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omeprazole/ sodium bicarbonate
generic
Adult Dosing .
Dosage forms: CAP: 20 mg/1100 mg, 40 mg/1100 mg; PWDR: 20 mg/1680 mg per pkt, 40 mg/1680 mg per pkt
Special Note
- [dosing clarification]
- Info: two 20 mg cap not bioequivalent to one 40 mg cap, two 20 mg pkt not bioequivalent to one 40 mg pkt due to sodium bicarbonate component; doses based on omeprazole component
GERD
- [non-erosive, symptomatic]
- Dose: 20 mg PO/NG/OG qd x4-8wk; Info: give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
- [erosive esophagitis, short-term tx]
- Dose: 20 mg PO/NG/OG qd x4-12wk; Info: give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
- [erosive esophagitis, maintenance tx]
- Dose: 20 mg PO/NG/OG qd; Info: give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
duodenal ulcer
- [20-40 mg PO/NG/OG qd x4-8wk]
- Info: usual maint. dose 20 mg PO/NG/OG qd; give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
gastric ulcer, benign
- [40 mg PO/NG/OG qd x4-8wk]
- Info: give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
upper GI bleeding prophylaxis, critically ill pts
- [40 mg PO/NG/OG qd x14 days]
- Start: 40 mg PO/NG/OG x1, then 40 mg PO/NG/OG x1 6-8h later; Info: give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not use cap; see PPI Administration Alternatives table
gastric ulcer prophylaxis, NSAID-assoc. (off-label)
- [20-40 mg PO/NG/OG qd]
- Info: give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
hypersecretory conditions (off-label)
- [individualize dose PO/NG/OG qd-tid]
- Start: 60 mg PO/NG/OG qd; Info: doses up to 120 mg PO tid have been used; divide doses >80 mg/day; give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
renal dosing
- [see below]
- renal impairment: no adjustment; Info: caution advised, sodium bicarbonate may cause sodium retention
- HD/PD: not defined
hepatic dosing
- [erosive esophagitis, maintenance tx]
- hepatic impairment: avoid use
- [all other indications]
- hepatic impairment: not defined
Peds Dosing .
- Dosage forms: CAP: 20 mg/1100 mg, 40 mg/1100 mg; PWDR: 20 mg/1680 mg per pkt, 40 mg/1680 mg per pkt
Special Note
- [dosing clarification]
- Info: two 20 mg cap not bioequivalent to one 40 mg cap, two 20 mg pkt not bioequivalent to one 40 mg pkt due to sodium bicarbonate component; doses based on omeprazole component
GERD, non-erosive symptomatic (off-label)
- [1-16 yo, >20 kg]
- Dose: 20 mg PO/NG/OG qd for up to 4wk; Alt: start 1 mg/kg/day PO/NG/OG divided qd-bid, then 0.2-3.5 mg/kg/day PO/NG/OG divided qd-bid; Info: give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
GERD, erosive esophagitis (off-label)
- [1-16 yo, >20 kg]
- Dose: 20 mg PO/NG/OG qd; Alt: start 1 mg/kg/day PO/NG/OG divided qd-bid, then 0.2-3.5 mg/kg/day PO/NG/OG divided qd-bid; Info: for short-term and maintenance tx; give >1h before meals or if on tube feeds, suspend tube feeding 3h before and 1h after dose; do not open cap, see PPI Administration Alternatives table
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: not defined
hepatic dosing
- [erosive esophagitis, maintenance tx]
- hepatic impairment: avoid use
- [all other indications]
- hepatic impairment: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- Asian pts w/ unknown CYP2C19 genotype (risk of incr. drug levels in erosive esophagitis maint. tx use)
- poor CYP2C19 metabolizers (erosive esophagitis maintenance tx use)
- hepatic impairment (erosive esophagitis maintenance tx use)
- Bartter syndrome
- acid-base disorder
- hypokalemia
- hypocalcemia
- caution: hypocalcemia risk
- caution: hypomagnesemia
- caution: sodium restriction
- caution: renal impairment
- caution: CHF
- caution: long-term use
- caution: high-dose use
Drug Interactions .
