PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Camber Pharmaceuticals, Inc.

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine hydrochloride suppositories 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 arous

Product summary:

Promethazine Hydrochloride Rectal Suppositories USP are available in boxes of 12 as follows: 12.5 mg, white to off-white colored bullet shaped suppository wrapped in an Alu/PE shell. NDC    31722-040-31 25 mg, white to off-white colored bullet shaped suppository wrapped in an Alu/PE shell. NDC    31722-041-31 Store refrigerated between 2º to 8ºC (36º to 46ºF). Dispense in well-closed container. For more information, call Annora Pharma Private Limited at 1-866-495-1995. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India.  Revised: 07/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE SUPPOSITORY
CAMBER PHARMACEUTICALS, INC.
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PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES USP, 12.5 MG AND 25 MG
RX ONLY
DESCRIPTION
Each rectal suppository contains 12.5 mg or 25 mg promethazine
hydrochloride. The
inactive ingredients present are ascorbyl palmitate, colloidal silicon
dioxide, glyceryl
monostearate, hard fat, and white wax. Promethazine hydrochloride
suppositories, USP
are for rectal administration only.
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-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride with the
following
structural formula:
Promethazine hydrochloride USP occurs as a white to faint yellowish,
crystalline
powder. It is very soluble in water, freely soluble in ethanol and in
methanol, practically
insoluble in ethyl acetate, diethyl ether and acetone.
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
17
20
2
1
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 suppositories are useful for:
Perennial and seasonal allergic rhiniti