PROMETHAZINE VC- promethazine hydrochloride and phenylephrine hydrochloride solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Par Pharmaceutical

INN (Nome Internazionale):

PROMETHAZINE HYDROCHLORIDE

Composizione:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Promethazine and phenylephrine hydrochloride oral solution 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).

Dettagli prodotto:

This preparation is a yellowish-orange oral solution with odor of apricot peach. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in a one pint (473 mL) bottle NDC 0603-1587-58. Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROMETHAZINE VC- PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE
HYDROCHLORIDE SOLUTION
PAR PHARMACEUTICAL
----------
PROMETHAZINE VC ORAL SOLUTION
(PROMETHAZINE AND PHENYLEPHRINE HYDROCHLORIDE ORAL SOLUTION)
RX ONLY
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Promethazine hydrochloride 6.25 mg;
phenylephrine hydrochloride 5 mg. Alcohol 7%.
Inactive Ingredients: Apricot peach flavor, ascorbic acid, citric
acid, FD&C yellow #6, menthol,
methylparaben, propylene glycol, propylparaben, purified water,
saccharin sodium, sodium benzoate,
sodium citrate and sucrose.
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 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 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 •HCI, and the following structural
formula:
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
17
20
2
9
13
2
configuration is responsible for its relative lack (1/10 that of
chlorpromazine) of dopamine antagonist
properties.
Promethazine is an H receptor blocking agent. In addition to its
antihistaminic action, it provides
clinically usefu