Amlodipine drug interactions: Difference between revisions

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==7 Drug Interactions==


==Drug Interactions==
===7.1 In Vitro Data===
 
In vitro data indicate that NORVASC has no effect on the human plasma protein binding of [[digoxin]], [[phenytoin]], [[warfarin]], and [[indomethacin]].
In vitro data indicate that Amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.
===7.2 Cimetidine===
 
Co-administration of NORVASC with [[cimetidine ]]did not alter the pharmacokinetics of NORVASC.
===Effect of Other Agents on Amlodipine Besylate Tablets===
===7.3 Grapefruit Juice===
 
Co-administration of 240 mL of [[grapefruit juice]] with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine.
[[Cimetidine]]: Coadministration of Amlodipine besylate tablets with cimetidine did not alter the pharmacokinetics of Amlodipine.
===7.4 Magnesium and Aluminum Hydroxide Antacid===
 
Co-administration of a magnesium and [[aluminum hydroxide]] antacid with a single dose of NORVASC had no significant effect on the pharmacokinetics of NORVASC.
[[Grapefruit juice]]: Coadministration of 240 mL of grapefruit juice with a single oral dose of Amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of Amlodipine.
===7.5 Sildenafil===
 
A single 100 mg dose of [[sildenafil ]]in subjects with essential hypertension had no effect on the pharmacokinetic parameters of NORVASC. When NORVASC and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
[[Antacid]]: Coadministration of the antacid with a single dose of Amlodipine besylate tablets had no significant effect on the pharmacokinetics of Amlodipine.
===7.6 Atorvastatin===
 
Co-administration of multiple 10 mg doses of NORVASC with 80 mg of [[atorvastatin ]]resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.
[[Sildenafil]]: A single 100 mg dose of [[sildenafil]] in subjects with essential hypertension had no effect on the pharmacokinetic parameters of [[Amlodipine]]. When Amlodipine besylate tablets and [[sildenafil]] were used in combination, each agent independently exerted its own blood pressure lowering effect.
===7.7 Simvastatin===
 
Co-administration of multiple doses of 10 mg of amlodipine with 80 mg [[simvastatin ]]resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of [[simvastatin ]]in patients on amlodipine to 20 mg daily.
===Effect of Amlodipine Besylate Tablets on Other Agents===
===7.8 Digoxin===
 
Co-administration of NORVASC with digoxin did not change serum [[digoxin ]]levels or digoxin [[renal clearance]] in normal volunteers.
[[Atorvastatin]]: Coadministration of multiple 10 mg doses of Amlodipine besylate tablets with 80 mg of atorvastatin resulted in no significant change in the steady state pharmacokinetic parameters of atorvastatin.
===7.9 Ethanol (Alcohol)===
 
Single and multiple 10 mg doses of NORVASC had no significant effect on the pharmacokinetics of [[ethanol]].
[[Digoxin]]: Coadministration of Amlodipine besylate tablets with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.
===7.10 Warfarin===
 
Co-administration of NORVASC with warfarin did not change the [[warfarin ]][[prothrombin ]]response time.
[[Ethanol]] (alcohol): Single and multiple 10 mg doses of Amlodipine besylate tablets had no significant effect on the pharmacokinetics of ethanol.
===7.11 CYP3A4 Inhibitors===
 
Co-administration of a 180 mg daily dose of [[diltiazem ]]with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure. [[Erythromycin ]]co-administration in healthy volunteers did not significantly change amlodipine systemic exposure. However, strong inhibitors of [[CYP3A4 ]](e.g., [[ketoconazole]], [[itraconazole]], [[ritonavir]]) may increase the plasma concentrations of amlodipine to a greater extent. Monitor for symptoms of [[hypotension ]]and [[edema ]]when amlodipine is co-administered with [[CYP3A4 ]]inhibitors.
[[Warfarin]]: Coadministration of Amlodipine besylate tablets with warfarin did not change the warfarin prothrombin response time.
===7.12 CYP3A4 Inducers===
 
No information is available on the quantitative effects of CYP3A4 inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with [[CYP3A4 ]]inducers.
In clinical trials, Amlodipine besylate tablets have been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
===7.13 Drug/Laboratory Test Interactions===
None known.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = NORVASC (AMLODIPINE BESYLATE) TABLET [CARDINAL HEALTH] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=44e5ad27-e062-461a-bdf4-192d852fbc49#nlm42230-3 | publisher =  | date =  | accessdate = 6 March 2014 }}</ref>


==Major Interactions==
==Major Interactions==
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{{FDA}}




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==References==
{{Reflist|2}}


[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
[[Category:Drugs]]

Revision as of 22:55, 12 March 2014

Amlodipine
NORVASC®, AMLODIPINE®, AMLODIPINE BESYLATE® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Amlodipine
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

7 Drug Interactions

7.1 In Vitro Data

In vitro data indicate that NORVASC has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.

7.2 Cimetidine

Co-administration of NORVASC with cimetidine did not alter the pharmacokinetics of NORVASC.

7.3 Grapefruit Juice

Co-administration of 240 mL of grapefruit juice with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine.

7.4 Magnesium and Aluminum Hydroxide Antacid

Co-administration of a magnesium and aluminum hydroxide antacid with a single dose of NORVASC had no significant effect on the pharmacokinetics of NORVASC.

7.5 Sildenafil

A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of NORVASC. When NORVASC and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.

7.6 Atorvastatin

Co-administration of multiple 10 mg doses of NORVASC with 80 mg of atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.

7.7 Simvastatin

Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

7.8 Digoxin

Co-administration of NORVASC with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.

7.9 Ethanol (Alcohol)

Single and multiple 10 mg doses of NORVASC had no significant effect on the pharmacokinetics of ethanol.

7.10 Warfarin

Co-administration of NORVASC with warfarin did not change the warfarin prothrombin response time.

7.11 CYP3A4 Inhibitors

Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure. Erythromycin co-administration in healthy volunteers did not significantly change amlodipine systemic exposure. However, strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A4 inhibitors.

7.12 CYP3A4 Inducers

No information is available on the quantitative effects of CYP3A4 inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A4 inducers.

7.13 Drug/Laboratory Test Interactions

None known.[1]

Major Interactions

Moderate Interactions

Minor Interactions





References

  1. ↑ "NORVASC (AMLODIPINE BESYLATE) TABLET [CARDINAL HEALTH]". Retrieved 6 March 2014.
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