PROMETHAZINE HYDROCHLORIDE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Strides Pharma Science Limited

INN (International namn):

PROMETHAZINE HYDROCHLORIDE

Sammansättning:

PROMETHAZINE HYDROCHLORIDE 12.5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 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 hydrochloride tablets are contraindicated for use in pediat

Produktsammanfattning:

Promethazine hydrochloride tablets, USP for oral administration are available as: 12.5 mg: Round, white to off-white, biconvex tablets, bisected on one side with debossed "P" above the bisect and debossed "12.5" below the bisect, plain on the reverse side: NDC 64380- 792- 06 bottles of 100s NDC 64380- 792- 08 bottles of 1000s 25 mg: Round, white to off-white, flat faced, beveled-edged tablets, bisected on one side with debossed "P" above the bisect and debossed "25" below the bisect, plain on the reverse side: NDC 64380- 793- 06 bottles of 100s NDC 64380- 793- 08 bottles of 1000s 50 mg: Round, white to off-white, biconvex tablets debossed P50 on one side and plain on the reverse side. NDC 64380- 794- 06 bottles of 100s NDC 64380- 794- 08 bottles of 1000s Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container, Protect from light. Manufactured by: Strides Pharma Science Ltd. Bengaluru -562106, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 03/2019

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
STRIDES PHARMA SCIENCE LIMITED
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PROMETHAZINE HYDROCHLORIDE TABLETS, USP
DESCRIPTION
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as (±)-10-[2-
(Dimethylamino) propyl] phenothiazine monohydrochloride and has the
following structural formula:
Promethazine hydrochloride is a racemic compound; the empirical
formula is C
H N S • HCl and its
molecular weight is 320.88.
Promethazine hydrochloride occurs as a white to faint yellow,
crystalline powder. It is freely soluble in
water and soluble in alcohol.
Each tablet for oral administration contains 12.5mg, 25 mg or 50 mg of
promethazine hydrochloride,
USP. The inactive ingredients include: magnesium stearate and
microcelac.
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 4 to 6 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:
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.
17
20
2
Dermographism.
Anaphylactic reactions