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Anti-emetic drugs

Palonosetron is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT3 receptors that are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema, to initiate the vomiting reflex. Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factorcs and is triggered by release of 5-HT3 in a cascade of neuronal event involving both the central nervous system and the gastrointestinal tract. The 5-HT3 receptor has been demonstrated to selectively participate in the emetic response. Palonosetron works by blocking the actions of Serotonin, associated with nausea and vomiting, at 5-HTs receptor. It is likely that Palonosetron works in the small intestine but it may also work in the brain.

Pharmacokinetics: Palonosetron exhibits linear dose-proportional pharmacokinetics over the doserange 1-90 pg/kg in healthy subjects and in patients with cancer. In cancer patients receiving single intravenous doses of Palonosetron in this dose range, the mean maximum plasma concentration (Cmax) ranges from 0.89 to 336 ng/ml and the area under the plasma concentration-time curve from zero to infinity (AUCo-co) ranges from 13.8 to 957 ng.h/ml. Palonosetron has a volume of distribution of approximately 6.9-7.9 L/kg, with approximately 62% bound to plasma proteins. Approximately 50% of Palonosetron is metabolized into two inactive metabolites that exhibit <1% of the 5-HT3 receptor antagonist activity. Approximately 40% of the drug is metabolised via kidney, 50% by liver CYP2D6 (mainly), CYP3A4 and CYP1A2 isoenzymes. About 50% of the drug goes under metabolism. After a single intravenous dose, approximately 40% is excreted as unchanged drug in the urine after 144 hours. Total body clearance of Palonosetron is 160±35 ml/h/kg, and renal clearance is 66.5±18.2 ml/h/kg in healthy subjects. Palonosetron exhibits a longer half-life (40 hours) and has a greater 5-HT3 receptor binding affinity.

Usual dosage: Adult tablet dosage: 0.5 mg daily. Adult IV dosage: A single IV dose of 0.075 mg should be administered over 10 seconds.

Chemotherapy-induced nausea and vomiting: Adult tablet dosage: 0.5 mg administered approximately 1 hour prior to the start of chemotherapy. Adult IV dosage: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before the start of chemotherapy.

Radiotherapy-induced nausea and vomiting: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before each week of radiation fraction.

Post-operative nausea and vomiting: A single IV dose of 0.075 mg should be administered over 10 seconds immediately before induction of anesthesia.

Children dosage: (1 month to 17 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.

The most common adverse reactions are headaches and constipation.

Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components.

In controlled clinical trials, Palonosetron injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents. Palonosetron did not inhibit the antitumor activity of cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C in murine tumor models. Concomitant administration of Palonosetron and metoclopramide has no significant pharmacokinetic interactions. In vitro studies indicated that palonosetron is not inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 & CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6 or CYP3A4/5. Therefore, the potential for clinically significant drug interactions with Palonosetron appears to be low.

Pregnancy category 'B'. It is not known whether Palonosetron is excreted in breast milk.

Use in elderly patients: No dosage adjustment is recommended in elderly patients >65 years of age.

Use in Children: (1 month to 10 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.

Use in patients with impaired renal and hepatic function: No dosage adjustment is recommended in patients with renal and hepatic dysfunction.

There is no known antidote to Palonosetron. Overdose should be managed with supportive care.

Store in a cool & dry place, protected from light.

Anti-emetic drugs

Palonosetron is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT3 receptors that are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema, to initiate the vomiting reflex. Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factorcs and is triggered by release of 5-HT3 in a cascade of neuronal event involving both the central nervous system and the gastrointestinal tract. The 5-HT3 receptor has been demonstrated to selectively participate in the emetic response. Palonosetron works by blocking the actions of Serotonin, associated with nausea and vomiting, at 5-HTs receptor. It is likely that Palonosetron works in the small intestine but it may also work in the brain.

Pharmacokinetics: Palonosetron exhibits linear dose-proportional pharmacokinetics over the doserange 1-90 pg/kg in healthy subjects and in patients with cancer. In cancer patients receiving single intravenous doses of Palonosetron in this dose range, the mean maximum plasma concentration (Cmax) ranges from 0.89 to 336 ng/ml and the area under the plasma concentration-time curve from zero to infinity (AUCo-co) ranges from 13.8 to 957 ng.h/ml. Palonosetron has a volume of distribution of approximately 6.9-7.9 L/kg, with approximately 62% bound to plasma proteins. Approximately 50% of Palonosetron is metabolized into two inactive metabolites that exhibit <1% of the 5-HT3 receptor antagonist activity. Approximately 40% of the drug is metabolised via kidney, 50% by liver CYP2D6 (mainly), CYP3A4 and CYP1A2 isoenzymes. About 50% of the drug goes under metabolism. After a single intravenous dose, approximately 40% is excreted as unchanged drug in the urine after 144 hours. Total body clearance of Palonosetron is 160±35 ml/h/kg, and renal clearance is 66.5±18.2 ml/h/kg in healthy subjects. Palonosetron exhibits a longer half-life (40 hours) and has a greater 5-HT3 receptor binding affinity.

