PROMETHAZINE HYDROCHLORIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

BluePoint Laboratories

INN (Algemene Internationale Benaming):

PROMETHAZINE HYDROCHLORIDE

Samenstelling:

PROMETHAZINE HYDROCHLORIDE 12.5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Promethazine Hydrochloride, is useful orally 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, USP are contraindicated for use

Product samenvatting:

Promethazine hydrochloride tablets USP, 12.5 mg are, white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of "ZC", "01" and bisect on one side and plain on the other side and are supplied as follows: NDC 68001-161-00 in bottle of 100 tablets Promethazine hydrochloride tablets USP, 25 mg are, white to off-white, round shape, biconvex, uncoated tablets debossed with the quadrisect and the logo of "Z", "C", "0" and "2" on one side and plain on the other side and are supplied as follows: NDC 68001-162-00 in bottle of 100 tablets NDC 68001-162-03 in bottle of 500 tablets NDC 68001-162-08 in bottle of 1000 tablets Promethazine hydrochloride tablets USP, 50 mg are, white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of "ZC03" on one side and plain on the other side and are supplied as follows: NDC 68001-163-00 in bottle of 100 tablets Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in light-resistant, tight container. Manufactured by: Zydus Lifesciences Ltd., India. For BluePoint Laboratories Rev.: 11/22

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
BluePoint Laboratories
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Patient Information Leaflet
Promethazine Hydrochloride Tablets, USP
(proe meth’ a zeen hye’ droe klor’ ide) Tablets, USP
This is a summary of the most important information about
promethazine. For details, talk to your healthcare
professional.
WHAT IS PROMETHAZINE?
Promethazine is an antihistamine which can be taken by mouth as a
tablet or syrup, 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?
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 therapy. However, this list is not
complete.
•
Severe drowsiness and reduced mental alertness. Promethazine 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 medicin

Productkenmerken

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
BLUEPOINT LABORATORIES
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PROMETHAZINE HYDROCHLORIDE TABLETS, USP
DESCRIPTION
Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or
50 mg
promethazine hydrochloride. The inactive ingredients present are
hydroxypropyl
cellulose, lactose monohydrate, low-substituted hydroxypropyl
cellulose and magnesium
stearate.
Promethazine hydrochloride is a racemic compound; the molecular
formula is C
H
N
S·HCl and its molecular weight is 320.88.
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as
_10H_-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, in hot dehydrated alcohol, and in
chloroform; practically
insoluble in ether, in acetone and in ethyl acetate.
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.
17
20
2
1
INDICATIONS AND USAGE
Promethazine Hydrochloride, is useful orally for:
Perennial and seasonal allergic