Prevacid FDT Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Lansoprazole

Indications/Uses

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; symptomatic relief in patients requiring continued NSAID treatment. Zollinger-Ellison syndrome, H pylori eradication. Short-term treatment of symptomatic GERD & erosive esophagitis in childn 12-17 yr.

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Dosage/Direction for Use

Adult 30 mg once daily. Duodenal ulcer 30 mg once daily for 4 wk. Gastric & stomal ulcer 30 mg once daily for 8 wk. Reflux esophagitis 30 mg once daily for 4-8 wk. Zollinger-Ellison syndrome Adjust dose according to patient's signs & symptoms. H pylori eradication Prevacid FDT 30 mg bd + amoxicillin 1 g bd or metronidazole 400 mg bd + clarithromycin 250-500 mg bd for 1 wk. Acid-related dyspepsia 30 mg once daily for 2-4 wk. Symptomatic GERD & erosive esophagitis Childn 12-17 yr 30 mg once daily for up to 8 wk. Treatment & prophylaxis of NSAID-associated benign gastric & duodenal ulcers; symptomatic relief in patient requiring continued NSAID treatment 15 or 30 mg once daily for 4-8 wk. Prophylaxis 15 or 30 mg once daily.

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Overdosage

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Administration

Should be taken on an empty stomach: Place tab on the tongue & allow it to disintegrate, w/ or w/o water. Do not chew. Tab may also be administered via oral syringe or nasogastric tube ≥8 French. For oral syringe or nasogastric tube administration, place 30 mg tab in syringe & draw up 10 mL of water. Shake syringe to disperse the tab & administer w/in 15 min. Refill syringe w/ 5 mL of water, shake gently & administer any remaining contents.

Contraindications

Hypersensitivity.

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Special Precautions

History of hypersensitivity. Discontinue use if subacute cutaneous lupus erythematosus occurs; at 1st signs or symptoms of severe cutaneous ARs or other signs of hypersensitivity. Exclude gastric malignancy if gastric ulcer is suspected. Increased risk of osteoporosis-related hip, wrist or spine fractures; Clostridium difficile-associated diarrhea. Hypomagnesemia may lead to hypocalcemia &/or hypokalemia. Vit B₁₂ malabsorption due to hypo- or achlorhydria. Ensure adequate vit D & Ca intake. High-dose & long-term use. Discontinue use for 14 days before chromogranin A measurements. Not recommended w/ HIV PIs eg, atazanavir, nelfinavir. Concomitant use w/ digoxin or drugs causing hypomagnesaemia eg, diuretics. Renal & hepatic impairment. Pregnancy. Avoid use during lactation. Elderly.

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Use In Pregnancy & Lactation

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Drug Interactions

Increased INR & prothrombin time w/ warfarin. Delayed absorption & reduced biovailability w/ sucralfate. Interfered absorption of ketoconazole, ampicillin esters, Fe salts, digoxin. Reduced bioavailability of HIV PIs eg, atazanavir, nelfinavir. Elevated & prolonged serum levels of MTX &/or its metabolite. Increased whole blood levels of tacrolimus. Increased systemic exposure w/ fluvoxamine.

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Caution For Usage

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Storage

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Description

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Action

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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).

Regulatory Classification

Presentation/Packing

Form

Prevacid FDT FD tab 30 mg

Packing/Price

28's

Prevacid FDT

lansoprazole

Manufacturer:

Takeda

Distributor:

Zuellig Pharma