Pantoprazol Farmoz

Pantoprazol Farmoz

pantoprazole

Manufacturer:

Tecnimede

Distributor:

T-BOMA
Concise Prescribing Info
Contents
Pantoprazole
Indications/Uses
20-mg tab: Symptomatic GERD & long-term management & prevention of relapse in reflux oesophagitis in adult & adolescent ≥12 yr. Prevention of gastroduodenal ulcers induced by NSAIDs in adult patients at risk w/ a need for continuous NSAID treatment. 40-mg tab: Reflux oesophagitis in adults & adolescents ≥12 yr. Eradication of H. pylori in combination w/ appropriate antibiotic therapy in adult patients w/ H. pylori-associated ulcers. Gastric & duodenal ulcer, Zollinger-Ellison syndrome & other pathological hypersecretory conditions in adults.
Dosage/Direction for Use
20-mg tab Adult & adolescent ≥12 yr Symptomatic GERD 20 mg/day. Long-term management & prevention of relapse in reflux oesophagitis 20 mg/day, increasing to 40 mg/day if a relapse occurs. After healing of the relapse, dose can be reduced to 20 mg. Adult Prevention of gastroduodenal ulcers induced by NSAIDs 20 mg/day. Patients w/ severe liver impairment Max: 20 mg daily. 40-mg tab Adult & adolescent ≥12 yr Reflux oesophagitis 1 tab (40 mg) daily, may be increased to 2 tab daily. Adult Eradication of H. pylori in combination w/ 2 appropriate antibiotics 1 tab pantoprazole bd + amoxicillin 1,000 mg bd + clarithromycin 500 mg bd; or 1 tab pantoprazole bd + metronidazole 400-500 mg bd (or tinidazole 500 mg) + clarithromycin 250-500 mg bd; or 1 tab pantoprazole bd + amoxicillin 1,000 mg bd + metronidazole 400-500 mg bd (tinidazole 500 mg). Gastric ulcer 1 tab/day, may be increased to 2 tab daily. Duodenal ulcer 1 tab/day, may be increased to 2 tab daily. Zollinger-Ellison syndrome & other pathological hypersecretory conditions 80 mg (2 tab) daily. Thereafter, dose can be titrated up or down as needed. Doses >80 mg daily should be divided & given bd.
Administration
Should be taken on an empty stomach: Take 1 hr before meals.
Contraindications
Hypersensitivity to pantoprazole or to substituted benzimidazoles.
Special Precautions
Regularly monitor liver enzymes during treatment in patients w/ severe liver impairment, especially in long-term use. Use of pantoprazole 20 mg as a preventive of gastroduodenal ulcers induced by NSAIDs should be restricted to patients who require continued NSAID treatment & have an increased risk to develop GI complications. May mask symptoms & delay diagnosis of gastric malignancy. Not recommended w/ co-administration of HIV PIs (eg, atazanavir). May reduce absorption of vit B12. Patients should be kept under regular surveillance in long-term treatment (especially >1 yr). Increased risk of GI infections eg, Salmonella & Campylobacter & possibly Clostridium difficile. Risk of hypomagnesemia. Increased risk of hip, wrist & spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Associated w/ very infrequent cases of subacute cutaneous lupus erythematosus (SCLE). Increased Chromogranin A (CgA) level may interfere w/ investigations for neuroendocrine tumours. Pregnancy & lactation. Not recommended for use in childn <12 yr.
Adverse Reactions
Fundic gland polyps (benign). Uncommon: Sleep disorders; headache, dizziness; diarrhoea, nausea/vomiting, abdominal distension & bloating, constipation, dry mouth, abdominal pain & discomfort; liver enzymes increased; rash/exanthema/eruption, pruritus; fracture of the hip, wrist or spine; asthenia, fatigue, malaise.
Drug Interactions
May interfere w/ absorption of drugs where oral bioavailability is dependent on gastric pH eg, some azole antifungals eg, ketoconazole, itraconazole, posaconazole & other medicines eg, erlotinib. Reduced bioavailability of atazanavir & other HIV PIs whose absorption is pH-dependent. Monitoring of prothrombin time & INR is recommended if co-administered w/ warfarin or phenprocoumon. Increased levels of methotrexate. Increased systemic exposure w/ CYP2C19 inhibitors eg, fluvoxamine. Reduced plasma conc w/ CYP2C19 & CYP3A4 inducers eg, rifampicin & St. John's wort.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
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).
Presentation/Packing
Form
Pantoprazol Farmoz gastro-resistant tab 20 mg
Packing/Price
6 × 10's
Form
Pantoprazol Farmoz gastro-resistant tab 40 mg
Packing/Price
6 × 10's
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