PROMETHAZINE HYDROCHLORIDE- 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:

Heritage Pharmaceuticals Inc.

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 12.5 mg

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, or 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 post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients. Promethazine hydrochloride tablets are contraindicated for use in p

Product summary:

Promethazine Hydrochloride Tablets USP, 12.5 mg are available for oral administration as orange colored, round shaped, biconvex tablets debossed "HP bisect 67"on one side and "Plain" other side and are supplied as: Bottles of 100:    NDC 23155-067-01 Promethazine Hydrochloride Tablets USP, 25 mg are available for oral administration as white, round, flat faced tablets debossed "HP 68" on one side and scored on the other side and are supplied as: Bottles of 100:    NDC 23155-068-01 Bottles of 1000:  NDC 23155-068-10 Promethazine Hydrochloride Tablets USP, 50 mg are available for oral administration as pink colored, round shaped, biconvex tablets debossed "HP 69" on one side and plain other side and are supplied as: Bottles of 100:    NDC 23155-069-01 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Keep tightly closed. Protect from light. Dispense in a tight, light-resistant container as defined in the USP. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901. DRUG (3784) 51U000000123US01 Revised: 09/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
HERITAGE PHARMACEUTICALS INC.
----------
RX ONLY
DESCRIPTION
Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg
of promethazine hydrochloride,
USP. The inactive ingredients present are lactose monohydrate,
magnesium stearate and
methylcellulose. 12.5 mg also contain FD and C Yellow No. 6 aluminum
lake; 50 mg also contains FD
and C Red No. 40 aluminum lake.
Promethazine hydrochloride is a racemic compound; the empirical
formula is C
H N S • HCl and its
molecular weight is 320.88.
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as 10_H_-
Phenothiazine-10-ethanamine, _N,N,_ α-trimethyl-, monohydrochloride,
(±)- with the following structural
formula:
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.
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 H 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 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 d