PROMETHAZINE HYDROCHLORIDE injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Promethazine Hydrochloride (UNII: R61ZEH7I1I) (Promethazine - UNII:FF28EJQ494)

Beschikbaar vanaf:

General Injectables & Vaccines, Inc

INN (Algemene Internationale Benaming):

Promethazine Hydrochloride

Samenstelling:

Promethazine Hydrochloride 50 mg in 1 mL

Toedieningsweg:

INTRAMUSCULAR

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. Children Less Than

Product samenvatting:

Promethazine Hydrochloride Injection, USP is available as follows: Storage 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. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. 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 FARMACEUTICA (PORTUGAL), S.A. Estrada do Rio da Mo, 8, 8A e 8B - Fervenca - 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Revised June 2016 462-638-00 PIN292-WES/1

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE INJECTION,
SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
PROMETHAZINE HCL 50 MG/ML INJECTION, USP 1 ML SINGLE DOSE AMPULE
BOXED WARNING
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 (10H-
Phenothiazine-10-ethanamine,N,N,a-trimethyl-, monohydrochloride,
(±)-) is a racemic
compound and has the following structural formula:
Each mL contains promethazine hydrochloride, either 25 mg or 50 mg,
edetate disodium
0.1 mg, calcium chloride 0.04 mg, sodium metabisu