How does antacid consumption affect rosuvastatin absorption. What are the potential consequences of simultaneous administration. Can timing adjustments mitigate interaction effects. How should healthcare providers advise patients taking both medications.

Understanding Rosuvastatin: A Potent HMG-CoA Reductase Inhibitor

Rosuvastatin is a powerful medication belonging to the class of drugs known as HMG-CoA reductase inhibitors, commonly referred to as statins. These drugs play a crucial role in managing dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. Rosuvastatin works by inhibiting the enzyme HMG-CoA reductase, which is responsible for cholesterol production in the liver.

What makes rosuvastatin stand out among other statins? Its high potency and favorable pharmacokinetic profile contribute to its effectiveness in lowering LDL cholesterol levels. Additionally, rosuvastatin has a longer half-life compared to many other statins, allowing for once-daily dosing and potentially improving patient adherence.

The Significance of Drug Interactions in Clinical Practice

Drug interactions are a critical consideration in modern healthcare, as patients often take multiple medications concurrently. These interactions can significantly alter the efficacy and safety profiles of drugs, potentially leading to reduced therapeutic effects or increased risk of adverse events. In the case of rosuvastatin, understanding its interactions with commonly used medications, such as antacids, is essential for optimal patient care.

Why are drug interactions particularly important for statins like rosuvastatin? Statins are widely prescribed medications, and many patients taking them may also require antacids for gastrointestinal issues. The potential for interaction between these two classes of drugs highlights the need for careful consideration and management in clinical practice.

Antacids: Composition and Mechanism of Action

Antacids are over-the-counter medications used to neutralize stomach acid and provide relief from symptoms such as heartburn, indigestion, and acid reflux. The specific antacid preparation used in this study contained a combination of aluminum hydroxide (220 mg/5 mL) and magnesium hydroxide (195 mg/5 mL), commonly known as co-magaldrox 195/220.

How do antacids work to alleviate gastrointestinal discomfort? These compounds react with stomach acid to form water and neutral salts, effectively raising the pH of the stomach contents. This neutralization process helps to reduce the irritation and discomfort caused by excess acid in the digestive tract.

Potential Mechanisms of Interaction with Rosuvastatin

The interaction between antacids and rosuvastatin likely occurs through several mechanisms:

• Altered gastric pH: Antacids increase the pH of the stomach, which can affect the solubility and absorption of rosuvastatin.
• Formation of complexes: The metal ions in antacids may form complexes with rosuvastatin, reducing its bioavailability.
• Changes in gastrointestinal motility: Some antacids can affect the rate at which the stomach empties, potentially altering the absorption kinetics of rosuvastatin.

Study Design: Assessing the Impact of Antacids on Rosuvastatin Pharmacokinetics

To investigate the potential interaction between rosuvastatin and antacids, researchers conducted a randomized, open-label, three-way crossover trial. This study design allows for a comprehensive evaluation of different dosing scenarios while minimizing inter-individual variability.

How was the study structured to evaluate the interaction? The trial involved 14 healthy male volunteers who received three different treatment regimens:

1. Rosuvastatin 40 mg alone
2. Rosuvastatin 40 mg plus 20 mL antacid suspension taken simultaneously
3. Rosuvastatin 40 mg plus 20 mL antacid suspension taken 2 hours after rosuvastatin

Each treatment was separated by a washout period of at least 7 days to ensure complete elimination of the drug from the body before the next administration.

Key Pharmacokinetic Parameters

The study focused on two primary pharmacokinetic parameters to assess the impact of antacid administration on rosuvastatin:

• Area under the plasma concentration-time curve (AUC_0-t): This parameter represents the total exposure to the drug over time.
• Maximum observed plasma concentration (C_max): This value indicates the peak concentration of the drug in the bloodstream.

Why are these parameters crucial for evaluating drug interactions? AUC and C_max provide valuable insights into the extent and rate of drug absorption, respectively. Changes in these parameters can significantly affect the therapeutic efficacy and safety profile of the medication.

