Rosuvastatin and Antacids: Impact on Pharmacokinetics and Clinical Implications
How does a combination antacid containing aluminium hydroxide and magnesium hydroxide affect rosuvastatin pharmacokinetics. What are the clinical implications of co-administering rosuvastatin with antacids. How can healthcare providers optimize rosuvastatin efficacy when antacids are necessary.
Understanding Rosuvastatin: A Powerful HMG-CoA Reductase Inhibitor
Rosuvastatin is a potent member of the statin class of medications, widely prescribed for the management of dyslipidemia. As a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, it plays a crucial role in reducing cholesterol levels and improving cardiovascular health. However, its effectiveness can be influenced by various factors, including interactions with other medications and supplements.
Key Features of Rosuvastatin
- Potent HMG-CoA reductase inhibitor
- Effectively lowers LDL cholesterol
- Reduces risk of cardiovascular events
- Commonly prescribed for dyslipidemia management
Can the efficacy of rosuvastatin be affected by common over-the-counter medications? This question is particularly relevant when considering antacids, which are frequently used by patients with gastrointestinal issues.
The Interaction Between Rosuvastatin and Antacids: A Closer Look
A clinical trial conducted by Paul D Martin and colleagues aimed to investigate the potential interaction between rosuvastatin and a combination antacid preparation containing aluminium hydroxide and magnesium hydroxide. This study provides valuable insights into how these commonly used medications may affect each other when administered concurrently.
Study Design and Methodology
The researchers employed a randomized, open-label, three-way crossover trial design to assess the impact of antacids on rosuvastatin pharmacokinetics. Fourteen healthy male volunteers participated in the study, which involved three separate dosing scenarios:
- 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
Each dosing scenario was separated by a washout period of at least 7 days to ensure complete elimination of the previous dose. This design allowed for a comprehensive evaluation of the interaction between rosuvastatin and antacids under different timing conditions.
Pharmacokinetic Parameters: Assessing the Impact of Antacids
The primary focus of the study was to determine how antacids affect the pharmacokinetics of rosuvastatin. Two key parameters were examined:
- 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 parameters provide crucial information about the drug’s bioavailability and absorption when administered with and without antacids. How significant was the impact of antacids on rosuvastatin’s pharmacokinetics?
Significant Findings: The Impact of Simultaneous Antacid Administration
The results of the study revealed a substantial interaction between rosuvastatin and antacids when administered simultaneously. The data showed:
- 54% reduction in rosuvastatin AUC(0-t) (90% confidence interval [CI]: 0.40-0.53)
- 50% reduction in rosuvastatin C(max) (90% CI: 0.41-0.60)
These findings indicate that when taken together, antacids significantly reduce the systemic exposure to rosuvastatin by approximately 50%. This reduction in bioavailability could potentially compromise the therapeutic efficacy of rosuvastatin in managing dyslipidemia.
Clinical Implications of Reduced Rosuvastatin Exposure
The substantial decrease in rosuvastatin bioavailability when co-administered with antacids raises important clinical considerations. Healthcare providers and patients should be aware of this interaction to ensure optimal treatment outcomes. Potential consequences of reduced rosuvastatin exposure may include:
- Diminished cholesterol-lowering effects
- Suboptimal cardiovascular risk reduction
- Need for dose adjustments or alternative administration strategies
Is there a way to mitigate this interaction while still allowing patients to use both medications when necessary?
Mitigating the Interaction: The Effect of Separated Administration
Recognizing the potential for interaction, the researchers also investigated the impact of administering antacids 2 hours after rosuvastatin. This approach yielded more favorable results:
- 22% reduction in rosuvastatin AUC(0-t) (90% CI: 0.68-0.90)
- 16% reduction in rosuvastatin C(max) (90% CI: 0.70-1.01)
While there was still a reduction in rosuvastatin exposure, the magnitude of the interaction was significantly less pronounced compared to simultaneous administration. This finding suggests that separating the administration of rosuvastatin and antacids by at least 2 hours can help preserve the statin’s therapeutic efficacy.
Practical Implications for Patient Care
Based on these results, healthcare providers can offer practical guidance to patients who require both rosuvastatin and antacids:
- Advise patients to take rosuvastatin at least 2 hours before antacids
- Consider alternative timing strategies for antacid administration
- Monitor lipid levels closely in patients using both medications
- Adjust rosuvastatin dosage if necessary, based on individual patient response
By implementing these strategies, clinicians can help ensure that patients receive the full benefits of rosuvastatin therapy while managing gastrointestinal symptoms with antacids when needed.
Limitations and Future Research Directions
While this study provides valuable insights into the interaction between rosuvastatin and antacids, it’s important to acknowledge its limitations and consider areas for future research:
- The study focused on single-dose administration of rosuvastatin
- Long-term effects of repeated antacid use were not evaluated
- The study population consisted of healthy male volunteers
- Only one specific antacid formulation was tested
Future studies could address these limitations by investigating:
- The impact of chronic antacid use on rosuvastatin pharmacokinetics
- Potential differences in the interaction among diverse patient populations
- The effects of various antacid formulations on rosuvastatin absorption
- Strategies to further minimize the interaction while maintaining therapeutic efficacy
How might the results differ in patients with existing cardiovascular disease or those requiring long-term antacid therapy?
Broader Implications for Medication Management
The findings of this study highlight the importance of considering potential drug-drug interactions in clinical practice, particularly when dealing with commonly used medications like statins and antacids. This research underscores several key points for healthcare providers and patients:
- The need for comprehensive medication reviews
- The importance of patient education regarding proper medication administration
- The value of pharmacokinetic studies in optimizing drug therapy
- The potential for seemingly benign over-the-counter medications to affect prescription drug efficacy
By raising awareness of these interactions, healthcare providers can make more informed decisions and provide better guidance to patients, ultimately improving treatment outcomes and patient safety.
