Is Protonix safe to use during pregnancy. What are the risks of taking Protonix while pregnant. How effective is Protonix for treating GERD in pregnant women. What alternatives are available for managing acid reflux during pregnancy.

Understanding Protonix and Its Use in Pregnancy

Protonix, also known by its generic name pantoprazole, is a proton pump inhibitor (PPI) commonly used to treat gastroesophageal reflux disease (GERD) and other acid-related conditions. For pregnant women experiencing severe acid reflux, the use of Protonix may be considered. However, it’s crucial to understand the potential risks and benefits associated with its use during pregnancy.

What is Protonix?

Protonix is a medication that works by reducing the amount of acid produced in the stomach. It belongs to a class of drugs called proton pump inhibitors, which are widely used to treat conditions such as GERD, stomach ulcers, and Zollinger-Ellison syndrome. The active ingredient, pantoprazole, directly inhibits the gastric parietal cells responsible for acid secretion.

How does Protonix work?

Protonix functions by irreversibly binding to and inhibiting the hydrogen-potassium ATPase enzyme system, also known as the proton pump, in the gastric parietal cells. This action effectively suppresses gastric acid production, providing relief from acid-related symptoms and allowing the esophagus and stomach lining to heal.

Pregnancy Risk Classification of Protonix

According to the information provided, Protonix (pantoprazole) is classified as having a “Human Data Suggest Low Risk” recommendation for use during pregnancy. This classification is based on available animal studies and limited human data, which suggest that the use of pantoprazole represents a low risk to the developing fetus.

FDA Pregnancy Category

Prior to 2015, the FDA used a letter-based category system to classify the risk of medications during pregnancy. While this system is no longer in use, it’s worth noting that Protonix was previously classified as Category B. This category indicated that animal studies had not shown a risk to the fetus, but there were no adequate and well-controlled studies in pregnant women.

Animal Studies and Reproductive Effects

Animal studies play a crucial role in assessing the potential risks of medications during pregnancy. In the case of Protonix, reproductive studies have been conducted on pregnant rats and rabbits to evaluate its safety.

Findings from animal research

The reproductive studies conducted on pregnant rats and rabbits used doses up to 88 and 16 times the recommended human dose, respectively, based on body surface area. At these doses, no evidence of impaired fertility or fetal harm was observed. These findings provide some reassurance regarding the safety of Protonix during pregnancy, although it’s important to note that animal studies do not always directly translate to human outcomes.

Human Data on Protonix Use During Pregnancy

While animal studies provide valuable insights, human data is crucial for assessing the safety of medications during pregnancy. The available human data on Protonix use during pregnancy is limited but provides some information on its potential risks.

Meta-analysis of proton pump inhibitors in pregnancy

A 2002 meta-analysis examined the use of proton pump inhibitors (PPIs) in pregnancy. The analysis included 5 cohort studies with a total of 593 infants exposed to PPIs, primarily omeprazole but also including lansoprazole and pantoprazole. The relative risk for major malformations was found to be 1.18 (95% confidence interval 0.72–1.94). This suggests that there was no significant increase in the risk of major malformations associated with PPI use during pregnancy.

European Network of Teratology Information Services study

A 2005 study by the European Network of Teratology Information Services reported on the outcomes of pregnancies exposed to various PPIs, including pantoprazole. In the pantoprazole group, which consisted of 53 pregnancies, the outcomes were as follows:

• 1 spontaneous abortion
• 3 elective abortions (none for congenital anomalies)
• 1 stillbirth
• 48 live births

Among the live births, one infant exposed early in gestation (week 2 for 8 days) had congenital toxoplasmosis. When compared to a nonexposed control group, there was no significant difference in the rate of major malformations between the pantoprazole and control groups (relative risk 0.55, 95% confidence interval 0.08–3.95).

Potential Risks and Concerns

While the available data suggests a low risk associated with Protonix use during pregnancy, there are some potential concerns that warrant consideration.

Childhood allergy and asthma

A population-based observational cohort study conducted in Sweden over a 10-year period (1995–2004) raised concerns about a potential association between in utero exposure to gastric acid-suppressing drugs and childhood allergy and asthma. The study found that children exposed to these medications during pregnancy had a slightly increased risk of developing allergic diseases or requiring prescriptions for asthma or allergy medications. However, it’s important to note that this study requires confirmation, and the observed association does not necessarily imply causation.

Carcinogenicity and mutagenicity

Similar to other PPIs, pantoprazole has shown carcinogenic effects in mice and rats, particularly in the gastrointestinal tract, liver, and thyroid. However, the dose-related nature of these tumors and the presumably limited in utero exposure during human gestation suggest a negligible risk for the developing fetus. Additionally, while some mutagenic tests showed positive results, others were negative, indicating mixed findings regarding the drug’s potential mutagenic effects.

Placental Transfer and Fetal Exposure

Understanding the extent to which Protonix crosses the placenta is crucial for assessing potential fetal exposure and associated risks.

Does Protonix cross the placenta?

It is not definitively known whether Protonix (pantoprazole) crosses the human placenta. The drug’s molecular weight (about 432 for the hydrated form) is low enough to potentially cross the placenta. However, its short elimination half-life and high protein binding may limit the amount of drug available to cross at the maternal-fetal interface. It’s worth noting that slow metabolizers may have higher embryo-fetal exposure due to the longer elimination half-life in these individuals.

Comparison to other proton pump inhibitors

While direct data on pantoprazole’s placental transfer is lacking, it’s helpful to consider similar drugs in the same class. Omeprazole, another PPI with similar molecular weight, elimination half-life, and protein binding characteristics, is known to cross the human placenta. This suggests that pantoprazole may also have the potential to cross the placenta, although the extent of fetal exposure may vary.

Recommendations for Use During Pregnancy

Given the available data and potential risks, it’s important to consider the appropriate use of Protonix during pregnancy.

When is Protonix recommended during pregnancy?

Protonix may be recommended during pregnancy when the potential benefits outweigh the risks. This typically occurs in cases of severe GERD or other acid-related conditions that significantly impact the mother’s health and quality of life. The decision to use Protonix should be made on an individual basis, considering factors such as the severity of symptoms, response to other treatments, and gestational age.

Precautions and monitoring

When Protonix is used during pregnancy, certain precautions should be taken:

1. Use the lowest effective dose for the shortest duration necessary to achieve symptom relief.
2. Regular monitoring of maternal and fetal health throughout the pregnancy.
3. Consider alternative treatments or lifestyle modifications when appropriate.
4. Inform healthcare providers about the use of Protonix during prenatal visits.
5. Be aware of potential signs of adverse effects and report them promptly.

Alternatives to Protonix During Pregnancy

For pregnant women experiencing acid reflux or GERD symptoms, there are several alternatives to consider before resorting to Protonix or other PPIs.

Lifestyle modifications

Many pregnant women can find relief from acid reflux symptoms through lifestyle changes, such as:

• Eating smaller, more frequent meals
• Avoiding trigger foods (e.g., spicy, fatty, or acidic foods)
• Not lying down immediately after eating
• Elevating the head of the bed
• Wearing loose-fitting clothing
• Maintaining a healthy weight gain during pregnancy

Over-the-counter antacids

For mild to moderate symptoms, over-the-counter antacids containing calcium carbonate or magnesium hydroxide may provide relief. These medications are generally considered safe during pregnancy when used as directed. However, it’s important to consult with a healthcare provider before using any medication during pregnancy.

H2 receptor antagonists

If antacids are insufficient, H2 receptor antagonists such as ranitidine or famotidine may be considered. These medications have a longer history of use during pregnancy and are often preferred as a first-line pharmacological treatment for GERD in pregnant women. However, the safety profile of these medications should also be discussed with a healthcare provider.

In conclusion, while Protonix (pantoprazole) appears to have a low risk profile during pregnancy based on available data, its use should be carefully considered and monitored. The decision to use Protonix during pregnancy should be made in consultation with a healthcare provider, weighing the potential benefits against the risks. Alternative treatments and lifestyle modifications should be explored first, reserving Protonix for cases where other options have failed to provide adequate relief. Ongoing research and long-term follow-up of children exposed to Protonix in utero will continue to inform our understanding of its safety during pregnancy.

Drugs in Pregnancy and Lactation: Tenth Edition

PANTOPRAZOLE

Gastrointestinal Agent (Antisecretory)

PREGNANCY RECOMMENDATION: Human Data Suggest Low Risk

BREASTFEEDING RECOMMENDATION: Limited Human Data—Probably Compatible

PREGNANCY SUMMARY

The animal and limited human data suggest that pantoprazole represents a low risk in pregnancy. A study showing an association between in utero exposure to gastric acid–suppressing drugs and childhood allergy and asthma requires confirmation. Moreover, the human pregnancy experience with other proton pump inhibitors (PPIs) has not shown a causal relationship with congenital malformations. However, malformations may have been missed, because of the design and size of the studies. If pantoprazole is required or if inadvertent exposure does occur early in gestation, the known risk to the embryo–fetus appears to be low. Long-term follow-up of offspring exposed during gestation is warranted.

FETAL RISK SUMMARY

Pantoprazole is a PPI that blocks gastric acid secretion by a direct inhibitory effect on the gastric parietal cell. It is used for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD). Pantoprazole is in the same class of PPIs as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, and rabeprazole. It is extensively metabolized to inactive metabolites. The terminal elimination half-life is about 1 hour but is 3.5–10 hours in patients with altered metabolism (slow metabolizers). Serum protein binding, primarily to albumin, is about 98% (1).

Reproductive studies have been conducted in pregnant rats and rabbits at doses up to 88 and 16 times, respectively, the recommended human dose based on BSA. No evidence was found at these doses of impaired fertility or fetal harm (1).

Similar to other PPIs, pantoprazole is carcinogenic in mice and rats (gastrointestinal, liver, and thyroid) (1). The dose-related nature of the tumors and the presumably limited in utero exposure to the drug during human gestation probably suggest a negligible risk. In addition, positive results were seen with pantoprazole in the in vitro human lymphocyte chromosomal aberration assays and in some mutagenic tests with mice, rats, and hamsters. In contrast, negative results were obtained in the in vitro Ames mutation assay, the mammalian cell-forward gene mutation assay, and in several other tests of mutagenicity (1).

It is not known if pantoprazole crosses the human placenta. The molecular weight (about 432 for the hydrated form) is low enough, but the short elimination half-life and high protein binding will limit the amount of drug available to cross at the maternal–fetal interface. Embryo–fetal exposure, however, may be higher in slow metabolizers because of the longer elimination half-life. Of interest, another PPI, omeprazole, has a similar molecular weight (about 345), elimination half-life (1 hour), and protein binding (about 95%), and is known to cross the human placenta. (See Omeprazole.)

A 2002 study conducted a meta-analysis involving the use of PPIs in pregnancy (2). In the 5 cohort studies analyzed, there were 593 infants, mostly exposed to omeprazole, but also including lansoprazole and pantoprazole. The relative risk (RR) for major malformations was 1.18, 95% confidence interval (CI) 0.72–1.94 (2).

A 2005 study by the European Network of Teratology Information Services reported the outcomes of pregnancies exposed to omeprazole (N = 295), lansoprazole (N = 62), or pantoprazole (N = 53) (3). In the pantoprazole group, the median duration of treatment was 14 days (range 7–23 days), and the dose used was 40 mg/day. The outcomes consisted of 1 spontaneous abortion (SAB), 3 elective abortions (EABs) (none for congenital anomalies), 1 stillbirth, and 48 live births. One infant exposed early in gestation (week 2 for 8 days) had congenital toxoplasmosis. Compared with a nonexposed control group, there was no difference in the rate of major malformations between the pantoprazole and control groups (RR 0. 55, 95% CI 0.08–3.95). Similar results were observed for omeprazole and lansoprazole (3).

A population-based observational cohort study formed by linking data from three Swedish national health care registers over a 10-year period (1995–2004) was reported in 2009 (4). The main outcome measures were a diagnosis of allergic disease or a prescription for asthma or allergy medications. The drug types included in the study were gastric acid suppressors, including H₂-receptor antagonists, prostaglandins, PPIs, combinations for eradication of Helicobacter pylori, and drugs for peptic ulcer disease and GERD. Of 585,716 children, 29,490 (5.0%) met the diagnosis and 5645 (1%) had been exposed to gastric acid–suppression therapy in pregnancy. Of these children, 405 (0.07%) were treated for allergic disease. For developing allergy, the odds ratio (OR) was 1.43, 98% CI 1.29–1.59, irrespective of the drug, time of exposure during pregnancy, and maternal history of allergy. For developing childhood asthma, but not other allergic diseases, the OR was 1.51, 95% CI 1.35–1.69, irrespective of the type of acid-suppressive drug and the time of exposure in pregnancy. The authors proposed three possible mechanisms for their findings: (a) exposure to increased amounts of allergens could cause sensitization to digestion labile antigens in the fetus, (b) maternal Th3 cytokine pattern could promote an allergy-prone phenotype in the fetus, and (c) maternal allergen-specific immunoglobulin E could cross the placenta and sensitize fetal immune cells to food and airborne allergens. Several limitations of the study that might have affected their findings were identified, including a general increase in childhood asthma but not necessarily an increase in allergic asthma (4). The study requires confirmation.

A second meta-analysis of PPIs in pregnancy was reported in 2009 (5). Based on 1530 exposed compared with 133,410 not-exposed pregnancies, the OR for major malformations was 1. 12, 95% CI 0.86–1.45. There also was no increased risk for SABs (OR 1.29, 95% CI 0.84–1.97) or preterm birth (OR 1.13, 95% CI 0.96–1.33) (5).

In a 2010 study from Denmark, covering the period 1996–2008, there were 840,968 live births among whom 5082 were exposed to PPIs between 4 weeks before conception to the end of the 1st trimester (6). In the exposed group there were 174 (3.4%) major malformations compared with 21,811 (2.6%) not exposed to PPIs (adjusted prevalence odds ratio [aPOR] 1.23, 95 CI 1.05–1.44). When the analysis was limited to exposure in the 1st trimester, there were 118 (3.2%) major malformations among 3651 exposed infants (aPOR 1.10, 95% CI 0.91–1.34). For exposure to pantoprazole in the 1st trimester, there were 21 (3.8%) major birth defects among 549 live births (aPOR 1.33, 95% CI 0.85–2.08) (see Esomeprazole, Lansoprazole, Omeprazole, and Rabeprazole for their data). The data showed that exposure to PPIs in the 1st trimester was not associated with a significantly increased risk of major birth defects (6). An accompanying editorial discussed the strengths and weaknesses of the study (7).

In a 2012 publication, the National Birth Defects Prevention study, a multisite population-based case–control study, examined whether nausea/vomiting of pregnancy (NVP) or its treatment were associated with the most common noncardiac defects (nonsyndromic cleft lip with or without cleft palate [CL/P], cleft palate alone [CP], neural tube defects [NTDs], and hypospadias) (8). PPI exposure included esomeprazole, lansoprazole, and omeprazole. There were 4524 cases and 5859 controls. NVP was not associated with cleft palate or NTDs, but modest risk reductions were observed for CL/P and hypospadias. Increased risks were found for PPIs (N = 7) and hypospadias (adjusted OR [aOR] 4.36, 95% CI 1.21–15.81), steroids (N = 10) and hypospadias (aOR 2.87, 95% CI 1.03–7.97), and ondansetron (N = 11) and CP (aOR 2.37, 95% CI 1.18–4.76) (8).

Another 2012 study, using the Danish nationwide registries, evaluated the risk of hypospadias after exposure to PPIs during the 1st trimester and throughout gestation (9). The study period, 1997 through 2009, included all liveborn boys that totaled 430,569 of whom 2926 were exposed to maternal PPI use. Hypospadias was diagnosed in 20 (0.7%) exposed boys, whereas 2683 (0.6%) of the nonexposed had hypospadias (adjusted prevalence ratio [aPR] 1.1, 95% CI 0.7–1.7). For the 5227 boys exposed throughout pregnancy, 32 (0.6%) had hypospadias (PR 1.0, 95% CI 0.7–1.4). When the analysis was restricted to mothers with 2 or more PPI prescriptions, the aPR of overall hypospadias was 1.7 (95% CI 0.9–3.3), and 1.6 (95% CI 0.7–3.9) for omeprazole. The authors concluded that PPIs were not associated with hypospadias (9).

A large retrospective cohort study from Israel covering the period 1998–2009 was published in 2012 (10). Among 114,960 live births, there were 110,783 singletons and 1239 EABs. Major malformations were observed in 6037 (5.5%) singletons and in 468 abortuses. Exposure to a PPI (lansoprazole, omeprazole, or pantoprazole) during the 1st trimester occurred in 1186 (1159 infants and 27 abortuses). In the exposed infants and abortuses, 80 (6.7%) had a major malformation compared with 6425 (5.9%) not exposed (aOR 1.06, 95% CI 0.84–1.33). A separate analysis with pantoprazole was not possible because of the limited number of exposures. However, the overall data showed that exposure to PPIs during the 1st trimester was not associated with an increased risk of major defects. Moreover, additional analysis revealed that exposure during the 3rd trimester was not associated with increased risk of perinatal mortality, premature delivery, low birth weight, or low Apgar scores (10).

Five reviews on the treatment of GERD have concluded that PPIs can be used in pregnancy with relative safety (11–15). Because there is either very limited or no human pregnancy data for the three newest agents in this class (dexlansoprazole, esomeprazole, and rabeprazole), other drugs in the class are preferred.

BREASTFEEDING SUMMARY

Small amounts of pantoprazole are excreted into breast milk. A 43-year-old mother, partially nursing a healthy 10-month-old, 8.2-kg, female infant was given a single 40-mg enteric-coated pantoprazole tablet (16). Breastfeeding was held while nine samples of maternal serum and six of breast milk were obtained over a 24-hour interval. The milk samples, about 10 mL each, were obtained at 0, 2, 4, 6, 8, and 24 hours postdose. Pantoprazole was detected only in the 2-hour (0.036 mg/L) and 4-hour (0.024 mg/L) samples, resulting in an estimated AUC of 0.103 mg·hr/L. The milk AUC was about 2.8% of the AUC for plasma. The peak maternal plasma concentration, 1.65 mg/L, occurred at 2 hours, but the levels were <0.025 mg/L at 8 and 24 hours postdose. If the infant had been nursing, the authors estimated that the infant dose would have been ≤0.14% of the weight-adjusted maternal dose (16).

The results of the above case are consistent with the relatively low molecular weight (about 432 for the hydrated form) that suggests pantoprazole will be excreted into breast milk. In addition, pantoprazole is unstable at acidic pH so the amount actually absorbed by the infant may have been less than estimated (16).

References

1.Product information. Protonix. Wyeth-Ayerst Pharmaceuticals, 2001.

2.Nikfar S, Abdollahi M, Moretti ME, Magee LA, Koren G. Use of proton pump inhibitors during pregnancy and rates of major malformations: a meta analysis. Dig Dis Sci 2002;47:1526–9.

3.Diav-Citrin O, Arnon J, Shechtman S, Schaefer C, Van Tonningen MR, Clementi M, De Santis M, Robert-Gnansia E, Valti E, Malm H, Ornoy A. The safety of proton pump inhibitors in pregnancy: a multicentre prospective controlled trial. Aliment Pharmacol Ther 2005;21:269–75.

4.Dehlink E, Yen E, Leichtner AM, Hait EJ, Fiebiger E. First evidence of a possible association between gastric acid suppression during pregnancy and childhood asthma: a population-based register study. Clin Exp Allergy 2009;39:246–53.

5.Gill SK, O’Brien L, Einarson TR, Koren G. The safety of proton pump inhibitors (PPIs) in pregnancy: a meta-analysis. Am J Gastroenterol 2009;104:1541–5.

6.Pasternak B, Hviid A. Use of proton-pump inhibitors in early pregnancy and the risk of birth defects. N Engl J Med 2010;363:2114–23.

7.Mitchell AA. Proton-pump inhibitors and birth defects—some reassurance, but more needed. N Engl J Med 2010;363:2161–3.

8.Anderka M, Mitchell AA, Louik C, Werler MM, Hernandez-Diaz S, Rasmussen SA, and the National Birth Defects Prevention Study. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol 2012;94:22–30.

9.Erichsen R, Mikkelsen E, Pedersen L, Sorensen HT. Maternal use of proton pump inhibitors during early pregnancy and the prevalence of hypospadias in male offspring. Am J Ther 2012 Feb 3; [Epub ahead of print].

10.Matok I, Levy A, Wiznitzer A, Uziel E. Koren G, Gorodischer R. The safety of fetal exposure to proton-pump inhibitors during pregnancy. Dig Dis Sci 2012;57:699–705.

11.Broussard CN, Richter JE. Treating gasto-oesophageal reflux disease during pregnancy and lactation. What are the safest therapy options? Drug Saf 1998;19:325–37.

12.Katz PO, Castell DO. Gastroesophageal reflux disease during pregnancy. Gastroenterol Clin North Am 1998;27:153–67.

13.Ramakrishnan A, Katz PO. Pharmacologic management of gastroesophageal reflux disease. Curr Treat Options Gastroenterol 2002;5:301–10.

14.Richter JE. Gastroesophageal reflux disease during pregnancy. Gastroenterol Clin N Am 2003;32:235–61.

15.Richter JE. Review article: the management of heartburn in pregnancy. Aliment Pharmacol Ther 2005;22:749–57.

16.Plante L, Ferron GM, Unruh M, Mayer PR. Excretion of pantoprazole in human breast milk. J Reprod Med 2004;49:825–7.



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Contents



Can you take Tums while pregnant?

Many pregnant women get heartburn, sometimes referred to as acid indigestion or acid reflux. This condition is generally harmless, but it can be very uncomfortable. Fortunately, most cases can be safely treated with over-the-counter remedies, along with simple diet and lifestyle changes.

Many women get relief by eating small, frequent meals and avoiding spicy or acidic foods. For those who need additional help, some prescription and over-the-counter heartburn medications are considered safe to take during pregnancy.

Here are some guidelines to help you understand which heartburn medicines are appropriate to use during pregnancy. (As with any medication, get the okay from your healthcare provider before taking these.)

Can you take Tums while pregnant?

Yes, Tums are safe to take during pregnancy. In fact, your first line of defense should probably be these chewable antacids made from calcium carbonate (sometimes just called “calcium” on the label). Fast, portable, and effective, they may be all you need to handle heartburn. They even taste pretty good and double as a calcium supplement.

