Pantoprazole

Pantoprazole用于治疗胃和esophagusproblems (such asacid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Pantoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

Pantoprazole may also be used to treat and prevent stomach and intestinal ulcers.

Pantoprazole is available under the following different brand names:Protonix.

Dosages of Pantoprazole:

Adult and Pediatric Dosage Forms & Strengths

Oral suspension

• 40 mg/packet

Powder for injection (Adult Only)

• 40 mg/vial

Tablet, delayed-release

• 20 mg
• 40 mg

Dosage Considerations – Should be Given as Follows:

Erosive Esophagitis Associated With GERD

• Treatment: 40 mg orally once/day for 8-16 weeks
• Maintenance of healing: 40 mg orally once/day
• Alternatively, 40 mg intravenously (IV) once/day for 7-10 days
• Children younger than 5 years:
  • Safety and efficacy not established
• Children 5 years and older:
  • 15 kg to less than 40 kg: 20 mg orally once/day for up to 8 weeks
  • 40 kg or greater: 40 mg orally once/day for up to 8 weeks

Short-term Treatment of GERD

• Oral therapy inappropriate or not possible: 40 mg IV infusion over 15 minutes once/day for 7-10 days; switch to orally once patient able to swallow

Zollinger-Ellison Syndrome

• 40 mg orally once/day; up to 240 mg/day administered in some patients
• 80 mg IV infusion every 8-12 hours up to 7 days; switch to orally once patient able to swallow

Peptic Ulcer Disease (Off-label)

• Duodenal ulcer: 40 mg orally once/day for 2 weeks
• Gastric ulcer: 40 mg orally once/day for 4 weeks

Common side effects of pantoprazole include:

• Headache
• Abdominal pain v
• Facial puffiness
• Generalized swelling (edema)
• Chest pain
• Diarrhea
• Constipation
• Itching
• Rash
• Gas
• High blood sugar (hyperglycemia)
• Nausea
• Vomiting
• Photosensitivity

Other side effects of pantoprazole include:

• Skin swelling
• Atrophicgastritis
• Anteriorischemic opticneuropathy
• Hepatocellular damage leading to hepatic failure
• Interstitialnephritis
• Pancreatitis
• Low white blood cell, red blood cell, andplatelet count
• Musclewasting(rhabdomyolysis)
• Risk of a severe allergic reaction (anaphylaxis)
• Stevens-Johnson syndrome
• Fatal toxicepidermalnecrolysis
• Erythema multiforme

Postmarketing side effects of pantoprazole reported include:

• Weakness
• Fatigue
• Feelingunwell(malaise)
• Hepatocellular damage leading to jaundice and hepatic failure
• Agranulocytosis,pancytopenia
• Taste disorders (loss of taste, changes in taste)
• Weight changes
• Low blood sodium (hyponatremia)
• Low blood magnesium
• Bonefracture
• Hallucinations
• Confusion
• Insomnia
• Drowsiness
• Interstitial nephritis
• Severedermatologicreactions (some fatal), includingerythemamultiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal), as well asangioedema(Quincke edema)
• Cutaneousand systemic lupus erythematosus
• Cyanocobalamin(Vitamin B-12) deficiency
• Clostridium difficile-associated diarrhea

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe Interactions of pantoprazole include:

• erlotinib
• nelfinavir
• rilpivirine

严重的Interactions of pantoprazole include:

• afatinib
• atazanavir
• dasatinib
• delavirdine
• digoxin
• edoxaban
• indinavir
• itraconazole
• ivacaftor
• ketoconazole
• mesalamine
• nilotinib
• nisoldipine
• pazopanib
• pomalidomide
• ponatinib
• riociguat
• sofosbuvir/velpatasvir
• venetoclax

Pantoprazole has moderate interactions with at least 52 different drugs.

Pantoprazole has mild interactions with at least 27 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

This medication contains pantoprazole. Do not take Protonix if you are allergic to pantoprazole or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Hypersensitivity to pantoprazole or other proton pump inhibitors (PPIs).

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Pantoprazole?"

Long-Term Effects

• Published observational studies suggest that PPI therapy may be associated with an increased risk forosteoporosis-related fractures of the hip,wrist, or spine, particularly with prolonged (greater than 1 year), high-dose therapy.
• Hypomagnesemiamay occur with prolonged use (greater than 1 year); adverse effects may result, includingtetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels, and the PPI had to be discontinued; consider monitoring magnesium levels before initiation of PPI treatment and periodically.
• Daily long-term use (e.g., longer than 3 years) may lead tomalabsorptionor a deficiency of cyanocobalamin.
• See "What Are Side Effects Associated with Using Pantoprazole?"

Cautions

• PPIs are possibly associated with increased incidence ofClostridium difficile-associated diarrhea (CDAD); consider the diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve
• Severe hepatic impairment
• Cutaneous lupus erythematosus (CLE) andsystemic lupus erythematosus(SLE与质子泵抑制剂)报告;避免使用超过medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to a specialist; most patients improve with discontinuation of PPI alone in 4-12 weeks; serological testing (e.g.ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations
• Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (greater than 1 year), high-dose therapy
• Decreasedgastricacidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results forneuroendocrinetumors; temporarily discontinue PPIs before assessing CgA levels
• PPIs may decrease the efficacy ofclopidogrelby reducing the formation of the active metabolite
• Therapy increases the risk ofSalmonella, Campylobacter, and other infections
• 低镁症与长期使用可能发生(好了er than 1 year); adverse effects may result, including tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum
• magnesium levels and the PPI had to be discontinued; consider monitoring magnesium levels before initiation of PPI treatment and periodically
• Infusion-related reactions includingthrombophlebitisand hypersensitivity reported
• Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin
• Acute interstitial nephritis was reported in patients taking proton pump inhibitors
• Relief of symptoms does not eliminate the possibility of a gastricmalignancy; consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or early symptomatic relapse after completing treatment with a PPI
• The risk of salmonella and campylobacter infections increased with the use of proton pump inhibitors
• May elevate and/or prolong serum concentrations ofmethotrexateand/or its metabolite when administered concomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy with high dose methotrexate administration

Pregnancy and Lactation

• Pantoprazole may be acceptable for use during pregnancy. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies are done and showed no risk
• It is not known whether pantoprazole is distributed into breast milk; it is not recommended for use while breastfeeding