Promethazine
Limited reviewed summaryFull monograph review pending
Review note before using historical content
Promethazine historical concentration and infusion advice is superseded
The restored article already warns against IV push, but other concentration and infusion-time examples conflict with the later FDA labeling update. Deep intramuscular administration is preferred; if IV administration is necessary, follow the updated exact-product dilution and infusion instructions. Do not use the old maximum-IV-concentration sentence or infusion examples as current instructions.
Safety sources and review scope
- FDA class-wide promethazine labeling safety update (opens in a new tab)Source URL: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-requires-updates-labeling-promethazine-hydrochloride-injection-products
Exact location: 2023-12-27 notice: administration recommendation paragraph; If intramuscular injection is not possible bullets; adult and pediatric dilution/infusion tables
Source family: FDA class-wide promethazine labeling safety update
Scope: Official route/concentration/administration update; not a complete individual product monograph.
- Promethazine U.S. prescribing information implementing FDA update (opens in a new tab)Source URL: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d02d52b-84bb-4e81-b352-125029eb39f6
Exact location: CONTRAINDICATIONS UUID0e9dd230-b07d-cda7-e063-6394a90ae084; DOSAGE AND ADMINISTRATION UUID0eade268-8023-e418-e063-6294a90a6ff9, Important Administration Information and Preparation/Administration for Diluted IV Infusion, Tables1/2
Source family: Promethazine U.S. prescribing information implementing FDA update
Scope: Example updated SPL version8 effective2024-01-05. It confirms the label change; stocked manufacturer/package and latest marketing status remain unreconciled.
Historical source in disagreement: Archived GlobalRPh article (opens in a new tab)Historical source URL: https://globalrph.com/dilution/promethazine/
Historical location: Drug Dilution:15–30 minute examples; Stability/Miscellaneous: Limit concentration paragraph and historical ISMP strategies
Review-note ID: H62-SAFETY-PROMETHAZINE-ADMINISTRATION. The historical source remains preserved; this note does not qualify its complete monograph.
Historical dilution reference. Verify the preparation against the label for the product in hand.
Original GlobalRPh article: Promethazine (opens in a new tab)Original source URL: https://globalrph.com/dilution/promethazine/ Retrieved 2026-11-04
Historical source details
Original publication date: unavailable in the retrieved article.
Source location and file checksums
- Original source URL
- https://globalrph.com/dilution/promethazine/ (opens in a new tab)
- Source date
- Not established in the retrieved source
- Retrieved
- 2026-11-04T19:47:24.201827+00:00
- Source location
- div.post-content
- Packaged content SHA-256
- 2dd4f01d4b5b9cebbd4a0fc3532d9ab8b2a155ba12f47798a9daf216ea448069
- Original response SHA-256
- 8356be5791a8cf5f99a89fc495f637c3dd450f1a5d5c268ed747f78741912194
- Source body SHA-256
- c675d139591292ad2d9f3b480197f6042ee80945fbf2ea8ee47cfdacaa9fec3f
Promethazine |
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| The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. | |
Usual Diluents |
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| NS, D5W | |
Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]Promethazine historical concentration and infusion advice is superseded The restored article already warns against IV push, but other concentration and infusion-time examples conflict with the later FDA labeling update. Deep intramuscular administration is preferred; if IV administration is necessary, follow the updated exact-product dilution and infusion instructions. Do not use the old maximum-IV-concentration sentence or infusion examples as current instructions. |
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| Follow your local protocol.... Detroit VAMC Dilution: [0 - 25 mg] [ 50 -100 ml] [ 15 - 30 min] Concentration studied in Trissel: (0.1 mg/ml) |
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Stability / MiscellaneousPromethazine historical concentration and infusion advice is superseded The restored article already warns against IV push, but other concentration and infusion-time examples conflict with the later FDA labeling update. Deep intramuscular administration is preferred; if IV administration is necessary, follow the updated exact-product dilution and infusion instructions. Do not use the old maximum-IV-concentration sentence or infusion examples as current instructions. |
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| EXP: 1 DAY (RT) Label: Do not Refrigerate. Protect from light.