Antacids containing magnesium hydroxide or magnesium oxide – like Maalox, Mylanta, and Rolaids – are probably safe when used occasionally at the recommended dosage. But they’re not your best option while pregnant because they also contain aluminum hydroxide. Aluminum can be constipating and, in large doses, toxic.

Bear in mind that swallowing any liquid, even the liquid you need to wash down a tablet, will cause your stomach to do what it does naturally: produce digestive juices – including acid, the very thing you’re trying to reduce. So it’s best to swallow or chew tablets with as little liquid as possible when you’re having trouble with heartburn.

All of these antacid medicines work by neutralizing the acid that’s already in your stomach and causing you pain. Chewable and liquid antacids act much more quickly than tablets because they’re already dissolved. You can experiment to see which you prefer and what works most effectively for you.

If you’re regularly taking the recommended dosage and aren’t getting relief from heartburn, talk to your doctor or midwife about whether you can take additional or different medications.

What about taking Alka-Seltzer while pregnant?

Remedies containing aspirin (such as Alka-Seltzer) should be avoided during pregnancy. Aspirin may be listed on a label as salicylate or acetylsalicylic acid. (Note: Sometimes aspirin is recommended for pregnant women, so it’s not always unsafe, but in this instance it’s not a good idea.)

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Also steer clear of sodium bicarbonate (baking soda), which is sold as an antacid in tablet form, and sodium citrate. Both are high in sodium, which causes water retention. And if you’re far enough along in your pregnancy to have gone into a panic trying to remove rings from your swollen fingers or looked down in horror at a pair of puffy ankles, you’ll understand why that’s the last thing you want right now.

Other heartburn medicine for pregnancy

If over-the-counter medicines aren’t helping enough with your heartburn, you may want to ask your provider about using something more effective and longer lasting, usually called an acid reducer. Instead of neutralizing your stomach acid like antacids do, acid reducers actually stop your stomach from producing most of the acid it normally would.

Acid reducers won’t help with the acid already in your stomach, so they work best when taken before a meal. Some acid-reducing medications, such as Pepcid Complete, are a combination of an acid reducer (such as famotidine) and an antacid (such as calcium carbonate or magnesium hydroxide), so they can provide immediate relief from the acid that’s already distressing you and reduce further acid production for up to 12 hours.

Pepcid is safe to take daily during pregnancy to prevent heartburn, and you can take calcium carbonate chewables like Tums with it if you still need relief. If this doesn’t help, many doctors will recommend proton pump inhibitors or PPIs. These include lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and esomeprazole (Nexium)

Some of these medicines are available over-the-counter and others require a prescription. All are currently considered safe to take during pregnancy, even during the first trimester. However, talk to your ob-gyn or midwife before taking medications for your heartburn. They can give you helpful tips, tricks, and safety guidance.

Read more about medications during pregnancy.

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Protonix (Pantoprazole) Side Effects, Warnings, Directions

• Generic Name: Pantoprazole
• Brand Name: Protonix

• Overview
• Consumer Information
• Professional Information
• Related Resources

Protonix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What is Protonix?

Protonix (pantoprazole sodium) oral suspension and delayed-release tablets is a proton pump inhibitor (PPI) used for short-term use. treatment (less than 10 days) of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis in adult patients.

What are the side effects of Protonix?

Common side effects of Protonix include:

• injection site reactions (redness, pain, swelling),
• Headache,
• nausea,
• vomiting,
• abdominal or abdominal pain,
• diarrhea,
• gas
• dizziness,
• joint pain,
• weight changes,
• drowsiness,
• feeling tired, or
• sleep problems (insomnia).

Dosage for Protonix

The recommended adult dose of Protonix is ​​40 mg once a day.

What drugs, substances or supplements interact with Protonix?

Protonix may interact with atazanavir, nelfinavir, ampicillin, blood thinners, digoxin, diuretics (water tablets), ketoconazole, iron, or methotrexate. Tell your doctor about all medications and supplements you are taking.

Protonix during pregnancy and lactation

Protonix is ​​not expected to cause harm to the fetus. Tell your doctor if you are pregnant or plan to become pregnant while taking Protonix. Protonix passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

More Information

Our Protonix Side Effects Treatment Center provides a comprehensive overview of available drug information about the potential side effects of this medication.

This is not a complete list of side effects and they may occur. Ask your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Consumer Information Protonix

Get emergency medical help if you have signs of an allergic reaction: hives; labored breathing; swelling of the face, lips, tongue, or throat.

Call your doctor right away if you have:

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• severe abdominal pain, diarrhoea, watery or bloody;
• sudden pain or trouble moving the hip, wrist or back;
• bruising or swelling with intravenous pantoprazole;
• kidney problems – urinating less than usual, blood in the urine, swelling, rapid weight gain;
• low magnesium levels – dizziness, fast or irregular heartbeat, tremors (trembling) or muscle twitches, feeling nervous, muscle cramps, muscle spasms in the arms and legs, coughing or feeling of choking; or
• new or worsening symptoms of lupus joint pain and skin rash on the cheeks or arms that is worse in sunlight.

With prolonged use of pantoprazole, a tumor of the stomach, called fundic gland polyps, may develop. Talk to your doctor about this risk.

If you take pantoprazole for more than 3 years, you may become deficient in vitamin B-12. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

• headache, dizziness;
• abdominal pain, gas, nausea, vomiting, diarrhoea;
• joint pain; or
• fever, rash or cold symptoms (most common in children).

This is not a complete list of side effects and they may occur. Ask your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Protonix (pantoprazole)

Learn More ‘ Professional Information Protonix

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere on the label:

• Acute tubulointerstitial nephritis [see WARNINGS AND PRECAUTIONS ]
• Clostridium difficile -Associated diarrhea [see WARNINGS AND PRECAUTIONS ]
• Bone fracture [see WARNINGS AND PRECAUTIONS ]
• Cutaneous and systemic lupus erythematosus [see WARNINGS AND PRECAUTIONS ]
• Cyanocobalamin (vitamin B-12) deficiency [see WARNINGS AND PRECAUTIONS ]
• Hypomagnesemia [see WARNINGS AND PRECAUTIONS ]
• Fundic gland polyps [see WARNINGS AND PRECAUTIONS ]

Clinical Trial Experience

Adverse reaction profiles for PROTONIX (pantoprazole sodium) for oral suspension, delayed release, and delayed-release tablets for PROTONYX (pantoprazole sodium) are similar .

Because clinical trials are conducted under a wide range of conditions, the incidence of adverse reactions observed in clinical trials of a medicinal product cannot be directly compared with the frequency in clinical trials of another medicinal product and may not reflect rates observed in clinical practice.

adults

Safety in nine US randomized comparative clinical trials in patients with GERD included 1473 patients taking PROTONIX (20 mg or 40 mg) orally, 299 patients on an H2 receptor antagonist, 46 patients on another PPI, and 82 patients on placebo. The most commonly reported adverse reactions are listed in Table 3.

Table 3: Adverse reactions reported in clinical trials in adult patients with GERD with an incidence of >2%

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	PROTONYX (n = 1473)%	Comparators (n = 345)%	Placebo (n = 82)%
Headache	12. 2	12.8	8.5
Diarrhea	8.8 901 91	9.6	4.9
Nausea	7.0	5.2	9.8
Stomach pain	6.2	4.1	6.1
Vomiting 90 191	4.3	3.5	2.4
Flatulence	3.9	2.9	3.7
Dizziness 189 Arthralgia	2.8	1.4	1.2

Additional adverse reactions reported for PROTONIX in clinical trials with ≤ 2%, listed below by body system:

Body as a whole: allergic reaction, hyperthermia, photosensitivity reaction, facial edema

Gastrointestinal: constipation, dry mouth, hepatitis

Hematologic: leukopenia, thrombocytopenia ), generalized edema, elevated triglycerides, elevated liver enzymes

Musculoskeletal: myalgia

Nervous: depression, dizziness

Skin and appendages: urticaria, rash, pruritus

Special Senses: Blurred vision

Pediatric patients

The safety of PROTONIX in the treatment of GERD-related EE was evaluated in pediatric patients aged 1 to 16 years in three clinical trials. Safety trials have included pediatric patients with EE; however, because EE is rare in the pediatric population, 249 pediatric patients with endoscopically confirmed or symptomatic GERD were also evaluated. All adverse reactions to PROTONIX in adults are considered relevant for pediatric patients. In patients aged 1 to 16 years, the most common (> 4%) adverse reactions include: URTI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.

See Use in Specific Populations for safety information in patients under 1 year of age.

Additional adverse reactions that have been reported for PROTONIX in pediatric patients in clinical trials with an incidence of & le; 4%, listed below by body system:

Body as a whole: allergic reaction, swelling of the face

Gastrointestinal tract: constipation, flatulence, nausea

Metabolic/nutrient: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase)

Musculoskeletal: arthralgia, myalgia

Nervous: dizziness, vertigo

Skin and appendages: urticaria

The following adverse reactions observed in adults in clinical trials have not been observed in pediatric patients in clinical trials, but are considered relevant for pediatric patients : photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leukopenia, and blurred vision.