Results: Quantifying the Impact of Antacid Co-administration

The study findings revealed significant changes in rosuvastatin pharmacokinetics when co-administered with antacids:

Simultaneous Administration

When rosuvastatin and antacid were taken together:

• AUC_0-t was reduced by 54% (90% confidence interval: 0.40-0.53)
• C_max was reduced by 50% (90% confidence interval: 0.41-0.60)

Separated Administration

When antacid was given 2 hours after rosuvastatin:

• AUC_0-t was reduced by 22% (90% confidence interval: 0.68-0.90)
• C_max was reduced by 16% (90% confidence interval: 0.70-1.01)

These results demonstrate a substantial reduction in rosuvastatin bioavailability when taken concurrently with antacids, with a less pronounced effect when administration is separated by 2 hours.

Clinical Implications of the Rosuvastatin-Antacid Interaction

The observed reduction in rosuvastatin exposure due to antacid co-administration has significant clinical implications. A decrease of approximately 50% in systemic exposure when taken simultaneously could potentially lead to suboptimal therapeutic effects, compromising the medication’s ability to effectively lower cholesterol levels.

How might this interaction affect patient outcomes? Reduced rosuvastatin efficacy could result in inadequate lipid control, potentially increasing the risk of cardiovascular events in patients with dyslipidemia. This underscores the importance of proper medication management and patient education.

Mitigating the Interaction

The study demonstrated that separating the administration of rosuvastatin and antacids by 2 hours significantly reduced the magnitude of the interaction. This finding provides a practical approach to minimizing the impact on rosuvastatin pharmacokinetics while still allowing patients to use both medications when necessary.

What strategies can healthcare providers employ to manage this interaction?

• Patient education: Inform patients about the potential interaction and the importance of proper timing when taking rosuvastatin and antacids.
• Medication scheduling: Advise patients to take rosuvastatin at least 2 hours before or after antacid use.
• Alternative treatments: Consider alternative acid-reducing medications with less potential for interaction, such as proton pump inhibitors, when appropriate.
• Monitoring: Regularly assess lipid levels to ensure that rosuvastatin remains effective despite potential interactions.

Limitations and Future Research Directions

While this study provides valuable insights into the rosuvastatin-antacid interaction, it’s important to acknowledge its limitations and identify areas for future research:

Study Limitations

• Single-dose administration: The study evaluated the interaction after a single dose of rosuvastatin, which may not fully reflect the effects of long-term, repeated dosing.
• Healthy volunteers: The study population consisted of healthy male volunteers, potentially limiting the generalizability to patients with dyslipidemia or other comorbidities.
• Specific antacid formulation: Only one antacid preparation was tested, and results may vary with different formulations or active ingredients.

Future Research Opportunities

To further elucidate the clinical significance of this interaction, future studies could explore:

• Long-term effects: Investigate the impact of chronic antacid use on rosuvastatin efficacy and safety.
• Diverse populations: Assess the interaction in patients with dyslipidemia, various age groups, and both genders.
• Alternative antacids: Evaluate the effects of different antacid formulations and other acid-reducing medications on rosuvastatin pharmacokinetics.
• Dose adjustments: Explore whether dose adjustments of rosuvastatin can compensate for the reduced bioavailability when co-administered with antacids.

Practical Recommendations for Healthcare Providers and Patients

Based on the findings of this study, several practical recommendations can be made to optimize the use of rosuvastatin in patients who may also require antacids:

For Healthcare Providers

1. Conduct thorough medication reviews: Identify patients taking both rosuvastatin and antacids regularly.
2. Educate patients: Explain the potential interaction and the importance of proper timing between medications.
3. Consider alternatives: Evaluate whether alternative acid-reducing medications with less interaction potential are appropriate for the patient.
4. Monitor lipid levels: Regularly assess cholesterol levels to ensure rosuvastatin remains effective.
5. Individualize treatment: Adjust rosuvastatin dosing or scheduling based on patient needs and response.

