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Hematology: leukopenia, thrombocytopenia.
Indications and Uses.
Output USP delayed pantoprazole sodium tablets indicate the following
Short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD).
Output USP delayed pantoprazole sodium tablets have been shown to cure and illuminate signs of erosive esophagitis in adult patients with short-term healing (up to 8 weeks); in adult patients who are still not healed after 8 months, 8 weeks of subsequent treatment is maintained. of pantoprazole According to the American Pharmacopoeia, the use of sodium tablets with delayed release can be considered; the safety of healing in children over 8 months has not been established.
Maintains healing of erosive esophagitis
Pantoprazole sodium tablets with delayed output USP have been shown to maintain healing of erosive esophagitis and reduce recurrent daytime and nighttime heartburn in GERD patients. The controlled study did not exceed 12 months.
Pathologic hypersecretory disorders including Zollinger-Elison syndrome
Output USP delayed pantoprazole sodium tablets are indicated for the long-term treatment of pathologic paralytic sector disorders, including Zollinger-Elison syndrome.
Medication and Administration
Pantoprazolnatrium is available in a delayed form. Appropriate dosages are listed in Table 1.
Table 1: Appropriate dosing schedule for delayed release pantoprazol sodium tablets.
*In mature patients who are not yet cured after 8 months of treatment, an additional 8 weeks of referral is maintained. of pantoprazole Use of sodium tablets with delayed release can be considered; doses of up to 240 mg per day were used.
Frequency of erosive esophagitis associated with GERD Indication for short-term treatment
Adults 40 mg once daily for 8 weeks* Infants (5 years and older)
Maintains healing of erosive esophagitis
Adults is 40 mg once daily
Pathologic hypersecretory conditions, including Zollinger-Ellison syndrome, ripe for 40 mg twice daily†.
The administration procedure is summarized in Table 2. Table 2: Administration notes
*Patients must be informed of this. pantoprazole Sodium-retaining tablets do not need to be broken, chewed, or crushed.
Formulation Description *The extended-release tablets should be taken whole orally with or without food.
Pantoprazole Sodium Delayed-Release Tablets
Pantoprazole sodium delayed-release tablets are swallowed whole orally with or without food in the stomach. If the patient has difficulty swallowing 40 mg tablets, two 20 mg tablets may be taken. The use of concomitant antacids does not affect absorption. of pantoprazole Sodium delayed-release tablets.
Contraindications.
Delayed-release sodium tablets are contraindicated in patients with known hypersensitivity to any component of the formulation [see description (11)] or to substituted benzoimidazoles.
Warnings and Precautions
Complications of gastric malignancy
Symptomatic response to therapy pantoprazole The presence of gastric malignancy is not excluded.
Atrophic gastritis may be observed on gastric body biopsy in patients undergoing long-term therapy. pantoprazole This is even more so in H. pylori-positive patients.
Cyanocobalamin (vitamin B-12) deficiency
In general, daily use of acidic products for a long period of time (e.g., 3 years or more) may lead to a reduction in multiple cyanocobalamin (vitamin B-12) symptoms caused by hypochlorhydria or achlorhydria. Exceptional reports of cyanocobalamin deficiency have been reported in the literature. This diagnosis is a step in reviewing whether there are clinical symptoms consistent with cyanocobalamin deficiency.
Diarrhea Associated with Clostridium difficile
Published observational studies have shown that PPI therapy is effective as a treatment modality. pantoprazole It may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. This diagnosis follows a trail of considerations for diarrhea that does not improve [see Adverse Effects (6. 2)].
Patients should use the lowest dose and shortest duration of PPI therapy that is optimal for symptom resolution.
A small number of observational studies have shown that treatment with proton pump inhibitors (PPIs) is associated with an increased risk of osteoporotic-related fractures of the legs, wrists, or spine. The risk of fracture was increased in patients receiving the highest dose, defined as several daily doses, and with long-term PPI therapy (>1 year). Patients are advised to use the lowest dose appropriate for the condition being treated and the shortest duration of PPI therapy. Patients at risk for osteoporosis-related fractures should be treated according to determined treatment guidelines [see Dosage and Administration (2) and Side Effects (6. 2)].
Symptomatic and asymptomatic hypomagnesaemia is most often observed occasionally in patients on PPIs for at least 3 months after 1 year of treatment. Non-symptomatic unwanted symptoms include tetany, cardiac rhythm disturbances, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and cessation of PPIs.
For patients who are expected to be treated for an extended period of time or who will be using PPIs in combination with medications such as Digoxin or medications that may cause hypomagnesemia (such as diuretics), health care providers have the option of sometimes predicting magnesium levels before PPI therapy. [See “Side Effects” (see 6. 2)].
Due to the acquired nature of GERD, long-term use is possible. of pantoprazole [See “Side Effects” (see 6. 2)]. Long-term studies in rodents. pantoprazole It is carcinogenic and has caused exceptional gastrointestinal tumors. The relevance of these results in human tumorigenesis is unknown [see Nonclinical Toxicology (13. 1)].
THC Interference with Urinalysis.
See “Drug Interactions” (7. 5).
Concurrent use of methotrexate and pantoprazole
In the literature, concurrent use of PPIs with methotrexate (especially at high doses; see information on the purpose of methotrexate) is expected to increase and extend serum levels of methotrexate and/or its metabolites, which may lead to Methotrexate Toxicity. If large doses of methotrexate are administered to some patients, temporary cessation of PPIs can be considered [see Drug Interactions (7. 6)].
Adverse Effects
Clinical Research Experience
Because clinical studies are performed in a variety of settings, the incidence of adverse reactions in clinical studies of one product cannot be directly related to the incidence in clinical studies of another product, and the incidence may not match the observed incidence. In medical practice.
Protection of 9 randomized controlled clinical studies in GERD patients in the U.S. included 1473 patients on oral pantoprazole (20 mg or alternative 40 mg), 299 patients on H2 receptor antagonists, 46 patients with different proton pump inhibitors, and 82 patients on placebo. The most common side effects are summarized in Table 3.
Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients With GERD at a Frequency of >2%.
Pantoprazole comparator placebo (n = 1473) (n = 345) (n = 82) ％％％％％％％％12, 2 12, 8 8, 5 diarrhea 8, 8 9, 6 4, 9 nasea 7 , 0 5, 2 9, 8 abdominal pain 6, 2 4, 1 6, 1. ATRALGIE 2, 8 1, 4 1, 2
Additional side effects have been reported for pantoprazole For clinical tests with an incidence of 2% or less, it is listed below per body system
General body: allergic reactions, pyrexia, photosensitive reactions, facial oedeema
Gastrointestinal: constipation, dry mouth, hepatitis.
Hematology: leukopenia, thrombocytopenia.
Metabolism/nutrition: CK (creatine kinase), generalized edema, increased triglycerides, increased liver enzymes
Nervous system: depression, dizziness
Skin and appendages: hives, skin rash, itching
Special senses: blurred vision
Safety of pantoprazole Treatment of erosive esophagitis (EE) associated with GERD was considered in pediatric patients aged 1 to 16 years in three clinical studies. Protective controls included pediatric patients with EE. However, because EE occurs rarely in the pediatric population, 249 pediatric patients with endoscopically proven or symptomatic GERD were nevertheless evaluated. All side effects in adults to pantoprazole are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (>(4%) Side effects include urticaria, headache, fever, diarrhea, nausea, skin rash, and abdominal pain.
For protection of patients under 1 year of age, see. Referral of Specific Populations (8, 4).
Additional side effects have been reported for pantoprazole In pediatric patients undergoing clinical testing, less than 4% in frequency and listed below by body system
Overall body: allergic reactions, facial edema
Gastrointestinal: constipation, flatulence, nausea
Metabolic/nutritional: increased triglycerides, increased liver enzymes, increased CK (creatine kinase)
Musculoskeletal: arthralgia, myalgia.
