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:

H.J. Harkins Company, Inc.

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

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 68382-040-01 in bottle of 100 tablets NDC 68382-040-05 in bottle of 500 tablets NDC 68382-040-10 in bottle of 1000 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 68382-041-01 in bottle of 100 tablets NDC 68382-041-05 in bottle of 500 tablets NDC 68382-041-10 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 68382-042-01 in bottle of 100 tablets NDC 68382-042-05 in bottle of 500 tablets NDC 68382-042-10 in bottle of 1000 tablets Keep tightly closed. Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in light-resistant, tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE TABLET
H.J. Harkins Company, Inc.
----------
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 medicines, tranquilizers or certain drugs for
depression.
•
Serious breathing problems. Promethazine should not be used in
pati

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE TABLET
H.J. HARKINS COMPANY, INC.
----------
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.
INDICATIONS AND USAGE
Promethazine Hydrochloride, is useful orally for.
Perennial and seasonal allergic rhinit