PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE- promethazine and phenylephrine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP 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 summary:

Promethazine Hydrochloride and Phenylephrine Hydrochloride Oral Solution, USP is a clear, pale yellow to yellow colored, citrus-flavored solution containing 6.25 mg Promethazine Hydrochloride, USP, 5 mg Phenylephrine Hydrochloride, USP and 7 percent alcohol in each teaspoonful (5 mL) Available as: 4 fl. oz (118 mL)         NDC  65162-679-86 16 fl. oz (473 mL)       NDC  65162-679-90 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx Only Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 05-2015-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE-
PROMETHAZINE AND PHENYLEPHRINE SOLUTION
AMNEAL PHARMACEUTICALS LLC
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PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
ORAL SOLUTION, USP
6.25 MG AND 5 MG/5 ML
RX ONLY
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Promethazine
hydrochloride, USP 6.25 mg; phenylephrine hydrochloride, USP 5 mg.
Alcohol 7%.
Inactive Ingredients: alcohol, ascorbic acid, caramel color, citric
acid, edetate disodium,
glycerin, methylparaben, natural & artificial citrus flavor, purified
water, saccharin
sodium, sodium benzoate, sodium citrate, sodium metabisulfite and
sucrose.
Promethazine hydrochloride, USP, a phenothiazine derivative, is
chemically designated as
(±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride.
Promethazine hydrochloride, USP 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, USP is a sympathomimetic amine salt which
is chemically
designated as (-)-_m_-Hydroxy-α-[(methylamino)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, USP 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.
Promethazine is an H recep