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6 Interactions found for:

Januvia and amlodipine
Interactions Summary
  • 4 Major
  • 1 Moderate
  • 1 Minor
  • Januvia
  • amlodipine

Drug Interactions

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

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

Drug and Food Interactions

Moderate
Januvia + Food

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

Alcohol may affect blood glucose levels in patients with diabetes. Both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) may occur, depending on how much and how often you drink. You should avoid using alcohol if your diabetes is not well controlled or if you have high triglycerides, neuropathy (nerve damage), or pancreatitis. Moderate alcohol consumption generally does not affect blood glucose levels if your diabetes is under control. However, it may be best to limit 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 your normal meal plan. Avoid drinking alcohol on an empty stomach or following exercise, as it may increase the risk of hypoglycemia. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Minor
Amlodipine + Food

The following applies to the ingredients: Amlodipine

Professional Content

The consumption of grapefruit juice may slightly increase plasma concentrations of amlodipine. The mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits. Data have been conflicting and the clinical significance is unknown. Monitoring for calcium channel blocker adverse effects (e.g., headache, hypotension, syncope, tachycardia, edema) is recommended.

References

  1. Bailey DG, Arnold JMO, Spence JD "Grapefruit juice and drugs - how significant is the interaction." Clin Pharmacokinet 26 (1994): 91-8
  2. Josefsson M, Zackrisson AL, Ahlner J "Effect of grapefruit juice on the pharmacokinetics of amlodipine in healthy volunteers." Eur J Clin Pharmacol 51 (1996): 189-93
  3. Bailey DG, Malcolm J, Arnold O, Spence JD "Grapefruit juice-drug interactions." Br J Clin Pharmacol 46 (1998): 101-10
  4. Vincent J, Harris SI, Foulds G, Dogolo LC, Willavize S, Friedman HL "Lack of effect of grapefruit juice on the pharmacokinetics and pharmacodynamics of amlodipine." Br J Clin Pharmacol 50 (2000): 455-63
  5. Josefsson M, Ahlner J "Amlodipine and grapefruit juice." Br J Clin Pharmacol 53 (2002): 405; discussion 406
  6. Kane GC, Lipsky JJ "Drug-grapefruit juice interactions." Mayo Clin Proc 75 (2000): 933-42

Drug and Pregnancy Interactions

The following applies to the ingredients: Amlodipine

Professional Content

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus (AU, US)
Use is contraindicated (UK)

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-Use of adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have shown significantly decreased litter size, increased intrauterine deaths and prolongation of gestation and duration of labor when this drug was given before mating, throughout mating, and during gestation. There are no controlled data in human pregnancy.

Reversible biochemical changes in the head of spermatozoa occurred in some patients treated with calcium channel blockers. There are no controlled data for this drug, but animal models have shown adverse effects on male fertility.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

References

  1. "Product Information. Norvasc (amlodipine)." Pfizer U.S. Pharmaceuticals PROD (2002):
  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: Sitagliptin (found in Januvia)

Professional Content

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: Amlodipine

Professional Content

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother (AU, US)
Use is contraindicated (UK)

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Infants exposed to this drug should be closely monitored.

References

  1. "Product Information. Norvasc (amlodipine)." Pfizer U.S. Pharmaceuticals PROD (2002):
  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: Sitagliptin (found in Januvia)

Professional Content

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: Professional 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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