TRIACIN-C- triprolidine and pseudoephedrine hydrochlorides and codeine phosphate syrup syrup

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Disponibbli minn:

STI Pharma LLC

INN (Isem Internazzjonali):

TRIPROLIDINE HYDROCHLORIDE

Kompożizzjoni:

TRIPROLIDINE HYDROCHLORIDE 1.25 mg in 5 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Triacin-C is indicated for temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. Triacin-C is contraindicated under the following conditions: Codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This drug should not be used in newborn or premature infants. Antihistamines should not be used to treat lower respiratory tract symptoms, including asthma. Hypersensitivity To (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, Triacin-C is controlled by the Drug Enforcemen

Sommarju tal-prodott:

Triacin-C, is supplied in a colorless, caramel flavored vehicle in 16 fl oz pint (473 mL) size bottles. Each 5 mL (one teaspoonful) of syrup for oral administration contains: Codeine Phosphate……10 mg WARNING: May be habit forming. Triprolidine Hydrochloride……1.25 mg Pseudoephedrine Hydrochloride……30 mg Alcohol 4.3%. Inactive ingredients: sodium benzoate, methylparaben, sodium saccharin, sorbitol, glycerin, citric acid, sodium citrate, caramel flavor and USP purified water. Store at controlled room temperature 20°to 25°C (68° to 77°F) [See USP Controlled Room Temperature.]. Dispense in a tight, light-resistant container as defined in the USP. Rx Only. Manufactured for STI Pharma LLC Langhorne, PA 19047 Rev 07/15

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

TRIACIN-C- TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE
PHOSPHATE
SYRUP SYRUP
STI PHARMA LLC
----------
TRIACIN-C (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL, AND CODEINE
PHOSPHATE SYRUP)
WARNING: DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO
MORPHINE RESPIRATORY
DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO RECEIVED CODEINE
FOLLOWING
TONSILLECTOMY AND/OR ADENOIDECTOMY AND HAD EVIDENCE OF BEING
ULTRA-RAPID METABOLIZERS OF
CODEINE DUE TO A CYP2D6 POLYMORPHISM (SEE WARNINGS - CODEINE PHOSPHATE
- DEATH
RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE).
DESCRIPTION
Each 5 mL (one teaspoonful) of syrup for oral administration contains:
Codeine Phosphate……10 mg
WARNING: May be habit forming.
Triprolidine Hydrochloride……1.25 mg
Pseudoephedrine Hydrochloride……30 mg
Alcohol 4.3%.
INACTIVE INGREDIENTS: sodium benzoate, methylparaben, sodium
saccharin, sorbitol, glycerin, citric acid,
sodium citrate, caramel flavor and USP purified water.
Triacin-C produces antitussive, antihistaminic and nasal decongestant
effects. The components have the
following chemical names and structural formulas:
CODEINE PHOSPHATE, USP
7,8-didehydro-4,5 α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1) (salt) hemihydrate
TRIPROLIDINE HYDROCHLORIDE, USP
(E)-2-[3(1-Pyrrolidinyl)-1-p-tolylpropenyl]pyridine monohydrochloride
monohydrate
PSEUDOEPHEDRINE HYDROCHLORIDE, USP
Benzenemethanol, α-[1-(methylamino)ethyl]-,[S-(R*, R*)]-
hydrochloride
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 blood brain barrier and is found in fetal
tis