Nervous system: dizziness, vertigo
Skin and appendages: ur measles
The following adverse reactions observed in adult patients during the clinical examination have not been reported in pediatric patients during the clinical examination, but were mentioned as urgent in pediatric patients: photosensitivity reactions, myalgia, hepatitis, thrombocytopenia, generalized edema, depression, leukopenia and leukopenia blurred pole
In the Zollinger-Ellison syndrome trial, adverse reactions were observed in 35 patients. pantoprazole Doses of 80 to 240 mg/day for up to 2 years were comparable to doses reported in adult patients with gastroesophageal reflux disease.
Appropriate adverse events were observed during post-registration use. of pantoprazole . Because these reactions are reported spontaneously in populations of uncertain size, it is not always possible to accurately assess their frequency or to establish a causal relationship to product efficacy.
These adverse reactions are listed below for each body system.
General disorders and conditions of use: asthenia, fatigue, malaise.
Hematologic: pancytopenia, agranulocytosis.
Hepatobiliary disorders: liver cell damage causing jaundice and liver failure.
Immune system disorders: anaphylaxis (including anaphylactic shock).
Infections and infestations: diarrhea associated with Clostridium difficile.
Investigations: weight composition
Drug metabolism and nutritional disorders: hyponatremia, hypomagnesemia.
Musculoskeletal system: rhabdomyolysis, bone fractures.
Nervous system: dysgeusia, dysgeusia of taste.
Mental disorders: hallucinations, confusion, insomnia, drowsiness.
Renal and urinary disorders: interstitial nephritis.
Skin and subcutaneous tissue: cutaneous reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal) and angioedema (Quincke’s edema).
Drug Interactions
Interference with antiretroviral therapy
Concomitant use of atazanavir or nelfinavir with proton pump inhibitors is not recommended. Concomitant use of atazanavir or nelfinavir with a proton pump inhibitor is expected to substantially reduce plasma concentrations of atazanavir or nelfinavir and may result in loss of therapeutic effect and development of drug resistance.
There have been postmarketing reports of increased INR and prothrombin time in patients treated with proton pump inhibitors. pantoprazole Also take warfarin at the same time; increased INR and prothrombin time may lead to abnormal bleeding and death. Patients taking proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.
Concurrent Use of pantoprazole In addition, clopidogrel in healthy subjects had no clinically relevant effect on the effects of the concentrated metabolite clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12, 3)]. When clopidogrel is administered at approved doses, there is no dose adjustment. of pantoprazole .
Drugs whose bioavailability may be affected by gastric pH
Pantoprazole causes prolonged inhibition of gastric acid secretion. Consequences, pantoprazole may interfere with drug absorption if gastric pH is considered important for determining bioavailability (e.g., ketoconazole, ampicillin esters, iron salts).
False positive urine test for THC
False positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving proton pump inhibitors have been reported. It is a footprint to distinguish between different confirmation methods for testing positive results.
Case reports, published population pharmacokinetic studies, and retrospective studies are available for the concurrent administration of PPIs and methotrexate (especially at the highest doses; see See methotrexate formulation) have demonstrated that methotrexate and/or its metabolite, hydroxymetalate, may increase and prolong serum levels. Finally and importantly, there are virtually no formal studies on the interaction of methotrexate with PPIs [see Warnings and Precautions (5. 9)].
Use in Specific Populations
Pregnancy Category b
Reproduction studies have been conducted in rats at oral doses up to 88 1 higher than the recommended human dose and in rabbits at oral doses up to 16 1 more than the recommended human dose and found no evidence of impaired fertility or damage to human Fetus. to pantoprazole There are no adequate and fully controlled studies in pregnant women. Because animal reproduction studies do not always predict reactions in humans, this product should be used during pregnancy only when clearly necessary [see Nonclinical Toxicology (13. 2)].
Pantoprazole and its metabolites are excreted in rat milk. Excretion of pantoprazole in breast milk was found after a single oral dose of 40 mg in a study of lactating mothers. The clinical importance of this finding is unpopular. Almost any drug that differs from breast milk can cause serious side effects in a nursing child. Based on proven carcinogenic potential. for pantoprazole Carcinogenicity studies in mice have concluded that the superiority of the product to the mother should be taken into account when either breastfeeding or discontinuing use of the product.
Safety and Efficacy of pantoprazole For short-term healing (up to 8 weeks), erosive esophagitis (EE) was associated with GERD in pediatric-aged patients ranging from 1 to 16 years of age; the efficacy of EE has not been demonstrated in patients younger than 1 year of age. Furthermore, there is no age-appropriate dosage strength appropriate for patients younger than 5 years of age. As a result. pantoprazole shown for short-term treatment of EE associated with GERD in patients older than 5 years of age. Protection and Efficacy of pantoprazole Except for EE, the drug is not offered for pediatric use for
1 to 16 years.
Use of pantoprazole In pediatric patients 1 to 16 years prior to short-term (up to 8 weeks) cure of EE associated with GERD, a) extrapolation of the results of necessary and good laboratory studies recognizing the approval of pantoprazole cure of GERD-related EE in adult patients, and b) safety, efficacy, and pharmacokinetic studies performed in pediatric patients [see Laboratory Studies (14, 1) and Clinical Pharmacology (12, 3)].
Safety of pantoprazole Treatment of EE associated with GERD in pediatric patients aged 1 to 16 years (5 years and 4 patients) was evaluated in three multichamber, randomized trials of 5 to 11 years. Infants with endoscopically diagnosed EE (defined as Hetzel-established endoscopic score ≥2) from 1 to 5 years were treated once daily at one of two dose values for 8 months of pantoprazole (approximately 0, 6 mg/kg or 1, 2 mg/kg). All four of these EE patients were cured after 8 months (Hetzel-Dent Score 0 or 1); because EE occurs rarely in the pediatric population, these studies included primarily pediatric patients with endoscopically proven or symptomatic GERD. Patients were treated with a series of doses of pantoprazole once daily for 8 months. See Conclusions on Protective Adverse Effects (6. 1). In these pediatric tests, the evaluations were inconclusive in terms of medical benefit because there was no placebo, intensive comparative material, or proof of dose response. of pantoprazole in symptomatic GERD in the pediatric population. Efficacy of pantoprazole for the treatment of symptomatic GERD in pediatric patients has not been established.
Data from clinical studies are an introduction to a of pantoprazole For short-term treatment of EE associated with GERD in pediatric patients 1 to 5 years, commercially inexpensive doses are appropriate for patients at least 5 years old [see Dosage and Administration (2)].
In a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of 2.4 L/h. Following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for >12, 5 to.< 25 kg), the plasma concentrations of pantoprazole Strongly variable, mean time to peak plasma concentration was 3 to 6 h. The estimated AUC for patients aged 1 to 5 years was 6, 8 mc g-HR/ml, a geometric mean AUC 37% higher than the AUC for adult patients receiving 1 pill 40 mg.
Neonates up to less than 1 year of age
Pantoprazole was found to be effective in a multicentric, randomized, double-blind, placebo-controlled study of cure in 129 pediatric patients between 1 and 11 months. Patients were enrolled if they had symptomatic GERD based on disease status and did not respond to non-pharmacologic interventions for GERD in the 2-month direction. Patients pantoprazole daily for 4 months in an open label phase, then patients were randomized in an equal pantoprazole treatment or placebo for an additional 4 months in a double-blind fashion. Efficacy was observed by the study method regarding the randomization period before the study stopped as a result of symptom reduction during the 4-week healing phase. There were no statistically important differences pantoprazole Placebo at the stopping frequency.
In this study, more frequently reported adverse effects (difference of more than 4%) with treatment compared to the placebo population increased the increase in CK, otitis media, rhinitis, and laryngitis.
