promethazine hcl- 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:

Watson Laboratories, Inc.

INN (International Name):

Promethazine hydrochloride

Pharmaceutical form:

INJECTION

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine HCl Injection is indicated for the following conditions: - Amelioration of allergic reactions to blood or plasma. 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. 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 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. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. - Active treatment of motion sickness. Active treatment of motion sickness. - Prevention and control of nausea and vomiting

Product summary:

Promethazine HCl Injection USP is available as follows: 25 mg/mL, 1 mL ampules, cartons of 25 50 mg/mL, 1 mL ampules, cartons of 25 Store at controlled room temperature 15º-30ºC (59º - 86ºF). Protect from light. Keep covered in carton until time of use. Do not use if solution has developed color or contains a precipitate. Literature revised: June 2004 Product Nos.: 1107-81, 0259-81 Watson Laboratories, Inc. Corona, CA 92880 USA 695302590591*B1

Summary of Product characteristics

PROMETHAZINE HCL- PROMETHAZINE HYDROCHLORIDE INJECTION
WATSON LABORATORIES, INC.
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PROMETHAZINE HCL INJECTION USP
RX ONLY
DESCRIPTION
Promethazine HCl Injection USP is a sterile, pyrogen-free solution for
deep intramuscular or
intravenous administration. Promethazine HCl
(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 = 320.89
Each mL contains: Promethazine HCl 25 mg or 50 mg, Edetate Disodium
0.1 mg, Calcium Chloride 0.04
mg, Sodium Metabisulfite 0.25 mg, with Phenol 5 mg as preservative, in
Water for Injection, q.s.
Buffered with Glacial Acetic Acid and Sodium Acetate, Trihydrate. The
pH range is 4.0 to 5.5. Sealed
under Nitrogen.
Promethazine HCl Injection is a clear, colorless solution. The product
is light sensitive. It should be
inspected before use and discarded if either color or particulate is
observed.
CLINICAL PHARMACOLOGY
Promethazine HCl is a phenothiazine derivative which possesses
antihistaminic, sedative, antimotion
sickness, antiemetic, and anticholinergic effects. Promethazine is a
competitive H receptor antagonist,
but does not block the release of histamine. Structural differences
from the neuroleptic phenothiazines
results in its relative lack (1/10) of dopamine antagonist properties.
In therapeutic doses, promethazine
HCl produces no significant effects on the cardiovascular system.
Clinical effects are generally
apparent within 5 minutes of an intravenous injection and within 20
minutes of an intramuscular injection.
Duration of action is four to six hours, although effects may persist
up to 12 hours. Promethazine HCl
is metabolized in the liver, with the sulfoxides of promethazine and
N-desmethylpromethazine being the
predominant metabolites appearing in the urine. Following intravenous
administration in healthy
volunteers, the plasma half-life for promethazine has been reported to
range from 9 to 16 hours. The
mean plasma half-life for promethazine after intramuscular
a