?

Recommended dosage:

For Short-Term Treatment of Erosive Esophagitis Associated With GERD:

In Adults:

• 40 mg once daily for up to 8 weeks

In Children (5 years and older):

• ≥ 15 kg to < 40 kg: 20 mg Once daily for up to 8 weeks.
• ≥ 40 kg: 40 mg Once daily for up to 8 weeks.

For Maintenance of Healing of Erosive Esophagitis:

• In Adults: 40 mg Once daily.

For Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome:

• In Adults: 40 mg twice daily.

Administration:

• Pantoprazole comes as a delayed-release tablet and as delayed-release granules to take by mouth.

Delayed-release tablets:

• Swallow Pantoprazole sodium delayed-release tablets whole, with or without food in the stomach.
• For patients unable to swallow a 40 mg tablet, two 20 mg tablets may be taken.
• Concomitant administration of antacids does not affect the absorption of Pantoprazole sodium delayed-release tablets.

Delayed-release granules:

• To take the granules, open the packet and either sprinkle the granules onto one teaspoonful of applesauce or into a cup containing one teaspoonful of apple juice.
• Do not mix the granules with water, other liquids, or other foods.
• Use all of the granules in the packet; do not divide the granules into smaller doses.
• If you sprinkle the granules into apple juice, stir the mixture for 5 seconds.
• Swallow the mixture of applesauce or apple juice and medication right away (within 10 minutes) without chewing or crushing the granules.
• If you sprinkled the granules on applesauce, take several sips of water to wash the granules down to your stomach.
• If you sprinkled the granules into apple juice, rinse the cup once or twice with apple juice and drink the apple juice right away to be sure you swallow any leftover granules.
• Pantoprazole granules mixed with apple juice may be given through a feeding tube.
• If you have a feeding tube, ask your doctor how you should take pantoprazole.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a delayed-release tablet and as delayed-release granules

This medicine is available in fallowing brand namesː

• Protonix

What side effects can this medication cause?

The most common side effects of pantoprazole sodium in adults include:

• headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.

The most common side effects of pantoprazole sodium in children include:

• upper respiratory infection, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain.

Pantoprazole sodium can cause serious side effects, including:

• acute interstitial nephritis
• Diarrhea caused by an infection (Clostridium difficile)
• Bone fractures (hip, wrist, or spine)
• Certain types of lupus erythematosus
• Low vitamin B-12 levels
• Low magnesium levels in your body
• fundic gland polyp

What special precautions should I follow?

• In adults, symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy.
• Acute interstitial nephritis has been observed in patients taking PPIs including pantoprazole. Discontinue pantoprazole if acute interstitial nephritis develops.
• PPI therapy like pantoprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
• PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
• Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving pantoprazole, discontinue the drug and refer the patient to the appropriate specialist for evaluation.
• Generally, daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
• Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
• PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Use the shortest duration of PPI therapy appropriate to the condition being treated.
• Serumchromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.
• There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs, including pantoprazole sodium delayed-release tablets.
• Concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.
• Pantoprazole can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take pantoprazole sodium delayed-release tablets.
• Pantoprazole therapy is associated with a low rate of transient and asymptomatic serum aminotransferase elevations and is a rare cause of clinically apparent liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Pantoprazole is not removed by hemodialysis.
• In case of overdosage, treatment should be symptomatic and supportive.

Can this medicine be used in pregnancy?

• Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole.
• Pantoprazole sodium delayed-release tablets may harm your unborn baby.
• Tell your doctor if you become pregnant or think you may be pregnant during treatment with Pantoprazole sodium delayed-release tablets.

Can this medicine be used in children?

• The safety and effectiveness of pantoprazole for short-term treatment (up to eight weeks) of EE associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age.
• It is not known if pantoprazole sodium delayed-release tablets are safe if used longer than 8 weeks in children.
• Pantoprazole sodium delayed-release tablets are not for use in children under 5 years of age.
• It is not known if Pantoprazole sodium delayed-release tablets are safe and effective in children for treatment other than EE.

What are the active and inactive ingredients in this medicine?

• Active ingredient : pantoprazole sodium (sesquihydrate), USP
• Inactive ingredients in pantoprazole sodium delayed-release tablets : calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate.

Who manufactures and distributes this medicine?

Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured For:

• TORRENT PHARMA INC., Basking Ridge, NJ 07920.

DISTRIBUTED BY:

• CARDINAL HEALTH
• DUBLIN, OH

What should I know about storage and disposal of this medication?

• Store pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

The antiulcer agents in clinical use

Proton Pump Inhibitors

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

Selective Histamine Type 2 Receptor Antagonists or H2 Blockers

• Cimetidine
• Famotidine
• Nizatidine
• Ranitidine

• Dailymed label info on Pantoprazole
• FDA Pantoprazole

Pantoprazole Resources
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