PROMETHEGAN- promethazine hydrochloride suppository

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Cosette Pharmaceuticals, Inc.

Vartojimo būdas:

RECTAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Promethazine HCl Suppositories, USP 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 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 HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine HCl Suppositories are 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. PROMETHAZINE HCL SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black Box Warning and Use in Pediatric Patients). Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see WARNINGS – Use in Pediatric Patients ). Clinical studies of Promethazine HCl formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Promethazine HCl Suppositories and observed closely.

Produkto santrauka:

Promethazine HCl Rectal Suppositories, USP are available in boxes of 12 and 1000 as follows:  50 mg, white, bullet-shaped suppository wrapped in silver foil.    Box of 12      NDC 0713-0132-12 50 mg, white, bullet-shaped suppository wrapped in silver foil.    Box of 1000  NDC 0713-0132-10 Store refrigerated between 2°-8°C (36°-46°F). Dispense in well-closed container. Distributed by : Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0132CPLNC1     VC7416 Iss. 06/2020

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PROMETHEGAN- PROMETHAZINE HYDROCHLORIDE SUPPOSITORY
COSETTE PHARMACEUTICALS, INC.
----------
PROMETHAZINE HYDROCHLORIDE
SUPPOSITORIES, USP
RX ONLY
DESCRIPTION
Each rectal suppository contains 50 mg promethazine HCl with ascorbyl
palmitate and
polysorbate 80 in a specially blended base of saturated vegetable
fatty acids.
Promethazine HCl Suppositories, USP are for rectal administration
only.
Promethazine HCl is a racemic compound; the empirical formula is C
H
N
S•HCl and
its molecular weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically
as 10 _H_-
Phenothiazine, 10-ethanamine, _N,N α_-trimethyl-, monohydrochloride,
(±)- with the
following structural formula:
Promethazine HCl 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 metabolized by the liver to a variety of compounds;
the sulfoxides of
promethazine and N-demethylpromethazine are the predominant
metabolites appearing
17
20
2
1
in the urine.
INDICATIONS AND USAGE
Promethazine HCl Suppositories, USP 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 a