For Patients

1. Follow scheduling instructions: Take rosuvastatin at least 2 hours before or after antacid use.
2. Maintain consistency: Establish a routine for taking medications to ensure proper timing and adherence.
3. Communicate with healthcare providers: Report any changes in medication use or new symptoms.
4. Monitor symptoms: Be aware of any changes in cholesterol levels or side effects.
5. Seek guidance: Consult healthcare providers before making any changes to medication regimens.

By implementing these recommendations, healthcare providers and patients can work together to minimize the impact of the rosuvastatin-antacid interaction and optimize therapeutic outcomes.

Broader Implications for Polypharmacy Management

The rosuvastatin-antacid interaction highlights the broader challenges associated with polypharmacy, particularly in patients with multiple chronic conditions. As the population ages and the prevalence of chronic diseases increases, the complexity of medication regimens grows, elevating the risk of drug interactions.

How can healthcare systems address the challenges of polypharmacy?

• Comprehensive medication reviews: Implement regular, systematic reviews of patient medication lists to identify potential interactions and optimize therapy.
• Electronic health records: Utilize advanced electronic health record systems with built-in drug interaction alerts to flag potential issues at the point of prescribing.
• Interprofessional collaboration: Foster communication between physicians, pharmacists, and other healthcare providers to ensure coordinated medication management.
• Patient-centered care: Involve patients in decision-making processes and educate them about their medications to improve adherence and safety.
• Deprescribing initiatives: Regularly assess the necessity of each medication and consider discontinuing or substituting drugs when appropriate to minimize the risk of interactions.

By addressing polypharmacy management on a systemic level, healthcare providers can improve patient outcomes, reduce adverse events, and optimize the use of medications like rosuvastatin in complex treatment regimens.

The effect of a combination antacid preparation containing aluminium hydroxide and magnesium hydroxide on rosuvastatin pharmacokinetics

Clinical Trial

. 2008 Apr;24(4):1231-5.

doi: 10.1185/030079908×280662.

Epub 2008 Mar 19.

Paul D Martin 
¹
, Dennis W Schneck, Aaron L Dane, Michael J Warwick

Affiliations

Affiliation

• ¹ AstraZeneca, Alderley Park, Cheshire, UK. [email protected]

• PMID:

  18355422

• DOI:

  10.1185/030079908×280662

Clinical Trial

Paul D Martin et al.

Curr Med Res Opin.

2008 Apr.

. 2008 Apr;24(4):1231-5.

doi: 10.1185/030079908×280662.

Epub 2008 Mar 19.

Authors

Paul D Martin 
¹
, Dennis W Schneck, Aaron L Dane, Michael J Warwick

Affiliation

• ¹ AstraZeneca, Alderley Park, Cheshire, UK. [email protected]

• PMID:

  18355422

• DOI:

  10.1185/030079908×280662

Abstract

Objective:

Rosuvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor used for the treatment of dyslipidaemia, may be co-administered with antacids in clinical practice. This trial assessed the effect of simultaneous and separated administration of an antacid preparation containing aluminium hydroxide 220 mg/5 mL and magnesium hydroxide 195 mg/5 mL (co-magaldrox 195/220) on the pharmacokinetics of rosuvastatin.

Research design and methods:

A randomised, open-label, three-way crossover trial was performed. Healthy male volunteers (n = 14) received a single dose of rosuvastatin 40 mg alone, rosuvastatin 40 mg plus 20 mL antacid suspension taken simultaneously, and rosuvastatin 40 mg plus 20 mL antacid suspension taken 2 h after rosuvastatin on three separate occasions with a washout of > or = 7 days between each.

Main outcome measures:

The primary parameters were area under the rosuvastatin plasma concentration-time curve from time zero to the last quantifiable concentration (AUC(0-t)) and maximum observed rosuvastatin plasma concentration (C(max)) in the absence and presence of antacid.

Results:

When rosuvastatin and antacid were given simultaneously, the antacid reduced the rosuvastatin AUC(0-t) by 54% (90% confidence interval [CI] for the treatment 0.40-0.53) and C(max) by 50% (90% CI 0.41-0.60). When the antacid was given 2 h after rosuvastatin, the antacid reduced the rosuvastatin AUC(0-t) by 22% (90% CI 0.68-0.90) and the C(max) by 16% (90% CI 0.70-1.01). The effect of repeated antacid administration was not studied and it cannot be discounted that this may have resulted in a stronger interaction than that observed here.

