ANTAXID Pantoprazole 40mg Enteric-Coated Tablet 28's
RXDRUG-DRP-1164-01
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
It is used in conditions where inhibition of gastric acid secretion may be beneficial, including gastro-oesophageal reflux disease, peptic ulcer disease, for Non-Steroidal Anti-Inflammatory Drug (NSAID)-associated ulceration, and in the treatment of pathological hypersecretory states such as the Zollinger-Ellison syndrome.
Dosage/Direction for Use
In the treatment of gastro-oesophageal reflux disease, the usual dose by mouth is 20 to 40 mg once daily for 4 weeks, increased to 8 weeks if necessary, in the USA, up to 16 weeks of therapy is permitted for healing erosive oesophagitis. For maintenance therapy, treatment can be continued with 20 to 40 mg daily. Alternatively, for recurring symptoms, an on-demand regimen of 20 mg daily may be given.
The usual dose for treatment of peptic ulcer disease is 40 mg once daily.
Treatment is usually given for 2 to 4 weeks of duodenal ulceration, or 4 to 8 weeks for benign gastric ulceration.
Patients who require prophylaxis for NSAID-associated ulceration may take 20 mg tablet.
In the treatment of pathological hypersecretory states such as Zollinger-Ellison syndrome, the initial dose is 80 mg daily, adjusted as required. Doses of up to 240 mg daily have been used. Daily doses greater than 80 mg should be given in 2 divided doses.
Doses of pantoprazole may need to be reduced in patients with hepatic impairment or as prescribed by the Physician.
The usual dose for treatment of peptic ulcer disease is 40 mg once daily.
Treatment is usually given for 2 to 4 weeks of duodenal ulceration, or 4 to 8 weeks for benign gastric ulceration.
Patients who require prophylaxis for NSAID-associated ulceration may take 20 mg tablet.
In the treatment of pathological hypersecretory states such as Zollinger-Ellison syndrome, the initial dose is 80 mg daily, adjusted as required. Doses of up to 240 mg daily have been used. Daily doses greater than 80 mg should be given in 2 divided doses.
Doses of pantoprazole may need to be reduced in patients with hepatic impairment or as prescribed by the Physician.
Overdosage
Experience in patients taking very high doses of pantoprazole is limited. There have been spontaneous reports of overdosage with pantoprazole 560 mg and undetermined amounts of chloroquine and zopiclone were also ingested. There have also been spontaneous reports of patients taking similar amounts of pantoprazole (400 mg and 600 mg) with no adverse effects.
Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.
Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.
Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.
Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.
Administration
May be taken with or without food: Swallow whole. Do not split/crush/chew.
Contraindications
Pantoprazole (Antaxid) 40 mg are contraindicated in patients with known hypersensitivity to any component of the formulation.
Special Precautions
General: Symptomatic response to therapy with pantoprazole does not produce the presence of gastric malignancy.
Dosing to the chronic nature of erosive esophagitis, there may be a potential for prolonged administration of pantoprazole. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown.
Generally, daily treatment with any acid-suppressing medications over a long period of time (eg. Longer than 3 years) may lead to malabsorption of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This possibility should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole, particularly in patients who were H. pylori positive.
Information for Patients: Patients should be cautioned that pantoprazole delayed-release tablets should not be split, crushed or chewed. The tablets should be swallowed whole, with or without food in the stomach. Concomitant administration of antacids does not affect the absorption of pantoprazole.
Use in Women: Erosive esophagitis healing rates in the 221 women treated with pantoprazole delayed-release tablets in U.S clinical trials were similar to those found in men. In the 122 women treated long-term with pantoprazole delayed-release 40 mg or 20 mg tablets, healing was maintenance at a rate similar to that in men. The incidence rates of adverse events were also similar for men and women.
Laboratory Tests: There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving most proton pump inhibitors, including pantoprazole. An alternative confirmatory method should be considered to verify positive results.
Use in Pregnancy: Teratogenic effects: Pregnancy Category B: Teratology studies have been performed in rats at oral doses up to 450 mg/kg/day (88 times the recommended human dose based on body surface area) and rabbits at oral doses up to 40 mg/kg/day (16 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Use in Lactation: Pantoprazole and its metabolite are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, 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.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: In short-term U.S clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥65 years old) treated with pantoprazole sodium delayed-release tablets were similar to those found in patients under the age of 65. The incidence rates of adverse events and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.
