PROMETHAZINE HYDROCHLORIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

McKesson Corporation dba SKY Packaging

INN (Nama Internasional):

PROMETHAZINE HYDROCHLORIDE

Komposisi:

PROMETHAZINE HYDROCHLORIDE 25 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Promethazine hydrochloride is 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 is contraindicated for use in pediatric patients less than two years of age. Promethazine is 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.

Ringkasan produk:

Promethazine hydrochloride tablets, USP for oral administration are available as: 25 mg : Round, white, scored tablets, debossed GG 225 on one side and plain on the reverse side and are supplied as: Boxes of 10x10 UD 100 NDC 63739-213-10 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from light. KEEP OUT OF THE REACH OF CHILDREN. Manufactured by Sandoz Inc. Princeton, NJ 08540 Distributed by: McKesson Corporation 4971 Southridge Blvd, Suite 101 Memphis, TN 38141 Rev. September 2018 MF1830REV09/18 21531

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
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PROMETHAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Promethazine hydrochloride, USP a phenothiazine derivative, is
designated chemically as
(±)-10-[2-(Dimethylamino)propyl]phenothiazine monohydrochloride and
has the
following structural formula:
Promethazine hydrochloride, USP is a racemic compound; the molecular
formula is C
H
N
S • HCl and its molecular weight is 320.88.
Promethazine hydrochloride, USP 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 25 mg or 50 mg of
promethazine
hydrochloride, USP. The inactive ingredients include: lactose
(monohydrate), magnesium
stearate and microcrystalline cellulose. The 50 MG also contains D & C
Red Lake Blend
(D & C Red #27 and D & C Red #30).
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 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.
17
20
2
1
INDICATIONS AND USAGE
Promethazine hydrochloride is useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic con