What are the main uses of Protonix. How does Protonix work to treat acid-related conditions. What are the most common side effects of taking Protonix. How does Protonix interact with other medications. What precautions should be taken when using Protonix.

Understanding Protonix: A Powerful Proton Pump Inhibitor

Protonix, known generically as pantoprazole, is a medication that belongs to a class of drugs called proton pump inhibitors (PPIs). These drugs work by reducing the amount of acid produced in the stomach, making them effective for treating various gastrointestinal conditions. Protonix is widely prescribed and has been the subject of numerous clinical studies to evaluate its efficacy and safety profile.

How Does Protonix Work?

Protonix functions by inhibiting the proton pump in the stomach’s parietal cells. This pump is responsible for the final step in acid production. By blocking this mechanism, Protonix significantly reduces stomach acid levels, providing relief for conditions exacerbated by excess acid.

Primary Uses of Protonix in Medical Treatment

Protonix is approved for several medical conditions related to excess stomach acid production. Its primary uses include:

• Gastroesophageal reflux disease (GERD)
• Erosive esophagitis
• Stomach ulcers
• Duodenal ulcers
• Zollinger-Ellison syndrome

In the treatment of GERD, Protonix has shown particular efficacy. It helps alleviate symptoms such as heartburn, difficulty swallowing, and the regurgitation of stomach contents. For patients with erosive esophagitis, Protonix aids in healing the damaged esophageal lining and prevents further erosion.

Protonix Dosage and Administration Guidelines

The appropriate dosage of Protonix varies depending on the condition being treated and individual patient factors. Typically, it is taken once daily, although some conditions may require twice-daily dosing. The standard dose for most adults is 40 mg per day, but this can range from 20 mg to 80 mg depending on the severity of the condition and the patient’s response to treatment.

Can Protonix Be Taken Twice Daily?

While the standard dosage is once daily, some patients may be prescribed Protonix 40 mg twice a day for certain conditions. This higher dosage is typically reserved for more severe cases or when the once-daily regimen does not provide adequate symptom relief. However, it’s crucial to follow the dosage prescribed by your healthcare provider and not adjust it without consultation.

Potential Side Effects and Risks of Protonix

Like all medications, Protonix can cause side effects. While many people tolerate the drug well, it’s important to be aware of potential adverse reactions. Common side effects include:

• Headache
• Diarrhea
• Nausea
• Stomach pain
• Vomiting
• Gas
• Dizziness

More serious side effects, although rare, can occur. These may include severe allergic reactions, kidney problems, and an increased risk of certain infections. Long-term use of Protonix has been associated with an increased risk of bone fractures, particularly in older adults.

Does Protonix Cause Bloating?

While bloating is not listed as one of the most common side effects of Protonix, some patients have reported experiencing this symptom. It’s important to note that gastrointestinal symptoms can be complex, and bloating may be related to the underlying condition being treated rather than the medication itself. If persistent bloating occurs, it’s advisable to consult with a healthcare provider.

Drug Interactions: What to Know When Taking Protonix

Protonix can interact with various medications, potentially altering their effectiveness or increasing the risk of side effects. According to the interaction checker, there are 163 known drug interactions with Protonix, categorized as follows:

• 16 major interactions
• 128 moderate interactions
• 19 minor interactions

Some of the most frequently checked interactions include those with:

1. Levothyroxine
2. Clopidogrel (Plavix)
3. Metformin
4. Aspirin
5. Atorvastatin (Lipitor)

It’s crucial to inform your healthcare provider about all medications, supplements, and herbal products you’re taking to avoid potential interactions.

Long-Term Use of Protonix: Benefits and Considerations

While Protonix can be highly effective in managing acid-related disorders, long-term use requires careful consideration. The duration of treatment depends on the condition being treated and individual patient factors. For some conditions, such as GERD, long-term or even indefinite use may be necessary to control symptoms and prevent complications.

How Long Can Protonix Be Taken Safely?

The safety of long-term Protonix use has been studied extensively. While it’s generally considered safe for extended periods, ongoing monitoring is recommended. Long-term use may be associated with certain risks, including:

• Vitamin B12 deficiency
• Increased risk of certain infections
• Potential for bone fractures
• Hypomagnesemia (low magnesium levels)

Regular check-ups and periodic reassessment of the need for continued therapy are important for patients on long-term Protonix treatment.

