DESCRIPTION
Promethazine hydrochloride
is a racemic compound; the
empirical formula is C17H20N2SHCl
and its molecular weight is 320.88.
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as N,N,a-trimethyl-10H-phenothiazine-10-ethanamine
monohydrochloride.
Promethazine hydrochloride
occurs as a white to faint
yellow, practically odorless, crystalline
powder which slowly oxidizes
and turns blue on prolonged exposure
to air. It is soluble in water
and freely soluble in alcohol.
Injection: Each ml
of the Tubex and Tubex Blunt Pointe Sterile Cartridge Units contains either
25 or 50 mg promethazine hydrochloride with 0.1 mg edetate disodium, 0.04
mg calcium chloride, not more
than 5 mg monothioglycerol and 5 mg phenol
with sodium acetate-acetic
acid buffer. Sealed under nitrogen.
Syrup: Each teaspoon
(5 ml) of Phenergan Syrup Plain contains 6.25 mg promethazine hydrochloride
in a flavored syrup base
with a pH between 4.7 and 5.2.
Alcohol 7%. The inactive ingredients present
are artificial and natural
flavors, citric acid, D&C Red 33, D&C Yellow 10, FD&C Blue
1, FD&C Yellow 6, glycerin, saccharin
sodium, sodium benzoate, sodium
citrate, sodium propionate,
water, and other ingredients.
Each teaspoon (5 ml) of
Phenergan Syrup Fortis contains 25 mg promethazine hydrochloride in a
flavored syrup base
with a pH between 5.0 and 5.5.
Alcohol 1.5%. The inactive ingredients present
are artificial and natural
flavors, citric acid, saccharin
sodium, sodium benzoate, sodium
propionate, water, and other ingredients.
Tablets and Suppositories: Each tablet
of Phenergan contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride.
The inactive ingredients present are lactose, magnesium
stearate, and methylcellulose. Each dosage strength also contains the
following: 12.5 mg¾FD&C Yellow 6
and saccharin sodium; 25
mg¾saccharin sodium; 50 mg¾FD&C
Red 40.
Each rectal suppository of
Phenergan contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride
with ascorbyl palmitate, silicon
dioxide, white wax, and cocoa butter.
CATEGORIES, BRAND NAMES
CATEGORIES: Anaphylaxis, adjunct; Anesthesia, adjunct;
Angioedema; Conjunctivitis, allergic; Dermographism; Hypersensitivity,
transfusion; Motion sickness; Pain, adjunct; Rhinitis, perennial allergic;
Rhinitis, seasonal allergic; Rhinitis, vasomotor; Sedation; Sedation,
obstetrical; Urticaria; Pregnancy Category C; DEA Class CV; FDA Approved
1955 Jun; Top 200 Drugs; WHO Formulary
FDA Drug Classes: Anesthesia, Adjuncts To; Antiemetics;
Antihistamines; Antitussives/Expectorants; Sedatives/Hypnotics; Vertigo/Motion
Sickness/Vomiting
BRAND NAMES:
BRAND NAMES: Allerfen; Anergan; Antiallersin; Atosil;
Avomine; Bonnox; Camergan; Fargan; Farganesse; Fenergan;
Goodnight; Hibechin; Hiberna; Insomn-Eze;
Lergigan; Metaryl; Pelpica; Pentazine; Phenazine; Phenergan;
Phenerzine; Phenoject-50; Pilothia; Pipolphene; Pro-50; Promacot; Prome;
Promergan; Promesan; Prometh; Promethacon; Promethazine Hcl; Promethegan;
Proneurin; Prorex; Prothiazine; Prozine; Pyrethia;
Sayomol; Xepagan
(Foreign Brand names outside U.S. in italics)
FOREIGN BRAND AVAILABILITY:
Allerfen (Italy)
Atosil (Germany)
Bonnox (Germany)
Farganesse (Italy)
Fenergan (Argentina; Peru)
Goodnight (New-Zealand)
Hibechin (Japan)
Hiberna (Japan)
Insomn-Eze (Australia)
Lergigan (Sweden)
Prome (Indonesia)
Proneurin (Germany)
Prothiazine (Israel)
Pyrethia (Japan; Taiwan)
HCFA JCODE(S): J2550 up to 50 mg IM, IV
COST OF THERAPY: $13.50 (Rhinitis; Phenergan Tablet; 25
mg; 1/day; 30 days)
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