Edit DrugProjectForm1: Chloramphenicol sodium succinate

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Instructions[edit | edit source]

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1.  Read before you proceed


1.1  Resources


1.1.1  DailyMed

1.1.1.1  DailyMed is a public service provided by the National Library of Medicine (NLM) that encompasses FDA approved labels (package inserts) of marketed drugs.

1.1.2  Drugs@FDA

1.1.2.1  Drugs@FDA is a searchable catalog of FDA approved drug products (both prescription and over the counter) which is also useful for confirmation of the marketing status.

1.1.3  Pillbox

1.1.3.1  Pillbox is developed to aid in the identification of unknown pills (oral solid dosage form medications). It combines images of pills with appearance and other information to enable users to visually search for and identify oral solid dosage form medications.
1.1.3.2  Once a pill has been identified, additional information is provided, including brand/generic name, ingredients, and the National Drug File identification number.
1.1.3.3  Links are provided to NLM drug information resources, such as drug labels from DailyMed and the Drug Information Portal, which searches NIH and FDA drug information resources.

1.1.4  Drug Information Portal

1.1.4.1  Drug Information Portal provides links to information on breastfeeding (LactMed), drug-induced liver injury (LiverTox), manufacturers drug label (DailyMed), clinical trials (ClinicalTrials.gov), and drug Identification and Image Display (Pillbox beta).
1.1.4.2  For detailed information, it also provides links to reviewed biological and physical data (HSDB), references from scientific journals (Medline/PubMed), references from toxicological journals (TOXLINE), biological activities and chemical structures (PubChem), biological activities against HIV/AIDS and other viruses (NIAID ChemDB), toxicological and chemical resources (ChemIDplus), information from the US Food & Drug Administration (Drugs@FDA), and information from the US Drug Enforcement Administration (DEA)

1.1.5 MedlinePlus

1.1.5.1  MedlinePlus is a service of the National Library of Medicine (NLM) which contains information for drugs, herbs, and supplements.

1.2  Generic name, active ingredient, compound, combination, trade name, formulation, and label


1.2.1  What is the generic name?

1.2.1.1  Search and confirm the generic name of the drug.
1.2.1.2  Use the generic name as the title of the landing page.

1.2.2  What is the active ingredient? Is there more than one compound for the active ingredient?

1.2.2.1  Search and confirm the compound(s) of the active ingredient.
1.2.2.2  If there is more than one type of compound, place links (as <h3> headings) of each compound at the top of the landing page.

1.2.3  Is the active ingredient provided as combinations with other active ingredients?

1.2.3.1  If the active ingredient is also provided as combinations with other active ingredients, place links (as <h3> headings) of each combination at the top of the landing page.

1.2.4  What is the trade name?

1.2.4.1  Search and confirm the trade names for the generic name and its compounds. Please note that the trade name may be identical to the generic name in certain cases.
1.2.4.2  Search and confirm the trade names for each combination (if any).
1.2.4.3  List the trade names of each compound and/or combination in parentheses.
1.2.4.4  Sort the list of compunds and/or combinations in alphabetical order.

1.2.5  What is the formulation?

1.2.5.1  Learn the concept of pharmaceutical formulations here.
1.2.5.2  Search and confirm the formulations for the generic name and its compounds and combinations. Please note that different formulations may have identical trade names.

1.2.6  Which label should be used?

1.2.6.1  Check the Marketing Start Date and the Revised date at the end of the label.
1.2.6.2  Choose the label that is most recently updated as a reference.

1.2.7  Example

For the generic name Metoprolol, there are two compounds of the active ingredient: metoprolol succinate and metoprolol tartrate.
Available compounds, combinations, and trade names of Metoprolol are as follows:
Metoprolol succinate (Toprol XL, Toprolxl XL)
Metoprolol succinate/Hydrochlorothiazide (Dutoprol)
Metoprolol tartrate (Lopressor)
Metoprolol tartrate/Arginine (Hypertensolol)
Metoprolol tartrate/Hydrochlorothiazide (Lopressor HCT)

2.  Creating or editing a drug page


2.1  Landing page


2.1.1  Go to WikiDoc.

2.1.2  Search with the generic name.

2.1.3  The generic name page should be organized as a landing page if multiple compounds exist.

2.1.4  At the top of the landing page, place the links (as <h3> headings) of compounds and/or combinations followed by trade names in parentheses (See Section 1.2 for instructions).

