Beximco-Pantoprazole

Beximco-Pantoprazole

pantoprazole

Manufacturer:

Beximco Pharma

Distributor:

Pharmatech Resources
Concise Prescribing Info
Contents
Pantoprazole
Indications/Uses
20-mg: Mild reflux disease & associated symptoms (eg, heartburn, acid regurgitation, pain on swallowing); long-term management & prevention of relapse in reflux oesophagitis. Prevention of gastroduodenal ulcers induced by nonselective, NSAIDs in patients w/ a need for continuous NSAID treatment. 40-mg: Duodenal ulcer; gastric ulcer; moderate & severe reflux oesophagitis.
Dosage/Direction for Use
20-mg Mild reflux disease & associated symptoms (eg, heartburn, acid regurgitation, pain on swallowing) 20 mg/day. Symptom is generally accomplished w/in 2-4 wk. Healing of associated oesophagitis 4-wk treatment period. Long-term management & prevention of relapse in reflux oesophagitis Maintenance dose: 20 mg/day, may be increased to 40 mg daily if a relapse occurs. Prevention of gastroduodenal ulcers induced by nonselective, NSAIDs in patient at risk w/ a need for continuous NSAID treatment 20 mg/day. Severe hepatic impairment 20 mg daily dose should not be exceeded. 40-mg Duodenal ulcer 40 mg/day w/in 2 wk. Healing may be achieved w/in 2 wk further if 2-wk period treatment is not sufficient. Gastric ulcer, moderate & severe reflux oesophagitis 40 mg/day in 4-wk period. If not sufficient, healing may be achieved w/in 4 wk further. Elderly & renal impairment 40 mg daily dose should not be exceeded. Severe hepatic impairment Reduce dose to 1 tab every other day.
Administration
Should be taken on an empty stomach: Take 1 hr before meals.
Contraindications
Hypersensitivity. Co-administration w/ atazanavir.
Special Precautions
Regular monitoring of liver enzymes in patients w/ severe liver impairment. Discontinue use in case of a rise of the liver enzymes during treatment, particularly on long-term use. Assess increased risk to develop GI complications according to individual risk factors eg, high age (>65 yr), history of gastric or duodenal ulcer or upper GI bleeding. Presence of any alarm symptoms (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis, anemia or malaena) & in present or suspected gastric ulcer. May reduce the absorption of vit B12 due to hypo- or achlorhydria on long-term therapy. Use the lowest dose & shortest duration of therapy appropriate in Clostridium difficile-associated diarrhoea; bone fracture. Monitor Mg levels prior to initiation of treatment & periodically. Concomitant use w/ methotrexate &/or its metabolite. Not to be used during pregnancy & lactation. Childn. 40-mg: Do not use for mild GI complaints eg, nervous dyspepsia. Not to be used in childn.
Adverse Reactions
Headache; diarrhoea, constipation, abdominal pain & discomfort, flatulence.
Drug Interactions
May reduce or increase absorption of drugs whose bioavailability is pH-dependent (eg, ketoconazole). Reduced absorption of atazanavir. Monitor prothrombin time/INR in patients treated w/ coumarin anticoagulants (eg, phenprocoumon or warfarin). May elevate & prolong serum levels of methotrexate (high dose eg, 300 mg).
ATC Classification
A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Additional Information
Exemptions granted for limited sale and supply without prescription (with effect from 1 Jan 2014):
As an oral solid preparation containing not more than 20 mg
Indication: For the relief of heartburn symptoms associated with acid reflux
Maximum daily dose: 20 mg
Maximum supply: 14 days
Minimum age: 18 years
Presentation/Packing
Form
Beximco-Pantoprazole gastro-resistant tab 40 mg
Packing/Price
3 × 10's
Form
Beximco-Pantoprazole gastro-resistant tab 20 mg
Packing/Price
3 × 10's
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