PROMETHAZINE HYDROCHLORIDE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Marlex Pharmaceuticals Inc

INN (Alþjóðlegt nafn):

PROMETHAZINE HYDROCHLORIDE

Samsetning:

PROMETHAZINE HYDROCHLORIDE 25 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

- Promethazine hydrochloride tablets, USP are useful for: - Perennial and seasonal allergic rhinitis - Vasomotor rhinitis - Allergic conjunctivitis due to inhalant allergens and foods - Mild, uncomplicated allergic skin manifestations of urticarial 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 con

Vörulýsing:

Promethazine hydrochloride tablets, USP are available as follows: 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 10135-0495-01 Bottles of 1000: NDC 10135-0495-10 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 10135-0496-01 Bottles of 1000, NDC 10135-0496-10 Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured for: MARLEX PHARMACEUTICALS INC. 50 McCullough Drive New Castle, DE, 19720 Distributed by: MARLEX PHARMACEUTICALS INC. 50 McCullough Drive New Castle, DE, 19720 Rev. 3 10/16 AN

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
MARLEX PHARMACEUTICALS INC
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PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE – PROMETHAZINE HYDROCHLORIDE TABLET
MARLEX PHARMACEUTICALS, INC.
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PROMETHAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Each 25 mg promethazine hydrochloride tablet for oral administration
contains 25 mg
promethazine hydrochloride.
Each 50 mg promethazine hydrochloride tablet for oral administration
contains 50 mg
promethazine hydrochloride.
Each tablet for oral administration contains 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.
Promethazine hydrochloride is a racemic compound; the empirical
formula is
C17H20N2S•HCl and its molecular weight is 320.88.
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as
10HPhenothiazine-10-ethanamine, N,N,a-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 and soluble in alcohol.
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 four to six hours,
although they may persist as long as 12 hours. Promethazine is
metabolized by