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6 Interactions found for:

Crestor and Vitamin D3
Interactions Summary
  • 2 Major
  • 1 Moderate
  • 3 Minor
  • Crestor
  • Vitamin D3

Drug Interactions

Minor
Vitamin D3 + Crestor

The following applies to the ingredients: Cholecalciferol (found in Vitamin D3) and Rosuvastatin (found in Crestor)

Coadministration of statins and vitamin D analogs may influence the pharmacologic effects of both agents. Some statins, such as atorvastatin, rosuvastatin, simvastatin and lovastatin, have been shown to increase serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels. In addition, vitamin D supplementation may decrease atorvastatin concentrations, but preserve its cholesterol-lowering efficacy. There is also evidence for a synergistic effect between statins and vitamin D in lowering cholesterol levels and reducing statin-related muscle adverse reactions, particularly in patients with vitamin D deficiency.

References

  1. "Product Information. Domnisol (calcifediol)." Flynn Pharma Ltd (2023):
  2. schwartz db "Effects of Vitamin D Supplementation in Atorvastatin-Treated Patients: A New Drug Interaction With an Unexpected Consequence" Clin Pharmacol and Therapeutic 75 (2009): 198-203
  3. Ertugrul, DT "STATIN-D Study: Comparison of the Influences of Rosuvastatin and Fluvastatin Treatment on the levels of 25 Hydroxyvitamin D" Cardiovasc Ther 29 (2011): 146-152
  4. Bhattacharyya S "Possible mechanisms of interaction between statins and vitamin D" Qjm Mon J Assoc Physician 105 (2012): 487-491
  5. wilding p "Cardiovascular disease, statins and vitamin D" Br J Nurs 21 (2012): 214-7
  6. Sathyapalan T "Atorvastatin Increases 25-Hydroxy Vitamin D Concentrations in Patients with Polycystic Ovary Syndrome" Clin Chem 56 (2010): 1696-1700
  7. wilczek he "Monitoring plasma levels of vitamin D metabolites in simvastatin (Zocor) therapy in patients with familial hypercholesterolemia" Cas Lek Cesk 133 (1994): 727-9
  8. Vybhav J "Safety of 50,000-100,000 Units of Vitamin D3/Week in Vitamin D-Deficient, Hypercholesterolemic Patients with Reversible Statin Intolerance" N Am J Med Sci 8 (2016): 156-162
  9. wilczek he "Iatropathogenic effect of Mevacor on vitamin D metabolism" Cas Lek Cesk 128 (1989): 1254-1256

Drug and Food Interactions

Moderate
Vitamin D3 + Food

The following applies to the ingredients: Cholecalciferol (found in Vitamin D3)

MONITOR: Additive effects and possible toxicity (e.g., hypercalcemia, hypercalciuria, and/or hyperphosphatemia) may occur when patients using vitamin D and/or vitamin D analogs ingest a diet high in vitamin D, calcium, and/or phosphorus. The biologically active forms of vitamin D stimulate intestinal absorption of calcium and phosphorus. This may be helpful in patients with hypocalcemia and/or hypophosphatemia. However, sudden increases in calcium or phosphorus consumption due to dietary changes could precipitate hypercalcemia and/or hyperphosphatemia. Patients with certain disease states, such as impaired renal function, may be more susceptible to toxic side effects like ectopic calcification. On the other hand, if dietary calcium is inadequate for the body's needs, the active form of vitamin D will stimulate osteoclasts to pull calcium from the bones. This may be detrimental in a patient with reduced bone density.

MONITOR: Grapefruit or grapefruit juice may alter the plasma concentrations of vitamin D analogs due to CYP450 3A4 inhibition. For analogs partially metabolized by CYP450 3A4, such as calcitriol, inhibitors can increase plasma concentrations, thereby elevating the risk of adverse effects like hypercalcemia and hyperphosphatemia. For prodrug analogs, such as calcifediol and doxercalciferol, CYP450 3A4 inhibition may affect activation and metabolic pathways, leading to variable net effects depending on the specific agent and individual patient factors. The effects of CYP450 3A4 inhibition on native vitamin D (cholecalciferol and ergocalciferol) are not noted. Clinical manifestations of such interactions may include alterations in serum calcium, phosphate, and parathyroid hormone (PTH) levels. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Pharmacokinetic interactions involving grapefruit juice are also subject to a high degree of interpatient variability, thus the extent to which a given patient may be affected is difficult to predict.

