PROMETHAZINE HYDROCHLORIDE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Commercializzato da:

XGen Pharmaceuticals DJB, Inc.

INN (Nome Internazionale):

PROMETHAZINE HYDROCHLORIDE

Composizione:

PROMETHAZINE HYDROCHLORIDE 25 mg in 1 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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. The use of promethazine hydrochloride injection is contraindicated: - In pediatric patients less than 2 years of age due to the risk of respiratory depression ( WARNINGS - Respiratory Depression ). - For use as an intravenous injection at concentrations greater than 1 mg/mL due to the risk of perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration ( see WARNINGS - Severe Tissue Injury, Including Gangrene and DOSAGE AND ADMINISTRATION ). - For use as an intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene ( see WARNINGS - Severe Tissue Injury, Including Gangrene ). - For use as a subcutaneous injection because chemical irritation and necrotic lesions have been reported ( see WARNINGS - Severe Tissue Injury, Including Gangrene ). - In patients in a comatose state. - In patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine hydrochloride or other phenothiazines.

Dettagli prodotto:

Promethazine Hydrochloride Injection, USP – 25 mg/1mL, 1 mL fill in a 1 mL ampul (NDC 39822-5525-2) packaged in carton of 25 (NDC 39822-5525-3) Promethazine Hydrochloride Injection, USP – 50 mg/1mL, 1 mL fill in a 1 mL ampul (NDC 39822-5550-5) packaged in carton of 25 (NDC 39822-5550-6) Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. Do not use if solution has developed color or contains a precipitate. Manufactured in Germany Distributed by: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 USA Rev. 12/2023 PZ-PI-04

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE INJECTION,
SOLUTION
XGEN PHARMACEUTICALS DJB, INC.
----------
PROMETHAZINE HYDROCHLORIDE INJECTION, USP
WARNINGS: RESPIRATORY DEPRESSION IN PEDIATRICS AND SEVERE
TISSUE INJURY, INCLUDING GANGRENE
RESPIRATORY DEPRESSION – PEDIATRICS
PROMETHAZINE HYDROCHLORIDE INJECTION SHOULD NOT BE USED IN PEDIATRIC
PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL
RESPIRATORY DEPRESSION. POST-MARKETING CASES OF RESPIRATORY
DEPRESSION,
INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE IN
PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. CAUTION SHOULD BE
EXERCISED
WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE INJECTION TO PEDIATRIC
PATIENTS 2 YEARS OF AGE AND OLDER (SEE WARNINGS - RESPIRATORY
DEPRESSION).
SEVERE TISSUE INJURY, INCLUDING GANGRENE
SEVERE CHEMICAL IRRITATION AND DAMAGE TO TISSUES REGARDLESS OF THE
ROUTE OF PARENTERAL ADMINISTRATION HAS BEEN REPORTED IN PATIENTS
TREATED WITH PROMETHAZINE HYDROCHLORIDE INJECTION INCLUDING GANGRENE,
TISSUE NECROSIS, AND THROMBOPHLEBITIS; AND IN SOME CASES, SURGICAL
INTERVENTION INCLUDING FASCIOTOMY, SKIN GRAFT, AND/OR AMPUTATION HAVE
BEEN REQUIRED (SEE WARNINGS - SEVERE TISSUE INJURY, INCLUDING
GANGRENE).
THE USE OF PROMETHAZINE HYDROCHLORIDE INJECTION BY THE FOLLOWING
ROUTES OF ADMINISTRATION IS CONTRAINDICATED:
O INTRAVENOUS INJECTION AT CONCENTRATIONS GREATER THAN 1 MG/ML
O INTRA-ARTERIAL INJECTION
O SUBCUTANEOUS INJECTION (SEE CONTRAINDICATIONS).
THE PREFERRED ROUTE OF ADMINISTRATION IS BY DEEP INTRAMUSCULAR
ADMINISTRATION.
PROMETHAZINE HYDROCHLORIDE INJECTION MAY BE ADMINISTERED
INTRAVENOUSLY AFTER DILUTION THROUGH AN INTRAVENOUS CATHETER INSERTED
IN A LARGE VEIN. PREFERABLY THROUGH A CENTRAL VENOUS CATHETER (SEE
DOSAGE AND ADMINISTRATION).
IF PAIN OCCURS AT THE INJECTION SITE DURING INTRAVENOUS INFUSION,
IMMEDIATELY DISCONTINUE THE INFUSION AND EVALUATE FOR POSSIBLE
ARTERIAL
INJECTION OR PERIVASCULAR EXTRAVASATION, AND INITIATE APPROPRIATE
MEDICAL MANAGEMENT.
DESCRIPTION
Promethazine hydrochlor