PROMETHAZINE HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

American Health Packaging

INN (Internationale Bezeichnung):

PROMETHAZINE HYDROCHLORIDE

Zusammensetzung:

PROMETHAZINE HYDROCHLORIDE 12.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 in pediatric patients less than two years of age. Promethazine hydrochloride tablets, USP 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.

Produktbesonderheiten:

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: Unit dose packages of 100 (10 x 10) NDC 68084-155-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
----------
PROMETHAZINE HYDROCHLORIDE TABLETS USP
8015401/0224
RX ONLY
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:
Perennia