Prevacid FDT/IV

Prevacid FDT/IV

lansoprazole

Manufacturer:

Takeda

Distributor:

DKSH
Concise Prescribing Info
Contents
Lansoprazole
Indications/Uses
FD tab: Gastric, duodenal & stomal ulcer & reflux esophagitis. Relief of reflux-like symptoms (eg, heartburn) &/or ulcer-like symptoms (eg, upper epigastric pain) associated w/ acid-related dyspepsia. Treatment & prophylaxis of NSAID-associated benign gastric & duodenal ulcers & relief of symptoms in patients requiring continued NSAID treatment. Eradication of H. pylori from the upper GIT in patients w/ peptic ulcer (duodenal or benign gastric ulcer) when used in combination w/ appropriate antibiotics. Maintenance treatment of healed duodenal ulcer & erosive esophagitis. GERD. Zollinger-Ellison syndrome (& other pathological hypersecretory condition). Short-term treatment of symptomatic GERD & erosive esophagitis for childn (1-17 yr). IV: Gastric duodenal & acute stress ulcer, acute gastric mucosal lesion accompanied by bleeding.
Dosage/Direction for Use
FD tab Adult Duodenal ulcer 30 mg once daily for 4 wk. H. pylori Eradication to reduce the risk of duodenal ulcer 30 mg w/ amoxicillin 1 g (or metronidazole 400 mg) & clarithromycin 250-500 mg, all bid (every 12 hr) for 7 days. Benign gastric & stomal ulcer 30 mg once daily for 8 wk. Reflux esophagitis 30 mg once daily for 4-8 wk. Acid-related dyspepsia 15 or 30 mg once daily for 2-4 wk. Treatment of NSAID-associated benign gastric & duodenal ulcer & relief of symptom 15 or 30 mg once daily for up to 4-8 wk. Prophylaxis of NSAID-associated benign gastric & duodenal ulcer & relief of symptom 15 or 30 mg once daily. Symptomatic GERD 15 mg once daily for up to 8 wk. Erosive esophagitis 30 mg once daily for up to 8 wk. Maintenance treatment of healed duodenal ulcer & erosive esophagitis 15 mg once daily. Zollinger-Ellison syndrome 60 mg once daily. Childn 12-17 yr Short-term treatment of symptomatic GERD: Non-erosive GERD 15 mg once daily for up to 8 wk, erosive esophagitis 30 mg once daily for up to 8 wk. Childn 1-11 yr Short-term treatment of symptomatic GERD & erosive esophagitis >30 kg 30 mg once daily for up to 12 wk, ≤30 kg 15 mg once daily for up to 12 wk. IV Adult Mix 1 vial (30 mg) w/ isotonic NSS or 5% D5W. Administer via IV inj or drip bid.
Administration
Should be taken on an empty stomach: Place tab on the tongue & allow it to disperse w/ or w/o water, then swallow. Do not chew/crush. Tab can be administered via oral syringe or fed through nasogastric tube.
Contraindications
Hypersensitivity. Rilpivirine-containing products. IV: Concomitant use w/ atazanavir sulfate.
Special Precautions
History of hypersensitivity. Hepatic disorders. Pregnancy & lactation. Childn & elderly. FD tab: Gastric malignancy. Acute interstital nephritis. Increased risk of Clostridium difficile-associated diarrhea & osteoporosis-related fractures of hip, wrist or spine. Vit B12 deficiency. Hypomagnesemia. Monitor Mg levels prior to treatment & periodically thereafter. Concomitant use w/ methotrexate. Cutaneous lupus erythematosus & SLE. False positive results in diagnostic investigations for neuroendocrine tumors due to increase in serum chromogranin A levels; secretin stimulation test; urine test for tetrahydrocannabinol. Phenylketonuria. IV: Patients w/ projectile/oozing bleeding or at risk for rapid bleeding should undergo endoscopic hemostasis.
Adverse Reactions
Diarrhea. FD tab: Headache; abdominal pain; constipation, nausea. IV: Increased ALT, AST, LDH, γ-GTP; hepatic dysfunction & disorder, fever, decreased leukocyte count. Anaphylactic reactions; pancytopenia, agranulocytosis or hemolytic anemia, granulocytopenia, thrombocytopenia; toxic epidermal necrolysis, Stevens-Johnson syndrome; interstitial pneumonia; interstitial nephritis.
Drug Interactions
Increased exposure of digoxin & tacrolimus. FD tab: Increased clearance of theophylline. May elevate & prolong serum conc of methotrexate &/or its metabolite hydroxymethotrexate, possibly leading to toxicities. Decreased exposure of some antiretroviral drugs (eg, rilpivirine, atazanavir & nelfinavir). Increased exposure of other antiretroviral drugs (eg, saquinavir). Increased INR & prothrombin time w/ warfarin. Reduced absorption of drugs dependent on gastric pH for absorption (eg, Fe salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole). May lead to serious adverse reactions w/ clarithromycin; amoxicillin. Decreased exposure w/ strong CYP2C19 or CYP3A4 inducers (eg, St. John's wort, rifampin, ritonavir-containing products). Increased exposure w/ strong CYP2C19 or CYP3A4 inhibitors (eg, voriconazole). Decreased & delayed absorption w/ sucralfate. IV: Decreased blood conc of theophylline. May diminish effects of atazanavir, rilpivirine HCl, itraconazole, gefitinib, bosutinib hydrate. May enhance effects of digoxin. Increase conc of methotrexate. May delay metabolism & excretion of phenytoin & diazepam.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC03 - lansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
FDT: D; Vial: S
Presentation/Packing
Form
Prevacid FDT/IV fast disintegrating tab 15 mg
Packing/Price
28's
Form
Prevacid FDT/IV fast disintegrating tab 30 mg
Packing/Price
28's
Form
Prevacid FDT/IV powd for inj 30 mg
Packing/Price
1's
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