Isosorbide dinitrate: Difference between revisions
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===== | =====Prophylaxis of Angina Pectoris===== | ||
* | * Isosorbide dinitrate are indicated for the prevention of [[angina pectoris]] due to [[coronary artery disease]]. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. | ||
* Dosing Information | * Dosing Information | ||
:* Dosage | :* '''''Initial Dosage''''' | ||
::* '''5–20 mg PO bid–tid''' | |||
:* '''''Maintenance Dosage''''' | |||
::* '''10–40 mg PO bid–tid''' | |||
* | |||
:* | :* A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen. | ||
:* Multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Isordil Titradose tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long. | |||
:* The effects of the second and later doses have been smaller and shorter-lasting than the effects of the first. | |||
:* Large controlled studies with other nitrates suggest that no dosing regimen with Isordil Titradose tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day. | |||
<!--Off-Label Use and Dosage (Adult)--> | <!--Off-Label Use and Dosage (Adult)--> |
Revision as of 20:58, 9 July 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi
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Overview
Isosorbide dinitrate is an anti-anginal nitrate that is FDA approved for the {{{indicationType}}} of angina pectoris due to coronary artery disease. Common adverse reactions include hypotension, lightheadedness, and headache.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Prophylaxis of Angina Pectoris
- Isosorbide dinitrate are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
- Dosing Information
- Initial Dosage
- 5–20 mg PO bid–tid
- Maintenance Dosage
- 10–40 mg PO bid–tid
- A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.
- Multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Isordil Titradose tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long.
- The effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.
- Large controlled studies with other nitrates suggest that no dosing regimen with Isordil Titradose tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Isosorbide dinitrate in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Isosorbide dinitrate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Isosorbide dinitrate in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Isosorbide dinitrate in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Isosorbide dinitrate in pediatric patients.
Contraindications
- Condition1
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Isosorbide dinitrate in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Isosorbide dinitrate in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Isosorbide dinitrate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Isosorbide dinitrate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Isosorbide dinitrate with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Isosorbide dinitrate with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Isosorbide dinitrate with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Isosorbide dinitrate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Isosorbide dinitrate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Isosorbide dinitrate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Isosorbide dinitrate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Isosorbide dinitrate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Isosorbide dinitrate in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Isosorbide dinitrate in the drug label.
Condition1
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Isosorbide dinitrate in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Isosorbide dinitrate in the drug label.
Pharmacology
There is limited information regarding Isosorbide dinitrate Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Isosorbide dinitrate in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Isosorbide dinitrate in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Isosorbide dinitrate in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Isosorbide dinitrate in the drug label.
Condition1
- Description
How Supplied
Storage
There is limited information regarding Isosorbide dinitrate Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Isosorbide dinitrate |?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::Isosorbide dinitrate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Isosorbide dinitrate in the drug label.
Precautions with Alcohol
- Alcohol-Isosorbide dinitrate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Isordil®[1]
Look-Alike Drug Names
- Isordil® — Plendil®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "ISORDIL TITRADOSE (isosorbide dinitrate) tablet".
- ↑ "http://www.ismp.org". External link in
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