2.1.4.1  <h3> headings should begin and end with three "=" signs.
2.1.4.2  Example: ===[[Metoprolol succinate]] ([[Toprol XL]], [[Toprolxl XL]])===

2.1.5  Redirect the trade name pages to its generic compound page.

2.1.5.1  Example 1: Redirect Lopressor to Metoprolol tartrate.
2.1.5.2  Example 2: Redirect both Toprol XL and Toprolxl XL to Metoprolol succinate.

2.1.6  Create or edit the Overview section and Category section.

2.1.6.1  The Overview section should include information about the drug class, usage, and adverse reactions.
2.1.6.2  The Category section should include all applicable categories for the drug in alphabetical order.
2.1.6.3  The name of category should be identical to the official FDA category.

2.2  Using the Drug Project Form


2.2.1  To create a drug page, Go to Form:DrugProjectForm.

2.2.2  Use the appropriate title for the drug page.

2.2.2.1  If there is more than one compound for a generic name, use the generic name with compound as the title.
2.2.2.1.1  Example 1: Use Metoprolol succinate as the title.
2.2.2.1.2  Example 2: Use Metoprolol tartrate as the title.
2.2.2.2  If there are combinations with other active ingredients, use the combination of each ingredient separated by the word "and" as the title.
2.2.2.2.1  Example 1: Metoprolol succinate and Hydrochlorothiazide as the title.
2.2.2.2.2  Example 2: Metoprolol tartrate and Arginine as the title.

2.2.3  Enter the title for the drug page in the field and left-click on the "Create or edit a Drug Page" button.

2.2.4  Follow the instructions under each tab to insert contents.

2.2.5  Left-click on the "Save page" button after completing each tab to minimize the risk of losing progress.

2.2.6  Quality check the completed section before proceeding to the next section.




Black Box Warning[edit | edit source]

Please enter the title of the Black Box warning:
Please enter the body of the Black Box warning:


Adult Indications and Dosage[edit | edit source]

Please enter FDA-labeled indications and dosing information for adults:
  • Step 1: Check the "Dosage And Administration" section from the FDA label
  • Step 2: Insert the dosing information for each indication
Please enter established off-label use and dosage for adults:
Please enter guideline-supported off-label use in this field:
Please enter non–guideline-supported off-label use in this field:


Pediatric Indications and Dosage[edit | edit source]

Please enter FDA-labeled indications and dosage information for children:
  • Step 1: Check the "Dosage And Administration" section from the FDA label
  • Step 2: Insert the dosing information for each indication
Please enter established off-label use and dosage for children:
Please enter guideline-supported off-label use in this field:
Please enter non–guideline-supported off-label use in this field:


Contraindications[edit | edit source]

Please enter the FDA reported contraindications:
  • Step 1: Check the "Contraindications" section from the FDA label
  • Step 2: Arrange the contents into bullet points


Warnings[edit | edit source]

Please enter the FDA reported warnings associated with the drug:
  • Step 1: Check the "Warnings" section from the FDA label
  • Step 2: Arrange the contents into bullet points


Adverse Reactions[edit | edit source]

Please enter the adverse reactions reported from clinical trial experience:
  • Step 1: Check the "Adverse Reactions" section from the FDA label
  • Step 2: Arrange the contents based on organ systems
Please enter the adverse reactions reported from postmarketing experience:
  • Step 1: Check the "Adverse Reactions" section from the FDA label
  • Step 2: Arrange the contents based on organ systems


Drug Interactions[edit | edit source]

Please enter established drug interactions:
  • Step 1: Check the "Drug Interactions" section from the FDA label
  • Step 2: Arrange the contents into bullet points


Use in Specific Populations[edit | edit source]

FDA Pregnancy Category:
Please enter information related to the FDA pregnancy category:
Australian Pregnancy Category:
Please enter information related to the Australian pregnancy category:
Please enter information related to the use of the drug during labor and delivery:
Please enter information related to the use of the drug during nursing:
Please enter information related to the use of the drug in pediatrics:
Please enter information related to the use of the drug in geriatrics:
Please enter information related to the use of the drug and gender:
Please enter information related to the use of the drug and race:
Please enter information related to the use of the drug in patients with renal impairment:
Please enter information related to the use of the drug in patients with hepatic impairment:
Please enter information related to the use of the drug in females of reproductive potential and males:
Please enter information related to the use of the drug in immunocompromised patients:
Others: Title of Section:

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