Protonix


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pantoprazole sodium

Apo-Pantoprazole (CA), Co Pantoprazole (CA), Gen-Pantoprazole (CA), Novo-Pantoprazole (CA), Pantoloc (CA) PMS-Pantoprazole (CA), Protium (UK), Protonix, Protonix IV, Ran-Pantoprazole (CA), Ratio-Pantoprazole (CA), Sandoz Pantoprazole (CA)

Pharmacologic class: Proton pump inhibitor

Therapeutic class: GI agent

Pregnancy risk category B

Action

Reduces gastric acid secretion and increases gastric mucus and bicarbonate production, creating protective coating on gastric mucosa

Availability

Granules (delayed-release oral suspension): 40 mg

Powder for injection (freeze-dried): 40 mg/vial

Tablets (delayed-release): 20 mg, 40 mg

Indications and dosages

Erosive esophagitis caused by gastroesophageal reflux disease (GERD)

Adults: 40 mg I.V. daily for 7 to 10 days or 40 mg P.O. daily for 8 weeks. May repeat P.O. course for 8 additional weeks.

Children ages 5 and older weighing 40 kg (88 lb) or more: 40 mg P.O. daily for up to 8 weeks

Children ages 5 and older weighing 15 kg (33 lb) to less than 40 kg (88 lb): 20 mg P.O. daily for up to 8 weeks

Erosive esophagitis

Adults: 40 mg P.O. daily

Pathologic hypersecretory conditions

Adults: Initially, 40 mg P.O. b.i.d., increased as needed to maximum of 240 mg P.O. daily; some patients may need up to 2 years of therapy. Alternatively, 80 mg I.V. q 12 hours, to a maximum of 240 mg/day (80 mg q 8 hours).

Contraindications

• Hypersensitivity to drug or any substituted benzimidazole

Precautions

Use cautiously in:
• severe hepatic disease
• atrophic gastritis with long-term use
• increased risk of osteoporosis-related hip, wrist, or spine fractures with long-term use or multiple daily doses
• concurrent use of atazanavir, nelfi-navir, or methotrexate
• pregnant or breastfeeding patients
• children.

Administration

• Be aware that oral granules may be mixed with applesauce or apple juice and given 30 minutes before a meal. Once mixed, give drug within 10 minutes.
• Know that oral granules may be mixed with 10 ml apple juice and administered into nasogastric tube using 60-ml catheter-tip syringe. Rinse syringe with additional apple juice so that no granules remain in syringe.
• For I.V. administration, use in-line filter provided. If Y-site is used, place filter below Y-site closest to patient.
• Dilute I.V. form with 10 ml of normal saline solution; further dilute in dextrose 5% in water, normal saline solution, or lactated Ringer's solution, as directed. Give over 15 minutes at a rate no faster than 3 mg/minute.
• Don't give I.V. form with other I.V. solutions.
• Know that I.V. form is indicated for short-term treatment of GERD in patients with history of erosive esophagitis as alternative to P.O. therapy.
• Be aware that symptomatic response doesn't rule out gastric cancer.

Adverse reactions

CNS: dizziness, headache

CV: chest pain

EENT: rhinitis

GI: vomiting, diarrhea, abdominal pain, dyspepsia

Metabolic: hyperglycemia

Musculoskeletal: hip, wrist, spine fractures (with long-term daily use)

Skin: rash, pruritus

Other: injection site reaction

Interactions

Drug-drug.Ampicillin, cyanocobalamin, digoxin, iron salts, ketoconazole: delayed absorption of these drugs Atazanavir, nelfinavir: substantially decreased atazanavir or nelfinavir plasma concentration with loss of therapeutic effect and development of drug resistance

Clarithromycin, diazepam, flurazepam, phenytoin, triazolam: increased panto-prazole blood level

Sucralfate: delayed pantoprazole absorption

Warfarin: increased bleeding

Drug-diagnostic tests.Aspartate aminotransferase, glucose: increased levels

Tetrahydrocannabinol test: false-positive result

Patient monitoring

• Assess for symptomatic improvement.
• Monitor blood glucose level in diabetic patient.

Patient teaching

• Tell patient to swallow delayed-release tablets whole without crushing, chewing, or splitting.
• Tell patient he may take tablets with or without food.
• Explain that antacids don't affect drug absorption.
• Instruct diabetic patients to monitor blood glucose level carefully and stay alert for signs and symptoms of hyperglycemia.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

pantoprazole

(pan-toe-pra-zole) ,

Panto IV

(trade name),

Pantoloc

(trade name),

Protonix

(trade name),

Protonix IV

(trade name),

Tecta

(trade name)

Classification

Therapeutic: antiulcer agents
Pharmacologic: proton pump inhibitors
Pregnancy Category: B

Indications

Erosive esophagitis associated with GERD.Decrease relapse rates of daytime and nighttime heartburn symptoms on patients with GERD.Pathologic gastric hypersecretory conditions.Adjunctive treatment of duodenal ulcers associated with Helicobacter pylori.