Dosing to the chronic nature of erosive esophagitis, there may be a potential for prolonged administration of pantoprazole. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown.
Generally, daily treatment with any acid-suppressing medications over a long period of time (eg. Longer than 3 years) may lead to malabsorption of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This possibility should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole, particularly in patients who were H. pylori positive.
Information for Patients: Patients should be cautioned that pantoprazole delayed-release tablets should not be split, crushed or chewed. The tablets should be swallowed whole, with or without food in the stomach. Concomitant administration of antacids does not affect the absorption of pantoprazole.
Use in Women: Erosive esophagitis healing rates in the 221 women treated with pantoprazole delayed-release tablets in U.S clinical trials were similar to those found in men. In the 122 women treated long-term with pantoprazole delayed-release 40 mg or 20 mg tablets, healing was maintenance at a rate similar to that in men. The incidence rates of adverse events were also similar for men and women.
Laboratory Tests: There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving most proton pump inhibitors, including pantoprazole. An alternative confirmatory method should be considered to verify positive results.
Use in Pregnancy: Teratogenic effects: Pregnancy Category B: Teratology studies have been performed in rats at oral doses up to 450 mg/kg/day (88 times the recommended human dose based on body surface area) and rabbits at oral doses up to 40 mg/kg/day (16 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Use in Lactation: Pantoprazole and its metabolite are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, 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.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: In short-term U.S clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥65 years old) treated with pantoprazole sodium delayed-release tablets were similar to those found in patients under the age of 65. The incidence rates of adverse events and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.
Use In Pregnancy & Lactation
Use in Pregnancy: Teratogenic effects: Pregnancy Category B: Teratology studies have been performed in rats at oral doses up to 450 mg/kg/day (88 times the recommended human dose based on body surface area) and rabbits at oral doses up to 40 mg/kg/day (16 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Use in Lactation: Pantoprazole and its metabolite are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, 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.
Use in Lactation: Pantoprazole and its metabolite are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, 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.
Adverse Reactions
Worldwide, more than 11,100 patients have been treated with pantoprazole in clinical trials involving various dosages and duration of treatment. In general, pantoprazole has been well-tolerated in both short-term and long-term trials. In two U.S. controlled clinical trials involving pantoprazole delayed release tablets 10-, 20-, or 40-mg doses for up to 8 weeks, there were no dose-related effects on the incidence of adverse events. The following adverse events considered by investigators to be possibly, probably, or definitely related to drug occurred in 1% or more in the individual studies of GERD patients on therapy with pantoprazole delayed release tablets.
In international short-term, double-blind or open-label clinical trials involving 20 mg to 80 mg per day, the following adverse events were reported to occur in 1% or more of 2805 GERD patients receiving pantoprazole for up to 8 weeks.
In international short-term, double-blind or open-label clinical trials involving 20 mg to 80 mg per day, the following adverse events were reported to occur in 1% or more of 2805 GERD patients receiving pantoprazole for up to 8 weeks.
Drug Interactions
Pantoprazole is metabolized through the cytochrome P450 system, primarily the CYP2C19 and CYP3A4 isozymes, and subsequently undergoes Phase II conjugation (see Pharmacology: Drug-Drug Interactions under Actions).
Based on studies evaluating possible interactions of pantoprazole with other drugs, no dosage adjustments is needed with concomitant use of the following: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam (and its active metabolite, desmethyldiazepam), diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, an oral contraceptive (levonorgestrel, ethinyl estradiol), metoprolol, nifedipine, phenytoin, warfarin (see text that follows), midazolam, clarithromycin, metronidazole, or amoxicillin. Clinically relevant interactions of pantoprazole with other drugs with the same metabolic pathways are not expected. Therefore, when coadministered with pantoprazole, adjustment of the dosage of pantoprazole of such drugs may not be necessary. There was also no interaction with concomitantly administered antacids. There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including pantoprazole, and warfarin concomitantly. Increase in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.