Implications for Other Medications
While this study focused specifically on rosuvastatin, the findings may have implications for other medications that could potentially interact with antacids. Healthcare providers should consider similar precautions when prescribing other drugs that may be affected by changes in gastric pH or chelation with metal ions present in antacids.
Do other statins or lipid-lowering medications exhibit similar interactions with antacids? This question warrants further investigation to ensure optimal management of dyslipidemia across various treatment regimens.
Conclusion: Balancing Efficacy and Safety in Rosuvastatin Therapy
The study by Paul D Martin and colleagues provides crucial insights into the interaction between rosuvastatin and antacids containing aluminium hydroxide and magnesium hydroxide. The key takeaways from this research include:
- Simultaneous administration of rosuvastatin and antacids can significantly reduce rosuvastatin bioavailability
- Separating the administration of rosuvastatin and antacids by at least 2 hours can mitigate this interaction
- Healthcare providers should be aware of this potential interaction and counsel patients accordingly
- Individualized approaches to medication management may be necessary for patients requiring both rosuvastatin and antacids
By understanding and addressing this interaction, clinicians can help ensure that patients receive the full benefits of rosuvastatin therapy while managing other health concerns that may require antacid use. This research underscores the importance of considering potential drug-drug interactions in clinical practice and highlights the need for ongoing studies to optimize medication management strategies.
As our understanding of pharmacokinetics and drug interactions continues to evolve, healthcare providers must stay informed and adapt their prescribing practices to provide the best possible care for their patients. By balancing the efficacy of rosuvastatin with the potential for interactions, clinicians can help patients achieve their lipid-lowering goals while minimizing the risk of adverse effects or reduced therapeutic benefit.
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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Crestor (Rosuvastatin) – Side Effects, Interactions, Uses, Dosage, Warnings
uses
What is Crestor (Rosuvastatin) used for?
- Hyperlipidemia
- Hyperlipoproteinemia Type III (Elevated beta-VLDL + IDL)
- Homozygous Familial Hypercholesterolemia
- Hypertriglyceridemia
- Atherosclerosis
- Prevention of Cardiovascular Disease
- Heterozygous Familial Hypercholesterolemia
warnings
What is the most important information I should know about Crestor (Rosuvastatin)?
You should not take rosuvastatin if you are allergic to it, or if you have:
- liver disease; or
- if you are pregnant or breast-feeding.
Do not take rosuvastatin if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are taking rosuvastatin. Stop taking rosuvastatin and tell your doctor right away if you become pregnant.
Do not breastfeed while you are taking rosuvastatin.
Tell your doctor if you have ever had:
- liver problems;
- kidney disease;
- a thyroid disorder;
- a habit of drinking more than 2 alcoholic beverages per day;
- if you are of Asian descent; or
- if you are 65 or older.
Rosuvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).
People of Asian descent may absorb rosuvastatin at a higher rate than other people. Make sure your doctor knows if you are Asian. You may need a lower than normal starting dose.
User Reviews & Rating
Overall rating for Crestor (Rosuvastatin)
2.6
out of 5
Side Effects
Easy to Use
Effectiveness
Read Crestor (Rosuvastatin) Reviews
Side Effects
What are the side effects of Crestor (Rosuvastatin)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- unexplained muscle pain, tenderness, or weakness;
- muscle weakness in your hips, shoulders, neck, and back;
- trouble lifting your arms, trouble climbing or standing;
- confusion, memory problems; or
- liver problems–upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- headache;
- weakness;
- muscle aches; or
- nausea, stomach pain.
This is not a complete list of side effects and others may occur.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Crestor (Rosuvastatin) if I’m pregnant or breastfeeding?
Contraindicated in pregnancy
Based on FDA pregnancy categories
Do not take rosuvastatin if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are taking rosuvastatin. Stop taking rosuvastatin and tell your doctor right away if you become pregnant.
Do not breastfeed while you are taking rosuvastatin.
Interactions
What drugs and food should I avoid while taking Crestor (Rosuvastatin)?
Avoid eating foods high in fat or cholesterol, or rosuvastatin will not be as effective.
Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.
Some antacids can make it harder for your body to absorb rosuvastatin.
Avoid taking an antacid that contains aluminum or magnesium within 2 hours after taking rosuvastatin.
Dosage Guidelines & Tips
How to take Crestor (Rosuvastatin)?
Use Crestor (Rosuvastatin) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
What should I do if I missed a dose of Crestor (Rosuvastatin)?
Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Crestor (Rosuvastatin)?
If you think you or someone else may have overdosed on: Crestor (Rosuvastatin), call your doctor or the Poison Control center
(800) 222-1222
If someone collapses or isn’t breathing after taking Crestor (Rosuvastatin), call 911
911
What to Expect
Rosuvastatin starts to lower cholesterol levels within about a week, but it may take up to a month before it works completely.
You may have to stay on rosuvastatin for the rest of your life. You’ll only experience the benefits while you take this medicine. Your cholesterol levels may go back up if you stop using rosuvastatin.
Secondary Uses
Statins, including rosuvastatin, have been studied or used to treat other medical conditions that they aren’t FDA-approved for. For example, rosuvastatin is sometimes given to patients after a heart or kidney transplant to improve outcomes.
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CRESTOR 10
Color: pink
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Form: film coated
Imprint: CRESTOR 10
CRESTOR 20
Color: pink
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Imprint: CRESTOR 20
CRESTOR, 40
Color: pink
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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.