Drug Monograph Template

From Pubdrug

Jump to: navigation, search

Notes:

This template is a final working version for contributors to use for adding individual drug monographs to the site. This is not a standard MediaWiki-style "template," rather a working outline of the information that would appear in such a template and it's general orientation and organization on the page.

Drug monograph objectives:

  1. Thoroughness -- Monographs should include all informational facets of any particular drug.
  2. Readability -- Sections and subsections of the monograph should be clearly labeled.
  3. Functionality -- Sections and subsections of the monograph should have clear and consistent purpose and use.
  4. Appearance -- The overall look of a drug monograph should be clean, uncluttered.

Please mark edits with your own notes and use the Discussion tab to talk over details of the template with PubDrug contributors.

This page was designed to guide the creation of a new medication monograph. For our continued effort to preserve a standardized format for transferability of data and ease in clinical utility, please conform to the template as much as possible. Creativity with linking, sub-paging, etc is encouraged, however if major formatting changes are made, we ask that you discuss the changes with the editor(s) before finalizing. If a major formatting change is implemented as a result of your creativity it is expected that you will aid in retrospectively editing all existing medication monographs to include such additions.

Remember, this database is created by professionals for professional use and it should go without saying that professional conduct is expected in all aspects of monograph creation, including cooperation with the editorial staff. We truly appreciate your time and effort. 


 When copying this template, begin after this line.


(Drug Name) Here Quick Reference
Memantine
IUPAC Name
Insert IUPAC name here
Chemical Information
Empirical Formula Insert Formula here as per this example:(C33H34FN2O5)2Ca•3H2O
Molecular Weight Insert molecular weight here
General Drug Information
Classification Insert drug classification here (ex: ACE-inhibitor)
Schedule Legend- If a controlled substance note the Schedule (C-II-V)
How Supplied Insert formulation followed by strength here Ex: Oral Tablets: 10, 20 mg etc.
Trade Names Insert Brand/Trade names here
Pregnancy Category Insert Bolded preg. category here
Breast Feeding Insert Breast feeding indications here
Generic Availability Insert generic availability Ex: Generic Available
Patent Expiration Date Insert Date of patent Expiration
Administration Information
Route(s) Insert routes of administration here
Method(s) Insert administration instructions for each route. Ex: Oral: Take in the morning on an empty stomach with 8 oz of water.
Pharmacokinetic Information
Absorption F = Insert bioavailability percent or fraction Ex: 55% or 0.55 (oral tablets)
F = Insert bioavailability of a different dosage form here Ex: 65% or 0.66 (subcutaneous injection)
Cmax = Insert Cmax here Ex: 10 mcg/dL if relevant.
tmax = Insert Tmax here Ex: 1-2 hours
Distribution Vd = Insert Volume of distribution here Ex: 381 L
Protein binding = Insert protein binding percent here Ex: >98%
Metabolism Insert metabolic pathway here Ex: Hepatic CYP 3A4 to active ortho- and parahydroxylated metabolites.
Excretion t1/2 = Insert half life here
Insert excretion pathway Ex: renal filtration, or biliary

For an detailed look at the wiki code with color coded instructions for editing the Quick Reference Chart to the right please click the link below for a pdf version.

Quick Reference Chart Template Guide

Also, see the Tables help page

For an example of a completed Drug Monograph See Atorvastatin

For main help page click here

Contents

[edit]

Brand/Trade Names of Drug 

Insert Brand/Trade Names for your drug here.
[edit]

Generic Name of Drug

This section should include the generic drug name followed by a phonetic pronunciation spelling. Also, you should insert an audio pronunciation link. 

The audio link must be a .wav file and the code presented as follows:  
[[media:Atorvastatin.wav| Click Here]]

To create audio files, the free program audacity is recommended. Export file as .wav.

Ex: Atorvastatin (a TORE va sta tin) Atorvastatin Pronunciation Click Here 

 All "Back to top" links must be corrected with the full URL for the new page.

