PROMETHAZINE VC WITH CODEINE- codeine phosphate, promethazine hydrochloride, and phenylephrine hydrochloride syrup

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520), PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Tillgänglig från:

Dispensing Solutions, Inc.

INN (International namn):

CODEINE PHOSPHATE

Sammansättning:

CODEINE PHOSPHATE 10 mg in 5 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Promethazine HCl, phenylephrine HCl and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. The combination of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosi

Produktsammanfattning:

Each 5 mL of reddish-clear syrup with odor of strawberry menthol contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL). Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

PROMETHAZINE VC WITH CODEINE - CODEINE PHOSPHATE, PROMETHAZINE
HYDROCHLORIDE, AND
PHENYLEPHRINE HYDROCHLORIDE SYRUP
DISPENSING SOLUTIONS, INC.
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PROMETHAZINE VC WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE,
USP, PHENYLEPHRINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP)
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains: Codeine
phosphate 10 mg; promethazine
hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%.
Inactive Ingredients: Ascorbic acid, citric acid, D&C Red #33, FD&C
Yellow #6, menthol,
methylparaben, propylene glycol, propylparaben, purified water,
saccharin sodium, sodium benzoate,
sodium citrate, strawberry flavor and sucrose.
Codeine is one of the naturally occurring phenanthrene alkaloids of
opium derived from the opium
poppy; it is classified pharmacologically as a narcotic analgesic.
Codeine phosphate may be chemically
designated as
7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1)(salt)
hemihydrate.
The phosphate salt of codeine occurs as white, needle-shaped crystals
or white crystalline powder.
Codeine phosphate is freely soluble in water and slightly soluble in
alcohol. It has a molecular weight
of 406.37, a molecular formula of C
H NO • H PO • ½H O and the following structural formula:
Promethazine hydrochloride, a phenothiazine derivative, is chemically
designated as (±)-10-[2-
(Dimethylamino)propyl] phenothiazine 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. It has a molecular weight of 320.88, a molecular
formula of C
H N S • HCI and
the following structural formula:
Phenylephrine hydrochloride is a sympathomimetic amine salt which is
chemically indicated as (-)-_m_-
Hydroxy-α-[(methyl-amino)-methyl] benzyl alcohol hydrochloride. It
occurs as white or nearly white
crystals, having a bitter taste. It is freel