Action

Binds to an enzyme in the presence of acidic gastric pH, preventing the final transport of hydrogen ions into the gastric lumen.

Therapeutic effects

Diminished accumulation of acid in the gastric lumen, with lessened acid reflux.
Healing of duodenal ulcers and esophagitis.
Decreased acid secretion in hypersecretory conditions.

Pharmacokinetics

Absorption: Tablet is enteric-coated; absorption occurs only after tablet leaves the stomach.
Distribution: Unknown.
Protein Binding: 98%.
Metabolism and Excretion: Mostly metabolized by the liver via the cytochrome P450 (CYP) system (primarily CYP2C19 isoenzyme, but also the CYP3A4 isoenzyme) (the CYP2C19 enzyme system exhibits genetic polymorphism; genetic implication 15–20% of Asian patients and 3–5% of Caucasian and Black patients may be poor metabolizers and may have significantly ↑ pantoprazole concentrations and an ↑ risk of adverse effects); inactive metabolites are excreted in urine (71%) and feces (18%).
Half-life: 1 hr.

Time/action profile (effect on acid secretion)

ROUTEONSET†PEAKDURATION†
PO 2.5 hrunknown1 wk
IV15–30 min2 hrunknown
†Onset = 51% inhibition; duration = return to normal following discontinuation

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric: Should be used during pregnancy only if clearly needed; Lactation: Discontinue breast feeding due to potential for serious adverse reactions in infants.
Use Cautiously in: Patients using high-doses for >1 year (↑ risk of hip, wrist, or spine fractures); Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • abdominal pain
  • diarrhea
  • eructation
  • flatulence

Endocrinologic

  • hyperglycemia

Fluid and Electrolyte

  • hypomagnesemia (especially if treatment duration ≥3 mo)

Musculoskeletal

  • bone fracture

Interactions

Drug-Drug interaction

May ↓ absorption of drugs requiring acid pH, including ketoconazole, itraconazole, atazanavir, ampicillin esters, and iron salts.May ↑ risk of bleeding with warfarin (monitor INR/PT).Hypomagnesemia ↑ risk of digoxin toxicity.May ↑ methotrexate levels

Route/Dosage

GERD

Oral (Adults) 40 mg once daily.
Oral (Children ≥5 yr) 15–39 kg–20 mg once daily for up to 8 wk; ≥40 kg–40 mg once daily for up to 8 wk.
Intravenous (Adults) 40 mg once daily for 7–10 days.

Gastric Hypersecretory Conditions

Oral (Adults) 40 mg twice daily, up to 120 mg twice daily.
Intravenous (Adults) 80 mg q 12 hr (up to 240 mg/day).

Availability (generic available)

Delayed-release tablets: 20 mg, 40 mg Cost: Generic — All strengths $368.22 / 90
Powder for injection: 40 mg/vial
Delayed-release oral suspension: 40 mg/packet Cost: $7.60 / 1 pkt

Nursing implications

Nursing assessment

  • Assess patient routinely for epigastric or abdominal pain and for frank or occult blood in stool, emesis, or gastric aspirate.
  • Lab Test Considerations: May cause abnormal liver function tests, including ↑ AST, ALT, alkaline phosphatase, and bilirubin.
    • May cause hypomagnesemia. Monitor serum magnesium prior to and periodically during therapy.

Potential Nursing Diagnoses

Acute pain (Indications)