Zollinger-Ellison Syndrome (ZE)

In clinical studies of ZE syndrome, adverse reactions reported in 35 patients treated with PROTONIX 80–240 mg/day for up to 2 years were similar to those in adult patients with GERD.

Post-Marketing Experience

The following adverse reactions have been reported during post-approval use of PROTONIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are listed below by body system:

Gastrointestinal disorders: fundic gland polyps

General disorders and administration conditions: asthenia, fatigue, malaise 3 Hematological: pancytopenia, agranulocytosis

Diseases of the hepatobiliary system: hepatocellular damage leading to jaundice and liver failure

Diseases of the immune system: anaphylaxis (including anaphylactic shock), systemic lupus erythematosus

Infections and infestations: Clostridium difficile associated diarrhea

Investigations: weight changes

9 0020 Metabolic and nutritional disorders: hyponatremia, hypomagnesemia

Skeletal -muscular disorders: rhabdomyolysis, bone fracture

Nervous: ageusia, dysgeusia

Psychiatric disorders: hallucinations, confusion, insomnia, drowsiness

Diseases of the kidneys and urinary tract: acute tubulointerstitial nephritis

Diseases of the skin and subcutaneous tissues: severe dermatological reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome , toxic epidermal necrolysis (TEN, some fatal), angioedema (angioedema), and cutaneous lupus erythematosus

that digoxin is used to treat

Read all FDA Prescribing Information for Protonix (Pantoprazole)

Read More burn

Concomitant drugs

• Aciphex
• Acid
• Acid oral solution
• Cantil
• Dexilant
• Esomeprazole Magnesium
• Gamunex
• Capidex

900 09 Levsin

• Nexium
• Nexium IV
• Pepsid
• Prevacid

• Prevacid IV
• Prevpac
• Prilosec
• Propulsid
• Raglan
• Raglan Injection
• Tagamet
• Talisia
• Yospral
• Zantac
• Zantac Injection
• Zegeride

Read Protonix User Reviews»

Patient Information x Protonix is ​​provided by Cerner Multum, Inc. and Protonix consumer information is provided by First Databank, Inc., used under license and subject to their respective copyrights.

Are you getting enough vitamin B12 – Latest news from Khabarovsk and the region

May 4, 2023, 10:30 pm

This substance is very useful. It is responsible for hematopoiesis, correction of neurological conditions, cardiovascular pathologies and a number of detoxification processes

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Khabarovsk Territory

Since the body does not produce vitamin B12 itself, it must be obtained from animal products or food supplements. And it should be done regularly. Although this vitamin is stored in the liver for up to five years, there is a risk of deficiency.

How much of this vitamin do you need?

The answer depends on many factors, including age, food habits and health, and what medications you take.

Average recommended daily doses, vary by age:

– Infants under 6 months: 0. 4 mcg

– Infants 7-12 months: 0.5 mcg

– Children aged 1- 3 years: 0.9 mcg

– Children aged 4-8 years: 1.2 mcg

– Children aged 9-13: 1.8 mcg

– Adolescents aged 14-18: 2.4 mcg 8 mcg per day while breastfeeding)

Food sources of vitamin B12

You can get vitamin B12 from animal products or from foods fortified with it.

Animal sources – dairy products, eggs, fish, meat and poultry.

Vitamin B12 deficiency

Most people get enough of this nutrient.

This vitamin becomes more difficult to absorb with age. It can also happen if you are on a diet or have had surgery that removed part of your stomach, or if you drink a lot of fluids.

You may also be more likely to be deficient in vitamin B12 if you:

– Atrophic gastritis, in which the lining of the stomach becomes thinner

– Pernicious anemia, which makes it difficult for your body to absorb vitamin B12

– Crohn’s disease, celiac disease, intestinal worms

– Alcohol abuse. One of the signs that you are deficient in vitamin B12 may be a swollen, inflamed tongue.

– Immune system disorders such as Graves’ disease or lupus some diabetes medicines, such as metformin

Vitamin B12 deficiency can develop if you follow a vegan or vegetarian diet. Vitamin B12 deficiency symptoms ice skin

– Constipation, diarrhea, loss of appetite or gas

– Nerve problems such as numbness or tingling, muscle weakness and trouble walking

– Loss of vision

– Mental problems such as depression, memory loss, or behavioral changes

If you have pernicious anemia or have problems absorbing vitamin B12, you will first need injections of this vitamin. You may need to keep taking these shots, take high doses of the supplement by mouth, or administer it nasally afterward.

If you don’t eat animal products, you have options. You can change your diet to include vitamin B12 fortified cereals, a supplement or vitamin B12 shots, or high doses of oral vitamin B12 if you are deficient.