Pantoprazole Sodium Sesquihydrate

Indications
Oral
Gastro-oesophageal reflux disease
Adult: 20-40 mg once daily in the morning for 4 wk, increased to 8 wk if necessary. Maintenance: 20-40 mg daily, increased to 40 mg each morning if symptoms return.
Hepatic impairment: Doses >40 mg daily have not been studied in hepatically-impaired patients.
Oral
Peptic ulcer
Adult: 40 mg once daily in the morning for 2-4 wk for duodenal ulceration or 4-8 wk for benign gastric ulceration.
Hepatic impairment: Doses >40 mg daily have not been studied in hepatically-impaired patients.
Oral
H.pylori infection
Adult: Triple therapy: 40 mg bid combined with clarithromycin 500 mg bid and either amoxicillin 1 g bid or metronidazole 400 mg bid.
Hepatic impairment: Doses >40 mg daily have not been studied in hepatically-impaired patients.
Oral
Prophylaxis of NSAID-induced ulcers
Adult: 20 mg daily.
Hepatic impairment: Doses >40 mg daily have not been studied in hepatically-impaired patients.
Oral
Zollinger-Ellison syndrome
Adult: Initially 80 mg daily, adjusted to individual requirements. Up to 240 mg daily may be used if needed. Daily doses >80 mg should be given in 2 divided doses.
Hepatic impairment: Doses >40 mg daily have not been studied in hepatically-impaired patients.
Intravenous
Zollinger-Ellison syndrome
Adult: As Na salt: 80 mg once or twice daily. Up to 240 mg daily may be given in divided doses. Convert to oral therapy as soon as possible. Dose to be given as slow inj or short-term infusion over 2-15 minutes.
Hepatic impairment: May need to reduce dose.
Intravenous
Gastro-oesophageal reflux disease
Adult: As Na salt: 40 mg daily. Convert to oral therapy as soon as possible. Dose to be given as slow inj or short-term infusion over 2-15 minutes.
Hepatic impairment: May need to reduce doses.
Intravenous
Peptic ulcer
Adult: As Na salt: 40 mg daily. Convert to oral therapy as soon as possible. Dose to be given as slow inj or short-term infusion over 2-15 minutes.
Hepatic impairment: May need to reduce doses.

Special Populations: Reduce dose in patients with severe hepatic impairment or give only on alternate days. Max dose: 20 mg daily or 40 mg on alternate days.

Reconstitution: Reconstitute with 10 ml 0.9% sodium chloride (final concentration 4 mg/ml). Reconstituted solution may be given IV (over 2 minutes) or diluted to 100 ml in glucose 5%, 0.9% sodium chloride, or lactated Ringer's and infused over 15 min.
Incompatibility: Y site incompatibility: midazolam and zinc.
Contraindications
Lactation.
Warnings / Precautions
Long-term therapy may lead to bacterial overgrowth in the GI tract. Hepatic impairment; monitor liver function regularly (if enzymes increase, discontinue); pregnancy; not recommended in children <18 yr; long term use may lead to atrophic gastritis.
Adverse Reactions
Diarrhoea, dizziness, pruritus, skin rashes, GI tract infections, chest pain, headache, nausea, pain, anxiety, hyperglycaemia; malaise or lassitude; myalgia; oedema; insomnia; hyperlipidaemia; flatulence, abdominal pain, constipation, eructation, dyspepsia, rectal disorder; urinary frequency, UTI; abnormalities in liver function; local site reaction; hypertonia, neck pain, weakness; bronchitis, cough, dyspnoea, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, flu syndrome.
Overdose Reactions
Treatment: supportive. Not removed by haemodialysis.
Drug Interactions
Decreased absorption of ketoconazole and itraconazole; may slightly increase digoxin plasma concentration; may reduce plasma concentration of atazanavir, avoid concomitant use; may enhance anticoagulant effect of coumarins; may cause gastric mucosal irritation with alcohol; may increase levels or effects of: bosentan, dapsone, fluoxetine, glimepiride, glipizide, losartan, montelukast, nateglinide, paclitaxel, phenytoin, warfarin, and zafirlukast; may decrease levels or effects of: aminoglutethimide, carbamazepine, phenytoin, and rifampicin.
See Below for More pantoprazole Drug Interactions
Lab Interactions
May produce false positive urine screening tests for tetrahydrocannabinol.
Food Interactions
Long term use (>3 yr) may lead to vitamin B12 malabsorption. May decrease oral absorption of iron salts.
Mechanism of Actions
Pantoprazole inhibits H+/K+ ATPase pump function thereby reducing gastric acid secretion. It also has a role in the eradication of H. pylori.
Absorption: Well absorbed; peak plasma concentrations: Approx 2-2.5 hr after oral dose. Oral bioavailability: Approx 77% with enteric-coated formulation (does not vary after single or multiple doses).
Distribution: Protein-binding: 98%; volume of distribution: 11-24 L.
Metabolism: Hepatic; mainly by cytochrome CYP2C19 and slightly by CYP2D6 and CYP2C0.
Excretion: Via urine (approx 80%) and bile (approx 20%). Elimination half life: approx 1 hr (prolonged in hepatic impairment; in patients with cirrhosis the elimination half life may be 3-10 hr).
Administration
Normal release: May be taken with or without food.
Controlled-release: Should be taken on an empty stomach. (Take 1 hr before meals. Swallow whole, do not chew/crush.)
Storage Conditions
Intravenous: IV (before reconstitution): <25 °C. Once reconstituted, store <25 °C and use within 12 hr. Oral: Store tablet at 15-30 °C.
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).
Storage
Intravenous: IV (before reconstitution): <25 °C. Once reconstituted, store <25 °C and use within 12 hr. Oral: Store tablet at 15-30 °C.
Available As
  • Pantoprazole Sodium Sesquihydrate 10 mg
  • Pantoprazole Sodium Sesquihydrate 20 mg
  • Pantoprazole Sodium Sesquihydrate 30 mg
  • Pantoprazole Sodium Sesquihydrate 40 mg
  • Pantoprazole Sodium Sesquihydrate 40 mg (2 tab)
  • Pantoprazole Sodium Sesquihydrate 500 mg
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