Pharmacokinetic population analysis showed increased systemic effects in patients <1 year of age with GERD compared to adult patients who received one dose of 40 mg (geometric mean AUC was 103% higher in preterm and neonatal patients with two doses, 5 mg obtained. of pantoprazole 1 month to 11 months was 23% higher in infants receiving approximately 1.2 mg/kg. In these patients, marked clearance (CL/F) increased with age (mean clearance: 0, 6 L/hour; spectrum: 0, 03 to 3, 2 L/hour).
These doses produced pharmacodynamic effects on the stomach, but not on the pH of the gastrointestinal tract. Subsequently, daily doses of 2, 5 mg became. of pantoprazole in preterm infants and neonates, there was an increase in the mean gastric pH (from 4.3 at baseline to 5.2 at steady-state) and in the mean % time that gastric pH was >4 (from 60% at baseline to 80% at steady state). Subsequently, the once daily dose approached 1, 2 mg/kg of pantoprazole in infants 1 through 11 months of age, there was an increase in the mean gastric pH (from 3.1 at baseline to 4.2 at steady-state) and in the mean % time that gastric pH was >4 (32% of baseline but up to 60% at steady state). This is not important in the least. No significant changes were observed in the percentage of time the averaged intraesophageal pH or gastrointestinal pH was< 4 in either age group.
Because pantoprazole Not shown to be effective in randomized placebo-controlled studies in this age group. of pantoprazole It has not been shown to treat symptomatic GERD in children younger than 1 year of age.
In a short-term U.S. clinical study, the degree of healing of esophageal infection was in 107 older patients (65 years and older) who were treated. pantoprazole The incidence of side effects and laboratory deviations in patients over 65 years of age was similar to that seen in patients under 65 years of age.
Healing erosion characteristics of the gastrointestinal tract with 221 women who underwent healing pantoprazole Sodium tablets with delayed release in the U.S. laboratory were similar to those found in men. With 122 women who were healed long-term with either pantoprazole 40 mg or 20 mg, healing was retained at a rate similar to that seen in men. The incidence of side effects remained similar in men and women.
Patients with hepatic dysfunction
Doses greater than 40 mg/day have not been studied in patients with hepatic dysfunction [see Clinical Pharmacology (12, 3)].
Overdose.
Patient experience with significantly higher doses of pantoprazole (>(240 mg) has been limited. Spontaneous reports of overdose by mail order exist in the generally well-known safety profile of pantoprazole .
Pantoprazole is not removed by hemodialysis. In case of overdose, healing must be symptomatic and supportive.
Single oral doses of pantoprazole At 709 mg/kg, it was fatal to mice, rats and dogs at 798 mg/kg and 887 mg/kg. Signs of acute toxicity were inaccessibility of hypoactivity, motility, ataxia, sitting, inflammation of limbs, lateral status, isolation, ear reflexes and tremor.
Description
Active Component in pantoprazole Sodium USP tablets with delayed release contain the substitution benzimidazole, sodium 5-(difluoroethoxy)-2-[[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole sesuhidic acid, its fusion. The sesse of the stomach is the muse, which is the aging music of the stomach, and the musie, which is the sesuhydrate fusion, is the fusion that it fuses. Fields
Pantoprazole sodium sesuhydrate gives a broken white crystalline powder and sinks from snow white. Pantoprazole has weak induction and sour properties. Pantoprazole sodium sesbidrato is readily soluble in water, fairly soluble in phosphate buffer at pH 7.4, and literally insoluble in N-hexaan.
The stability of the connection in aqueous solution is pH-dependent. Failure rate increases with decreasing pH. At ambient temperature, the half-life takes about 2, 8 hours at pH 5 and about 220 hours at pH 7, 8.
Pantoprazole sodium USP is supplied in the form of inexpensive delayed-declaration tablets in two doses (20 mg and 40 mg).
Each pantoprazole Delayed release USP sodium tablets are 45, 1 mg, or 22, 55 mg. of pantoprazole Sodium Squihydrate with appropriate inactive ingredients (corresponding to 40 mg or 20 mg, respectively). mg pantoprazole (respectively) with appropriate inactive ingredients: calcium carbonate, calcium stearate, d& amp; c yellowish #10 dural varnish, fd& amp; c yellowish #6 dural varnish, hypromellose, iron oxide dark, iron oxide yellow, mammary gland hemon hydrate, low subsides Hydroxypropyl cellulose, methacrylate copolymer, microcrystalline cellulose, polyethylene – glyheylen – grun – grion – free – free – ray – free – length – length – length – length – length glycon – length – length – length – length glycon – length – length Length Glycora – Freidin – Freidin – Frieze, Titanium Dioxide, Triethylcytophosphate.
Clinical Pharmacology
Mechanism
Pantoprazole is a proton pump debris (PPI) that disrupts the final stage of gastric acid production by covalent binding to the (H+, K+)-ATPase enzyme system on gastric parietal cell secretion. This effect results in suppression of both basic and stimulated gastric juice secretion, regardless of stimulation. （Binding to the (H+, K+) – ATPase means that the antimicrobial effect of all test doses (20-120 mg) lasts for more than 24 hours.
By the criteria of maximum oxygen stimulation favoring pentagastrin, a dose-dependent decrease in gastric acid production occurs after one oral (20-80 mg) or single intravenous (20-120 mg) dose in healthy volunteers. mg) pantoprazole With healthy volunteers. Pantoprazole administered once daily causes a hardening inhibition of gastric acid secretion. Subsequently, initial oral doses of 40 mg pantoprazole 51% mean inhibition is reached after 2.5 h. After 7 days of daily dosing, mean inhibition increases to 85%. Pantoprazole increased by more than 95% in 50% of subjects. Acid secretion normalized again within a week of the last dose. of pantoprazole There were virtually no symptoms of rickettsial hypersecretion.
In a series of dose-effect relationships pantoprazole , at oral doses ranging 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. 40 mg treatment of pantoprazole considerably greater increase in gastric pH than the 20 mg dose; doses above 40 mg (60, 80, 120 mg) did not cause an imminent significant increase in mean gastric pH. Efficacy. of pantoprazole The mean pH values at the end of the first double-blind cross-over test are shown in Table 4.
Table 4: Effect of a single daily dose of oral pantoprazole on intragastric pH
*Very different from placebo. †Variates significantly from 20 mg dose.
Day 7 median pH time Placebo 20 mg 40 mg 80 mg
8:00 to 8:00 (24 hours) 1, 3 2, 9*3, 8*, †3, 9*, †
8 a.m. to 10 p.m. (daytime)1. Monday through Friday.6 3. 2* 4. 4*, † 4. 8*, †
10 p.m. to 8 a.m. (nighttime)1, 2 2. 1* 3, 0* 2, 6*
Effects of serum stomach
Gastric sober serum levels were studied in two double-blind trials on acute healing of erosive esophagitis (EE) in which 682 patients with gastroesophageal reflux disease (GERD) received 10, 20, or 40 mg. of pantoprazole For up to 8 months. after 4 weeks of treatment, mean gastric values increased by 7%, 35%, and 72% in the 10, 20, and 40 mg treatment groups compared to pretreatment values. similar increases in serum gastric values were seen during the 8-week visit, with increases of 3%, 26%, and 84% in three of the pantoprazole dosing groups. Mean serum gastric values remained within normal limits during maintenance therapy pantoprazole Sodium delayed-release tablets.
In an international long-term study of more than 800 patients, a mean increase was observed during the first months of treatment compared to the cold serum values during preparative therapy. pantoprazole 40 mg per day during technical studies of GERD in patients with refractory GERD, at doses above 40 mg per day. Cold serum values generally remained approximately 2- to 3-fold higher for up to 4 years of repeat studies in clinical studies.
After short-term treatment pantoprazole elevated gastric values were normal again at least after 3 months.
Encyclomaffin-like (ECL) cell effects
39 patients treated orally. pantoprazole 40 mg to 240 mg for up to 5 years (most of whom received 40 mg to 80 mg) showed a slight increase in ECL cell density beginning in the first year of use, reaching a plateau after 4 years.