Overview
omeprazole
PPI
- CYP2C19 substrate
- CYP3A4 substrate
- CYP2C19 inhibitor, moderate
- gastric pH modulator
- hypomagnesemia
sodium bicarbonate
antacid
- gastric pH modulator
- urine alkalinizer
Contraindicated
- mavacamten
- rilpivirine
Avoid/Use Alternative
- abrocitinib
- atazanavir
- bosutinib
- captopril
- cefpodoxime proxetil
- cefuroxime axetil
- clopidogrel
- dacomitinib
- dasatinib
- dextroamphetamine
- erlotinib
- esomeprazole
- ferrous gluconate
- ferrous sulfate
- fosinopril
- gefitinib
- infigratinib
- ketoconazole
- levoketoconazole
- lisdexamfetamine
- mefenamic acid
- mesalamine
- methadone
- methamphetamine
- methenamine
- methylphenidate
- mexiletine
- naproxen
- nelfinavir
- neratinib
- nilotinib
- nirogacestat
- pazopanib
- pexidartinib
- pirfenidone
- posaconazole
- rifampin
- selpercatinib
- sotorasib
- sparsentan
- St. John's wort
- triazolam
- velpatasvir
- vonoprazan
Monitor/Modify Tx
- acetazolamide
- adagrasib
- amiloride
- amphotericin
- belumosudil
- belzutifan
- bumetanide
- calcium acetate
- calcium carbonate
- calcium chloride
- calcium citrate
- calcium gluconate
- cannabidiol
- cannabis
- cenobamate
- ceritinib
- cetuximab
- chloramphenicol
- chlorothiazide
- chlorthalidone
- cilostazol
- citalopram
- clobazam
- cobicistat
- cyanocobalamin (vitamin B12)
- cyclosporine
- cysteamine
- diazepam
- digoxin
- domperidone
- elagolix
- escitalopram
- ethacrynic acid
- fedratinib
- fexinidazole
- flibanserin
- fluconazole
- fluoxetine
- fluvoxamine
- foscarnet
- fosphenytoin
- furosemide
- hydrochlorothiazide
- idelalisib
- indapamide
- itraconazole
- ledipasvir
- letermovir
- levothyroxine
- lithium
- lonafarnib
- lumacaftor/ivacaftor
- mannitol
- methazolamide
- methotrexate
- metolazone
- mifepristone
- necitumumab
- nefazodone
- octreotide
- patiromer
- peppermint
- phenytoin
- quinidine (antiarrhythmic)
- ribociclib
- ritonavir
- rosuvastatin
- saquinavir
- spironolactone
- stiripentol
- sucralfate
- tacrolimus
- tofacitinib
- torsemide
- triamterene
- tucatinib
- voriconazole
- warfarin
Caution Advised
- amantadine
- amphetamine
- apalutamide
- aspirin
- bendamustine
- bosentan
- butalbital
- capsicum
- carbamazepine
- carisoprodol
- ciprofloxacin
- dabrafenib
- dicloxacillin
- disulfiram
- doxepin
- doxepin topical
- efavirenz
- encorafenib
- enzalutamide
- ephedra
- ephedrine injection
- flecainide
- fosamprenavir
- ginkgo
- ivosidenib
- lopinavir/ritonavir
- lorlatinib
- magnesium salicylate
- memantine
- methohexital
- mitapivat
- mitotane
- modafinil
- mycophenolate mofetil
- mycophenolic acid
- nafcillin
- pentobarbital
- phenobarbital
- primidone
- proguanil
- pseudoephedrine
- quinidine (CYP2D6 inhibitor)
- quinine
- repotrectinib
- rifabutin
- rifapentine
- salsalate
- tipranavir
- tocilizumab
- zanubrutinib
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- erythema multiforme
- drug rxn w/ eosinophilia and systemic sx
- acute generalized exanthematous pustulosis
- tubulointerstitial nephritis
- renal impairment
- hepatic impairment
- pancreatitis
- C. difficile-assoc. diarrhea
- fractures
- metabolic alkalosis
- seizures
- tetany
- lupus erythematosus
- agranulocytosis
- neutropenia
- thrombocytopenia
- hemolytic anemia
- hyponatremia
- hypomagnesemia (long-term use)
- pneumonia (critically ill pts)
- tachycardia (critically ill pts)
- hyperpyrexia (critically ill pts)
- atrial fibrillation (critically ill pts)
Common Reactions
- fever (critically ill pts)
- thrombocytopenia (critically ill pts)
- HTN (critically ill pts)
- hypotension (critically ill pts)
- headache
- atrial fibrillation (critically ill pts)
- rash
- abdominal pain
- hyperpyrexia (critically ill pts)
- oral candidiasis (critically ill pts)
- bradycardia (critically ill pts)
- diarrhea
- dizziness
- vitamin B12 deficiency (long-term use)
- fundic gland polyps (long-term use)
Safety/Monitoring .
Monitoring Parameters
consider Mg at baseline, then periodically if long-term tx or hypocalcemia risk; consider Ca at baseline, then periodically if hypocalcemia risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
omeprazole: weigh risk/benefit during pregnancy; possible risk of teratogenicity based on conflicting human data
sodium bicarbonate: weigh risk/benefit during pregnancy; inadequate human data available, though possible risk of fluid retention based on drug's mechanism of action
Lactation
Clinical Summary
may use while breastfeeding; inadequate human data available, though risk of infant harm not expected based on limited drug excretion into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for omeprazole: liver extensively; CYP450: 2C19 (primary), 3A4 substrate; Info: prodrug converted to active sulfenamide form; for sodium bicarbonate: none; CYP450: none
Excretion: for omeprazole: urine 77% (minimally unchanged), bile, feces; Half-life: 0.5-1h, 3h (chronic hepatic dz); for sodium bicarbonate: urine; Half-life: unknown
Subclass: Proton Pump Inhibitors (PPIs)
Mechanism of Action
omeprazole inhibits gastric parietal cell hydrogen-potassium ATPase (proton pump inhibitor); sodium bicarbonate increases gastric pH, enhancing absorption of omeprazole (antacid)
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: generic
DEA/FDA: OTC/Rx
Approximate Retail Price
from http://www.goodrx.com/omeprazole-sodium-bicarbonate
oral capsule:
- 20 mg/1100 mg (30 ea): $53.00
- 40 mg/1100 mg (30 ea): $60.00
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