Names and pronunciation
(pan-toe-pray′zole) Pantoloc , Protonix, Tecta
Source page 1020
Individual generic drug information
Extracted information for pantoprazole only.
(pan-toe-pray′zole) Pantoloc , Protonix, Tecta
Source page 1020
Func. class.: Proton pump inhibitor
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Chem. class.: Benzimidazole
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Do not confuse: Protonix/Lotronex/protamine
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ACTION: Suppresses gastric secretion by inhibiting hydrogen/potassium ATPase enzyme system in gastric parietal cell; characterized as gastric acid pump inhibitor because it blocks the final step of acid production
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USES: Severe erosive esophagitis; maintenance of long-term pathologic hypersecretory conditions, including Zollinger-Ellison syndrome
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Unlabeled uses: Duodenal/gastric ulcer, NSAID ulcer prophylaxis, Helicobacter pylori–associated ulcer, dyspepsia, gas- troesophageal reflux disease (GERD)
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Extracted information for pantoprazole only.
CONTRAINDICATIONS: Hyper sensitivity to this product or benzimidazole Precautions: Pregnancy, breastfeeding, children, proton pump hypersensitivity
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SIDE EFFECTS CNS: Headache, insomnia, asthenia, fatigue, malaise, insomnia, somnolence GI: Diarrhea, abdominal pain, flatu- lence, pancreatitis, weight changes, CDAD INTEG: Rash META: Hyperglycemia, weight gain/loss, hyponatremia, hypomagnesemia, vitamin B12 deficiency MS: Myalgia, rhabdomyolysis P SYST: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, angi- oedema
Source page 1021
INTERACTIONS Increase: pantoprazole levels—clar- ithromycin, diazePAM, phenytoins, flu- razepam, triazolam Increase: bleeding—warfarin Decrease: effect of each of these drugs: protease inhibitors (atazanavir, indinavir, nelfinavir) Decrease: absorption of these prod- ucts—sucralfate, calcium carbonate, vit B12, ketoconazole, itraconazole, atazana- vir, ampicillin, iron salts, separate doses Decrease: clopidogrel effect Drug/Herb Decrease: effect of pantoprazole—St. John’s wort
Source pages 1021, 1022
Extracted information for pantoprazole only.
DOSAGE AND ROUTES GERD (unlabeled) • Adult: PO 40 mg/day × 8 wk, may re- peat course Erosive esophagitis • Adult: IV 40 mg/day × 7-10 days; PO 40 mg/day × 8 wk; may repeat PO course. Child ≥5 yr and >40 kg: PO 40 mg daily for up to 8 wk; 15-39 kg: 20 mg daily for up to 8 wk Pathologic hypersecretory conditions • Adult: PO 40 mg bid; IV 80 mg q12hr, max 240 mg/day Peptic ulcer/GI bleed (unlabeled) • Adult: IV 80 mg bolus then 40 mg IV bid × 72 hr Duodenal ulcer/gastric ulcer/ NSAID ulcer prophylaxis (unlabeled) • Adult: PO 40 mg/day H. pylori–associated ulcers (unlabeled) • Adult: PO 40 or 80 mg bid; may be used with other products
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Available forms: Del rel tabs 20, 40 mg; powder for inj 40 mg/vial; del rel granules for susp 40 mg
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Administer: PO route • Swallow del rel tabs whole; do not break, crush, or chew; take del rel tabs at same time of day • May take with/without food • Suspension: give in apple juice 30 min before a meal or sprinkled on 1 tbsp of applesauce IV route • Use of Protonix IV vials with spiked IV system adapters is not recommended • Visually inspect for particulate matter and discoloration before use • When using a Y-site, immediately stop use if a precipitation or discoloration occurs • Reconstitution of vial: use 40-mg vial/10 mL NS; do not freeze • Two-minute slow IV infusion injection: dilute one or two 40-mg vials with 10 mL NS per vial to 4 mg/mL; store ≤24 hr at room temperature before use; infuse slowly over ≥2 min; do not give with other IV fluids or medications; flush line with D5W, NS, or LR before and after each dose • Fifteen-minute IV infusion: dilute each 40-mg dose with 10 mL NS; the reconsti- tuted vial should be further admixed with 100 mL (for 1 vial) or 80 mL (for 2 vials) of D5W, NS, or LR (to 0.4 mg/mL or 0.8 mg/ mL, respectively); store ≤6 hr at room temperature before further dilution; the ad- mixed solution (0.4 mg/mL or 0.8 mg/mL) may be stored at room temperature and must be used