Rosuvastatin and Antacids: Understanding Their Interaction and Effects on Pharmacokinetics
How does the combination of antacids containing aluminium hydroxide and magnesium hydroxide affect rosuvastatin pharmacokinetics. What are the implications of simultaneous and separated administration of these medications. How can patients optimize their treatment regimen when using both rosuvastatin and antacids.
The Importance of Studying Drug Interactions: Rosuvastatin and Antacids
Drug interactions are a critical aspect of pharmacology that can significantly impact patient care and treatment outcomes. One such interaction that has garnered attention is between rosuvastatin, a widely prescribed statin medication, and antacids containing aluminium hydroxide and magnesium hydroxide. Understanding this interaction is crucial for healthcare providers and patients alike to ensure optimal therapeutic effects and minimize potential risks.
What is Rosuvastatin?
Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, commonly known as a statin. It is primarily used to treat dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. By inhibiting the HMG-CoA reductase enzyme, rosuvastatin effectively reduces cholesterol production in the liver, leading to improved lipid profiles and decreased cardiovascular risk.
The Role of Antacids in Healthcare
Antacids are over-the-counter medications used to neutralize stomach acid and provide relief from symptoms such as heartburn, indigestion, and acid reflux. Combination antacid preparations containing aluminium hydroxide and magnesium hydroxide are popular due to their complementary effects and relatively low side effect profile.
Exploring the Pharmacokinetic Interaction: Study Design and Methodology
To investigate the potential interaction between rosuvastatin and antacids, researchers conducted a randomized, open-label, three-way crossover trial. This study design allows for the comparison of different treatment conditions within the same group of participants, reducing inter-individual variability and increasing statistical power.
Study Parameters and Participants
The study involved 14 healthy male volunteers who received three different treatment regimens with a washout period of at least 7 days between each:
- A single dose of rosuvastatin 40 mg alone
- Rosuvastatin 40 mg plus 20 mL antacid suspension taken simultaneously
- Rosuvastatin 40 mg plus 20 mL antacid suspension taken 2 hours after rosuvastatin
Key Pharmacokinetic Measurements
The primary parameters measured in this study were:
- Area under the rosuvastatin plasma concentration-time curve from time zero to the last quantifiable concentration (AUC(0-t))
- Maximum observed rosuvastatin plasma concentration (C(max))
These measurements were taken in the absence and presence of antacid to quantify the impact of the interaction.
Significant Findings: The Impact of Antacids on Rosuvastatin Pharmacokinetics
The study revealed substantial effects of antacid administration on rosuvastatin pharmacokinetics, with the timing of antacid intake playing a crucial role in the magnitude of the interaction.
Simultaneous Administration: A Dramatic Reduction in Rosuvastatin Exposure
When rosuvastatin and antacid were given simultaneously, the results were striking:
- Rosuvastatin AUC(0-t) was reduced by 54% (90% confidence interval [CI] for the treatment 0.40-0.53)
- Rosuvastatin C(max) was reduced by 50% (90% CI 0.41-0.60)
These findings indicate that concurrent administration of antacids can significantly decrease the systemic exposure to rosuvastatin, potentially compromising its therapeutic efficacy.
Separated Administration: Mitigating the Interaction
When the antacid was given 2 hours after rosuvastatin, the impact was notably less pronounced:
- Rosuvastatin AUC(0-t) was reduced by 22% (90% CI 0.68-0.90)
- Rosuvastatin C(max) was reduced by 16% (90% CI 0.70-1.01)
This demonstrates that separating the administration of rosuvastatin and antacids can help mitigate the interaction, though some reduction in rosuvastatin exposure still occurs.
Clinical Implications: Optimizing Rosuvastatin Therapy in Patients Using Antacids
The findings of this study have important implications for clinical practice, particularly for patients who require both rosuvastatin and antacid therapy.
