HYCOFENIX hydrocodone bitartrate pseudoephedrine hydrochloride guaifenesin liquid

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)

Beschikbaar vanaf:

Mission Pharmacal Company

INN (Algemene Internationale Benaming):

GUAIFENESIN

Samenstelling:

GUAIFENESIN 200 mg in 5 mL

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

New Drug Application

Productkenmerken

HYCOFENIX- HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDE,
GUAIFENESIN LIQUID
MISSION PHARMACAL COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYCOFENIXTM SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR HYCOFENIX.
HYCOFENIX (HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND
GUAIFENESIN) ORAL SOLUTION, CII
INITIAL U.S. APPROVAL: 2015
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY
DEPRESSION, COMA, AND DEATH [_SEE WARNINGS_
_AND PRECAUTIONS (5.1), DRUG INTERACTIONS (7.1)_]. AVOID USE OF OPIOID
COUGH MEDICATIONS IN PATIENTS TAKING
BENZODIAZEPINES, OTHER CNS DEPRESSANTS, OR ALCOHOL. _SEE FULL
PRESCRIBING INFORMATION FOR COMPLETE BOXED_
_WARNING._
INDICATIONS AND USAGE
HYCOFENIX is a combination of hydrocodone, an opioid antitussive,
pseudoephedrine, a nasal decongestant, guaifenesin,
an expectorant indicated for the symptomatic relief of cough, nasal
congestion, and to loosen mucus associated with the
common cold.
Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age (8.4)
DOSAGE AND ADMINISTRATION
Adults and adolescents 18 years of age and older: 10 mL every 4 to 6
hours, not to exceed 4 doses (40 mL) in 24 hours
(2.1)
Measure HYCOFENIX with an accurate milliliter measuring device. (5.10)
DOSAGE FORMS AND STRENGTHS
Oral solution: Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg;
pseudoephedrine hydrochloride, USP, 30 mg; and
guaifenesin, USP, 200 mg. (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to hydrocodone bitartrate,
pseudoephedrine hydrochloride, guaifenesin, or any of
the inactive ingredients of HYCOFENIX. (4)
Patients receiving monoamine oxidase inhibitor (MAOI) therapy or
within 14 days of stopping such therapy. (4)
Patients with narrow angle glaucoma, urinary retention, severe
hypertension, or severe coronary artery disease. (4)
WARNING