Non-clinical testing in Sprague-Dawley rats with lifetime exposure (24 months) to pantoprazole doses ranging from 0, 5 to 200 mg/kg/day resulted in dose-escalating proliferation of gastric ECL cells and neuroendocrine (NE) cells. Gastric tumors of NE cells in rats may be the result of an acquired increase in serum gastric concentrations. The high density of ECL cells in the rat stomach makes this pattern highly sensitive to the proliferative effects of elevated gastrin concentrations caused by proton pump inhibitors. Nevertheless, virtually no elevation of gastric serum was observed after administration of of pantoprazole dose of 0.5 mg/kg/day. In one study of gastric glands, NE cells were observed without concurrent proliferative changes in ECL cells in one female rat after a 12-month dose. pantoprazole 5 mg/kg/day and 9 months dose repair [see Nonclinical Toxicology (13. 1)].
Pantoprazole sodium retention drug is prepared in the form of intestine-coated pills, i.e. absorption of pantoprazole begins only after the pills have left the stomach. The piexalm concentration (CMAX) and the area under the serum concentration-time curve (AUC) increase proportionally with oral and intravenous doses from 10 mg to 80 mg. Pantoprazole does not accumulate and its pharmacokinetics do not change with multiple daily doses. After oral or intravenous administration, serum concentrations of of pantoprazole Dalen is bioparturized and has a terminal removal half value of approximately 1 hour.
For a wide range of metabolizers with normal hepatic function, that is, oral administration of digestive coating 40 mg pantoprazole tablets received, the peak concentration (CMAX) is 2.5 µg/mL. The time to peak concentration (TMAX) is 2.5 hours and the mean total area under the plasma concentration-time curve (AUC) is 4. 8 µg-H/mL (range 1. 4 to 13. 3 µg-H/mL). Intravenous administration after of pantoprazole For a wide range of metabolizers, arterial clearance varies from 7, 6 to 14 l/h and the undisputed size of the spread varies from 11 to 23, 6 L.
After single or multiple oral doses of 40 mg of pantoprazole sodium retention tablets, peak plasma concentrations are now of pantoprazole reached after approximately 2.5 hours and CMAX was 2.5 µg/mL. Pantoprazole undergoes a small first-pass metabolism, leading to an unconditional bioavailability of approximately 77%. Absorption of pantoprazole is not affected by concurrent administration of gastric acid inhibitors.
Administration of pantoprazole Tablets accompanied by food with food have the opportunity to stop absorption for up to 2 hours or more. However, CMAX and absorption rate (AUC) do not do this. of pantoprazole However, absorption (AUC) does not change. So, pantoprazole Sodium tablets with delayed release can be taken without taking meal times into account.
Apparent Size of Distribution of pantoprazole varies from about 11.0 to 23.6 liters and is mainly partitioned into extracellular water. Protein binding in serum of pantoprazole In albumin is initially about 98%.
Pantoprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) system. The metabolism of pantoprazole is independent of the route of administration (intravenous or oral); penetration by CYP2C19 followed by sulfation is considered the most important method of metabolism. The other route of metabolism is oxidation by CYP3A4. There is little evidence that metabolites produce significant pharmacological effects. the pantoprazole Metabolites have significant pharmacological potential.
After a single oral or intravenous dose with a 14C label, metabolites have no significant pharmacological potential. pantoprazole In healthy volunteers with normal metabolism, approximately 71% of the dose was excreted in urine and 18% in feces via bile tongue excretion. There was no unchanged renal excretion pantoprazole .
Only slight or marginal increases in in pantoprazole AUC (43%) and CMAX (26%) were seen in older volunteers (64 to 76 years) after repeated oral dosing compared to younger subjects. Dose adjustment based on age is not recommended.
The pharmacokinetics of pantoprazole has been studied in children less than 16 years of age in four disclosed branded randomized clinical trials in pediatric patients with suspected/proven gastroesophageal reflux disease. The pediatric granule formulation was studied in boys less than 5 years of age. and pantoprazole An extended-release tablet formulation was studied in pediatric patients aged 5 years and older.
PK population analysis showed a nonlinear increase in arterial clearance with increasing body weight. Arterial clearance increased further with age in children under 3 years of age.
Neonates to age 5 years
See Implementation in specific populations (8. 4).
Children and adolescents from 6 to 16 years of age
The pharmacokinetics of pantoprazole Extended-release tablets were observed in 6- to 16-year-old boys with clinically diagnosed gastroesophageal reflux disease PK characteristics at single oral doses of 20 mg or 40 mg of pantoprazole tablets in children 6 to 16 years of age varied widely (%CV spectra ranged from 40 to 80%). The geometric mean AUC estimated as a result of the population PK analysis was 40. mg pantoprazole Compared to the PK of adult patients, the PK of pediatric patients was approximately 39% higher, and 10% higher in boys aged 6 to 11 and 12 to 16 years, consistent with this (Table 6).
Table 6: Characteristics of PK in boys and adolescents aged 6 to 16 years and with gastroesophageal reflux disease treated with pantoprazole 40 mg tablets
*Geometric mean† Mean
6 to 11 years (n = 12) 12 to 16 years (n = 11) Cmax (MCG/ML)* 1. 8 1. 8 Tmax (H)† 2. 0 2. 0 AUC (MCG – H/ML)* 6. 9 5. 5 Cl/F (L/h)† 6. 6 6 6. 8
Unrepresentative increase in in pantoprazole AUC and CMAX in women compared to men; nevertheless, normalized clearance values are identical for women and men. Dose adjustment based on gender is not recommended; in pediatric patients aged 1 to 16 years, there was no clinically important effect of gender on clearance of pantoprazole as demonstrated by population pharmacokinetic analysis.
Pharmacokinetic parameters in patients with less severe renal impairment are for pantoprazole comparable to those in healthy subjects. No dose adjustment is required in patients with renal impairment or on hemodialysis.
In patients with hepatic impairment (Paug with cirrhosis), the maximum pantoprazole concentrations increased only in light (1.5 hr) compared to awake subjects. However, mean serum halking time increased from 7 to 9 hours, and mean AUC increased by 5-7 in patients with hepatic dysfunction. These increases were only observed in poor metabolizers of CYP2C19 with virtually no dose adjustment promised. These pharmacokinetic configurations in patients with hepatic impairment result in the least accumulation of drug after several days of administration. No dose adjustment is necessary in patients with severe to less severe hepatic impairment. Doses greater than 40 mg/day have not been studied in patients with hepatic impairment.
Pantoprazole is metabolized by the major CYP2C19 and slightly by CYPS 3A4, 2D6, and 2C9 support In studies into the vivo interactions of pharmaceutical drugs with CYP2C19 substraten (Diazepam [also a CYP3A4 substrate and phenytoin [also a CYP3A4-Inducer and Clopidogrel,) Nifedipine, Midazolam and Claritromycine (CYP3 A4-Substat Substraten), DIPEN6, DICEN6, DICEN6, dic. naproxen and piroxicam (CYP2C9 substrate) and theophylline (CYP1A2 substrate) in healthy study subjects in pharmacokinetics of pantoprazole were not significantly altered.
Clopidogrel is partially metabolized to his active metabolite using CYP2C19. In a clinical crossover study, 66 healthy study subjects received clopidogrel (300 mg loading dose with an additional 75 mg per day). pantoprazole (80 mg concurrently with clopidogrel) in a 5-day direction; at day 5, the mean AUC of the concentrated metabolite of clopidogrel was reduced by approximately 14% (geometric mean ratio is 86%, 90% CI is 79-93%). pantoprazole at the same time compared to clopidogrel administered with clopidogrel. Pharmacodynamic properties were still measured, showing that changes in inhibition of plate aggregation (induced by 5 μMADP) correlated with changes in the effects of clopidogrel’s concentrated metabolites. The clinical significance of this finding is unclear.