Recommendations for Healthcare Providers
Based on the study results, healthcare providers should consider the following recommendations:
- Advise patients to avoid taking rosuvastatin and antacids simultaneously
- Recommend separating the administration of rosuvastatin and antacids by at least 2 hours
- Monitor lipid levels closely in patients using both medications to ensure adequate therapeutic response
- Consider dose adjustments of rosuvastatin if necessary, based on individual patient response and lipid profiles
Patient Education and Adherence
Educating patients about the potential interaction between rosuvastatin and antacids is crucial for ensuring treatment success. Healthcare providers should emphasize the importance of proper timing and adherence to the prescribed regimen. Patients should be encouraged to:
- Maintain a consistent schedule for taking rosuvastatin and antacids
- Keep a medication log to track the timing of each dose
- Communicate any concerns or difficulties in following the prescribed regimen to their healthcare provider
Limitations and Future Research Directions
While this study provides valuable insights into the interaction between rosuvastatin and antacids, it is important to acknowledge its limitations and consider areas for future research.
Study Limitations
Several factors limit the generalizability of the study findings:
- The study included only healthy male volunteers, potentially limiting applicability to other populations
- The effect of repeated antacid administration was not studied, which may result in a stronger interaction
- The study focused on a single dose of rosuvastatin, while long-term therapy is typical in clinical practice
Future Research Opportunities
To further elucidate the interaction between rosuvastatin and antacids, future studies could explore:
- The effects of long-term, concurrent use of rosuvastatin and antacids
- The impact of different antacid formulations and dosing regimens on rosuvastatin pharmacokinetics
- The potential for dose adjustments to compensate for reduced rosuvastatin exposure in patients requiring antacid therapy
- The interaction between rosuvastatin and other commonly used medications that may affect gastric pH or drug absorption
Practical Considerations for Patients and Healthcare Providers
Managing the potential interaction between rosuvastatin and antacids requires careful consideration and planning. Both patients and healthcare providers play crucial roles in optimizing treatment outcomes.
Strategies for Minimizing Drug Interactions
To minimize the impact of antacids on rosuvastatin efficacy, consider the following strategies:
- Schedule rosuvastatin intake at bedtime and antacid use earlier in the evening
- Explore alternative treatments for acid-related symptoms, such as proton pump inhibitors or H2 receptor antagonists, which may have less interaction with rosuvastatin
- Implement lifestyle modifications to reduce the need for antacids, such as dietary changes and weight management
Monitoring and Follow-up
Regular monitoring and follow-up are essential for patients taking both rosuvastatin and antacids. Healthcare providers should:
- Conduct periodic lipid profile assessments to ensure rosuvastatin efficacy
- Evaluate the ongoing need for antacid therapy and explore alternative treatments if necessary
- Adjust rosuvastatin dosage based on individual patient response and lipid goals
- Encourage open communication with patients about their medication regimen and any challenges they may face
Broader Implications for Pharmacotherapy and Patient Care
The interaction between rosuvastatin and antacids serves as a reminder of the complex nature of pharmacotherapy and the importance of considering potential drug interactions in clinical practice.
Importance of Medication Reconciliation
This study highlights the critical role of medication reconciliation in patient care. Healthcare providers should:
- Regularly review and update patients’ medication lists, including over-the-counter and herbal products
- Use electronic health records and drug interaction databases to identify potential interactions
- Collaborate with pharmacists to optimize medication regimens and minimize adverse effects
Personalized Medicine and Drug Interactions
As we move towards more personalized approaches to medicine, understanding individual variability in drug responses and interactions becomes increasingly important. Future research should focus on:
- Identifying genetic factors that may influence susceptibility to drug interactions
- Developing predictive models to assess the risk and magnitude of drug interactions in individual patients
- Exploring novel drug delivery systems or formulations that may reduce the potential for interactions
- Investigating the role of the gut microbiome in modulating drug absorption and metabolism
In conclusion, the study of rosuvastatin and antacid interactions provides valuable insights into the complexities of pharmacotherapy and the importance of careful medication management. By understanding and addressing these interactions, healthcare providers can optimize treatment outcomes and improve patient care in the management of dyslipidemia and related conditions.
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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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
| 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) | 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) | 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) | 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) | ICD I48.1 |
Recurrent myocardial infarction, unspecified Manual of cardiology (ed. | ICD I22.9 |
| Consequences of cerebral infarction | ICD I69.3 |
Angina | ICD I20.9 |
Juvenile arterial hypertension | ICD I10 |
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)Date added: 07/05/2023
© Compendium 2019
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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.