PROMETHAZINE HYDROCHLORIDE injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Cardinal Health 107, LLC

INN (International Nazwa):

PROMETHAZINE HYDROCHLORIDE

Skład:

PROMETHAZINE HYDROCHLORIDE 25 mg in 1 mL

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Promethazine hydrochloride injection is indicated for the following conditions: Promethazine hydrochloride injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression ( see  WARNINGS - Respiratory Depression) . Promethazine hydrochloride injection is contraindicated in comatose states. Under no circumstances should promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS - Severe Tissue Injury, Including Gangrene). Promethazine hydrochloride injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection. Promethazine hydrochloride injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.

Podsumowanie produktu:

Promethazine Hydrochloride Injection, USP is available as follows: 25 mg/mL Overbagged with 5 x 1 mL vials per bag, NDC 55154-2861-5 Store at 20° to 25°C (68° to 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. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Distributed by: Cardinal Health Dublin, OH 43701 L35883810224 Revised May 2020 462-232-06

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE INJECTION
CARDINAL HEALTH 107, LLC
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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 ADMINISTRATION.
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
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