PROMETHAZINE HYDROCHLORIDE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Dispensing Solutions Inc.

DCI (Dénomination commune internationale):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 25 mg in 1 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 s

Descriptif du produit:

Promethazine Hydrochloride Injection, USP is available as follows: 25 mg/mL 50 mg/mL They are supplied by Dispensing Solutions Inc. as follows: Store at 20 °-25 °C (68 °-77 °F) [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. Baxter is a trademark of Baxter International Inc. Manufactured by Baxter Healthcare Corporation Deerfield, IL 60015 USA For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) This product was Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE INJECTION,
SOLUTION
DISPENSING SOLUTIONS INC.
----------
PROMETHAZINE HYDROCHLORIDE INJECTION, USP
RX ONLY
WARNINGS
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. POSTMARKETING 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
PROMETHAZINE HYDROCHLORIDE INJECTION CAN CAUSE SEVERE CHEMICAL
IRRITATION AND DAMAGE TO
TISSUES REGARDLESS OF THE ROUTE OF ADMINISTRATION. IRRITATION AND
DAMAGE CAN RESULT FROM
PERIVASCULAR EXTRAVASATION, UNINTENTIONAL INTRA-ARTERIAL INJECTION,
AND INTRANEURONAL OR
PERINEURONAL INFILTRATION. ADVERSE REACTIONS INCLUDE BURNING, PAIN,
THROMBOPHLEBITIS, TISSUE
NECROSIS, AND GANGRENE. IN SOME CASES, SURGICAL INTERVENTION,
INCLUDING FASCIOTOMY, SKIN
GRAFT, AND/OR AMPUTATION HAVE BEEN REQUIRED (SEE WARNINGS - Severe
Tissue Injury,
Including Gangrene).
DUE TO THE RISKS OF INTRAVENOUS INJECTION, THE PREFERRED ROUTE OF
ADMINISTRATION OF
PROMETHAZINE HYDROCHLORIDE INJECTION IS DEEP INTRAMUSCULAR INJECTION.
SUBCUTANEOUS
INJECTION IS CONTRAINDICATED. SEE DOSAGE AND ADMINISTRATION FOR
IMPORTANT NOTES ON
ADMINIS TRATION.
DESCRIPTION
Promethazine hydrochloride injection, USP is a sterile, pyrogen-free
solution for deep intramuscular or
intravenous administration. Promethazine hydrochloride
(10_H_-Phenothiazine-10-ethanamine,_N,N,_α-
trimethyl-, monohydrochloride, (±)-) is a racemic compound and has
the following structural formula:
C H CLN S 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 m