MANAGEMENT: Given the narrow therapeutic index of vitamin D and vitamin D analogs, the amounts of calcium, phosphorus, and vitamin D present in the patient's diet, as well as grapefruit consumption may need to be taken into consideration. Specific dietary guidance should be discussed with the patient and regular lab work should be monitored as indicated. Calcium, phosphorus, and vitamin D levels should be kept within the desired ranges, which may differ depending on the patient's condition. Patients should also be counseled on the signs and symptoms of hypervitaminosis D, hypercalcemia, and/or hyperphosphatemia.

References

  1. "Product Information. Drisdol (ergocalciferol)." Validus Pharmaceuticals LLC (2023):
  2. "Product Information. Fultium-D3 (colecalciferol)." Internis Pharmaceuticals Ltd (2024):
  3. "Product Information. Ostelin Specialist Range Vitamin D (colecalciferol)." Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare (2024):
  4. "Product Information. Rocaltrol (calcitriol)." Atnahs Pharma UK Ltd (2021):
  5. "Product Information. Calcitriol (calcitriol)." Strides Pharma Inc. (2019):
  6. "Product Information. Calcitriol (GenRx) (calcitriol)." Apotex Pty Ltd (2024):
  7. "Product Information. Ergocalciferol (ergocalciferol)." RPH Pharmaceuticals AB (2022):
  8. "Product Information. Sandoz D (cholecalciferol)." Sandoz Canada Incorporated (2020):
  9. Fischer V, Haffner-Luntzer M, Prystaz K, et al. "Calcium and vitamin-D deficiency marginally impairs fracture healing but aggravates posttraumatic bone loss in osteoporotic mice. https://www.nature.com/articles/s41598-017-07511-2" (2024):
  10. National Institutes of Health Office of Dietary Supplements "Vitamin D https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/#h37" (2024):

Drug and Pregnancy Interactions

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

The following applies to the ingredients: Cholecalciferol (found in Vitamin D3)

Use is not recommended unless there is a deficiency.

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

Comments:
-Vitamin D supplementation should begin a few months prior to pregnancy.

Animal studies at high doses have shown teratogenicity. There are no controlled data in human pregnancy. Because vitamin D raises calcium levels, it is suspect in the pathogenesis of supravalvular aortic stenosis syndrome, which is often associated with idiopathic hypercalcemia of infancy, but excessive vitamin D intake or retention has not been found consistently in these mothers. A study of 15 patients with maternal hypoparathyroidism, treated with high dose vitamin D during pregnancy (average 107,000 international units per day) to maintain normal calcium levels, produced all normal children. Vitamin D deficiency is associated with reduced fetal growth, neonatal hypocalcemia (with and without convulsions), rickets, and defective tooth enamel.

AU TGA pregnancy category Exempt: Medicines exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm" (2010):
  4. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health (2015):

Drug and Breastfeeding Interactions

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):

The following applies to the ingredients: Cholecalciferol (found in Vitamin D3)

Use is not recommended unless the clinical condition of the woman requires treatment.

Excreted into human milk: Yes

Comments:
-Make allowance for any maternal dose if prescribing this product to a breast fed infant.
-Consider monitoring the infant's serum calcium if the mother is receiving pharmacologic doses of vitamin D.
-Vitamin D supplementation is recommended in exclusively breast fed infants.

The required dose of vitamin D during lactation has not been adequately studied; doses similar to those for pregnant women have been suggested.

Chronic ingestion of large doses of vitamin D by the mother may lead to hypercalcemia in the breastfed infant.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health (2015):
  4. IOM (Institute of Medicine). "Dietary Reference Intakes for Calcium and Vitamin D." Washington, DC: The National Academies Press (2011):

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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