package insert

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package insert

printed materials available in the legal pharmacologic description of a drug, subject to detailed regulatory specifications, including approved chemical and proprietary names, description and classification, clinical pharmacology, approved indications and usage, contraindications, warnings, precautions, adverse reactions, drug abuse and dependence information, overdosage discussion, dosage and administration, formulations, and appropriate references; in the U.S., such materials are negotiated between the drug's manufacturer(s) and the U.S. Food and Drug Administration.
See also: label (3).

package insert (P.I.)

a leaflet that, by order of the U.S. Food and Drug Administration, must be placed inside the package of every prescription drug. The leaflet must include the trademark for the drug, its generic name, and its mechanism of action; state its indications, contraindications, warnings, precautions, adverse effects, and dosage forms; and include instructions for the recommended dose, time, and route of administration.


A description of a drug product or device provided by the manufacturer and approved by the regulatory authority of a particular country or jurisdiction, which includes indications for its use, who should use it, adverse events, instructions for use, and safety information.

package insert

Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific information–eg, indications for use; forms of administration, side effects, etc; it is more cynically described as a hard-to-handle and difficult-to-read package 'stuffer' printed in Lilliputian type on Bible paper. See Advertising.

pack·age in·sert

(pak'ăj in'sĕrt)
A manufacturer's printed guideline for the use and dosing of a drug; includes the pharmacokinetics, dosage forms, and other relevant information about a drug.
References in periodicals archive ?
The manufacturers' package inserts for clozapine, paliperidone, risperidone, and lurasidone have recommended dosage adjustments based on renal function (Table 1).
Currently in India, the structure and content of the information on the inserts appears to be geared towards prescribers only and the text in Schedule Y of the rules does refer to package inserts as prescribing information.
Across the 5 resources, the average percentage of FDA package insert biomarkers that were identified in the drug monographs was 81.
With all that going for them, package inserts cost a bit more than other alternative media: between $40/M and $60/M.
Johnson & Johnson spokesman Bob Kniffin said the company considers Duragesic to be a "safe and effective drug when used in accordance with package inserts.
The following revisions were also made to the Agenerase package insert regarding the use of the Ageneruse plus ritonavir.
In 1999 the FDA revised stavudine's package insert to reflect its inclusion as a first-line component of combination antiretroviral HIV therapy.
announced the revision of the package insert for the oral androgen receptor signaling inhibitor XTANDI Capsules 40mg.
Then I made the mistake of consulting the PDR and reviewing the package insert.
The package insert for amitriptyline advises doctors to carefully monitor patients with cardiovascular disorders and notes that the medication can cause cardiac arrhythmias, sinus tachycardia, myocardial infarction, and stroke, as well as both elevated and depressed blood sugar levels.
And the complete package insert can be found on the Gilead site at: http://www.