Sandbox Trandolapril: Difference between revisions

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:* '''0.5 mg/day''' and have their dosage titrated to the optimal response.
:* '''0.5 mg/day''' and have their dosage titrated to the optimal response.
|offLabelAdultGuideSupport=<b>Condition 1</b>
|offLabelAdultGuideSupport=<h4>Acute ST segment elevation myocardial infarction</h4>


* Developed by: (Organization)
* Developed by: (Organization)
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:* (Dosage)
:* (Dosage)
|offLabelAdultNoGuideSupport=<b>Condition 1</b>
|offLabelAdultNoGuideSupport=<h4>Acute ST segment elevation myocardial infarction</h4>


* Dosing Information
* Dosing Information


:* There is limited information about <i>Off-Label Non–Guideline-Supported Use</i> of Sandbox Trandolapril in adult patients.
:* '''4 mg/day'''<ref name="pmid7477219">Køber L, Torp-Pedersen C, Carlsen JE, Bagger H, Eliasen P, Lyngborg K et al. (1995) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=7477219 A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. Trandolapril Cardiac Evaluation (TRACE) Study Group.] ''N Engl J Med'' 333 (25):1670-6. [http://dx.doi.org/10.1056/NEJM199512213332503 DOI:10.1056/NEJM199512213332503] PMID: [http://pubmed.gov/7477219 7477219]</ref>
|fdaLIADPed=<b>Condition 1</b>
 
=====Diabetic nephropathy=====


* Dosing Information
* Dosing information


:: (Dosage)
:* '''2-4 mg/day'''<ref name="pmid9752891">Bauduceau B, Genès N, Chamontin B, Vaur L, Renault M, Etienne S et al. (1998) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=9752891 Ambulatory blood pressure and urinary albumin excretion in diabetic (non-insulin-dependent and insulin-dependent) hypertensive patients: relationships at baseline and after treatment by the angiotensin converting enzyme inhibitor trandolapril.] ''Am J Hypertens'' 11 (9):1065-73. PMID: [http://pubmed.gov/9752891 9752891]</ref>
|offLabelPedGuideSupport=<b>Condition 1</b>
:* '''1 mg/day'''<ref name="pmid10978394">Nakamura T, Ushiyama C, Suzuki S, Hara M, Shimada N, Ebihara I et al. (2000) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=10978394 Urinary excretion of podocytes in patients with diabetic nephropathy.] ''Nephrol Dial Transplant'' 15 (9):1379-83. PMID: [http://pubmed.gov/10978394 10978394]</ref>
:* '''2 mg/day'''<ref name="pmid9872248">Malik RA, Williamson S, Abbott C, Carrington AL, Iqbal J, Schady W et al. (1998) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=9872248 Effect of angiotensin-converting-enzyme (ACE) inhibitor trandolapril on human diabetic neuropathy: randomised double-blind controlled trial.] ''Lancet'' 352 (9145):1978-81. [http://dx.doi.org/10.1016/S0140-6736(98)02478-7 DOI:10.1016/S0140-6736(98)02478-7] PMID: [http://pubmed.gov/9872248 9872248]</ref>


* Developed by: (Organization)
=====Nondiabetic kidney disease=====


* Class of Recommendation: (Class) (Link)
* Dosing information


* Strength of Evidence: (Category A/B/C) (Link)
:* '''1 mg PO qd-3 mg PO bid''' <ref name="pmid12531578">Nakao N, Yoshimura A, Morita H, Takada M, Kayano T, Ideura T (2003) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=12531578 Combination treatment of angiotensin-II receptor blocker and angiotensin-converting-enzyme inhibitor in non-diabetic renal disease (COOPERATE): a randomised controlled trial.] ''Lancet'' 361 (9352):117-24. [http://dx.doi.org/10.1016/S0140-6736(03)12229-5 DOI:10.1016/S0140-6736(03)12229-5] PMID: [http://pubmed.gov/12531578 12531578]</ref>
|fdaLIADPed=<b>Condition 1</b>


* Dosing Information/Recommendation
* Dosing Information


:* (Dosage)
:: (Dosage)
|offLabelPedGuideSupport=There is limit information about the guideline-supported off-label use
|offLabelPedNoGuideSupport=<b>Condition 1</b>
|offLabelPedNoGuideSupport=<b>Condition 1</b>


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Revision as of 21:07, 14 May 2014

Sandbox Trandolapril
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Disclaimer

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Black Box Warning

WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
When pregnancy is detected, discontinue MAVIK as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Overview

Sandbox Trandolapril is an angiotensin converting enzyme inhibitor that is FDA approved for the {{{indicationType}}} of hypertension, heart failure post myocardial infarction or left-ventricular dysfunction post myocardial infarction. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, syncope, hyperkalemia, indigestion, dizziness, Serum blood urea nitrogen raised, cough.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension

  • Dosing Information
  • Recommended initial dosage(for non-black patients): 1 mg PO qd
  • Recommended initial dosage(for black patients): 2 mg PO qd
  • Required dosage for most patients: 4-8 mg PO qd

Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction

  • Dosing information
  • Recommended starting dosage: 1 mg PO qd
  • Followed-by: 4 mg PO qd

Dosage Adjustment in Renal Impairment or Hepatic Cirrhosis

  • Dosing information
  • 0.5 mg/day and have their dosage titrated to the optimal response.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Acute ST segment elevation myocardial infarction

  • Developed by: (Organization)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Acute ST segment elevation myocardial infarction

  • Dosing Information
Diabetic nephropathy
  • Dosing information
Nondiabetic kidney disease
  • Dosing information
  • 1 mg PO qd-3 mg PO bid [5]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

  • Dosing Information
(Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limit information about the guideline-supported off-label use

Non–Guideline-Supported Use

Condition 1

  • Dosing Information
  • There is limited information about Off-Label Non–Guideline-Supported Use of Sandbox Trandolapril in pediatric patients.

Contraindications

  • Condition 1
  • Condition 2
  • Condition 3
  • Condition 4
  • Condition 5

Warnings

WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
When pregnancy is detected, discontinue MAVIK as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Postmarketing Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Drug Interactions

  • (Drug 1)
  • (Description)
  • (Drug 2)
  • (Description)
  • (Drug 3)
  • (Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sandbox Trandolapril in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sandbox Trandolapril in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sandbox Trandolapril during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sandbox Trandolapril in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sandbox Trandolapril in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sandbox Trandolapril in geriatric settings.

Gender

There is no FDA guidance on the use of Sandbox Trandolapril with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sandbox Trandolapril with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sandbox Trandolapril in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sandbox Trandolapril in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sandbox Trandolapril in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sandbox Trandolapril in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sandbox Trandolapril Administration in the drug label.

Monitoring

There is limited information regarding Sandbox Trandolapril Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sandbox Trandolapril and IV administrations.

Overdosage

There is limited information regarding Sandbox Trandolapril overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Sandbox Trandolapril Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sandbox Trandolapril Mechanism of Action in the drug label.

Structure

There is limited information regarding Sandbox Trandolapril Structure in the drug label.

Pharmacodynamics

There is limited information regarding Sandbox Trandolapril Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sandbox Trandolapril Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sandbox Trandolapril Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sandbox Trandolapril Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sandbox Trandolapril How Supplied in the drug label.

Storage

There is limited information regarding Sandbox Trandolapril Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Sandbox Trandolapril |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Sandbox Trandolapril |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Sandbox Trandolapril Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sandbox Trandolapril interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Sandbox Trandolapril Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sandbox Trandolapril Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Køber L, Torp-Pedersen C, Carlsen JE, Bagger H, Eliasen P, Lyngborg K et al. (1995) A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. Trandolapril Cardiac Evaluation (TRACE) Study Group. N Engl J Med 333 (25):1670-6. DOI:10.1056/NEJM199512213332503 PMID: 7477219
  2. ↑ Bauduceau B, Genès N, Chamontin B, Vaur L, Renault M, Etienne S et al. (1998) Ambulatory blood pressure and urinary albumin excretion in diabetic (non-insulin-dependent and insulin-dependent) hypertensive patients: relationships at baseline and after treatment by the angiotensin converting enzyme inhibitor trandolapril. Am J Hypertens 11 (9):1065-73. PMID: 9752891
  3. ↑ Nakamura T, Ushiyama C, Suzuki S, Hara M, Shimada N, Ebihara I et al. (2000) Urinary excretion of podocytes in patients with diabetic nephropathy. Nephrol Dial Transplant 15 (9):1379-83. PMID: 10978394
  4. ↑ Malik RA, Williamson S, Abbott C, Carrington AL, Iqbal J, Schady W et al. (1998) Effect of angiotensin-converting-enzyme (ACE) inhibitor trandolapril on human diabetic neuropathy: randomised double-blind controlled trial. Lancet 352 (9145):1978-81. DOI:10.1016/S0140-6736(98)02478-7 PMID: 9872248
  5. ↑ Nakao N, Yoshimura A, Morita H, Takada M, Kayano T, Ideura T (2003) Combination treatment of angiotensin-II receptor blocker and angiotensin-converting-enzyme inhibitor in non-diabetic renal disease (COOPERATE): a randomised controlled trial. Lancet 361 (9352):117-24. DOI:10.1016/S0140-6736(03)12229-5 PMID: 12531578

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