PROMETHAZINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Available from:

QPharma Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine Hydrochloride Tablets are useful for:      Perennial and seasonal allergic rhinitis.           Vasomotor rhinitis.      Allergic conjunctivitis due to inhalant allergens and foods.    Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.          Amelioration of allergic reactions to blood or plasma.            Dermographism.        Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled.      Preoperative, postoperative and obstetric sedation.     Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.               Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.      Sedation in both children and adults as well as relief of apprehens

Product summary:

Promethazine Hydrochloride Tablets, USP for oral administration are available as: 25 mg: White to off-white, flat-faced, beveled edge, round, uncoated tablets, debossed with “AN” above “521” with single line bisect separating them on one side and plain on the other side are supplied as: Bottles of 12:    NDC 42708-119-12 Store at 20º to 25°C (68° to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Distributed by: QPHARMA Rev. 10-2015-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
QPHARMA INC
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PROMETHAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as 10-
[2-(Dimethylamino)propyl]phenothiazine monohydrochloride and has the
following
structural formula:
Promethazine hydrochloride is a racemic compound; the empirical
formula is C
H
N
S HCl and its molecular weight is 320.88.
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 freely soluble in water and soluble in alcohol.
Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg
promethazine
hydrochloride, USP. The inactive ingredients include: lactose
anhydrous, magnesium
stearate, and microcrystalline cellulose. The 50 MG also contains D&C
Red # 27 Lake.
CLINICAL PHARMACOLOGY
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 H1 receptor blocking agent. In addition to its
antihistaminic action, it
provides clinically useful sedative and antiemetic effects.
Promethazine is well absorbed from the gastrointestinal tract.
Clinical effects are
apparent within 20 minutes after oral administration and generally
last four to six hours,
although they may persist as long as 12 hours. Promethazine is
metabolized by the liver
17
20
2
to a variety of compounds; the sulfoxides of promethazine and N-
demethylpromethazine are the predominant metabolites appearing in the
urine.
INDICATIONS AND USAGE
Promethazine Hydrochloride Tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated a