Sandbox Trandolapril
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Black Box Warning
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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.
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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
Condition 1
- Developed by: (Organization)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- There is limited information about Off-Label Non–Guideline-Supported Use of Sandbox Trandolapril in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition 1
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
- Developed by: (Organization)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
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.
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