Usual dosage: Adult tablet dosage: 0.5 mg daily. Adult IV dosage: A single IV dose of 0.075 mg should be administered over 10 seconds.

Chemotherapy-induced nausea and vomiting: Adult tablet dosage: 0.5 mg administered approximately 1 hour prior to the start of chemotherapy. Adult IV dosage: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before the start of chemotherapy.

Radiotherapy-induced nausea and vomiting: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before each week of radiation fraction.

Post-operative nausea and vomiting: A single IV dose of 0.075 mg should be administered over 10 seconds immediately before induction of anesthesia.

Children dosage: (1 month to 17 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.

The most common adverse reactions are headaches and constipation.

Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components.

In controlled clinical trials, Palonosetron injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents. Palonosetron did not inhibit the antitumor activity of cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C in murine tumor models. Concomitant administration of Palonosetron and metoclopramide has no significant pharmacokinetic interactions. In vitro studies indicated that palonosetron is not inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 & CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6 or CYP3A4/5. Therefore, the potential for clinically significant drug interactions with Palonosetron appears to be low.

Pregnancy category 'B'. It is not known whether Palonosetron is excreted in breast milk.

Use in elderly patients: No dosage adjustment is recommended in elderly patients >65 years of age.

Use in Children: (1 month to 10 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.

Use in patients with impaired renal and hepatic function: No dosage adjustment is recommended in patients with renal and hepatic dysfunction.

There is no known antidote to Palonosetron. Overdose should be managed with supportive care.

Store in a cool & dry place, protected from light.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Sofosbuvir and Velpatasvir combination is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection-

• Without cirrhosis or with compensated cirrhosis
• With decompensated cirrhosis for use in combination with ribavirin

Hepatic viral infections (Hepatitis C)

It is a fixed-dose combination tablet containing sofosbuvir and velpatasvir for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor and velpatasvir is an NS5A inhibitor.

The recommended dosage is one tablet (400 mg of Sofosbuvir and 100 mg of Velpatasvir) taken orally once daily. Recommended treatment regimen:

• Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A): one tablet once daily for 12 weeks
• Patients with decompensated cirrhosis (Child-Pugh B or C): one tablet once daily and Ribavirin for 12 weeks. The recommended dosage of Ribavirin is based on bodyweight (1000 mg/day for patients < 75 kg and 1200 mg/day for ≥ 75 kg, in two divided dose/day)

The most common side effects of Sofosbuvir and Velpatasvir combination include headache and tiredness. Treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (a medicine used to treat certain heart problems).

Sofosbuvir, Velpatasvir and Ribavirin combination regimen is contraindicated in patients for whom Ribavirin is contraindicated.

Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with Sofosbuvir and Velpatasvir combination is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.

Drugs may decrease the concentrations of sofosbuvir and/or velpatasvir: Antacids, H2-receptor antagonists, Proton-pump inhibitors etc.

Coadministration is not recommended with: topotecan, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine, efavirenz, Tipranavir, Ritonavir, Hypericum perforatum.

Coadministration of Sofosbuvir and Velpatasvir combination, with Rosuvastatin, Atorvastatin may significantly increase the concentration of Rosuvastatin, Atorvastatin.

No adequate human data are available to establish whether or not Sofosbuvir and Velpatasvir combination poses a risk to pregnancy outcomes. If Sofosbuvir and Velpatasvir combination administered with Ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partner is pregnant or going to be pregnant in next six months.

Renal impairment patient: No dosage recommendation can be given for patients with severe renal impairment (eGFR ≤30 mL/min/1.73 m²) or with ESRD, due to higher exposures of the predominant sofosbuvir metabolite.

If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose includes monitoring of vital signs as well as observation of the clinical status of the patient.

Store in a cool and dry place (preferably below 30° C). Keep out of reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e 

• Peptic ulcer diseases
• Gastroesophageal reflux diseases
• Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison Syndrome

Proton Pump Inhibitor

Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.

Oral:

• Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
• Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
• Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
• Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
• Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
• Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.

IV Injection:

• Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
• Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
• Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
• Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
• Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.

Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.

No significant drug interactions have been observed in clinical studies.

US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.

Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.

Keep in a dry place, away from light and heat. Keep out of the reach of children.