PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate syrup

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520), PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Beschikbaar vanaf:

Physicians Total Care, Inc.

INN (Algemene Internationale Benaming):

CODEINE PHOSPHATE

Samenstelling:

CODEINE PHOSPHATE 10 mg in 5 mL

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. The combination of promethazine 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. 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. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with resp

Product samenvatting:

Promethazine with Codeine Syrup, a clear purple syrup with odor of grape menthol, contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in: 4 fluid ounce (118 mL) NDC 54868-1029-1 , 8 fluid ounce (237 mL) NDC 54868-1029-0 . and pint (473 mL) NDC 54868-1029-2 .

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

PROMETHAZINE WITH CODEINE - PROMETHAZINE HYDROCHLORIDE AND CODEINE
PHOSPHATE SYRUP
PHYSICIANS TOTAL CARE, INC.
----------
PROMETHAZINE WITH CODEINE SYRUP (PROMETHAZINE HYDROCHLORIDE, USP
AND CODEINE PHOSPHATE, USP)
CV
RX ONLY
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Promethazine hydrochloride 6.25 mg;
codeine phosphate 10 mg. Alcohol 7%.
Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C
red #3, grape blend flavor,
menthol, methylparaben, propylene glycol, propylparaben, purified
water, saccharin sodium, sodium
benzoate, sodium citrate 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:
18
21
3
3
4
2
17
20
2
CLINICAL PHARMACOLOGY
CODEINE:
Narcotic analgesics, including codeine, exert their primary effects on
the central nervous system and
gastrointestinal tract. The analgesic effects of codeine are due to
its central action; however, the
precise sites of action have not been determined, and the mechanisms
involved appear