PROMETHAZINE HYDROCHLORIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

STAT Rx USA LLC

INN (Tarptautinis Pavadinimas):

PROMETHAZINE HYDROCHLORIDE

Sudėtis:

PROMETHAZINE HYDROCHLORIDE 25 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 post-operative 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 p

Produkto santrauka:

Promethazine Hydrochloride Tablets USP, 25 mg are scored, round, white tablets imprinted DAN DAN and 5307 supplied in: Bottles of 10 NDC # 16590-191-10 Bottles of 15 NDC # 16590-191-15 Bottles of 20 NDC # 16590-191-20 Bottles of 28 NDC # 16590-191-28 Bottles of 30 NDC # 16590-191-30 Bottles of 45 NDC # 16590-191-45 Bottles of 56 NDC # 16590-191-56 Bottles of 60 NDC # 16590-191-60 Bottles of 120 NDC # 16590-191-72 Bottles of 112 NDC # 16590-191-73 Bottles of 75 NDC # 16590-191-75 Bottles of 90 NDC # 16590-191-90 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Keep tightly closed. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Protect from light. Manufactured By: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: June 2009 190824 0609B Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA. 30501

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
STAT RX USA LLC
----------
PROMETHAZINE HYDROCHLORIDE TABLETS USP
REVISED: JUNE 2009
RX ONLY
190824
DESCRIPTION
Promethazine hydrochloride is a racemic compound.
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as 10 _H_-
Phenothiazine-10-ethanamine, _N, N_,α-trimethyl-, monohydrochloride,
(±)- with the following structural
formula:
C
H N S•HCl M.W. 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 soluble in water and freely
soluble in alcohol.
Each tablet, for oral administration, contains 25 mg or 50 mg of
promethazine hydrochloride. In addition
each tablet contains the following inactive ingredients: dibasic
calcium phosphate, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate and stearic acid.
Promethazine Hydrochloride Tablets USP, 50 mg also contain anhydrous
lactose.
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 four 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
17
20
2
1
Promethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhi