PROMETHAZINE HYDROCHLORIDE injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Physicians Total Care, Inc.

INN (International Adı):

PROMETHAZINE HYDROCHLORIDE

Kompozisyon:

PROMETHAZINE HYDROCHLORIDE 25 mg in 1 mL

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 tha

Ürün özeti:

Promethazine Hydrochloride Injection, USP is available as follows: Store at 20 º   - 25 ºC   (68º - 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 by:                              HIKMA FARMACÊUTICA (PORTUGAL), S.A.  Estrada do Rio da Mó, nº 8, 8A e 8B - Fervença,  2705 – 906 Terrugem SNT  PORTUGAL Distributed by: WEST-WARD PHARMACEUTICAL CORP. 465 Industrial Way West Eatontown, NJ 07724 USA Iss.: Oct  2009 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK       74146

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE INJECTION
PHYSICIANS TOTAL CARE, INC.
----------
PROMETHAZINE HYDROCHLORIDE INJECTION
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. 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
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 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:
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 mg
in Wate