Conclusions:

Simultaneous dosing with rosuvastatin and antacid resulted in a decrease in rosuvastatin systemic exposure of approximately 50%. This effect was mitigated when antacid was administered 2 h after rosuvastatin.

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Publication types

MeSH terms

Substances

Rosuvastatin and Tums Antacid Naturals Interactions

This report displays the potential drug interactions for the following 2 drugs:

• rosuvastatin
• Tums Antacid Naturals (calcium carbonate)

Edit list (add/remove drugs)

• Consumer
• Professional

Interactions between your drugs

Taking the rosuvastatin and calcium carbonate doses too close together may interfere with the absorption of rosuvastatin and reduce its effectiveness. To prevent or minimize the interaction, rosuvastatin and calcium carbonate dosing should be separated by at least two hours. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Switch to professional interaction data

Drug and food interactions

Calcium absorption may be increased by taking it with food. However, foods high in oxalic acid (spinach or rhubarb), or phytic acid (bran and whole grains) may decrease calcium absorption. Calcium may be taken with food to increase absorption. Consider spacing calcium administration for at least 2 hours before or after consuming foods high in oxalic acid or phytic acid. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Switch to professional interaction data

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

• Rosuvastatin drug interactions
• Rosuvastatin uses and side effects
• Tums Antacid Naturals drug interactions
• Drug Interactions Checker

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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

Rosuvastatin: instruction, price, analogues | Biofarm

film-coated tablets (Rosuvastatin)

Manufacturer:

Biofarm

Composition and form of release

You can pay for medicines with a card pidtrimka

Classification

Atherosclerosis of the aorta	ICD I70. 0
Atherosclerosis of the arteries of the extremities	ICD I70.2
Atherosclerotic heart disease	ICD I25.1
Hypertensive heart disease without (congestive) heart failure	ICD I11.9
Hypertension (AH) with heart disease and heart failure (HF)	ICD I11.0
Other specified lesions of cerebral vessels	ICD I67.8
Other forms of angina pectoris	ICD I20.8
Cerebral infarction caused by thrombosis of the cerebral arteries	ICD I63.3
Post-infarction coronary heart disease (CHD), (past myocardial infarction)	ICD I25.2
Ischemic heart disease with hypertension (CHD with HT)	ICD I25. 9
Ischemic heart disease with angina pectoris	ICD I25.0
Unstable angina Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris) Manual of Cardiology (ed. V.N. Kovalenko, 2008) … Acute coronary syndrome without persistent ST segment elevation	ICD I20.0
Acute transmural (with Q wave) infarction of the inferior myocardial wall Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome with ST segment elevation (MI with Q wave) Manual of cardiology (ed. V.N. Kovalenko, 2008) … Acute myocardial infarction	ICD I21. 1
Acute transmural infarction of the anterior myocardial wall Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris) Manual of cardiology (ed. V.N. Kovalenko, 2008) … Acute myocardial infarction Manual of Cardiology (ed. V.N. Kovalenko, 2008) … Acute coronary syndrome without persistent ST segment elevation	ICD I21.0
Persistent atrial fibrillation Manual of cardiology (edited by V.N. Kovalenko, 2008) … Clinical protocol for providing medical care to patients with atrial fibrillation (flutter) Manual of cardiology (ed. V.N. Kovalenko, 2008) … Diagnosis and treatment of atrial fibrillation	ICD I48.1
Recurrent myocardial infarction, unspecified Manual of cardiology (ed. V.N. Kovalenko, 2008) … Clinical protocol for the provision of medical care to patients with acute coronary syndrome without ST segment elevation (MI without Q wave and unstable angina pectoris) Manual of cardiology (ed. V.N. Kovalenko, 2008) … Acute myocardial infarction Manual of Cardiology (ed. V.N. Kovalenko, 2008) … Acute coronary syndrome without persistent ST segment elevation	ICD I22.9
Consequences of cerebral infarction	ICD I69.3
Angina	ICD I20.9
Juvenile arterial hypertension	ICD I10