within 24 hr from the time of initial reconstitution; infuse over 15 min at 7 mL/min; do not administer with other IV fluids or medications; flush IV line with D5W, NS, or LR before and after each dose Y-site compatibilities: Acyclovir, allopu- rinol, amifostine, amikacin, aminoca- proic acid, aminophylline, amoxicillin- clavulanate, amphotericin B liposome, ampicillin, ampicillin-sulbactam, anidu- lafungin, azithromycin, bleomycin, bumetanide, calcium gluconate, CARBO- platin, carmustine, ceFAZolin, cefOXitin, cefTAZidime, ceftizoxime, cefTRIAXone, cefuroxime, clindamycin, cyclophospha- mide, cycloSPORINE, cytarabine, dex- trose 3.3% in sodium chloride 0.3%, digoxin, dimenhyDRINATE, DOCEtaxel, DOPamine, doripenem, doxycycline, enalaprilat, EPINEPHrine, ertapenem, fluorouracil, foscarnet, fosphenytoin, furosemide, ganciclovir, gentamicin, granisetron, heparin, hydrocortisone, HYDROmorphone, imipenem-cilastatin, inamrinone, insulin (regular), irinote- can, isoproterenol, magnesium, manni- tol, mesna, methohexital, methyldopate, metoclopramide, nafcillin, nitroglycerin, nitroprusside, ofloxacin, oxytocin, PACLi- taxel, pentazocine, PENTobarbital, phen- ylephrine, piperacillin-tazobactam, potassium chloride, procainamide, rifAMPin, sodium bicarbonate, succinylcholine, SUFentanil, sulfa- methoxazole-trimethoprim, teniposide, theophylline, thiopental, ticarcillin, ticar- cillin-clavulanate, tigecycline, tirofiban, tobramycin, traMADol, vasopressin, zidovudine
Source pages 1020, 1021
Extracted information for pantoprazole only.
Assess: • CDAD: bowel sounds; abdomen for pain, swelling; anorexia; diarrhea with blood, mucus • Hepatic studies: AST, ALT, alk phos during treatment • For vit B12 deficiency in patients re- ceiving long-term therapy • Serious skin reactions: toxic epider- mal necrolysis, Stevens-Johnson syn- drome, exfoliative dermatitis: fever, sore throat, fatigue, thin ulcers; lesions in the mouth, lips • Electrolyte imbalances: hyponatre- mia; hypomagnesemia in patients using product 3 mo to 1 year; if hypomagne- semia occurs, use of magnesium sup- plements may be sufficient; if severe, discontinuation of product may be re- quired • Rhabdomyolysis, myalgia: muscle pain, increased CPK; weakness, swelling of affected muscles • Beers: avoid in older adults for >8 wk unless for high-risk patients; risk of Clostridium difficile, fractures • Pregnancy/breastfeeding: use only if clearly needed; do not breastfeed
Source page 1022
Evaluate: • Therapeutic response: absence of epi- gastric pain, swelling, fullness
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report severe diarrhea; black, tarry stools; abdominal pain; product may have to be discontinued; do not treat diarrhea with OTC products without approval of provider (CDAD) • That hyperglycemia may occur in dia- betic patients • To take as directed, not to skip or double dose • To avoid alcohol, salicylates, NSAIDs; may cause GI irritation • To continue taking even if feeling better • To notify prescriber if pregnant or plan- ning to become pregnant; not to breastfeed
Source page 1022
Extracted information for pantoprazole only.
PHARMACOKINETICS Peak 2.4 hr, duration >24 hr, half-life 1.5 hr, protein binding 97%, eliminated in urine as metabolites and in feces; in geriatric patients, elimination rate decreased; some Asian patients (15%-20%) may be poor metabolizers
Source page 1021
Filter the extracted dose blocks for this individual drug.
GERD (unlabeled)
• Adult: PO 40 mg/day × 8 wk, may re- peat course Erosive esophagitis
Candidate age grouping · source page 1020
GERD (unlabeled)
• Adult: IV 40 mg/day × 7-10 days; PO 40 mg/day × 8 wk; may repeat PO course. Child ≥5 yr and >40 kg: PO 40 mg daily for up to 8 wk; 15-39 kg: 20 mg daily for up to 8 wk Pathologic hypersecretory conditions
Candidate age grouping · source page 1020
GERD (unlabeled)
• Adult: PO 40 mg bid; IV 80 mg q12hr, max 240 mg/day Peptic ulcer/GI bleed (unlabeled)
Candidate age grouping · source page 1020
GERD (unlabeled)
• Adult: IV 80 mg bolus then 40 mg IV bid × 72 hr Duodenal ulcer/gastric ulcer/ NSAID ulcer prophylaxis (unlabeled)
Candidate age grouping · source page 1020
GERD (unlabeled)
• Adult: PO 40 mg/day H. pylori–associated ulcers (unlabeled)
Candidate age grouping · source page 1020
GERD (unlabeled)
• Adult: PO 40 or 80 mg bid; may be used with other products
Candidate age grouping · source page 1020