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:

Sun Pharmaceutical Industries, 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 angiodema. 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 postoperative 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 pediat

Product summary:

Promethazine hydrochloride tablets, USP contains 12.5 mg, 25 mg or 50 mg as promethazine hydrochloride, USP and are supplied as follows: 12.5 mg : Light peach, round, biconvex, uncoated tablets, debossed “107” on one side and scored on the other side. NDC          57664-107-83         Bottles of 30   CRC NDC          57664-107-88         Bottles of 100 CRC NDC          57664-107-08         Bottles of 100 NDC          57664-107-13         Bottles of 500 NDC          57664-107-18         Bottles of 1000 25 mg : White to off-white, round, flat face bevel edge, uncoated tablets, debossed “108” on one side and scored on the other side. NDC          57664-108-83         Bottles of 30   CRC NDC          57664-108-88         Bottles of 100 CRC NDC          57664-108-08         Bottles of 100 NDC          57664-108-13         Bottles of 500 NDC          57664-108-18         Bottles of 1000 50 mg : Light pink, round, biconvex, uncoated tablets, debossed “109” on one side and plain on the other side. NDC          57664-109-83         Bottles of 30   CRC NDC          57664-109-88         Bottles of 100 CRC NDC          57664-109-08         Bottles of 100 NDC          57664-109-13         Bottles of 500 NDC          57664-109-18         Bottles of 1000 Store at 20° - 25°C (68° - 77°F). (See USP Controlled Room Temperature). Dispense in tight, light-resistant container. Distributed by: Sun Pharmaceutical Industries, Inc.                              Cranbury, NJ 08512  6044T04 Rev. 07/2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
DESCRIPTION
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 is a racemic compound; the molecular
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: hypromellose, lactose monohydrate,
magnesium stearate, and
microcrystalline cellulose. The 12.5 mg contains FD&C Yellow No.6
aluminum lake. The 50 mg
contains D&C Red Lake Blend No.27 aluminum lake and D & C Red No. 30
aluminum 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 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 rhin