Date added: 07/05/2023

© Compendium 2019

Recommended analogues of Rosuvastatin:

Klivas 10

film-coated tablets 10 mg blister No. 10, 30, 90

Acino

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Klivas 20

film-coated tablets 20 mg blister no. 10, 30, 90

Acino

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Crestor

film-coated tablets 5 mg blister no. 28

9000 2 AstraZeneca

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Crestor

film-coated tablets 10 mg blister № 28

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Crestor 9000 3

film-coated tablets 20 mg blister, № 28

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Crestor

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9 0002 Mertenil

film-coated tablets 5 mg blister no. 30

Gedeon Richter

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Mertenil

film-coated tablets 10 mg blister no. 30 9 0003

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Mertenil

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Gedeon Richter

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Gledpharm Ltd

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Ozalex ^®

film-coated tablets 20 mg blister, № 28

90 002 Gladpharm Ltd

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Preventer

90

Darnitsa

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Preventor

film-coated tablets 20 mg blister pack, No. 30, 90

Darnitsa

Prices in pharmacies 9 0003

Rovamed

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90 002 Rozastin

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Roxera ^®

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Sandoz

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9 0002 Farmak

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5 herbs and spices that can reduce the effect of drugs

• Health

Many seemingly harmless herbs and herbal preparations can interact with various drugs and reduce their effect. So, when prescribing dietary supplements for yourself, you should be very careful.

March 4, 20231

Source:

iStockphoto

We know about the health benefits of garlic and green tea, both recognized as powerful antioxidants. It is very useful to use them in the diet in moderation, but it can be unsafe to get involved in preparations based on them. And not only them. There are other herbs and spices that seriously affect the effectiveness of the pharmaceutical preparations you take, writes ProNews.

Turmeric

This spice and dietary supplements with curcumin are often called “fool’s gold”. Science considers its antitumor, anti-inflammatory and antibacterial properties to be only potential. But the interaction of curcumin with drugs can even be dangerous.

There is evidence that curcumin may reduce the effect of many antidepressants and neuroleptics. It is also known to interact with anticoagulants, antacids, drugs to control blood pressure.

– Whole turmeric, turmeric extract or pure curcumin are credited with at least 175 different beneficial physiological effects and more than 600 different indications, explains renowned physician, toxicologist Alexei Vodovozov. “But if you search the available databases for relevant studies, it turns out that of them are at the preclinical stage, , that is, cell cultures and laboratory animals (mice and rats). And the results found are of interest mainly to mice and rats, because they are transferred to humans very, very rarely.

Read also

Garlic

Garlic extract can reduce the concentration of cardiac glycosides, glucocorticoids – drugs that transport P-glycoprotein protein across the cell membrane – such as colchicine, quinidine, desloratadine, digoxin, rosuvastatin and others , writes ProNews

Garlic extract can also thin the blood like aspirin, which can be a problem if you are taking blood thinners.

– It happens that people take both aspirin and anticoagulants, then the risk of bleeding increases exponentially. I have had such cases. People go to the hospital to the surgeons on the operating table, because they have gastrointestinal bleeding, , doctor Boris Shelyapin told Doctor Peter earlier.

Green tea

Everyone knows about the benefits of green tea – it has antioxidant properties, anti-inflammatory, promotes the expansion of cerebral vessels, improves its nutrition, oxygen supply. All this is true, if you drink 2-3 cups of quality green tea a day. Although it is not shown to everyone – after all, a drink can lower blood pressure and harm ulcers.

Taking green tea extract as a dietary supplement can also be hazardous to health. There is evidence that green tea extract may reduce the effectiveness of some statins and some beta-blockers used to treat hypertension. Also concentrated green tea supplements may interact with some vasoconstrictors.

Thistle or milk thistle

This plant is believed to have many beneficial properties, and the active substance silymarin contained in it is called the first “protector” of the liver.