Severe generalised myalgia and bone pain were reported in a patient who received methotrexate and pantoprazole. The same reaction occurred on rechallenge with the combination, but not with methotrexate alone. Although methotrexate concentrations were unchanged, concentrations of the metabolite 7-hydroxymethotrexate were raised suggesting an interaction with its renal elimination.
Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (eg. Ketoconazole, ampicillin esters, and iron salts).
Based on studies evaluating possible interactions of pantoprazole with other drugs, no dosage adjustments is needed with concomitant use of the following: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam (and its active metabolite, desmethyldiazepam), diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, an oral contraceptive (levonorgestrel, ethinyl estradiol), metoprolol, nifedipine, phenytoin, warfarin (see text that follows), midazolam, clarithromycin, metronidazole, or amoxicillin. Clinically relevant interactions of pantoprazole with other drugs with the same metabolic pathways are not expected. Therefore, when coadministered with pantoprazole, adjustment of the dosage of pantoprazole of such drugs may not be necessary. There was also no interaction with concomitantly administered antacids. There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including pantoprazole, and warfarin concomitantly. Increase in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.
Severe generalised myalgia and bone pain were reported in a patient who received methotrexate and pantoprazole. The same reaction occurred on rechallenge with the combination, but not with methotrexate alone. Although methotrexate concentrations were unchanged, concentrations of the metabolite 7-hydroxymethotrexate were raised suggesting an interaction with its renal elimination.
Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (eg. Ketoconazole, ampicillin esters, and iron salts).
Storage
Store at temperatures not exceeding 25°C. Protected from moisture.
Action
Pharmacology: Pharmacodynamics: Mechanism of action: Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding in the (HK)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (HK)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested.
Antisecretory Activity: Under maximal acid stimulatory conditions using pentagastrin, a dose dependent decrease in gastric acid output occurs after a single dose of oral (20-120 mg) pantoprazole in healthy volunteers. Pantoprazole given once daily results in increasing inhibition of gastric acid secretion. Following the initial dose of 40 mg pantoprazole, a 51% mean inhibition was achieved by 2.5 hours. With once a day dosing for 7 days the mean inhibition was increased to 85%.
Pantoprazole suppressed acid secretion in excess of 95% in half of the subjects. Acid secretion had returned to normal within a week after the last dose of pantoprazole, there was no evidence of rebound hypersecretion.
In a series of dose-response studies pantoprazole, at oral doses from 20 to 120 mg, caused dose-related increases in median basal gastric pH and in the percent of time gastric pH was >3 and >4. Treatment with 40 mg of pantoprazole produced optimal increases in gastric pH which were significantly greater than the 20-mg dose. Doses higher than 40 mg (60, 80, 120 mg) did not result in further significant increases in median gastric pH. The effects of pantoprazole on median pH from one double-blind crossover study.
Antisecretory Activity: Under maximal acid stimulatory conditions using pentagastrin, a dose dependent decrease in gastric acid output occurs after a single dose of oral (20-120 mg) pantoprazole in healthy volunteers. Pantoprazole given once daily results in increasing inhibition of gastric acid secretion. Following the initial dose of 40 mg pantoprazole, a 51% mean inhibition was achieved by 2.5 hours. With once a day dosing for 7 days the mean inhibition was increased to 85%.
Pantoprazole suppressed acid secretion in excess of 95% in half of the subjects. Acid secretion had returned to normal within a week after the last dose of pantoprazole, there was no evidence of rebound hypersecretion.
In a series of dose-response studies pantoprazole, at oral doses from 20 to 120 mg, caused dose-related increases in median basal gastric pH and in the percent of time gastric pH was >3 and >4. Treatment with 40 mg of pantoprazole produced optimal increases in gastric pH which were significantly greater than the 20-mg dose. Doses higher than 40 mg (60, 80, 120 mg) did not result in further significant increases in median gastric pH. The effects of pantoprazole on median pH from one double-blind crossover study.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
Features
Brand
Antaxid
Full Details
Dosage Strength
40mg
Drug Ingredients
- Pantoprazole
Drug Packaging
Enteric-Coated Tablet 28's
Generic Name
Pantoprazole
Dosage Form
Enteric-Coated Tablet
Registration Number
DRP-1164-01
Drug Classification
Prescription Drug (RX)
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