In vivo studies still show that pantoprazole Heeft Geen Copyright Kinetiek van Geschikte Stoffen (Cisapride, Theofylline, Diazepam [en Zijn Active Metaboliet, Desmethyldiazepam], Feryto Yu, Warfarin, Metoprolol, Nificipine, Naificipine, Maparatomime, Tuberculosis, Tuberculosis, Tuberculosis, Naificipine, Nificipine, Nifidipine, EOL, Aroprontor, Aroprocamepine, Aromazepine, Midazolam, Claritromycin, Naproxin, Pyroxy-ecol. estradiol]). Dose adjustment of these substances is not necessary if they are taken together pantoprazole In Veldin et al. in vivo studies, digoxin, ethanol, glyburide, antipyrine, caffeine, metronidazole, and amoxicillin had no clinically significant interactions with the drugs. pantoprazole .
Based on studies evaluating possible interactions of pantoprazole In other medications, no dose adjustments implemented simultaneously with appropriate implementation: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam (and active metabolite, desmecidazepam), diclofen, naproxim, naproxim, digrocimama anor, , oral, Oral anor, Oral anor, Oral anor, Oral anor, Oral anor, Oral anor, Oral anor, Oral anor, Oral contraceptives (levonor quality/ethinyl estradiol), metoprolol, nifedipine, phenytoin, warfarin, midazolam, clarithromycin, metronidazole or amoxicillin.
There were no concurrent interactions with gastric acid inhibitors.
There have been postmarketing reports of increased INR and prothrombin time in patients treated with proton pump inhibitors. pantoprazole and warfarin [see drug interactions (7. 2)].
No significant interactions between medications have been observed in clinical studies, but the potential for significant interactions between medications at doses higher than once a day at the highest dose. of pantoprazole It has not been studied in individuals with poor metabolism or liver damage.
In clinical pharmacological studies, pantoprazole 40 mg, once daily for 2 months, did not affect values of the following hormones: cortisol, testosterone, triiodothyronine (T3), thyroxine (T4), thyroid hormone (TSH), siloid binding protein, gland bushings, bushing gland, bushing insulin ( TSH), tyronine binding protein, glucagon, renin, aldosterone, follicle stimulating hormone, luteinizing hormone, prolactin, elevated hormones.
In a 1-year study of GERD patients treated with either pantoprazole 40 mg or as an alternative 20 mg, there was little or no change in combined levels of T3, T4, and TSH compared to basal values.
CYP2C19 exhibits well-known genetic polymorphisms, as several subpopulations are deficient (e.g., about 3% of Caucasians and African Americans and 17% to 23% of Asians are considered poor metabolizers). However, these subpopulations. of pantoprazole Poor metabolizers have a sensory half-life of 3, 5 to 10 hours in mature individuals, but there is still a low accumulation (less than 23%) of once-daily doses; no dose adjustment is necessary for mature patients considered poor metabolizers of CYP2C19.
Similar to adults, pediatric patients with inadequate CYP2C19 metabolic genotype (CYP2C19 *2/ *2), broad pediatric (CYP2C19 *1/ *1) and intermediate (CYP2C19 *1/ /1/1/1) and intermediate *x) metabolizers. Poor metabolizers showed an apparent oral clearance of about 10 compared to broad metabolizers.
For popular pediatric poor metabolizers, dose reduction is a footnote to consider.
Nonclinical Toxicology
Carcinogenesis, mutagenesis, and birth defects
In a 24-month carcinogenicity study, Sprague-Dawley rats treated orally with doses ranging from 0, 5 to 200 mg/kg/day, about 0, 1-40 better than the effects on the body surface of a 50 kg person. In the eye stomach 40 mg/day was administered in a dose-dependent manner, causing treatment from 0, 5 to 200 mg/kg/day, causing enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. In the forestomach, treatment at 50 and 200 mg/kg/day (approximately 10 and 40 above the recommended human dose based on body surface) caused benign pavement cell papillomas and malignant pavement cell carcinomas. Associated exceptional gastrointestinal tumors. pantoprazole Treatment included duodenal adenocarcinoma at 50 mg/kg/day and benign polyps and adenocarcinoma of the gastric fundus at 200 mg/kg/day. In the liver, for hepatocellular adenomas and carcinomas, healing resulted in doses 0, 5 to 200 mg/kg/day in carbohydrate. In the thyroid gland, healing resulted in 200 mg/kg/day in both male and female rats with variant follicular follicular follicular cysts and carcinomas surrounded by a surface.
In a 24-month carcinogenicity study, Fischer 344 rats were treated orally at doses of 5-50 mg/kg/day. In gastric oogDag, treatment with 5-50 mg/kg/day caused enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. It is quite possible that the dose selection in this study was not necessary for an extensive evaluation of carcinogenic potential. of pantoprazole .
In a 24-month carcinogenicity study, B6C3F1 mice were treated orally at doses ranging from 5-150 mg/kg/day, 0, 5-15 at the recommended human dose based on body surface. liver treatment at 150 mg/kg/day increased the number of hepatocellular adenomas and cancers in male mice. 5-150 mg/kg / day treatment caused hyperplasia of ECL cells in the stomach.
A 26-week carcinogenicity study in MUIS P53 +/- was not positive.
Pantoprazole was one of two micronucleus studies in mice for clastogenic effects, in an in vitr o-chinese hamster ovary test and positive in a human chromosome aberration test. A double total was observed in the rat in vivo shared DNA binding test. Pantoprazole was negative in the in vitro Ames-Mutation test, in vitro DNA DSB test (UDS test), in vitro and in vitro AS52/GPT cell matachietie test, in vitro thymidine kinase cell chromatinization test.
There was no effect on fertility or reproductive performance at least pantoprazole In male rats up to 500 mg/kg/day orally (exceeding the human dose based on body surface) and in female rats 450 mg/kg/day (exceeding the recommended human dose of over 88 A was administered on the body surface).
Animal toxicity and/or pharmacology
Studies were conducted in neonatal/young and adult rats and dogs. Data from these studies show that animals of both age groups respond to pantoprazole in the same manner. Gastric composition, including gastric weight gain, increased frequency of eosinophilic key cells in adult and neonatal/larval rats, and major cytosis in adult rats and neonatal/larval dogs were observed in the gastric mucosa background at periodic doses. Erythrocyte mass characteristics, cholesterol and triglyceride structures, liver weight gain, enzyme induction, and hepatocyte hypertrophy electrograms were still observed at repeated doses in rats and dogs. Absolutely selective recovery of these effects was seen in animals of both age groups after the recovery period.
Reproductive substance studies
There have been reproductive studies in rats at oral doses up to 450 mg/kg/day (88 times the recommended human dose based on body surface) and in rabbits at oral doses based on in vitro, and these have not produced signs of reduced fertility or fetal damage. to pantoprazole .
Clinical Studies
Sodium retention tablets have been used in appropriate clinical studies.
Erosive esophagitis (EE) associated with gastroesophageal reflux disease (GERD)
Multichamber centered, double-blind, placebo-controlled study vs. of pantoprazole Sixty-three patients with evidence of reflux and endoscopically diagnosed with EE grade 2 or higher (Hetzel-Dent scale) were treated with 10 mg, 20 mg, or 40 mg once daily. In this study, approximately 25% of enrolled patients had grade 3 volume EE and 10% had grade 4. The percentage of patients cured in this study (per protocol, n = 541) is shown in Table 7.
Table 7: Cure rates for erosive esophagitis (per protocol)
10 mg/day 20 mg/day 40 mg/day (n = 153) (n = 158) (n = 162) (n = 68)
4 45, 6%*58, 4%*, † 75, 0%*, ‡ 14, 3%8 66, 0%*83, 5%*, † 92, 6%*, ‡ 39, 7%
In this study, all pantoprazole The healing group had more important healing characteristics than the placebo group. This was true regardless of H. pylori status for the 40 mg and 20 mg healing groups. mg pantoprazole Healing group. 40 mg dose of pantoprazole produced significantly higher cure rates than either the 20 mg dose or the 10 mg dose.
