PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride tablet tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Direct Rx

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

রচনা:

PROMETHAZINE HYDROCHLORIDE 25 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 patients. Promethazine Hydrochloride Tablets, USP are contraindicate

পণ্য সারাংশ:

Promethazine Hydrochloride Tablets, USP for oral administration are available as: 12.5 mg: White to off-white, biconvex, round uncoated tablets, debossed with “AN” and bisect on one side and “745” on the other side are supplied as: Bottles of 100:    NDC 65162-745-10 Bottles of 500:    NDC 65162-745-50 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: Bottles of 100:    NDC 65162-521-10 Bottles of 500:    NDC 65162-521-50 Bottles of 1000:  NDC 65162-521-11 50 mg: Pink color, biconvex, round tablets, embossed with “AN” above “522” on one side and plain on the other side are supplied as: Bottles of 100:    NDC 65162-522-10 Bottles of 500:    NDC 65162-522-50 Store at 20º-25°C (68°-77ºF) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container. Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY  11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 10-2008

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET TABLET
DIRECT RX
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PROMETHAZINE HYDROCHLORIDE
DESCRIPTION
RX ONLY
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:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated aller