PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE syrup

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Beschikbaar vanaf:

Akorn

INN (Algemene Internationale Benaming):

PROMETHAZINE HYDROCHLORIDE

Samenstelling:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. 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 are 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 thrombosis of compromised vascular beds). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI).

Product samenvatting:

This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL). Keep tightly closed. Protect from light. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Made in U.S.A. Rev. 802:01 08/16

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE-
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SYRUP
AKORN
----------
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
SYRUP
RX ONLY
DESCRIPTION
Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup is a
yellow-orange
colored, fruit flavored syrup. Each 5 mL (one teaspoonful), for oral
administration
contains: Promethazine hydrochloride 6.25 mg; phenylephrine
hydrochloride 5 mg.
Alcohol 7%.
INACTIVE INGREDIENTS: Sucrose syrup, sodium benzoate, sodium citrate,
propylene
glycol, citric acid, ascorbic acid, methylparaben, propylparaben, FD&C
Yellow No. 6,
natural tangerine extract and purified water.
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 • HCl, and the following structural formula:
Phenylephrine hydrochloride is a sympathomimetic amine salt which is
chemically
designated as (-)-m-Hydroxy-α-[(methyl amino)methyl]benzyl alcohol
hydrochloride. It
occurs as white or nearly white crystals, having a bitter taste. It is
freely soluble in water
and alcohol. Phenylephrine hydrochloride is subject to oxidation and
must be protected
from light and air. It has a molecular weight of 203.67, a molecular
formula of C H
NO
• HCl, and the following structural formula:
17
20
2
9
13
2
CLINICAL PHARMACOLOGY
PROMETHAZINE:
Promethazine is a phenothiazine derivative which differs structurally
from the
antipsychotic phenothiazines by the presence of a branched side chain
and no ring
substitution. It is thought that this configuration is responsible for
its relative lack (1/10
that of chlorpromazine) of dopamine antagonist properties.
Promethazin