A significantly higher percentage of patients who pantoprazole 40 mg had complete heartburn relief day and night and less reflux from the first day of healing, compared to placebo. Patients pantoprazole used significantly less antacid per day than patients taking placebo.
In a multicenter, double-blind U.S. study of 243 EE patients with evidence of reflux and endoscopically diagnosed grade 2 or higher, pantioprazole 40 mg and 20 mg once daily were compared to nizatidine 150 mg twice daily. Patient cure rates (n = 212 according to the protocol) are shown in Table 8.
Table 8: Esophagitis cure rates (per protocol)
20 mg/day 40 mg/day 150 mg twice daily (n = 72) (n = 70) (n = 70) (n = 70)
4 61.4%* 64.0%* 22.2%8 79.2%* 82.9%* 41.4%
Once-daily treatment pantoprazole 40 mg or 20 mg resulted in significantly higher cure rates at 4 and 8 months compared to twice daily treatment with 150 mg nizatidine. Regardless of Helicobacter pylori status, significantly better healing characteristics were achieved in the 40 mg treatment group compared to nizatidine.
A significant portion of patients, the pantoprazole in the cure group experienced complete relief of heartburn and reflux at night on day 1 and heartburn during the day on day 2, compared to patients taking nizatidine 150 mg twice daily. Patient. pantoprazole used significantly less antacid per day than those taking nizatidine.
Pediatric patients aged 5 to 16 years
The efficacy of pantoprazole Because of similar pathophysiology, cure of EE associated with gastroesophageal reflux disease in pediatric patients aged 5 to 16 years can be inferred from an appropriate and complete examination performed in adult patients. Four pediatric patients with endoscopically diagnosed EE were studied in a multicenter, randomized, double-blind, parallel treatment study study. Infants with endoscopically diagnosed EE (defined as a Hetzel Dent endoscopy score of 2 or higher) were treated once daily for 8 months at one of two dose levels. of pantoprazole (20 mg or 40 mg); all four patients with EE were cured after 8 months (Hetzel-Dent score 0 or 1).
Long-term maintenance of healing of erosive esophagus
Two independent, multicenter, randomized, double-blind, controlled studies were conducted to demonstrate efficacy in patients with mature gastroesophageal reflux disease with endoscopically confirmed erosive esophagitis. of pantoprazole of long-term maintenance of healing. In two U.S. studies, 386 and 404 patients received 10 mg, 20 mg, or 40 mg sustained-release sodium tablets, respectively. of pantoprazole sodium delayed-release tablets once daily or 150 mg ranitidine twice daily. Table. 9, pantoprazole 40 mg and 20 mg were significantly better than ranitidine at each time point with respect to maintenance of healing. And not only that, pantoprazole 40 mg was superior to all other treatments studied.
Table 9: Long-term maintenance of healing of erosive gastroesophageal reflux disease (GERD maintenance): Percentage of patients who maintained healing
Pantoprazole Pantoprazole Ranitidine 20 mg/day 40 mg/day 150 mg twice daily
Study 1 n = 75 n = 74 n = 74 n = 75 mo 1 91* 99* 68 mo 3 82* 93*, † 54 mo 6 76* 90*, † 44 mo 12 70* 86*, † 35 Study 2 n = 74n = 88 n = 84 mo 1 89* 92*, † 62 mo 3 78* 91*, † 47 mo 6 72* 88*, † 39 mo 12 72* 83* 37
Pantoprazole 40 mg was superior to ranitidine in reducing the number of daytime and nighttime heartburn episodes from month 1 to month 12 after healing. As shown in Table 10, in one study, pantoprazole 20 mg once daily was still effective in reducing the number of daytime and nighttime heartburn episodes.
Table 10: Number of Heartburn Episodes (Mean ± SD)
Pantoprazole ranitidine 40 mg daily 150 mg twice daily 5. 1 ± 1. 6* 18. 3 ± 1. 6 at night 3. 9 ± 1. 1* 11. 9 ± 1. January 12 2. 9 ± 1. 5* 17. 5 ± 1. 5 at night 2. 5 ± 1. 2* 13. 8 ± 1.
Pathologic hypersecretory disorders including Zollinger-Elison syndrome
In a multiliterate public study of 35 patients with pathologic hyperacidity disorders such as Zollinger-Elison syndrome with or without multiple endocrine tumor types I, pantoprazole Gastric acid secretion was successfully controlled; doses on the spectrum of 80 mg per day to 240 mg per day kept gastric acid production below 10 mgV/B in patients equipped with acid reduction and below 5 mgV/H in patients with acid reduction.
Doses were initially titrated to individual patient needs and adapted for some patients based on clinical response over time [see Dose and Entrance (2)]. Pantoprazole was well tolerated at these dose levels over a long period of time (more than 2 years in some patients).
Drug Guide for Patients
-COVET, those patients. pantoprazole Sodium tablets with delayed release do not need to be broken, crowded, or chewed. pantoprazole Delayed-release sodium tablets should be swallowed whole, with or without food in the stomach. of pantoprazole Delayed-release sodium tablets. The patient should speak up immediately and seek help for vascular or neurologic symptoms such as heart palpitations, dizziness, seizures, and tetany. This is because it may be a symptom of hypomagnesemia to speak up immediately and seek help for diarrhea. It does not improve. This can be a symptom of associated Clostridium difficile diarrhea [see Warnings and Precautions (5. 4)].
Pantoprazol-Natrium (Pan-Top-Pra-Zol soe-dee-um) tablets delayed USP release
Read the directions for this drug before use pantoprazole There is a delayed release and each time you get a new intake of sodium tablets. You have the option of having current information. This information is not a substitute for an interview with your doctor about your condition or treatment.
What is the most important information I need to know about pantoprazole Sodium retention tablets?
Sodium stack tablets have a good chance of helping with acid related complaints, but still have the potential for stomach complaints. Discuss this with your own physician.
Sodium retention tablets have every opportunity to cause nonsense side effects.
Diarrhea. Sodium-resistant medications may increase the risk of suffering from severe diarrhea. This diarrhea can be caused by an infection in the intestines (Clostridium difficile).
If liquid stools, abdominal pain, or fever do not pass, call a physician immediately. Bone fractures. People who use proton pump inhibitors at a certain number of daily doses for an extended period of time (more than one year) are at increased risk for leg, wrist, or spine fractures. Absolute. pantoprazole Sodium tablets with delayed release are taken as indicated, at low doses for healing, and for short periods of time. Talk to your doctor about your risk of fracture pantoprazole Sodium delayed-release tablets.
Sodium tablets with delayed release have every chance of other nonsense side effects. What are the possible side effects of sodium tablets with delayed release? of pantoprazole Sodium tablets with delayed release? What are the possible side effects of sodium tablets with delayed release?
What are pantoprazole Sodium retention tablets?
Sodium-resistant drugs are prescription drugs called proton pump inhibitors (PPIs). Sodium-resistant drugs lower the number of acids in the stomach.
Pantoprazole sodium-resistant tablets are ripe.
up to 8 months to treat acid-related damage to the mucous membranes of the digestive tract (erosive esophagitis or EE) and to illuminate symptoms caused by gastroesophageal reflux disease (GERD). The physician may decide to prescribe an additional 8 weeks if necessary. of pantoprazole Sodium tablets with delayed release. To support healing of acid-related damage to the mucous membranes of the gastrointestinal tract and to prevent the return of heartburn as a result of GERD. It is unknown if if pantoprazole Sodium tablets with delayed release are harmless and effective when used for more than 12 months (1 year).
Gerd is created when acid in the belly returns to the tube (esophagus) that connects your eater to the belly. This can create a burning sensation in the chest and throat, a sour taste and debris. For long-term treatment of the disorder your stomach boils very large amounts of acid. This includes the rarest condition called Zollinger-Elison syndrome.