Dilution opinion (D. McAuley): Antiemetic: Oral, I.M., I.V., rectal: 12.5 to 25 mg every 4 to 6 hours as needed. -------------------------------------------------------------------------------- Background information: Title: Action needed to prevent serious tissue injury with IV promethazine. "ISMP believes these long-standing hazards require further action on the part of healthcare providers, FDA, and promethazine manufacturers. In the 1970s, after numerous reports of infiltration and inadvertent intraarterial injection of hydroxyzine, FDA asked the manufacturer to revise the label and remove IV as an approved route. Today the drug is only indicated for IM or oral administration. Similarly, FDA should carefully investigate adverse events with this drug to determine if labeling changes are warranted, including removal of approval for IV administration." Safe Practice Recommendations: ... [See ISMP for further info ] Limited direct quotes from this source. Along with the manufacturer recommendations, the following strategies should be considered to prevent or minimize tissue damage when giving IV promethazine.... [See ISMP for further info ] Limit concentration. Since 25 mg/mL is the highest concentration of promethazine that can be given IV, stock only this concentration (not the 50 mg/mL concentration). Limit the dose. Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients. Hospitals have reported that these smaller doses have proven quite effective. Dilute the drug. Require further dilution of the 25 mg/mL strength to reduce vesicant effects and enable slow administration. For example, dilute the drug in 10 to 20 mL of normal saline if it will be administered via a running IV, or prepare the medication in minibags containing normal saline if there is time for pharmacy to dispense them as needed for individual patients. Extravasation can also be recognized more quickly when promethazine is diluted than if the drug is given in a smaller volume. Use large patent veins. Give the medication only through a large-bore vein (preferably via a central venous access site, but absolutely no hand or wrist veins). Check patency of the access site before administration... [See ISMP for further info ] Inject into the furthest port. Administer IV promethazine through a running IV line at the port furthest from the patient's vein. Educate patients. Before administration of the drug, tell patients to let you know immediately if burning or pain occurs during or after the injection. Use alternatives. Consider safer alternatives that can be used for the various conditions treated with IV promethazine. For example, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists may be used for both prophylaxis and as a rescue antiemetic. ... [See ISMP for further info ] Remove from formulary. Some hospitals that have continued to experience adverse outcomes despite safety measures have removed promethazine from their formulary or banned its IV use.The above message comes from "ISMP", who is solely responsible for its content. Nursing forum responses (Various sources - original sources unknown) -------------------------------------------------------------------------------- "Mosby's drug guide for nurses states to dilute with 9ml NaCl and administer over 2 minutes. Always dilute phenergan when giving it IV. My DH was in ER a while ago for what turned out to be food poisoning, they gave him undiluted phenergan and his vein sclerosed from wrist to bicep (no I'm NOT exaggerating)" -------------------------------------------------------------------------------- "As a nurse, I have had many patients complain aobut how much Phenergan burns. I would always just politely tell them them that it would burn and then push it slow diluted in 10 cc's of NS but then it was my turn. I was hospitalized and was given IV Phenergan and it not only burned like heck but I swear I felt like I was having a full blown MI. My entire arm was numb not to mention the IV site had to be changed and I developed phlebitis all around the site. I don't give Phenergan anymore without diluting it in 50 cc's of NS. I learned my lesson." |
Reviewed product information
Phenergan promethazine hydrochloride injection, Hikma 25 mg/mL, 1 mL vial. Adult IV guidance only when deep IM administration is not possible. Excludes the 50 mg/mL presentation.
The FDA safety communication and corresponding U.S. label address severe tissue injury. Use the adult table for the ordered dose. Keep the earlier safety notice above the historical article.
Preparation sources checked 2026-11-13.
Route Safety
Deep IM administration is preferred. If IV use is necessary, dilute for infusion and use a catheter in a large vein, preferably central. Avoid hand and wrist veins.
