PHENERGAN- promethazine hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PHENERGAN 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. PHENERGAN Injection is contraindicat

Product summary:

PHENERGAN Injection (promethazine hydrochloride injection, USP) is available as follows: 25 mg/mL    1 mL vials packaged in 25s (NDC 0641-6084-25) 50 mg/mL   1 mL vials packaged in 25s (NDC 0641-6085-25) 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. Phenergan is a registered trademark of Wyeth and is used under license. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised May 2020 462-024-06                                                                                                                                                 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENERGAN- PROMETHAZINE HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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PHENERGAN INJECTION (PROMETHAZINE HYDROCHLORIDE INJECTION, USP)
RX ONLY
WARNINGS
RESPIRATORY DEPRESSION – PEDIATRICS
PHENERGAN 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
PHENERGAN INJECTION TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER
(SEE
WARNINGS - Respiratory Depression).
SEVERE TISSUE INJURY, INCLUDING GANGRENE
PHENERGAN 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 PHENERGAN INJECTION IS DEEP INTRAMUSCULAR INJECTION.
SUBCUTANEOUS INJECTION IS CONTRAINDICATED. SEE DOSAGE AND
ADMINISTRATION FOR IMPORTANT NOTES ON ADMINISTRATION.
DESCRIPTION
PHENERGAN Injection (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
17
21
2
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
Water for Injecti