PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride injection

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Henry Schein, Inc.

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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: Hikma Pharmaceuticals USA Inc. Berkley Heights, NJ 07922 Revised September 2020 462-638-02 PIN292-WES/3

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE INJECTION
HENRY SCHEIN, INC.
----------
PROMETHAZINE HCL 25 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 GANGRENEPROMETHAZINE 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 metabisulfite 0.25 mg and
phenol 5