Delayed-release pantoprazole sodium is used for up to 8 months in children over 5 years of age to cure acid-related damage to the mucous membranes of the digestive tract (erosive esophagitis or EE) caused by GERD.
It is not known if pantoprazole Delayed-release sodium tablets are not dangerous when used for more than 8 months in children. Delayed-release sodium tablets are not for use in children under 5 years of age.
Who should not take pantoprazole Sodium retention tablets?
Do not take pantoprazole Delayed-release sodium tablets if you have
allergic to pantoprazole Sodium or one of the other ingredients. in pantoprazole Delayed-release sodium tablets. See this medication administration cover sheet for a complete list of ingredients. in pantoprazole Allergy to Proton Pump Inhibitors (PPIs).
What should I tell my doctor before taking pantoprazole Sodium retention tablets?
Before taking pantoprazole If you are taking extended-release sodium tablets, tell your doctor if
You have been told that you have a low magnesium level in your blood, have liver problems, have another illness, are pregnant, or are planning to gain weight. Not known. if pantoprazole Sodium delayed-release tablets are harmful to the baby during pregnancy. Is breastfeeding or planning to breastfeed. Pantoprazole sodium delayed-release tablets are more likely to be contaminated with milk. It is your and your doctor’s decision whether or not to take treatment. pantoprazole You are taking the delayed-release sodium tablets or are breastfeeding. Do not bother making both. Always talk to your doctor about how to feed your baby if you pantoprazole Sodium delayed-release tablets.
Tell your doctor about all medications you are taking, including prescription and over-the-counter medications, vitamins, and herbal supplements. Pantoprazole sodium delayed-release tablets may affect the effects of other medications, and other medications may affect the effects of other medications. how pantoprazole Delayed-release sodium tablets are effective.
Be sure to inform your doctor if you
Atazanavir (Reatase®) Nelfinavir (Virasept®) Warfarin (Coumadin®, Jantoven®) Ketoconazole (Nizoral®) Ampicillin Products containing iron-based antibiotics, including methotrexate
If you are not sure, ask your doctor or pharmacist for a list of these medications.
Know what medications you are taking. Keep a list of them so you can show your doctor or pharmacist when you get new medications.
How should I take pantoprazole Sodium retention tablets?
Take pantoprazole Use extended-release sodium tablets literally as prescribed by your doctor. Do not change or discontinue the dosage! pantoprazole Take the extended-release sodium tablets without consulting your doctor. If you forget to take it of pantoprazole Since these are extended-release sodium tablets, take them as soon as you remember. If the time for the correct dose is approaching, do not take the forgotten dose. Take the correct dose on time. Do not take two doses to make up a missed dose. If you notice a lot of pantoprazole sodium delayed-release tablets, call your physician immediately or go to the emergency department at your local health center. For detailed intake notes, please see the actual medication end-of-life instructions. pantoprazole Sodium Delayed-Release Tablets
What are the possible side effects of pantoprazole Sodium retention tablets?
All Pantoprazole Sodium Extended-Release Tablets can cause serious side effects, including the following
See “What is the most important information about following in the footsteps of the Nobility?” pantoprazole Sodium tablets with delayed release? What are the possible side effects of sodium tablets with delayed release?
Chronic (long-term) inflammation of the gastric mucosa (atrophic gastritis). Taking. pantoprazole Sodium tablets with delayed release may increase the risk of gastric mucosal inflammation for an extended period of time. Whether to file a complaint. Tell your doctor if you have abdominal pain, nausea, vomiting, or weight loss. Vitamin B-12 Deficiency. The remaining tablets lower the amount of acid in the stomach. Pancreatic acid is important for correct absorption of vitamin B-12. Talk to your own doctor about the possibility of vitamin B-12 deficiency in case you have had vitamin B-12 deficiency for several years. on pantoprazole Used sodium tablets with long delayed release (more than 3 years). Low magnesium content in your body. This problem can be serious. Low magnesium content may occur in some people who have been using proton pump inhibitors for at least 3 months. If a layer of magnesium content occurs, this usually occurs after a year of healing. You can have signs of magnesium in the layers.
Tell your doctor immediately if you have any of these symptoms
Abnormal or fast heartbeat tremor, jerky movement or vibration (trembling) muscle sample arm cramps, leg or cramp synthesis
Your doctor can determine your body’s magnesium levels before you start taking pantoprazole Sodium tablets with delayed release or during healing in your case pantoprazole Sodium tablets with delayed release over a longer period of time are used.
The most well-known side effects of pantoprazole sodium retention pills in adults are
Headache Nausea Diarrhea Gas Dizziness Joint Abdominal Pain
The most well-known side effects of pantoprazole Sodium laden pills used in boys are: Sodium laden pills used in boys are: Sodium laden pills used in boys are
Upper respiratory tract infection nausea skin rash fever diarrhea abdominal pain
Other side effects:
Severe allergic reactions. If you get any of the symptoms right, tell your own doctor! pantoprazole Sodium tablets with delayed release
Your doctor has the option to stop pantoprazole Sodium tablets with delayed release if you experience any of these symptoms.
Tell your own doctor about any side effects you are concerned about or that do not pass.
These are not all possible side effects pantoprazole Delayed-release sodium tablets. Ask your doctor or pharmacist for more information.
Ask your doctor about side effects; you can report side effects to the FDA at 1-800-FDA-1088.
How should I store pantoprazole Sodium retention tablets?
Store pantoprazole Delayed-release sodium tablets are available at room temperatures of 20-25 degrees Celsius.
Keep pantoprazole Sodium tablets with delayed release and all medications outside the reach of boys.
General Information on pantoprazole Sodium Delayed-Release Tablets
Medications may be prescribed for purposes other than those listed in the Medication Guide. They should not be used use pantoprazole Sodium tablets with delayed release for non-prescribed conditions. Give none. pantoprazole Sodium delayed release tablets to others, even if they have the same symptoms. They have every opportunity to do damage to them.
This drug guide looks at the most powerful information about it pantoprazole Sodium tablets with delayed release. For more information, contact your physician. You can ask your own doctor or pharmacist for information written for health care professionals.
Call 1-888-838-2872 for more information.
Which Ingredient in pantoprazole Sodium retention tablets?
Active ingredient: pantoprazole sesviuhyhydrate Sodium
Inactive ingredients in pantoprazole Sodium tablets with delayed release: calcium carbonate, calcium stearate, yellowish lake #10, yellowish fd & amp; C #6, hypromellose, iron oxide, yellowish, lactose oxygenate, low deposition agent hydroxypropyl cytosis, Mehridation, Microclalla, Microclallina, Microcelluse, Microcellulic acid, Microacid. Cellulose, polyethylene glycol, propylene glycol, shellac polish, sodium carbonate, anhydrous, stearic acid, toque, titanium dioxide, triethylcytolate.
INSTRUCTIONS.
Delayed release pantoprazole sodium tablets:
You can take pantoprazole Released sodium tablets delayed with food or on an empty stomach. Swallow. pantoprazole Pantoprazole sodium tablets with delayed release is the entire tablet. If you have difficulty swallowing a pantoprazole Sodium tablets with delayed release of 40 mg, you can take two 20 mg tablets instead. Do not split, break, or crush sodium-resistant tablets. pantoprazole Sodium delayed-release tablets.
Label.
Pantoprazole Sodium DR 40 mg.
Delayed Declaration Tablet contains all pantoprazole Sodium, USP, for 40 mg. of pantoprazole .
Dosage: see prescription
Save at 68-77 degrees Fahrenheit.
Store in impenetrable, non-severe resistance packs. Avoid humidity.
Store in a space that is difficult for children to reach.
Manufactured by Teva Pharmaceuticals, Sellersville, PA Lot #.
