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5 Interactions found for:

Ozempic and Vitamin D3
Interactions Summary
  • 2 Major
  • 1 Moderate
  • 2 Minor
  • Ozempic
  • Vitamin D3

Drug Interactions

No drug interactions were found for selected drugs: Ozempic, Vitamin D3.

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

Drug and Food Interactions

Moderate
Ozempic + Food

The following applies to the ingredients: Semaglutide (found in Ozempic)

MONITOR: Glucagon-like peptide-1 (GLP-1) receptor agonists and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists can delay gastric emptying, which may impact the absorption of concomitantly administered oral medications. Mild to moderate decreases in plasma concentrations of coadministered drugs have been demonstrated in pharmacokinetic studies for some GLP-1 receptor agonists (e.g., exenatide, lixisenatide), but not others. According to the prescribing information, liraglutide did not affect the absorption of several orally administered drugs to any clinically significant extent, including acetaminophen, atorvastatin, digoxin, griseofulvin, lisinopril, and an oral contraceptive containing ethinyl estradiol-levonorgestrel. Likewise, no clinically relevant effect on absorption was observed for concomitantly administered oral drugs studied with albiglutide (digoxin, ethinyl estradiol-norethindrone, simvastatin, warfarin), dulaglutide (acetaminophen, atorvastatin, digoxin, ethinyl estradiol-norelgestromin, lisinopril, metformin, metoprolol, sitagliptin, warfarin), or semaglutide (atorvastatin, digoxin, ethinyl estradiol-levonorgestrel, metformin, warfarin). The impact of dual GLP-1 and GIP receptor agonist tirzepatide on gastric emptying was reported to be dose- and time-dependent, with the greatest effect observed after a single 5 mg dose but diminished after subsequent doses. When acetaminophen was administered following a single 5 mg dose of tirzepatide, acetaminophen peak plasma concentration (Cmax) was decreased by 50% and its median time to peak plasma concentration (Tmax) delayed by 1 hour. However, no significant impact on acetaminophen Cmax and Tmax was observed after 4 consecutive weekly doses of tirzepatide (5 mg/5 mg/8 mg/10 mg), and the overall exposure (AUC) of acetaminophen was unaffected. Tirzepatide at lower doses of 0.5 mg and 1.5 mg also had minimal effects on acetaminophen exposure.

MANAGEMENT: Although no specific dosage adjustment of concomitant medications is generally recommended based on available data, potential clinical impact on some oral medications cannot be ruled out, particularly those with a narrow therapeutic index or low bioavailability, those that depend on threshold concentrations for efficacy (e.g., antibiotics), and those that require rapid gastrointestinal absorption (e.g., hypnotics, analgesics). Pharmacologic response to concomitantly administered oral medications should be monitored more closely following initiation, dose adjustment, or discontinuation of a GLP-1 receptor agonist or a dual GLP-1 and GIP receptor agonist.

References

  1. "Product Information. Byetta (exenatide)." Amylin Pharmaceuticals Inc (2005):
  2. "Product Information. Victoza (liraglutide)." Novo Nordisk Pharmaceuticals Inc (2010):
  3. "Product Information. Tanzeum (albiglutide)." GlaxoSmithKline (2014):
  4. "Product Information. Trulicity (dulaglutide)." Eli Lilly and Company (2014):
  5. "Product Information. Adlyxin (lixisenatide)." sanofi-aventis (2016):
  6. "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2022):
  7. "Product Information. Mounjaro (tirzepatide)." Eli Lilly and Company Ltd (2023):
  8. "Product Information. Mounjaro (tirzepatide)." Lilly, Eli and Company (2023):
  9. Eli Lilly Canada Inc. "Product monograph including patient medication information MOUNJARO tirzepatide injection. https://pdf.hres.ca/dpd_pm/00068421.PDF" (2023):

Drug and Pregnancy Interactions

The following applies to the ingredients: Semaglutide (found in Ozempic)

Benefit should outweigh risk

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

Risk summary: Available data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other maternal or fetal outcomes; based on animal data, there may be potential risks to the fetus from exposure during pregnancy. Additionally weight loss offers no benefit to a pregnant patient and may cause fetal harm.

Comments:
-Poorly controlled diabetes during pregnancy is associated with both maternal and fetal risks.
-When pregnancy is recognized for a women on Wegovy, this drug should be discontinued and the patient should be advised of the risk to a fetus.
-Women of childbearing potential should be encouraged to use contraception during therapy; if pregnancy is desired, stop treatment at least 2 months prior to a planned pregnancy due to its long washout period.
-A pregnancy registry has been created to monitor pregnancy outcomes in women exposed to semaglutide (Wegovy) during pregnancy; pregnant women exposed to Wegovy and healthcare providers are encourage to contact Novo Nordisk at 1-800-727-6500.

Studies in pregnant rats have shown embryofoetal mortality, structural abnormalities, and alterations to growth when administered during organogenesis at maternal exposures below the maximum recommended human dose (MRHD). Early pregnancy losses and structural abnormalities were observed in rabbits at doses below the MRHD. In cynomolgus monkeys, early pregnancy losses and structural abnormalities were observed at exposures of 10-fold or higher that of the MRHD. In rabbits and monkeys, these finding coincided with marked maternal body weight loss. Salcaprozate sodium (SNAC), an absorption enhancer in the oral tablet has been shown to cross the placenta and reach fetal tissue in rats. Administration of SNAC to pregnant rats has shown an increase in number of stillbirths and a decrease in pup viability. There are no adequate and well-controlled studies in pregnant women.

Clinical considerations:
-Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. In the US, the estimated background risk of major birth defects in women with pregestational diabetes with an HbA1c greater than 7 is 6% to 10%; in women with pregestational diabetes and a HbA1c greater than 10, this risk has been reported as 20% to 25%.
-Appropriate weight gain based on pre-pregnancy weight is recommended for all pregnant patients because of the obligatory weight gain that occurs in maternal tissues during pregnancy.

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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2022):
  4. "Product Information. Rybelsus (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2021):
  5. "Product Information. Wegovy (0.25 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc ORIG-1 (2021):

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: Semaglutide (found in Ozempic)

Oral Administration: Not recommended
Subcutaneous Administration: Benefit should outweigh risk

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

Comments:
-Oral tablets: Breastfeeding is not recommended with maternal use of the oral tablet due to the possible accumulation of the absorption enhancer (salcaprozate sodium) in breastfed infant; if therapy is necessary, the subcutaneous injection should be used.
-Subcutaneous injection: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.
-Some authorities advise against semaglutide use during lactation as a risk to the breastfed child cannot be excluded.

Subcutaneous formulation: In lactating rats, this drug was detected in milk at levels 3 to 12-fold lower than maternal plasma. There are no data on the presence of this drug in human milk, the effects on milk production, or the effects on the breastfed infant. It is assumed that because this drug is a peptide molecule and is over 99% protein bound, if excreted, the amount in milk would be low. Additionally, it is believed that if excreted in milk, infant absorption would be unlikely as it would probably be destroyed in the infant's gastrointestinal tract.

Oral Tablet: Salcaprozate sodium (SNAC) is present in the oral formulation as an absorption enhancer. SNAC and/or its metabolites have been found in concentrated quantities in the milk of lactating rats. There are no data in the presence of SNAC in human milk, however, the enzyme needed to clear SNAC (UGT2B7) is lower in infants compared to adults and therefore higher SNAC plasma levels may occur in breastfed infants. The potential for serious adverse reactions due to accumulation of SNAC are unknown.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
  4. "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2022):
  5. "Product Information. Rybelsus (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2021):

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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