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6 Interactions found for:

Januvia and atorvastatin
Interactions Summary
  • 4 Major
  • 2 Moderate
  • 0 Minor
  • Januvia
  • atorvastatin

Drug Interactions

No drug interactions were found for selected drugs: Januvia, atorvastatin.

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

Drug and Food Interactions

Moderate
Atorvastatin + Food

The following applies to the ingredients: Atorvastatin

GENERALLY AVOID: Coadministration with grapefruit juice may increase the plasma concentrations of atorvastatin. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. When a single 40 mg dose of atorvastatin was coadministered with 240 mL of grapefruit juice, atorvastatin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 16% and 37%, respectively. Greater increases in Cmax (up to 71%) and/or AUC (up to 2.5 fold) have been reported with excessive consumption of grapefruit juice (>=750 mL to 1.2 liters per day). Clinically, high levels of HMG-CoA reductase inhibitory activity in plasma is 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.

ADJUST DOSING INTERVAL: Fibres such as oat bran and pectin may diminish the pharmacologic effects of HMG-CoA reductase inhibitors by interfering with their absorption from the gastrointestinal tract.

MANAGEMENT: Patients receiving therapy with atorvastatin should limit their consumption of grapefruit juice to no more than 1 liter per day. Patients should be advised to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by fever, malaise and/or dark colored urine. Therapy should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed. In addition, patients should either refrain from the use of oat bran and pectin or, if concurrent use cannot be avoided, to separate the administration times by at least 2 to 4 hours.

References

  1. Richter WO, Jacob BG, Schwandt P "Interaction between fibre and lovastatin." Lancet 338 (1991): 706
  2. McMillan K "Considerations in the formulary selection of hydroxymethylglutaryl coenzyme a reductase inhibitors." Am J Health Syst Pharm 53 (1996): 2206-14
  3. "Product Information. Lipitor (atorvastatin)." Parke-Davis PROD (2001):
  4. Boberg M, Angerbauer R, Fey P, Kanhai WK, Karl W, Kern A, Ploschke J, Radtke M "Metabolism of cerivastatin by human liver microsomes in vitro. Characterization of primary metabolic pathways and of cytochrome P45 isozymes involved." Drug Metab Dispos 25 (1997): 321-31
  5. Bailey DG, Malcolm J, Arnold O, Spence JD "Grapefruit juice-drug interactions." Br J Clin Pharmacol 46 (1998): 101-10
  6. Lilja JJ, Kivisto KT, Neuvonen PJ "Grapefruit juice increases serum concentrations of atorvastatin and has no effect on pravastatin." Clin Pharmacol Ther 66 (1999): 118-27
  7. Neuvonen PJ, Backman JT, Niemi M "Pharmacokinetic comparison of the potential over-the-counter statins simvastatin, lovastatin, fluvastatin and pravastatin." Clin Pharmacokinet 47 (2008): 463-74

Moderate
Januvia + Food

The following applies to the ingredients: Sitagliptin (found in Januvia)

GENERALLY AVOID: Alcohol may cause hypoglycemia or hyperglycemia in patients with diabetes. Hypoglycemia most frequently occurs during acute consumption of alcohol. Even modest amounts can lower blood sugar significantly, especially when the alcohol is ingested on an empty stomach or following exercise. The mechanism involves inhibition of both gluconeogenesis as well as the counter-regulatory response to hypoglycemia. Episodes of hypoglycemia may last for 8 to 12 hours after ethanol ingestion. By contrast, chronic alcohol abuse can cause impaired glucose tolerance and hyperglycemia. Moderate alcohol consumption generally does not affect blood glucose levels in patients with well controlled diabetes. A disulfiram-like reaction (e.g., flushing, headache, and nausea) to alcohol has been reported frequently with the use of chlorpropamide and very rarely with other sulfonylureas.

MANAGEMENT: Patients with diabetes should avoid consuming alcohol if their blood glucose is not well controlled, or if they have hypertriglyceridemia, neuropathy, or pancreatitis. Patients with well controlled diabetes should limit their alcohol intake to one drink daily for women and two drinks daily for men (1 drink = 5 oz wine, 12 oz beer, or 1.5 oz distilled spirits) in conjunction with their normal meal plan. Alcohol should not be consumed on an empty stomach or following exercise.

References

  1. Jerntorp P, Almer LO "Chlorpropamide-alcohol flushing in relation to macroangiopathy and peripheral neuropathy in non-insulin dependent diabetes." Acta Med Scand 656 (1981): 33-6
  2. Jerntorp P, Almer LO, Holin H, et al. "Plasma chlorpropamide: a critical factor in chlorpropamide-alcohol flush." Eur J Clin Pharmacol 24 (1983): 237-42
  3. Barnett AH, Spiliopoulos AJ, Pyke DA, et al. "Metabolic studies in chlorpropamide-alcohol flush positive and negative type 2 (non-insulin dependent) diabetic patients with and without retinopathy." Diabetologia 24 (1983): 213-5
  4. Hartling SG, Faber OK, Wegmann ML, Wahlin-Boll E, Melander A "Interaction of ethanol and glipizide in humans." Diabetes Care 10 (1987): 683-6
  5. "Product Information. Diabinese (chlorpropamide)." Pfizer U.S. Pharmaceuticals PROD (2002):
  6. "Product Information. Glucotrol (glipizide)." Pfizer U.S. Pharmaceuticals PROD (2002):
  7. "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  8. Skillman TG, Feldman JM "The pharmacology of sulfonylureas." Am J Med 70 (1981): 361-72
  9. "Position Statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes related complications. American Diabetes Association." Diabetes Care 25(Suppl 1) (2002): S50-S60
  10. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Drug and Pregnancy Interactions

The following applies to the ingredients: Atorvastatin

According to some authorities: Use is contraindicated during pregnancy or in patients of childbearing potential not using contraception.