Rejected by Northwind Pharmaceuticals, Indianapolis, IN 46256
Pantoprazolnatrium – Introduction, Side Effects, and Almost Everything Else
Pantoprazole is used to treat certain stomach and esophageal problems (such as acid reflux). It works by lowering the amount of acid produced by the stomach. This drink relieves symptoms such as heartburn, swallowing problems, and coughing. It helps heal acid damage in the stomach and digestive tract, helps prevent stomach ulcers, and helps prevent cancer of the digestive tract. Pantoprazole belongs to a class of drugs commonly known as proton pump inhibitors (PPIs).
How to use Pantoprazolnatrium
Read your pharmacist’s drug instructions before starting the method. pantoprazole And each time you get a refill. If you have any questions, ask your own doctor or pharmacist.
Take orally as prescribed by your doctor, usually once a day. The dose and duration of healing will depend on your welfare status and response to healing.
Pills can be taken with or without food. The pills are completely swallowed. Do not analyze the drink or chew it finely. This may damage the product.
If taking with cereal, take dose 30 minutes before meals. To take internally, open roll and mix grain with applesauce or apple juice. Do not mix with other foods or liquids. Do not make the grains fine and do not chew. Sprinkle 1 teaspoon (5 milliliters) of applesauce over the grain and swallow the entire mixture immediately (within 10 minutes). Follow this with a sip of water. Alternatively, mix the grains with 1 teaspoon (5 milliliters) of apple juice in a small bowl, stir for 5 seconds, and swallow the entire mixture immediately. To be sure you have ingested the entire amount, rinse the cup once or twice with apple juice, mix in the remaining grains, and swallow the juice. Do not prepare the mixture in advance for later use.
If inserting the grains via a stomach probe (nasogastric or stomach hose), ask your doctor for detailed instructions on how to mix and ingest the grains the correct way.
If necessary, a stomach acid inhibitor can be taken at the same time as this medication. If you are still taking scralfate, incorporate it pantoprazole scralfate at least 30 minutes before.
Use this drink regularly to get the most benefit. Take it daily at the same time to help you understand Even if you feel better than others, continue to take the drink during the prescribed healing period.
Let your own doctor know if you experience any hugging or worsening. The risk of side effects increases over time. Ask your own physician how long you should use this medication.
Side effects
Headache and diarrhea may occur. If one of these effects persists or gets worse, tell your doctor or pharmacist right away.
Remember that this drug is prescribed because your doctor has determined that the benefit for you is greater than the risk of side effects. Almost everyone who uses this medication has no serious side effects.
Tell your doctor immediately if you have any of the following serious side effects: signs of low magnesium content in the blood (muscle cramps, irregular heartbeat, cramps, etc.), symptoms of lupus (for example, skin rash on the nose and cheeks, new or new or worsening joint pain).
This drug can cause unpleasant intestinal disturbances caused by a microorganism called C. difficile. This condition can occur during treatment or months after treatment has stopped. Tell your doctor immediately if you are suffering from: diarrhea that does not stop, pain in the abdomen or lower abdomen, blood/mucus in the stool.
If you have any of these symptoms, do not use drugs for diarrhea or opioids, as they may well aggravate your symptoms.
In rare cases, proton pump inhibitors ( as pantoprazole ) caused vitamin B-12 deficiency. Risk increases with daily (>3 years) intake over a long period of time. Tell your doctor immediately if you have any signs of vitamin B-12 deficiency (e.g., unusual impotence, painful tongue, or numbness/tingling in the hands/feet).
Very responsible allergic reactions to this product are rare. However, if you notice signs of a severe allergic reaction, including fever, swollen lymph nodes, skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, shortness of breath, signs of kidney problems (such as changes in the number of urine monsters) you should consult medical assistance immediately.
This is not an absolute list of possible side effects. If you notice any other effects not mentioned above, contact your physician or pharmacist.
In the U.S., call your doctor for medical advice regarding side effects. 1-800-FDA-1088 or you can report side effects to the FDA at www. FDA.Gov/Medwatch.
For medical advice on side effects, call your doctor in Canada; you can report side effects to Health Canada by calling 1-866-234-2345.
Precautionary Measures
Before taking pantoprazole Tell your doctor or pharmacist if you are allergic to this product. or similar medications (e.g., lansoprazole, omeprazole); or if you have other allergies. This product contains inactive ingredients that may cause allergic reactions or other problems. Consult your pharmacist for more information.
Before using this medication, tell your doctor or pharmacist about your own medical conditions, especially liver problems and lupus.
Some symptoms may be symptoms of a more serious condition. Seek medical help immediately if you are suffering from: head/sweating/dizziness, chest/jaw/arm/shoulder pain (especially in the case of shortness of breath, in the case of unusual sweating), inexplicable weight loss (especially if there is chest/arm/shoulder pain.
Operate with your own physician or dentist regarding all products you are using (including prescription products, non-prescription resources, and herbal products).
Proton pump inhibitors (such as as pantoprazole ) especially long-term use, higher doses, and can increase the risk of fractures in the elderly. Talk to your doctor or pharmacist about techniques to prevent bone loss/fractures, such as calcium (e.g. calcium citrate) or vitamin D supplements.
The elderly may be more sensitive to the side effects of this medication, especially bone and fracture costs (see above) and C. difficile infection (see section Side Effects).
During pregnancy, this medication may be used only when indicated as a matter of course. Consult your physician about the risks and dangers.
This medication can be converted to breast milk. Consult your physician before breastfeeding.
Interchange.
section for more information on how to apply.
Interactions between medications can alter the effectiveness of the medication or increase the risk of serious side effects. This document does not include all possible interactions between medications. Keep a list of all products you use (including prescription drugs or including prescription drugs and herbal products) and share it with your physician or pharmacist. Do not encourage your physician to start, stop, or change the dosage of each medication.
Products that can have interactions with these products: methotrexate (especially curative at the highest doses).
Some foods require stomach acid so that the body can successfully digest them. Pantoprazole reduces stomach acidity and may alter the function of these foods. Many of the affected products include ampicillin, atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, and several azole antiemetics (itraconazole, ketoconazole, posaconazole).
These drugs interfere with certain laboratory tests (including urine tests for tetrahydrocannabinol THC and blood tests to look for certain tumors) and make the test results correct. Ensure that the laboratory staff and all physicians understand that you are using this product.
About Us
Family Medicine
In 2024 our team of doctors and nurses provide a comprehensive range of family planning services. Our doctors have expertise in antenatal care, preconception planning, and STD checks. Contraceptive advice including Mirena and Implanon insertion is available.
- Early detection of illness;
- Family planning;
- Promotion of healthy lifestyle;
- Skin cancer checks;
- Sports injuries;
- Weight reduction;
- Workers compensation and third party.
Children's Health
Baby Weighing Service. Babies can be booked with our Nurse for weighing, a doctors appointment is not required to use this service. Contact reception for a appointment to have your baby weighed.
Immunisations. At Tuggeranong Square children's immunisation is regarded an important part of your childs health care. Our doctors take immunising children very seriously. and to ensure all children are immunised Tuggeranong Square Medical Practice doctors BULK BILL for all childhood immunisations. Tuggeranong Square Medical Practice also ensures the Practice Nursing Staff are highly trained in childhood immunisations.
Women's Health
Our practice is dedicated to treating a wide spectrum of women’s health concerns. We offer pre-natal, antenatal and postnatal care, contraceptive options, pap screening, and preventative health care advice. We provide assistance, advice and support through all stages of life, recognising the many issues many women may face from adolescence through to the peri and post-menopausal period.
- Cervical Screening tests;
- Reproductive health. Including Mirena and Implanon insertion;
- Shared antenatal care.
Men's Health
We encourage men to present routinely to their GP to discuss all aspects of their health. We provide comprehensive advice and support for men to address the prevention and management of various health conditions. This may include assessments for cardiovascular risk, diabetes, cancer prevention, mental health assessments, STD screening, sports injuries and the importance of sleep as it relates to other areas of health.
- Preventative Healthcare. Including cardiovascular screening, mental health and cancer checks;
- Prostate examination.