Back to top

[edit]

Description

This section showcases the drugs utility as a member of a class of drugs and it is also the time to distinguish it from other members of a class (either positively or negatively). Remember, this is a non-biases drug information source. If you find that one drug in a class is proven superior to the others for whatever reason, this is the place to state that information. Generally, this section is 2 paragraphs, the first will discuss some disease background for the disease the drug treats and the benefit(s) the drug brings treatment. Also, product history should be included in the first paragraph (i.e. digoxin come from the Digitalis purpurea plant, etc). The second paragraph is reserved for specific efficacy information. Here you would include the primary outcome or what the drug is supposed to do (i.e. it is supposed to lower blood pressure) and how efficacious it is at completing that task (i.e. it will lower the blood pressure on average of 15 mmHg at 100 mg daily). This is where you would compare the drug’s efficacy with others in its class or drugs in other classes.


Back to top

[edit]

Mechanism of action

This data will come from mainly a reputable, current pharmacology text, as well as the package insert. Try to be as complete and descriptive as possible. To often drug references are scarce on the MOA, which leads to an incomplete understanding of the drugs mechanism. And if the pharmacist completely understands a drugs mechanism it will truly help in predicting drug/drug or drug/food interactions, adverse reactions, and side effect without having to refer back to the drug information source.

Back to top

[edit]

Time Required for Therapeutic Response

  • Initial: EX: within 2 weeks[1]
  • Maximum: Ex: within 4 weeks[1]

Back to top

[edit]

Pharmacokinetics

Insert the Pharmacokinetic data as separated into Absorption, Distribution, Metabolism, & Excretion. This section requires focus because the information must be in your own words and will likely come from multiple sources. Package inserts, the primary phase I and phase II trials (if available), and PK review articles will have this information available. Make sure to be as complete as possible. We want to have the most complete source for clinical reference in one place.

[edit]

Absorption

[edit]

Distribution

[edit]

Metabolism

[edit]

Excretion

Back to top

[edit]

Special Population Pharmacokinetics

  • Renal insufficiency
  • Hepatic insufficiency
  • Hemodialysis
  • Geriatric
  • Pediatric
  • Gender

Back to top

[edit]

Indications

[edit]

FDA Approved Indications 

FDA-Approved and Non-FDA Approved Indications.  This section should have the primary clinical trials
which led to the indication approval or validation of the non-approved indication cited.  These
studies are generally discussed heavily in the current package inserts.
  • 1st Indication
  • 2nd Indication, etc.


Back to top

[edit]

Non-FDA Approved Indications

  • 1st Indication
  • 2nd Indication, etc.


Back to top

[edit]

Dosage

  • 1st Indication
    • Starting Dose:
    • Titration Schedule:
    • Maintenance Dose:
  • 2nd Indication
    • Starting Dose:
    • Titration Schedule:
    • Maintenance Dose:


  • Maximum Dosage Limits
    • Adults:
    • Elderly:
    • Adolescents and children >=10 years:
    • Children < 10 years:
  • Dosage Adjustment
    • Renal insufficiency:
    • Hepatic insufficiency:
    • Hemodialysis:
    • Geriatric:
    • Pediatric:
    • Gender:

Back to top

[edit]

Administration

  • Route:
  • Method:
  • Special considerations:
  • Route:
  • Method:
  • Special considerations:

Back to top

[edit]

Monitoring Parameters

  • Parameter 1
  • Parameter 2
  • etc

Back to top

[edit]

Contraindications/Precautions

[edit]

Contraindications

  • 1st
  • 2nd
  • etc


Back to top

[edit]

Precautions

  • 1st
  • 2nd
  • etc


Back to top

[edit]

Pregnancy indications

  • Pregnancy category:
  • Teratogenicity:

Back to top

[edit]

Breast-feeding indications

  • Secretion into breast milk:

Back to top

[edit]

Drug-Drug Interactions

Note: The blue info bottons are used for two reasons:

  1. Captions can be placed at each place an info button is inserted, which is then displayed on the screen when the mouse arrow is place over top of the botton;
  2. Every image (such as the info button) has it's own page where the image is uploaded to. The info button pages can be redirected to separate pages used to describe the drug interaction as a class (e.g. CYP 3A4 Inhibitors) or if the drug interaction is not well defined and is unique to the drug you are writing the monograph for, you can redirect a button to a general "Your Drug Interactions" page (e.g. Atorvastatin Drug Interactions) where you can discuss the interacting drug(s) in more detail. Please search pubdrug.org before creating a new general drug interactions page (e.g. CYP 3A4 Inducers) to prevent duplicating pages designed to give the same information. If you do find that the general drug interaction page already exists, simply view that page and click in the redirected from page at the top to view the image file (info button) to insert into your text. The red question button should be left as is, for it is linked to a legend explaining the severity levels. 
Also be sure to superscript the info button as such: 
<sup>[[image:Atorvastatin_Drug_Interactions.gif | Caption here]]</sup>

The file name should be inserted after the image:(e.g.Atorvastatin_Drug_Interactions.gif) and the 
caption you wish to appear when the mouse is placed over the info button is written after the 
vertical bar (e.g. | The risk of myopathy or rhabdomyolysis is increased when atorvastatin is
co-administered with fibric acid divatives). 

<sup>Place text here</sup> is the function used to superscript the text within. 
Directions for linking the "i" button to your DI page
# Save the "i" icon to "my pictures"
# Rename "i" icon ex. Memantine Drug Interactions
# Upload Image to the webpage
# Insert image into wiki code ex:[[image:Memantine Drug Interaction.GIF)
# Save page
# Click on "i" button which will take you to a page which says :[[image:"Memantine" Drug Interaction.GIF) go to edit on this page
# type in: #redirect your drug name here Drug Interaction

this will link you DI page to the "i" button

Atorvastatin Drug/Drug Interaction Chart
Severity Level Click here to see Severity Level Legend Increased Effect/Toxicity Decreased Effect
4 List drugs that increase effect/toxicity as follows: clofibrate[1] The risk of myopathy or rhabdomyolysis is increased when atorvastatin is co-administered with fibric acid derivatives. fenofibrate[1] The risk of myopathy or rhabdomyolysis is increased when atorvastatin is co-administered with fibric acid derivatives. List drugs that decrease effect.
3 List drugs that increase effect/toxicity. List drugs that decrease effect.
2 List drugs that increase effect/toxicity List drugs that decrease effect.
1 List drugs that increase effect/toxicity. List drugs that decrease effect.


Back to top

[edit]

Drug-Food-Herb Interactions

Atorvastatin Drug/Food/Herb Interaction Chart
Severity Level Click here to see Severity Level Legend Increased Effect/Toxicity Decreased Effect
4 List herbs/food that increase effect. List food/herbs that decrease effect.
3 List herbs/food that increase effect. List food/herbs that decrease effect.
2 List herbs/food that increase effect. List food/herbs that decrease effect.
1 List herbs/food that increase effect. List food/herbs that decrease effect.

Back to top

[edit]

Adverse Reactions/Side Effects 

Give a general statement about the overall phase III trial tolerability of the drug: 

EX: Atorvastatin is generally well tolerated with a low discontinuation rate (<2%) in clinical trials 
involving 2502 patients.  The most common adverse reactions experienced in clinical trials 
were constipation, flatulence, dyspepsia, and abdominal pain.[2][1]


Atorvastatin Adverse Reactions Chart
Incidence Body System Adverse Reactions
> 10 % All List Adverse reactions as follows: Headache (3-17%)
2-10% CNS List CNS AEs
CV List CV AEs
Dermatologic List Derm AEs
GI List GI AEs
GU List GU AEs
Neuromuscular & skeletal List NM AEs
Respiratory List resp AEs
Misc List misc AEs
< 2% All List all AE's with incidence <2%


Back to top

[edit]

Overdosage Measures 

Explain general overdosage measures.

