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5 Interactions found for:

Plavix and Crestor
Interactions Summary
  • 5 Major
  • 0 Moderate
  • 0 Minor
  • Plavix
  • Crestor

Drug Interactions

Major
Plavix + Crestor

The following applies to the ingredients: Clopidogrel (found in Plavix) and Rosuvastatin (found in Crestor)

ADJUST DOSE: Coadministration with clopidogrel may increase the plasma concentrations of drugs that are substrates of the breast cancer resistance protein (BCRP) such as rosuvastatin. The proposed mechanism is decreased rosuvastatin clearance due to inhibition of BCRP-mediated intestinal and hepatic transport by clopidogrel and its metabolite. In 20 patients with stable coronary artery disease, administration of rosuvastatin 40 mg daily with a 300 mg loading dose of clopidogrel increased rosuvastatin peak plasma concentration (Cmax) and systemic exposure (AUC) by 1.3- and 2.0-fold, respectively. Following continued administration of rosuvastatin with clopidogrel 75 mg daily for 7 days, rosuvastatin AUC was increased by 1.4-fold while Cmax was not significantly altered. High levels of HMG-CoA reductase inhibitory activity in plasma are associated with an increased risk of musculoskeletal toxicity. Myopathy manifested as muscle pain and/or weakness associated with grossly elevated creatine kinase exceeding ten times the upper limit of normal has been reported occasionally. Rhabdomyolysis has also occurred rarely, which may be accompanied by acute renal failure secondary to myoglobinuria and may result in death. Isolated cases of suspected rosuvastatin-induced hepatotoxicity have also been reported in patients concomitantly treated with clopidogrel.

MANAGEMENT: When concomitant use of clopidogrel is required, the lowest possible starting dosage or a reduction of the existing dosage of rosuvastatin should be considered. Some authorities recommend not exceeding 20 mg/day of rosuvastatin when prescribed with clopidogrel. Alternatively, a different HMG-CoA reductase inhibitor that is not a substrate for BCRP (e.g., fluvastatin, pitavastatin, pravastatin, simvastatin) may be considered. Patients should be advised to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Rosuvastatin should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed.

References

  1. "Product Information. Ach-Rosuvastatin (rosuvastatin)." Accord Healthcare Inc (2023):
  2. "Product Information. Rosuvastatin (rosuvastatin)." Milpharm Ltd (2023):
  3. "Product Information. Rosuvastatin (Pharmacor) (rosuvastatin)." Pharmacor Pty Ltd (2020):
  4. "Product Information. ACT Clopidogrel (clopidogrel)." Teva Canada Limited (2022):
  5. "Product Information. Plavix (clopidogrel)." Sanofi (2023):
  6. "Product Information. Clopidogrel (Lupin) (clopidogrel)." Generic Health Pty Ltd (2023):
  7. Pinheiro LF, Franca CN, Izar MC, et al. "Pharmacokinetic interactions between clopidogrel and rosuvastatin: effects on vascular protection in subjects with coronary heart disease." Int J Cardiol 158 (2012): 125-9

Drug and Food Interactions

No food interactions were found for selected drugs: Plavix, Crestor.

This does not necessarily mean no interactions exist. Always consult your healthcare provider.

Drug and Pregnancy Interactions

The following applies to the ingredients: Clopidogrel (found in Plavix)

Use is not recommended. When possible, discontinue this drug 5 to 7 days prior to labor, delivery, or neuraxial blockade.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary: Available data from cases reported in published literature and postmarketing surveillance have not identified an association with use of this drug in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes.

While this drug is known to cross the placenta, animal studies have failed to reveal evidence of fetal harm. Reproduction studies performed in rats and rabbits at doses of 500 and 300 mg/kg/day (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis) revealed no evidence of impaired fertility or fetotoxicity. There are no controlled data in human pregnancy.

Use of this drug during labor or delivery will increase the risk of maternal bleeding and hemorrhage. Avoid neuraxial blockade during use of this drug.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

References

  1. "Product Information. Plavix (clopidogrel)." Bristol-Myers Squibb PROD (2001):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

The following applies to the ingredients: Rosuvastatin (found in Crestor)

Contraindicated

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Safety in pregnant women has not been established and there is no apparent benefit to use during pregnancy. Because HMG-CoA reductase inhibitors (statins) decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, this drug may cause fetal harm during pregnancy.

Comments:
-This drug should be discontinued as soon as pregnancy is recognized, and the patient should be apprised of the potential harm to the fetus.
-Women of childbearing potential should use adequate methods of contraception during therapy.

Animal studies have failed to reveal evidence of teratogenicity in doses approximating the maximum human dose of 40 mg/day. Limited published data has not shown an increased risk of major congenital malformations or miscarriage, although there have been rare reports of congenital anomalies following intrauterine exposure to other statins. Several cases of serious fetal abnormalities were reported in 2 series of 178 and 143 cases among pregnant women taking a HMG-CoA reductase inhibitor (statin) during the first trimester of pregnancy. These included limb and neurological defects, spontaneous abortions and fetal deaths. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. There are no controlled data in human pregnancy.

Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hyperlipidemia therapy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

References

  1. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf" (2007):
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Drug and Breastfeeding Interactions

The following applies to the ingredients: Clopidogrel (found in Plavix)

This drug has been used without apparent harmful effects. However, use is not recommended or contraindicated per some authorities. Benefit should outweigh risk in case of use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

References

  1. "Product Information. Plavix (clopidogrel)." Bristol-Myers Squibb PROD (2001):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

The following applies to the ingredients: Rosuvastatin (found in Crestor)

Contraindicated

Excreted into human milk: Yes (in low amounts)

Comments:
-Due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism, women who require treatment with this drug should not breastfeed.

References

  1. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):

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.

Switch to: Consumer Interactions

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.

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