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

Risk summary: Based on its mechanism of action, this drug may cause fetal harm when administered during pregnancy.
-Available data on the use of statins in pregnant women have not identified a drug-related risk of major congenital malformations and are insufficient to inform a drug-related risk of miscarriage.

Comments:
-If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient should be apprised of the potential harm to the fetus.
---According to some authorities: Alternatively, the ongoing needs of the individual patient should be considered.
-According to some authorities: Patients of childbearing potential should use effective contraception during therapy; this drug should be used in patients of childbearing potential only when they are highly unlikely to conceive and have been informed of the potential.

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity; however, at maternally toxic doses, increased postimplantation loss and decreased fetal body weights have been observed. No adverse developmental effects were observed in pregnant rats or rabbits administered oral doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg (based on body surface area [mg/m2]); in rats administered this drug during gestation and lactation, decreased postnatal growth and development delay were observed at doses at least 6 times the MRHD. This drug crosses the rat placenta and reaches levels in the fetal liver equivalent to that of maternal plasma. A study of statin-exposed pregnant women compared to controls did not find a significant teratogenic effect from maternal use of statins in the first trimester, after adjusting for potential confounders. Rare cases of congenital anomalies after intrauterine exposure to HMG-CoA reductase inhibitors have been reported. There are no controlled data in human pregnancy.

Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Because this drug decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol, it may cause fetal harm when used during pregnancy.

Treatment of hyperlipidemia is not generally necessary during pregnancy. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term primary hypercholesterolemia therapy for most patients.

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. Lipitor (atorvastatin)." Viatris Specialty LLC SUPPL-81 (2024):
  2. "Product Information. Atorvaliq (atorvastatin)." Carolina Medical Products Company SUPPL-2 (2024):
  3. "Product Information. Lipitor (atorvastatin)." Aspen Pharmacare Australia Pty Ltd (2023):
  4. "Product Information. Lorstat (atorvastatin)." Alphapharm Pty Ltd (2024):
  5. "Product Information. Lipitor (atorvastatin)." Viatris UK Healthcare Ltd (2024):
  6. "Product Information. Atorvastatin (atorvastatin)." Rosemont Pharmaceuticals Ltd (2024):

The following applies to the ingredients: Sitagliptin (found in Januvia)

Use is not recommended unless the benefit outweighs the risk to the fetus

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Limited data available with this drug in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; there are risks to the mother and fetus associated with poorly controlled diabetes during pregnancy.

Comments: In the US, Merck Sharp & Dohme Corporation maintains a pregnancy registry to monitor pregnancy outcomes of women exposed to this drug while pregnant; health care providers are encouraged to report any prenatal exposure (1-800-989-8999).

Studies in rats and rabbits with doses approximately 30 and 20-times the maximum recommended human dose (MRHD), respectively did not adversely affect developmental outcomes. At doses up to 100 times MRHD, an increase in the incidence of rib malformations was observed. Placental transfer was observed in pregnant rats and rabbits. There are no adequate and well-controlled studies in pregnancy women.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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. "Product Information. Januvia (sitagliptin)." Merck & Co., Inc (2006):
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Drug and Breastfeeding Interactions

The following applies to the ingredients: Atorvastatin

Until more data are available, an alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is not recommended during use of this drug.
-According to some authorities: Use is contraindicated.

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

Comments:
-Another drug in this class is excreted into human milk.
-Statins (including this drug) decrease synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; they may cause harm to the breastfed infant.
-The effects in the nursing infant are unknown; based on the mechanism of action, there is the potential for serious adverse reactions in nursing infants.

Due to a concern over disruption of infant lipid metabolism, it is generally agreed that women taking a statin should not breastfeed; however, others have argued that children homozygous for familial hypercholesterolemia are treated with statins starting at 1 year of age, statins have low oral bioavailability, and risks to the breastfed infant are low. Some evidence indicates that this drug can be taken by nursing mothers with no obvious developmental problems in their infants.

In cases of patients with homozygous familial hypercholesterolemia, 6 patients breastfed 11 infants after restarting statin therapy postpartum; the specific statin was not reported, but most of the women on statin therapy were using this drug (40 or 80 mg/day). Normal early child development was reported for all offspring; children started school at the appropriate age with no learning difficulties reported.

References

  1. Bethesda (MD): National Institute of Child Health and Human Development (US) "Atorvastatin - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK501361/" (2024):
  2. "Product Information. Lipitor (atorvastatin)." Viatris Specialty LLC SUPPL-81 (2024):
  3. "Product Information. Atorvaliq (atorvastatin)." Carolina Medical Products Company SUPPL-2 (2024):
  4. "Product Information. Lipitor (atorvastatin)." Aspen Pharmacare Australia Pty Ltd (2023):
  5. "Product Information. Lorstat (atorvastatin)." Alphapharm Pty Ltd (2024):
  6. "Product Information. Lipitor (atorvastatin)." Viatris UK Healthcare Ltd (2024):
  7. "Product Information. Atorvastatin (atorvastatin)." Rosemont Pharmaceuticals Ltd (2024):

The following applies to the ingredients: Sitagliptin (found in Januvia)

US: Use caution
AU and UK: Use is not recommended.

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

The effects in the nursing infant are unknown

This drug is secreted in the milk of lactating rats at milk to plasma ratio of 4:1. Pups of rats administered this drug at 1000 mg/kg/day from gestation day 6 through lactation day 20 showed reduced birth weight and postnatal weight gain (observed prior to and after weaning). No functional or behavioral toxicity was observed. Due to lack of human data, an alternate drug may be preferred.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Januvia (sitagliptin)." Merck & Co., Inc (2006):
  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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