Peptisolv IV

Peptisolv IV

omeprazole

Manufacturer:

Centurion Ilac

Distributor:

JustRight Healthcare

Marketer:

JustRight Healthcare
Concise Prescribing Info
Contents
Omeprazole
Indications/Uses
Treatment of duodenal/gastric ulcers, NSAID-associated gastric & duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome. Symptomatic treatment of GERD. Long-term treatment of patients w/ healed reflux esophagitis. H. pylori eradication in peptic ulcer, in combination w/ appropriate antibiotics. Prevention of relapse of duodenal/gastric ulcers, NSAID-associated gastric & duodenal ulcers in patients at risk.
Dosage/Direction for Use
IV Reconstituted soln should be given at max rate of 4 mL/min over at least 2.5 min. Patient who cannot use oral treatment 40 mg IV daily. Zollinger-Ellison syndrome Adjust dose individually. Initially 60 mg daily. More frequent & higher doses may be required. If daily dose exceeds 60 mg, divide dose to be given bid. Patient w/ hepatic impairment 10-20 mg daily may be sufficient.
Contraindications
Hypersensitivity to omeprazole or substituted benzimidazoles. Concomitant use w/ nelfinavir.
Special Precautions
Should be administered w/ gradual IV inj. Should not be added to infusion soln. May slightly increase risk of GI infections (eg, Salmonella & Campylobacter). Reports of association w/ increased risk of hip, wrist or spine fractures as a result of osteoporosis; increased risk in patients on high doses [ie, taking multiple daily doses or prolonged treatment (≥1 yr)]. Rare reports of symptomatic or asymptomatic hypomagnesemia in patients treated w/ PPI for at least 3 mth & in most cases for 1 yr. Monitor Mg levels before initiating PPI treatment & during follow-up in patients expected to receive prolonged treatment or those taking PPIs concomitantly w/ digoxin or drugs that may cause hypomagnesemia (eg, diuretics). Co-administration w/ atazanavir is not recommended. Can reduce vit B12 absorption. Avoid concomitant use w/ clopidogrel. Potential interactions w/ drugs that metabolize through CYP2C19 should be considered when initiating or ending treatment. Increased CgA levels may cause false +ve results in diagnostic tests for neuroendocrine tumors; temporarily stop PPI treatment before chromogranin A (CgA) level evaluation, tests should be repeated if baseline CgA levels are high. Regularly monitor patients treated for longer than 1 yr. Dizziness & visual impairment may occur; affected patients should not drive or use machines. Should be used during pregnancy only if benefits to the mother outweigh potential risks to the fetus. Preferable to avoid use during lactation. Limited experience w/ use in childn.
Adverse Reactions
Headache, abdominal pain, constipation, diarrhea, flatulence, nausea/vomiting.
Drug Interactions
Absorption of medicinal products that are pH-dependent may decrease or increase depending on the reduced gastric acidity during treatment. Decreased plasma levels of atazanavir & nelfinavir. Increased digoxin bioavailability. Decreased mean exposure to the active metabolite of clopidogrel & mean reduction in max inhibition of platelet aggregation w/ clopidogrel. Significant reduction in absorption of posaconazole, erlotinib, ketoconazole & itraconazole. Reduced metabolism of other drugs metabolized by CYP2C19 enzyme [eg, diazepam, phenytoin, warfarin (R-warfarin) & other vit K antagonists & cilostazol]. Increased Cmax & AUC of cilostazol. Monitor phenytoin plasma conc during the 1st 2 wk after initiating omeprazole treatment. Increased plasma levels of saquinavir & tacrolimus. Reports of increased MTX levels when co-administered w/ PPIs. Increased serum levels w/ CYP2C19 &/or CYP3A4 inhibitors (eg, clarithromycin & voriconazole). Decreased serum levels w/ CYP2C19 &/or CYP3A4 inducers (eg, rifampicin).
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Peptisolv IV lyo powd for inj 40 mg
Packing/Price
(+ 10 mL diluent) 1's