Protonix in Special Populations: Pregnancy, Breastfeeding, and Elderly

The use of Protonix in special populations requires careful consideration. In pregnancy, Protonix is classified as Category B, meaning animal studies have not shown a risk to the fetus, but there are no adequate studies in pregnant women. The decision to use Protonix during pregnancy should be made in consultation with a healthcare provider, weighing the potential benefits against the risks.

For breastfeeding mothers, limited data suggest that Protonix is excreted in human milk. The effects on the nursing infant are not well-established, and caution is advised. Elderly patients may be more sensitive to the effects of Protonix and may require dose adjustment or additional monitoring.

Comparing Protonix to Other Proton Pump Inhibitors

Protonix is one of several proton pump inhibitors available for the treatment of acid-related disorders. Other common PPIs include omeprazole, esomeprazole, and lansoprazole. While these medications work through similar mechanisms, there are differences in their pharmacokinetics, dosing regimens, and potential for drug interactions.

Pantoprazole vs. Omeprazole: Key Differences

Pantoprazole (Protonix) and omeprazole are both effective PPIs, but they have some notable differences:

• Onset of action: Pantoprazole may have a slightly faster onset of action.
• Duration of effect: Pantoprazole typically has a longer duration of acid suppression.
• Drug interactions: Pantoprazole generally has fewer drug interactions compared to omeprazole.
• Dosing flexibility: Pantoprazole is available in both oral and intravenous forms, offering greater flexibility in certain clinical settings.

The choice between pantoprazole and omeprazole often depends on individual patient factors, potential drug interactions, and specific treatment goals.

Patient Experiences and Reviews of Protonix

Patient experiences with Protonix vary, as is common with most medications. According to reviews on Drugs.com, Protonix has an average rating of 7.1 out of 10 based on 78 reviews. The majority of reviewers (64%) reported a positive experience, while 23% reported a negative experience.

Reviews for specific conditions include:

• GERD: 50 reviews
• Stomach Ulcer: 9 reviews
• Barrett’s Esophagus: 7 reviews
• Erosive Esophagitis: 6 reviews
• Duodenal Ulcer: 3 reviews
• Peptic Ulcer: 3 reviews

These reviews provide valuable insights into real-world experiences with Protonix, although it’s important to remember that individual responses to medication can vary significantly.

Conclusion: Making Informed Decisions About Protonix Use

Protonix (pantoprazole) is a powerful and widely-used medication for treating various acid-related gastrointestinal conditions. Its effectiveness in reducing stomach acid production makes it a valuable tool in managing conditions like GERD, ulcers, and erosive esophagitis. However, like all medications, it comes with potential side effects and interactions that need to be carefully considered.

When considering Protonix as a treatment option, it’s essential to have a thorough discussion with your healthcare provider. Factors to consider include:

• The specific condition being treated
• Potential drug interactions with other medications you’re taking
• Your overall health status and any pre-existing conditions
• The expected duration of treatment
• Potential long-term effects of proton pump inhibitor use

By weighing these factors and staying informed about the latest research and guidelines, patients and healthcare providers can make the best decisions regarding the use of Protonix. Regular follow-ups and open communication about any side effects or concerns are crucial for optimizing treatment outcomes and ensuring patient safety.

As research in gastroenterology continues to evolve, our understanding of the long-term effects of PPIs like Protonix grows. Staying informed about the latest developments and guidelines can help both patients and healthcare providers make the most appropriate treatment decisions, balancing the benefits of symptom relief with potential risks associated with long-term use.

Protonix Interactions Checker – Drugs.com

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There are 163 drugs known to interact with
Protonix (pantoprazole), along with
4 disease interactions.

Of the total drug interactions,
16 are major, 128 are moderate, and 19 are minor.

Does Protonix interact with my other drugs?

Enter other medications to view a detailed report.

• View all 163 medications that may interact with Protonix
• View Protonix disease interactions (4)

Most frequently checked interactions

View interaction reports for Protonix (pantoprazole) and the medicines listed below.

• Major
• Moderate
• Minor
• Unknown

• albuterol
• amlodipine
• aspirin
• atorvastatin
• Cymbalta (duloxetine)
• folic acid
• gabapentin
• Lasix (furosemide)
• levothyroxine
• Lexapro (escitalopram)
• Lipitor (atorvastatin)
• lisinopril
• losartan
• Lyrica (pregabalin)
• metformin
• metoprolol
• Plavix (clopidogrel)
• potassium chloride
• prednisone
• Singulair (montelukast)
• Synthroid (levothyroxine)
• tramadol
• trazodone
• Tylenol (acetaminophen)
• Vitamin B12 (cyanocobalamin)
• Vitamin D3 (cholecalciferol)
• Xanax (alprazolam)
• Zofran (ondansetron)
• Zoloft (sertraline)
• Zyrtec (cetirizine)

Protonix disease interactions

There are 4 disease interactions with Protonix (pantoprazole) which include:

• C. diff
• liver disease
• bone fractures
• hypomagnesemia

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More about Protonix (pantoprazole)

• Protonix consumer information
• Compare alternatives
• Pricing & coupons
• Reviews (80)
• Drug images
• Side effects
• Dosage information
• Patient tips
• During pregnancy
• Generic availability
• Support group
• Drug class: proton pump inhibitors
• Breastfeeding
• En español

Related treatment guides

• Erosive Esophagitis
• Barrett’s Esophagus
• Duodenal Ulcer
• GERD

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.

Major	Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate	Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor	Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown	No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Protonix Reviews & Ratings – Drugs.com

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Protonix
has an average rating of 7.1 out of 10 from a total of 78 reviews
on Drugs. com.
64% of reviewers reported a positive experience, while 23% reported a negative experience.

Reviews for Protonix

Frequently asked questions

• Pantoprazole vs. omeprazole: What’s the difference between them?
• Can you take pantoprazole 40 mg twice a day?
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Reviews may be edited to correct grammar/spelling or to remove inappropriate language and content. Reviews that appear to be created by parties with a vested interest are not published. This information is not intended to endorse any particular medication. While these reviews may be helpful, they are not a substitute for the expertise, knowledge, and judgement of healthcare professionals.

More about Protonix (pantoprazole)

• Check interactions
• Compare alternatives
• Pricing & coupons
• Drug images
• Side effects
• Dosage information
• Patient tips
• During pregnancy
• Generic availability
• Support group
• Drug class: proton pump inhibitors
• Breastfeeding
• En español

Patient resources

• Drug Information
• Protonix oral/injection
• Protonix (Pantoprazole Intravenous) (Advanced Reading)
• Protonix (Pantoprazole Oral) (Advanced Reading)
• Protonix (Pantoprazole Delayed-Release Granules)
• Protonix (Pantoprazole Delayed-Release Tablets)

Professional resources

• Prescribing Information

Other formulations

• Protonix IV

Related treatment guides

• Erosive Esophagitis
• Barrett’s Esophagus
• Duodenal Ulcer
• GERD

Protonix I.

V. – instructions for use, dosage, composition, analogues, side effects / Pillintrip

WARNINGS

Included as part of PRECAUTIONS section.

PRECAUTIONS

Sequelae of symptomatic response

Symptomatic response to pantoprazole therapy does
does not exclude the presence of malignant neoplasms of the stomach.

Hypersensitivity and severe skin reactions

Anaphylaxis and other serious reactions such as erythema
multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) have
reported with the use of intravenous pantoprazole. It may require an emergency
treatment .

Injection site reactions

Thrombophlebitis has been associated with administration
intravenous pantoprazole.

Potential to exacerbate zinc deficiency

PROTONIX contains disodium edetate (salt form
EDTA), a chelator of metal ions, including zinc. Therefore, zinc supplements
should be considered in patients treated with PROTONIX I. V. for injection who
susceptible to zinc deficiency. Caution should be exercised when using other EDTA-containing
products are also administered intravenously.

Clostridium Difficile associated diarrhea

Published observational studies show that PPI therapy
how PROTONIX may be associated with an increased risk of Clostridium
difficile associated diarrhea, especially in hospitalized patients. This
the diagnosis should be considered in diarrhea that does not improve.

Patients should use the lowest dose and shortest duration
PPI therapy appropriate to the condition being treated.

Broken bones

Several published observational studies suggest this
proton pump inhibitor (PPI) therapy may be associated with an increased risk
with fractures of the hip, wrist or spine associated with osteoporosis. Risk
the fracture was enlarged in patients treated with a high dose, defined as multiple
daily doses and long-term PPI therapy (a year or more). Patients should use
lowest dose and shortest duration of PPI therapy consistent with
the condition is being treated. Patients at risk of fractures associated with osteoporosis
should be administered in accordance with established treatment guidelines.

Hepatic effects

Mild, transient increases in transaminases have been
observed in clinical studies. The clinical significance of this discovery in
the large population of subjects receiving intravenous pantoprazole is unknown. .

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, was
rarely reported in patients treated with PPIs for at least three months, and in
most cases after a year of therapy. Serious adverse events include tetany
arrhythmias and seizures. In most patients, treatment of hypomagnesaemia
necessary replacement of magnesium and discontinuation of PPI

For patients who are expected to be on long-term treatment or who
take PPIs with drugs such as digoxin or drugs that can cause
hypomagnesemia (eg. , diuretics), healthcare professionals may consider
monitoring magnesium levels prior to initiating PPI treatment, and
periodically.

Interference with urine screen for THC

Can produce false positive urinalysis for THC
(tetrahydrocannabinol)

.

Simultaneous use of protonix with methotrexate

Literature suggests that concomitant use of PPIs with
methotrexate (mainly at high doses;

Preclinical toxicology

Carcinogenesis, mutagenesis, impaired fertility

In a 24-month Sprague-Dawley rat carcinogenicity study
treated orally with doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times
an effect on the body surface area of ​​a 50 kg human administered a dose of 40 mg/day.
In the gastric fund, treatment is performed at a dose of 0.5 to 200 mg / kg / day
enterochromaffin-like (ECL) cell hyperplasia and benign and malignant
neuroendocrine cell tumors in a dose-dependent manner. In the forest stomach
treatment at a dose of 50 and 200 mg / kg / day (about 10 and 40 times the recommended person
dose based on body surface area) caused benign squamous papillomas and
malignant squamous cell carcinomas. Rare gastrointestinal tumors are associated
with pantoprazole treatment included duodenal adenocarcinoma at age 50
mg / kg / day and benign polyps and adenocarcinomas of the gastric fund in 200
mg/kg/day. The liver is treated at a dose of 0.5 to 200 mg/kg/day
dose escalation for hepatocellular adenomas and related doses
carcinomas. In the thyroid gland, treatment at a dose of 200 mg / kg / day increased
frequency of follicular cell adenomas and carcinomas in both men and women
rats.

In a 24-month Fischer 344 rat carcinogenicity study
treated orally with doses of 5 to 50 mg/kg/day, about 1 to 10
multiply the recommended human dose based on body surface area. in the stomach
Fundus, treated at a dose of 5 to 50 mg/kg/day, produces enterochromaffin-like (ECL)
cell hyperplasia; and benign and malignant neuroendocrine cell tumors. Dose
selection for this study may not have been sufficient for a comprehensive assessment
carcinogenic potential of pantoprazole.

In a 24-month carcinogenicity study, B6C3F1 mice were
orally treated with doses of 5 to 150 mg/kg/day, 0. 5 to 15 times more
recommended human dose based on body surface area. In the liver treatment at 150
mg/kg/day caused an increase in the frequency of hepatocellular adenomas and
carcinomas in female mice. Treatment of 5 to 150 mg/kg/day is also done
hyperplasia of ECL cells of the stomach.

26-week Carcinogenicity Study in Transgenic Mice
was not positive.

