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Pantoprazole information from DrugsUpdate  

See Available Brands of Pantoprazole in India

P - Caution when used during pregnancy.
L - Contraindicated in Lactation.
LI - Lab *

Pantoprazole (Sold as Pantotab; Pantopan; Protium; Protonix; Pantozol; Pantor; Pantoloc; Astropan; Controloc; Pantecta; Inipomp; Somac; Ulcepraz; Pantodac) is a proton pump inhibitor drug used for short-term treatment of erosion and ulceration of the esophagus caused by gastroesophageal reflux disease. Initial treatment is generally of eight weeks' duration, after which another eight week course of treatment may be considered if necessary. It can be used as a maintenance therapy for long term use after initial response is obtained. This medication may affect the results of certain lab tests, such as drug screenings (pantoprazole can cause a false positive for THC). It is recommended you make sure laboratory personnel and your doctor know you are using this drug. The active ingredient in Protonix (pantoprazole sodium). Delayed-Release Tablets is a substituted benzimidazole,sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion.

Pharmacodynamics

Pharmacokinetics

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 hour (prolonged in hepatic impairment; in patients with cirrhosis the elimination half life may be 3-10 hours).

Pantoprazole Indications / Pantoprazole Uses

Information Not Available

Pantoprazole Adverse Reactions / Pantoprazole Side Effects

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.

Precautions

Information Not Available

Special 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.

Other 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.

Other Interactions

Food Interaction


Long term use (>3 yr) may lead to vitamin B12 malabsorption. May decrease oral absorption of iron salts.

Dosage

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
Prevention 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.

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.

Food(before/after)

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.)

List of Contraindications

Pantoprazole and Pregnancy

Caution when used during pregnancy.


Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).



Pantoprazole and Lactation

Contraindicated in Lactation.

Pantoprazole and Children

Safety and effectiveness in pediatric patients have not been established.

Pantoprazole and Geriatic

In short-term U.S. clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥ 65 years old) treated with Pantoprazole sodium were similar to those found in patients under the age of 65. The incidence rates of adverse events and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.

Pantoprazole and Other Contraindications

Lactation


 

Storage

Intravenous
IV (before reconstitution) <25 °C.
Once reconstituted, store <25 °C and use within 12 hours.

Oral
Store tablet at 15-30 °C.

Lab interference

Intravenous
IV (before reconstitution) <25 °C.
Once reconstituted, store <25 °C and use within 12 hours.

Oral
Store tablet at 15-30 °C.

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