PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE syrup

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Saatavilla:

Atlantic Biologicals Corps

INN (Kansainvälinen yleisnimi):

PROMETHAZINE HYDROCHLORIDE

Koostumus:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Promethazine hydrochloride and codeine phosphate 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. Promethazine hydrochloride and codeine phosphate syrup is a Schedule V Controlled Substance. Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE- PROMETHAZINE
HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
ATLANTIC BIOLOGICALS CORPS
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PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
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: Boysenberry flavor, citric acid, D&C Red 33,
FD&C Blue 1, FD&C Yellow 6,
glycerin, saccharin sodium, sodium benzoate, sodium citrate, sodium
propionate, sucrose and purified
water.
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 • ½ H 0, 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 0N S•HCl, and the
following structural formula:
CLINICAL PHARMACOLOGY
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 to be quite
18213342
1722
complex. Codeine resembles morphine both structurally