PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Nostrum Laboratories, Inc.

INN (nemzetközi neve):

PROMETHAZINE HYDROCHLORIDE

Összetétel:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Promethazine HCl Oral Solution is 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 Oral Solution is contraindicated for use in pediatric patients less than two years of age. Promethazine HCl Oral Solution is 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.

Termék összefoglaló:

Promethazine Hydrochloride Oral Solution USP, 6.25 mg/5 mL, is a clear, green oral solution supplied as follows: NDC 70408-146-34    Bottle of 16 fl. oz. (473 mL) with a child-resistance cap. Keep bottles tightly closed. This package is child-resistant. Keep out of reach of children. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SOLUTION
Nostrum Laboratories, Inc.
----------
PATIENT INFORMATION LEAFLET
PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP 6.25 mg/5 mL
(Promethazine
Hydrochloride Syrup, 6.25 mg per 5 mL)
Rx Only
WHAT IS PROMETHAZINE HCL ORAL SOLUTION?
Promethazine is an antihistamine which can be taken by mouth as an
oral solution or tablet, rectally as a
suppository, or by injection. It can be used for:
•
“hay fever,” or, a stuffy runny nose from allergy
•
watery, itchy eyes due to inhaled allergies and foods
•
mild allergic skin reactions with itching and swelling
•
allergic reactions to blood or plasma
•
dermographism, a form of hives known as “skin writing”
•
serious allergic reactions along with epinephrine and other treatments
•
sedation before or after surgery, or during childbirth
•
prevention and control of nausea and vomiting after surgery
•
along with meperidine (demerol) or other pain medicines
•
sedation, relief of anxiety, and production of light sleep from which
the patient can be easily
aroused
•
treatment and prevention of motion sickness
WHO SHOULD NOT USE PROMETHAZINE HCL ORAL SOLUTION?
Promethazine should not be given to:
•
children under two years of age
•
patients who are unconscious
•
patients who are allergic to promethazine, any of the ingredients in
promethazine, or to other
phenothiazines
•
patients with lung symptoms including asthma
•
children who are vomiting unless the vomiting is prolonged and there
is a known cause
WHAT ARE THE RISKS?
The following are the major potential risks and side effects of
Promethazine HCl Oral Solution therapy.
However, this list is not complete.
•
Severe drowsiness and reduced mental alertness. Promethazine HCl Oral
Solution may cause
drowsiness which may impair your ability to ride a bike, drive a car,
or operate machinery. This
may be worsened if taken with alcohol or other drugs that also cause
central nervous system
(CNS) slowing such as sedatives, pain medicines, tranquil

Termékjellemzők

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SOLUTION
NOSTRUM LABORATORIES, INC.
----------
PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
DESCRIPTION
Each teaspoonful (5 mL) of Promethazine HCl Oral Solution contains
6.25 mg
promethazine HCl in a flavored syrup base with a pH between 4.7 and
5.2. Alcohol 7%.
The inactive ingredients present are ascorbic acid, citric acid, D&C
Yellow No. 10, edetate
disodium, ethyl alcohol, FD&C Blue No. 1, FD&C Red No. 40, glycerin,
methylparaben,
pineapple flavor, purified water, sodium benzoate, sodium citrate,
sucralose, and
sucrose.
Promethazine HCl is a racemic compound; the molecular formula is C
H
N S•HCl and
its molecular weight is 320.89. Promethazine HCl, a phenothiazine
derivative, is
chemically designated as 10-[2- (Dimethylamino)propyl] phenothiazine
monohydrochloride. Its structural formula is:
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 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-
desmethylpromethazine are the predominant metabolites appearing in the
urine.
17
20
2
1
INDICATIONS AND USAGE
Promethazine HCl Oral Solution is useful fo