Pantoprazole was positive in in vitro people
lymphocyte chromosomal aberration assays in one of two mouse micronuclei
tests for clastogenic effects and in vitro Chinese hamster ovary
direct cell mutation/HGPRT assay for mutagenic effects. Equivalent results were
observed in an in vivo rat liver DNA covalent binding assay. Pantoprazole was
negative in in vitro Ames mutation assay in vitro unscheduled DNA
synthesis assay (UDS) with rat hepatocytes, in vitro AS52 / GPT mammal
gene mutation assay in cell direction in vitro thymidine kinase mutation test
with L5178Y mouse lymphoma cells and rat bone marrow cell in vivo
analysis of chromosomal aberration.

No effect on fertility or reproduction
performance when taking pantoprazole at oral doses up to 500 mg/kg/day
male rats (98 times the recommended human dose based on body surface area) and
450 mg/kg/day in female rats (88 times the recommended human dose depending on the body
surface area).

Use in certain populations

Pregnancy

Teratogenic effects – Pregnancy category B

Reproduction studies have been performed in rats in
intravenous doses up to 20 mg/kg/day (4 times the recommended human dose
on the body surface) and rabbits at intravenous doses up to 15 mg/kg/day (6
times the recommended human dose depending on body surface area) and identified
there is no evidence of impaired fertility or harm to the fetus due to pantoprazole. There
however, there are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies don’t always predict humans
In response, this medication should be used during pregnancy only if clearly needed.

Nursing mothers

Pantoprazole and its metabolites are excreted in milk
rats. Excretion of pantoprazole in breast milk was found in a study a
single mother after a single dose of 40 mg. Clinical relevance
this find is unknown. Many drugs that are excreted in breast milk have
potential for serious adverse reactions in infants. Based
carcinogenic potential shown for pantoprazole in rodent carcinogenicity
research, a decision must be made whether to terminate care or
stop taking the drug, taking into account the benefits of the drug for
Mother.

Pediatric use

Safety and effectiveness of PROTONIX I.V. in pediatric
patients were not created.

Geriatric use

No age difference in safety profile
intravenous pantoprazole has been seen in international trials involving 86 elderly people
(≥ 65 years) and 200 young (<65 years) patients with erosive esophagitis associated with GERD. The frequency of healing of esophagitis in 107 elderly patients (≥ 65 years) treated with oral pantoprazole in the US, clinical trials were similar to those found in patients under that age out of 65. The frequency of occurrence of adverse events and laboratory abnormalities in
patients aged 65 years and older were similar to those associated with patients
younger than 65 years old.

Gender

No gender difference in safety profile
intravenous pantoprazole was seen in an international trial involving 166 men
and 120 women with erosive esophagitis associated with GERD. Erosion
healing rate of esophagitis in 221 women treated with oral pantoprazole in the US
clinical trials were similar to those found in men. Incidence rates
adverse reactions were also similar for men and women.

Liver failure

Doses above 40 mg/day have not been studied in
patients with liver failure.

Why is it prescribed, side effects

According to doctors, diseases of the digestive system are diseases of civilization. Each person at least once faced such manifestations as abdominal pain, heartburn, belching, bloating, nausea, vomiting, diarrhea, constipation. Gastrointestinal diseases in terms of the number of hospitalizations rank third after pregnancy and cardiovascular diseases.

According to clinical guidelines in the complex therapy of gastric ulcers and gastroesophageal reflux disease (GERD), drugs from the PPI group – proton pump inhibitors are used. Using the example of the drug Pantoprazole, we analyze how such drugs “work” in the body, what they help with and what side effects they have. Compare Pantoprazole with Omeprazole, Rabeprazole and Nolpaza.

Pantoprazole: what helps

Hydrochloric acid, contained in gastric juice, stimulates the production of digestive enzymes, activates gastric motility and destroys pathogens that come with food. It is produced in the parietal cells of the gastric mucosa, and the proton pump enzyme controls this process.

Excessive secretion of hydrochloric acid is dangerous for the mucous membrane of the esophagus, stomach and duodenum. To reduce its production, Pantoprazole is prescribed, which blocks the action of the proton pump and reduces the aggressive effect of gastric juice on the gastrointestinal mucosa.

All items Pantoprazole

Pantoprazole What is it used for

What is Pantoprazole used for? Under what diseases and conditions is it necessary to reduce the secretion of hydrochloric acid? Before answering the questions, we clarify that the indications for the use of the drug depend on the dosage. Pantoprazole tablets are produced in two types:

1. Pantoprazole 20 mg is indicated for the relief of heartburn and regurgitation in GERD in adults. The drug reduces the aggressiveness of gastric juice, which is thrown into the esophagus and prevents the formation of erosion, ulcers and burns.

