This Choreo returns the records available in the DailyMed database associated with a given drug's SetID. In order to find out a drug's SetID, you can first run either the SearchByName or SearchByNDC Choreos. A complete description of the DailyMed service is avaliable here.
The optional Components input allows you to determine the specific parts of a record you want returned. As a general guide, a record for a drug listed in the DailyMed database will contain information organized under the following topics (or Components):
Description Clinical Pharmacology Indications and Usage Contraindications Warnings Precautions Adverse Reactions Overdosage Dosage and Administration How Supplied Patient Counseling Information Supplemental Patient Material Boxed Warning Patient Package Insert Highlights Full Table of Contents Medication Guide
It is important to note that each drug record in the database may have information available for only some of the Components above. Additionally, for some drugs, the database may contain information under Components not listed above. To obtain a complete list of Components available for a drug you want to research, you can first run the GetComponents Choreo. You can specify more than one Components input at a time by entering a comma delimited list.
Here's an example of an acceptable input:
SetID: 5bc62cef-1c78-4ddb-bdde-0574e5218f63
Components: Usage,Warnings
The following is an example of the partial XML information returned by this Choreo:
<?xml version="1.0" encoding="UTF-8"?>
<?xml-stylesheet type="text/xsl" href="http://www.accessdata.fda.gov/spl/stylesheet/spl.xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 http://www.accessdata.fda.gov/spl/schema/spl.xsd">
<component>
<structuredBody>
<component xmlns="urn:hl7-org:v3">
<section>
<id root="6f18a255-d338-4b69-83b3-9a3e34b68af4"/>
<code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/>
<text>
<content styleCode="bold">INDICATIONS AND USAGE</content>
<paragraph>Lidocaine Hydrochloride Injection, USP is indicated for
production of local or regional anesthesia by infiltration
techniques such as percutaneous injection and intravenous
regional anesthesia by peripheral nerve block techniques such as
brachial plexus and intercostal and by central neural techniques
such as lumbar and caudal epidural blocks, when the accepted
procedures for these techniques as described in standard textbooks are
observed.</paragraph>
</text>
<effectiveTime value="20120713"/>
</section>
</component>
<component xmlns="urn:hl7-org:v3">
<section>
<id root="7a7c0c15-b86b-4d00-bf63-a140950dde25"/>
<code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/>
<text>
<paragraph>
<content styleCode="bold">INDICATIONS AND USAGE</content>
<br/>Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isontonic single dose vehicle, solvent, or diluent for substances to administered intravenously,k intramuscularly or sub-cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered.<br/>
</paragraph>
</text>
<effectiveTime value="20120713"/>
</section>
</component>
<component xmlns="urn:hl7-org:v3">
<section>
<id root="48023b2c-42fe-40cc-9b9f-9a6a05e06f84"/>
<code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/>
<text>INDICATIONS AND USAGE<paragraph>Lidocaine Hydrochloride and Epinephrine Injection, USP is
indicated for production of local or regional anesthesia by infiltration
techniques such as percutaneous injection, by peripheral nerve block
techniques such as brachial plexus and intercostal and by central neural
techniques such as lumbar and caudal epidural blocks, when the accepted
procedures for these techniques as described in standard textbooks are
observed.</paragraph>
</text>
<effectiveTime value="20120713"/>
</section>
</component>
<component xmlns="urn:hl7-org:v3">
<section>
<id root="5b6dded6-6693-482b-aad4-5219eeed6de6"/>
<code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/>
<text>INDICATIONS AND USAGE<paragraph>Bupivacaine Spinal is indicated for the production of subarachnoid block (spinal anesthesia).</paragraph>
<paragraph>Standard textbooks should be consulted to determine the accepted
procedures and techniques for the administration of spinal anesthesia.</paragraph>
</text>
<effectiveTime value="20120713"/>
</section>
</component>
<component xmlns="urn:hl7-org:v3">
<section>
<id root="662851ca-d868-4dfb-84fe-b51f8f4ba663"/>
<code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
<text>
<content styleCode="bold">WARNINGS</content>
<paragraph>LIDOCAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION AND
NERVE BLOCK, SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED
IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE
EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY
AFTER ENSURING THE <content styleCode="bold">
<content styleCode="emphasis">IMMEDIATE</content></content>
AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY
EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC
REACTIONS AND RELATED EMERGENCIES (See also <content>
<content styleCode="emphasis">ADVERSE REACTIONS</content></content> and <content>
<content styleCode="emphasis">PRECAUTIONS</content></content>).
DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION
FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF
ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.</paragraph>
<paragraph>Intra-articular infusions of local anesthetics following arthroscopic
and other surgical procedures is an unapproved use, and there have been
post-marketing reports of chondrolysis in patients receiving such
infusions. The majority of reported cases of chondrolysis have involved
the shoulder joint; cases of gleno-humeral chondrolysis have been
described in pediatric and adult patients following intra-articular
infusions of local anesthetics with and without epinephrine for periods
of 48 to 72 hours. There is insufficient information to determine
whether shorter infusion periods are not associated with these findings.
The time of onset of symptoms, such as joint pain, stiffness and loss
of motion can be variable, but may begin as early as the 2nd month after
surgery. Currently, there is no effective treatment for chondrolysis;
patients who experienced chondrolysis have required additional
diagnostic and therapeutic procedures and some required arthroplasty or
shoulder replacement.</paragraph>
<paragraph>To avoid intravascular injection, aspiration should be performed
before the local anesthetic solution is injected. The needle must be
repositioned until no return of blood can be elicited by aspiration.
Note, however, that the absence of blood in the syringe does not
guarantee that intravascular injection has been avoided.</paragraph>
<paragraph>Local anesthetic solutions containing antimicrobial preservatives
(e.g., methylparaben) should not be used for epidural or spinal
anesthesia because the safety of these agents has not been established
with regard to intrathecal injection, either intentional or accidental.</paragraph>
</text>
<effectiveTime value="20120713"/>
</section>
</component>
<component xmlns="urn:hl7-org:v3">
<section>
<id root="f24196d4-99a5-4028-95cd-e8c72a20086e"/>
<code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
<text>
<paragraph>
<content styleCode="bold">WARNING</content>
<br/>Sodium Chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia.</paragraph>
<paragraph>Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis. Excessive amounts by parental routes may precipitate congestive heart failure and acute pulmonary edema, especially seen in patients with preexisting cardiovascular disease and those receiving coricos-teroids, corticotrophin or other drugs that may give rise to sodium retention. For use in newborns, when a Sodium Chloride solution is required for preparation or diluting medications, or in flushing intravenous catheters, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.<br/>
</paragraph>
</text>
<effectiveTime value="20120713"/>
</section>
</component>
</structuredBody>
</component>
</document>