PSEUDODINE C- triprolidine hydrochloride, pseudoephedrine hydrochloride and codeine phosphate syrup

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Osta kohe

Laadi alla Toote omadused (SPC)
28-11-2008

Toimeaine:

Triprolidine Hydrochloride (UNII: YAN7R5L890) (Triprolidine - UNII:2L8T9S52QM), Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F), Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520)

Saadav alates:

Wockhardt USA, Inc.

INN (Rahvusvaheline Nimetus):

Triprolidine Hydrochloride, Pseudoephedrine Hydrochloride and Codeine Phosphate

Ravimvorm:

SYRUP

Koostis:

1.25 mg in 5 mL

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Pseudodine™ C Cough Syrup is indicated for temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. Pseudodine™ C Cough Syrup is contraindicated under the following conditions: This drug should not be used in newborn or premature infants. Antihistamines should not be used to treat lower respiratory tract symptoms, including asthma. (1) codeine phosphate or other narcotics; (2) triprolidine hydrochloride or other antihistamines of similar chemical structure; or (3) sympathomimetic amines, including pseudoephedrine. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and in patients on monoamine oxidase (MAO) inhibitor therapy (see PRECAUTIONS, Drug Interactions ). Like other medications containing a narcotic, Pseudodine™ C Cough Syrup is controlled by the Drug Enforcement Administration. It is classified under Schedule V. Codeine can produce drug dependence of the morphine typ

Toote kokkuvõte:

Pseudodine™ C Cough Syrup (Triprolidine Hydrochloride 1.25 mg/5 mL, Pseudoephedrine Hydrochloride 30 mg/5 mL and Codeine Phosphate 10 mg/5 mL) is supplied as a colorless, raspberry-flavored syrup in the following sizes: 4 fl oz (118 mL) 1 Pint (473 mL) Store at 20 ° to 25 °C (68 ° to 77 °F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP.

Toote omadused

                                PSEUDODINE C- TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE
HYDROCHLORIDE AND CODEINE
PHOSPHATE SYRUP
WOCKHARDT USA, INC.
----------
PSEUDODINE™ C
COUGH SYRUP
(TRIPROLIDINE HYDROCHLORIDE,
PSEUDOEPHEDRINE HYDROCHLORIDE &
CODEINE PHOSPHATE)
CV
RX ONLY
DESCRIPTION
EACH 5 ML (TEASPOONFUL) OF PSEUDODINE™ C COUGH SYRUP FOR ORAL
ADMINISTRATION CONTAINS:
Triprolidine Hydrochloride,
USP .............
1.25 mg
Pseudoephedrine
Hydrochloride, USP.....
30 mg
Codeine Phosphate, USP
........................
10 mg
Alcohol
...................................................
4.4%
In addition, the following inactive ingredients are present:
Artificial Fruit Flavor; Artificial Raspberry
Flavor; Liquid Sugar; Menthol, USP; Methylparaben, NF; Propylene
Glycol, USP; Purified Water, USP;
Sodium Benzoate, NF; Sodium Citrate, USP and Sorbitol Solution, USP.
IT MAY ALSO CONTAIN Citric
Acid, USP.
Pseudodine™ C Cough Syrup has antitussive, antihistaminic and nasal
decongestant effects. The
components of this product have the following chemical names and
structural formulas:
CODEINE PHOSPHATE, USP:
7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1) (salt) hemihydrate.
C H NO •H PO •½ H O M.W. 4 06.37
TRIPROLIDINE HYDROCHLORIDE, USP:
(_E_)-2-[3-(1-Pyrrolidinyl)-1-_p_-tolylpropenyl]pyridine
monohydrochloride monohydrate.
18
21
3
3
4
2
C H N •HCL•H O M.W. 332.87
PSEUDOEPHEDRINE HYDROCHLORIDE, USP:
Benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)]-,
hydrochloride.
C H NO•HCL M.W. 201.69
CLINICAL PHARMACOLOGY
CODEINE
Codeine probably exerts its antitussive activity by depressing the
medullary (brain) cough center,
thereby raising its threshold for incoming cough impulses.
Codeine is readily absorbed from the gastrointestinal tract, with a
therapeutic dose reaching peak
antitussive effectiveness in about 2 hours and persisting for 4 to 6
hours. Codeine is rapidly distributed
from blood to body tissues and taken up preferentially by
parenchymatous organs such as liver, spleen
and kidney. It passes the 
                                
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