Back to top

[edit]

Product Information and Distribution 

Replace fields with correct information and delete this sentence.


Atorvastatin Product Availability Information
Name Manufacturer Dosage Form Strength Quantity NDC Storage Markings
Lipitor[1] Pfizer Oral Tablets 10 mg 90 00071-0155-23 20-25°C (68-77°F) PD 155/10
5000 00071-0155-34
100 blister Pk 00071-0155-40
20 mg 90 00071-0156-23 PD 156/20
5000 00071-0156-94
100 blister Pk 00071-0156-40
40 mg 90 00071-0157-23 PD 157/40
500 00071-0157-73
100 blister Pk 00071-0157-40
80 mg 90 00071-0158-23 PD 158/80
500 00071-0158-73
64 blister Pk 00071-0158-92


  • Manufacturers/Distributors
  • Inactive ingredients 
Ex: Calcium carbonate

Back to top

[edit]

Pharmacogenomic information 

Search pharmgkb.orgfor information on your drug and place an external link.

Ex: Atorvastatin Pharmacogenomic Information

Back to top

[edit]

Patient Information

Create a bulleted list of the most important information to express to a patient during initial counseling. This should include specific administration instructions, OTC products to avoid, the most common side effects, rare side effects that should be reported to a physician, pregnancy and breast feeding precautions, and other drug specific precautions.

Ex:

  • May be taken with or without food.
  • May cause dizzines. Use caution when driving or operating heavy machinery.

Back to top

[edit]

References 

References on Pubdrug.org should conform to ICMJE format.  The easiest way to ensure correct 
formatting is to import all your references into endnote and then reference a blank page in word 
from where you can copy and paste the citation text into your wiki-citation.

Instructions for Wiki-citations is on the following help page: Wiki Footnotes


  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 Lipitor® (atorvastation calcium) package insert. New York, NY; Parke-Davis; 2006 Dec.
  2. ↑ Lexi-Comp (2003). Drug Information Handbook. 11th Edition., APhA.
[edit]

PUBMED References 

List Pubmed references as links to the abstracts on Pubmed as per the example below.

To import the citation from pubmed follow the instructions on Importing PubMed References

[edit]

Efficacy Trial Articles

  1. Bakker-Arkema, R. G., M. H. Davidson, et al. (1996). "Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia." JAMA 275(2): 128-33
  2. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet. 2003 Apr 5;361(9364):1149-58.Full Text Here


Back to top

[edit]

Therapeutic Class Comparison Trial Articles

  1. Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study)Am J Cardiol. 1998 Mar 1;81(5):582-7.
  2. Comparative efficacy study of atorvastatin vs simvastatin, pravastatin, lovastatin and placebo in type 2 diabetic patients with hypercholesterolaemia. Diabetes Obes Metab. 2000 Dec;2(6):355-62.


Back to top

[edit]

Pharmacokinetics Articles

Back to top

[edit]

Drug Interaction Articles

  1. Williams D, Feely J. Pharmacokinetic-pharmacodynamic drug interactions with HMG-CoA reductase inhibitors. Clin Pharmacokinet. 2002;41(5):343-70


Back to top

[edit]

Images

Back to top

[edit]

External Links 

List external links to webpages as per example below:
  • Manufacturers/Distributors

Pfizer Pharmaceuticals; Pfizer

  • Clinical treatment guidelines

Hypercholesterolemia: NCEP ATP Treatment Guidelines

  • Patient information pages

Lipitor patient information; Pfizer prescription payment assistance program

  • Healthcare professional information pages

Lipitor healthcare professional information; Lipitor Package Insert

  • Other resources

American Heart Association

Back to top 

 When copying this template, stop right before this line.
Retrieved from "http://www.smbrower.com/mediawiki/index.php/Drug_Monograph_Template"
Personal tools