PROMETHAZINE HYDROCHLORIDE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Apotheca, Inc

INN (International Nazwa):

PROMETHAZINE HYDROCHLORIDE

Skład:

PROMETHAZINE HYDROCHLORIDE 25 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Promethazine hydrochloride tablets 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 and 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 pat

Podsumowanie produktu:

25 mg:  White to off-white, flat-faced, beveled edge, round, uncoated tablets, debossed with “AN” above “521” with single line bisect separating them on one side and plain on the other side are supplied as: 12634-0418-92            Bottle of    2 12634-0418-94            Bottle of    4 12634-0418-95            Bottle of    5 12634-0418-96            Bottle of    6 12634-0418-99            Bottle of    9 12634-0418-00            Bottle of    10 12634-0418-82            Bottle of    12 12634-0418-85            Bottle of    15 12634-0418-80            Bottle of    20 12634-0418-74            Bottle of    24 12634-0418-71            Bottle of    30 12634-0418-40            Bottle of    40 12634-0418-60            Bottle of    60 12634-0418-01            Bottle of    100 12634-0418-91            Blister Pack               1 12634-0418-65            Blister Card Pack of    5 12634-0418-66            Blister Card Pack of    6 12634-0418-61            Blister Card Pack of    10 12634-0418-52            Blister Card Pack of    12 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY  11788 Repacdage and Distributed by: Apotheca, Inc. Phoenix, AZ 85006

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
APOTHECA, INC
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PROMETHAZINE HYDROCHLORIDE TABLET
DESCRIPTION
Promethazine Hydrochloride, a phenothiazine derivative, is designated
chemically as 10- [2-
(Dimethylamino)propyl]phenothiazine monohydochloride and has the
following structural formula:
Promethazine hydrochloride is a racemic compound; the empirical
formula is C17H20N2S HCl and its
molecular weight is 320.88.
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 and
soluble in alcohol.
Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg
promethazine hydrochloride, USP.
The inactive ingredients include: lactose anhydrous, magnesium
stearate, and microcrystalline
cellulose. The 50 mg also contains D&C Red # 27 Lake.
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 H1 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 for 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 tablets are useful for:
Promethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens a