Revision as of 13:08, 13 May 2015 by Aparna Vuppala(talk | contribs)(Created page with "{{DrugProjectFormSinglePage |authorTag={{AV}} <!--Overview--> |genericName=promethazine hydrochloride (suppository) |aOrAn= a |drugClass= |indication= |hasBlackB...")
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Promethazine (rectal) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Promethazine (rectal) FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Promethazine (rectal) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Promethazine (rectal) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Promethazine (rectal) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Promethazine (rectal) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Promethazine (rectal) in pediatric patients.
Contraindications
Condition1
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Promethazine (rectal) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Promethazine (rectal) in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Promethazine (rectal) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Promethazine (rectal) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Promethazine (rectal) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Promethazine (rectal) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Promethazine (rectal) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Promethazine (rectal) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Promethazine (rectal) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Promethazine (rectal) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Promethazine (rectal) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Promethazine (rectal) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Promethazine (rectal) in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Promethazine (rectal) in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Promethazine (rectal) in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Promethazine (rectal) in the drug label.
Pharmacology
There is limited information regarding Promethazine (rectal) Pharmacology in the drug label.
Mechanism of Action
Structure
Each rectal suppository of Phenadoz contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, and cocoa butter. Phenadoz Suppositories are for rectal administration only.
Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride,(±)- with the following structural formula:
01.png){kind=link}