Promethazine, Hydrochloride Injection, USP

DESCRIPTION

id: e477a361-02b4-4ca1-9ecb-96e4f728804f
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Promethazine hydrochloride injection, USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine hydrochloride (10H-Phenothiazine-10-ethanamine,N,N,a-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula:

C₁₇H₂₁ClN₂S                                    MW=320.88

Each mL contains promethazine hydrochloride, either 25 mg or 50 mg, edetate disodium 0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and phenol 5 mg in Water for Injection. pH 4.0 to 5.5; buffered with acetic acid-sodium acetate. Promethazine hydrochloride injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.

CLINICAL PHARMACOLOGY

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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Promethazine hydrochloride is a phenothiazine derivative which possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. Promethazine is a competitive H₁ receptor antagonist, but does not block the release of histamine. Structural differences from the neuroleptic phenothiazines result in its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Clinical effects are generally apparent within 5 minutes of an intravenous injection and within 20 minutes of an intramuscular injection. Duration of action is four to six hours, although effects may persist up to 12 hours. Promethazine hydrochloride is metabolized in the liver, with the sulfoxides of promethazine and N-desmethylpromethazine being the predominant metabolites appearing in the urine. Following intravenous administration in healthy volunteers, the plasma half-life for promethazine has been reported to range from 9 to 16 hours. The mean plasma half-life for promethazine after intramuscular administration in healthy volunteers has been reported to be 9.8 ± 3.4 hours.

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Promethazine hydrochloride injection is indicated for the following conditions: Amelioration of allergic reactions to blood or plasma.
In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
Active treatment of motion sickness.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
As an adjunct to analgesics for the control of postoperative pain.
Preoperative, postoperative, and obstetric (during labor) sedation.
Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

OVERDOSAGE

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displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Signs and symptoms of overdosage range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in pediatric patients receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms—dry mouth; fixed, dilated pupils; flushing; etc, as well as gastrointestinal symptoms, may occur.

HOW SUPPLIED

id: 362d315b-d8ef-4eaa-9cac-8f3124bf85c7
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Promethazine hydrochloride injection, USP is available as follows:

NDC Number	Strength	Package
54868-0262-1	50 mg/mL	1 mL fill in a 2 mL vial 25 vial per shelf tray

PRINCIPAL DISPLAY PANEL – 50 mg/mL Vial Label

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 54868-0262-1
Rx only Promethazine
Hydrochloride
Injection, USP 50 mg/mL FOR DEEP INTRAMUSCULAR
USE ONLY 1 mL Single Dose Vials 25 Vials