2. Pantoprazole 40 mg tablets are used for:

• exacerbation of gastric and duodenal ulcers to allow them to heal;
• erosive gastritis, including those associated with the use of non-steroidal anti-inflammatory drugs, to protect the mucous membrane;
• complex eradication of the bacterium Helicobacter pylori, which becomes more sensitive to antibiotics at elevated pH;
• Zollinger-Ellison syndrome to prevent the formation of erosions and ulcers.

Pantoprazole: side effects

If the drug is used according to indications and in accordance with the instructions, side effects are rare. Headache and diarrhea were reported in only 1% of patients. Also possible:

• dizziness;
• benign polyps of gastric glands;
• bloating, constipation;
• dry mouth, nausea, vomiting;
• abdominal pain and discomfort;
• dermatitis, pruritus, rash;
• fractures.

Pantoprazole or Omeprazole: which is better?

Omeprazole is the first and most studied proton pump inhibitor. Indications for use are generally similar to those of Pantoprazole. The main difference is that omeprazole at a dose of 20 mg is approved for the treatment of children from 2 years of age with GERD and from 4 years of age in the eradication of Helicobacter pylori, and Pantoprazole is indicated only for adult patients from 18 years of age.

Preparations differ in the form of release. Omeprazole is produced in the form of microcapsules enclosed in an enteric shell and placed in a capsule. Pantoprazole is an enteric coated tablet. Omeprazole capsules can be dissolved in acidified water, juice or fruit puree. In this form, they are convenient for children and patients with difficulty swallowing.

Omeprazole is more likely than pantoprazole to cause headache, drowsiness, lethargy and gastrointestinal side effects, has more interactions with other drugs

What analogues have in common: both drugs are taken before meals, they act 24 hours after the start of administration and are compatible with antacids. But, despite the similarity of action, patients should not independently decide what to take – Omeprazole or Pantoprazole. To do this, you need to consult a doctor, as the drugs have differences.

All products Omeprazole

26 reviews

Pantoprazole or Rabeprazole: which is better?

Rabeprazole is also a PPI and has a number of advantages over Pantoprazole: it works up to 48 hours, it is allowed for children from 12 years of age with GERD at a dosage of 20 mg, it can be used regardless of food intake.

Another “positive” difference between Rabeprazole is that it is active at almost any pH of gastric juice, while Pantoprazole acts only at pH not higher than 3.

The preparations contain various active and excipients, have their own characteristics of purpose, so the choice of Pantoprazole or Rabeprazole is made by the attending physician.

All products Rabeprazole

10 reviews

Pantoprazole or Nolpaza: which is better?

Under the name Pantoprazole, the drug is produced by Russian companies, and Nolpaza is an analogue of the Slovenian company KRKA. Pantoprazole and Nolpaza are complete analogues with the same active ingredient. They differ in manufacturers, excipients and the place of synthesis of substances. So, pantoprazole for Nolpaza is produced in Slovenia, and for Pantoprazole – in Spain and India.

According to the instructions for medical use, Nolpaza is approved for the treatment of children from 12 years of age. Therefore, the drug has an advantage in pediatric practice. In other cases, Nolpaza and Pantoprazole are interchangeable, taking into account the dosages prescribed by the doctor and the appointment.

Be aware that all proton pump inhibitors increase the risk of osteoporosis and certain gastrointestinal infections. If PPIs are prescribed, then other drugs that reduce the acidity of gastric juice should not be taken.

All products Nolpaza

20 reviews

Summary

• Pantoprazole blocks the action of the proton pump enzyme, reduces the production of hydrochloric acid and reduces the aggressive effect of gastric juice on the mucous membranes of the gastrointestinal tract.
• Pantoprazole is indicated for the treatment of GERD, gastric and duodenal ulcers, erosive gastritis, and Zollinger-Ellison syndrome.
• If the drug is used according to indications and in accordance with the instructions, then side effects are rare.