Sources and exact locations
Claim ID: IVR-70-PROMETHAZINE-001
Review basis: FDA postmarketing safety assessment
Source 1
PHENERGAN U.S. prescribing information (opens in a new tab)
Exact location: Important Administration Information for Adult and Pediatric Patients 2 Years of Age and Older (SPL section 417cce0e-dd9f-4739-ae0f-18a6398c7bee); Preparation and Administration Instructions for Diluted Intravenous Infusion in Adults (SPL section 1cfdf8d9-79d5-4584-8733-f87251357977)
Publisher: DailyMed / Hikma Pharmaceuticals USA Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:07.348573+00:00
Source 2
FDA promethazine injection safety communication (opens in a new tab)
Exact location: If intramuscular injection is not possible, first bullet
Publisher: U.S. Food and Drug Administration
Source family: U.S. Food and Drug Administration
Retrieved: 2026-11-13T14:23:07.428917+00:00
FDA safety communication underpinning the label update. These documents are related evidence.
Dilution
Use only 0.9% sodium chloride for dilution. IV concentrations above 1 mg/mL are contraindicated. Use the dose-specific adult dilution table.
Sources and exact locations
Claim ID: IVR-70-PROMETHAZINE-002
Review basis: FDA postmarketing safety assessment
Source 1
PHENERGAN U.S. prescribing information (opens in a new tab)
Exact location: WARNING: RESPIRATORY DEPRESSION IN PEDIATRICS AND SEVERE TISSUE INJURY, INCLUDING GANGRENE (SPL section 1f481ae1-6ac8-4575-97dc-de183cc2f310); Preparation and Administration Instructions for Diluted Intravenous Infusion in Adults (SPL section 1cfdf8d9-79d5-4584-8733-f87251357977)
Publisher: DailyMed / Hikma Pharmaceuticals USA Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:07.348573+00:00
Source 2
FDA promethazine injection safety communication (opens in a new tab)
Exact location: Diluent and concentration bullets; adult Table 1
Publisher: U.S. Food and Drug Administration
Source family: U.S. Food and Drug Administration
Retrieved: 2026-11-13T14:23:07.428917+00:00
FDA safety communication underpinning the label update. These documents are related evidence.
Adult Preparation Example
For a prescribed 25 mg adult dose, use 50 mL of 0.9% sodium chloride for dilution. Infuse over 20 to 40 minutes and do not exceed 2.5 mL/min.
Sources and exact locations
Claim ID: IVR-70-PROMETHAZINE-003
Review basis: FDA postmarketing safety assessment
Source 1
PHENERGAN U.S. prescribing information (opens in a new tab)
Exact location: Preparation and Administration Instructions for Diluted Intravenous Infusion in Adults (SPL section 1cfdf8d9-79d5-4584-8733-f87251357977)
Publisher: DailyMed / Hikma Pharmaceuticals USA Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:07.348573+00:00
Source 2
FDA promethazine injection safety communication (opens in a new tab)
Exact location: Adult Table 1, 25 mg row and preceding infusion-time paragraph
Publisher: U.S. Food and Drug Administration
Source family: U.S. Food and Drug Administration
Retrieved: 2026-11-13T14:23:07.428917+00:00
FDA safety communication underpinning the label update. These documents are related evidence.
Safety resources for this medication (1)
Read the linked communication and current prescribing information before use. Resource dates and affected product scopes differ; a listed resource is not a full monograph or a lot-specific clearance.
Product identifiers and clinical review status
Selected prescribing information available. Full monograph review pending.
Selected product identity
Matched to U.S. product NDC 0641-6084 for the preparation statements shown.
View product identifiers and primary-label provenance
- Selected product scope
- Phenergan promethazine hydrochloride injection, Hikma 25 mg/mL, 1 mL vial. Adult IV guidance only when deep IM administration is not possible. Excludes the 50 mg/mL presentation.
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application number(s)
- ANDA083312
- NDC(s)
- 0641-6084-01; 0641-6084-25
- DailyMed Set ID
- 481866da-a712-48a5-853f-8e84aacaab6d
- SPL version
- 8
- Label printed revision date
- Not established
- SPL effective date
- 2024-05-20
- Retrieved
- 2026-11-13T14:23:07.348573+00:00
- Downloaded XML SHA-256
- dacccf6673cf58652022b1b926dd4d4cb4cfb1f4feed74e19fcdd83ed9e82b9d
What remains to be completed
- Extract and verify presentation-specific IV preparation.
- Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
- Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.
Open the original GlobalRPh site monograph (historical; not revalidated) (opens in a new tab)