Implementation

  • Do not confuse Protonix (pantoprazole) with Lotronex (alosetron) or protamine.
  • Patients receiving pantoprazole IV should be converted to PO dosing as soon as possible.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
  • Oral: May be administered with or without food. Do not break, crush, or chew tablets.
    • Antacids may be used concurrently.
  • Intravenous Administration
  • Intravenous: Reconstitute each vial with 10 mL of 0.9% NaCl. Reconstituted solution is stable for 6 hr at room temperature.
  • Diluent: Administer undiluted.Concentration: 4 mg/mL.
  • Rate: Administer over at least 2 min.
  • Intermittent Infusion: Diluent: Dilute further with D5W, 0.9% NaCl, or LR.Concentration: 0.4–0.8 mg/mL. Diluted solution is stable for 24 hr at room temperature.
  • Rate: Administer over 15 min at a rate of <3 mg/min.
  • Y-Site Compatibility: allopurinol, alprostadil, amifostine, aminocaproic acid, amikacin, aminophylline, amphotericin B lipid complex, amphotericin B liposome, ampicillin, amipcillin/sulbactam, anidulafungin, argatroban, azithromycin, bleomycin, bumetanide, carboplatin, carmustine, ceftaroline, ceftriaxone, cyclophosphamide, cytarabine, docetaxel, doripenem, doxorubicin liposome, doxycycline, ertapenem, fluorouracil, foscarnet, fosphenytoin, ganciclovir, granisetron, imipenem/cilastatin, irinotecan., mesna, methyldopate, paclitaxel, penicillin G sodium, pentazocine, pentobarbital, phenobarbital, phentolamine, phenylephrine, potassium chloride, procainamide, rifampin, succinylcholine, sufentanyl, telavancin, teniposide, theophylline, ticarcillin/clavulanate, tigecycline, tirofiban, vasopressin, zidovudine, zoledronic acid
  • Y-Site Incompatibility: alemtuzumab, alfentanil, amphotericin B colloidal, atropine, aztreonam, buprenorphine, butorphanol, calcium acetate, calcium chloride, cefepime, cefoperazone, cefotaxime, cefotetan, chloramphenicol, chlorpromazine, ciprofloxacin, cisatracurium, cisplatin, dacarbazine, dactinomycin, dantrolene, daptomycin, daunorubicin hydrochloride, dexamethasone, dexmedetomidine, dexrazoxane, diazepam, diltiazem, diphenhydramine, dobutamine, dolasetron, doxorubicin hydrochloride, droperidol, ephedrine, epirubicin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, fluconazole, fludarabine, furosemide, gemcitabine, glycopyrrolate, haloperidol, heparin, hydralazine, hydromorphone, hydroxyzine, idarubicin, ifosfamide, insulin/regular, ketorolac, labetalol, leucovorin, levofloxacin, levorphanol, lidocaine, linezolid, lorazepam, mechlorethamine, melphalan, meperidine, meropenem, methotrexate, methylprednisolone, metoprolol, metronidazole, midazolam, milrinone, mitomycin, mitoxantrone, morphine, mycophenolate, nalbuphine, naloxone, nesiritide, nicardipine, norepinephrine, ondansetron, palonosetron, pancuronium, pemetrexed, pentamidine, phenytoin, potassium acetate, potassium phosphates, prochlorperazine, promethazine, propranolol, quinupristin/dalfopristin, ranitidine, remifentanil, rocuronium, sodium acetate, sodium phosphates, streptozocin, thiotepa, tolazoline, topotecan, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, solutions containing zinc

Patient/Family Teaching

  • Instruct patient to take medication as directed for the full course of therapy, even if feeling better.
  • Advise patient to avoid alcohol, products containing aspirin or NSAIDs, and foods that may cause an increase in GI irritation.
  • Advise patient to report onset of black, tarry stools; diarrhea; or abdominal pain to health care professional promptly. Instruct patient to notify health care professional immediately if rash, diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professional.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in abdominal pain heartburn, gastric irritation and bleeding in patients with GERD; may require up to 4 wk of therapy.
  • Healing in patients with erosive esophagitis. Therapy is continued for up to 8 wk.

Protonix

(prō-tŏn′ĭks)
A trademark for the drug pantoprazole sodium.
References in periodicals archive ?
The settlement amount will be paid to Pfizer's subsidiary, Wyeth and Takeda, to include damages caused because of the launch of 'at-risk' generic versions of Protonix.
The Department of Justice (DOJ) had accused Wyeth of marketing Protonix for unapproved uses and says the pharmaceutical company also made claims about the drug that had not been proved.
Therefore, the present work aims to discuss the anti-ulcer effects of Cedrus deodara root oil on stomach tissues of albino rats in comparison with the known anti-ulcer drugs mainly femotidine and protonix.
Other examples of proton pump inhibitors include Nexium, Prilosec, Protonix, and Aciphex.
Others include popular brands such as Nexium, Prilosec, Protonix, and Aciphex.
Because clopidogrel can irritate the stomach in some patients, many doctors also prescribe a PPI such as Prilosec, Nexium, Aciphex, Prevacid or Protonix.
Wyeth has launched a generic version of Protonix tablets through a distribution agreement with Prasco Laboratories.
Protonix is indicated for the treatment and maintenance of healing erosive esophagitis caused by GERD and for the reduction of daytime and nighttime heartburn associated with GERD.
seeking to prevent the launch of a generic version of PROTONIX (pantoprazole sodium) prior to resolution of ongoing patent litigation between the parties.
Lipitor, a cholesterol-lowering drug with an average cost of $75; Zoloft, an antidepressant with an average cost of $55; Protonix, a drug used for gastritis/ esophagitis with an average cost of $85; Paxil, an antidepressant with an average cost of $73; and Effexor XR, an antidepressant with an average cost of $84.
3% of the increase from 2000 to 2001 and included: Drug Increase Ulcer drug Protonix 490.