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HYCOFENIX
Overview
What is HYCOFENIX?
HYCOFENIX (hydrocodone bitartrate, pseudoephedrine hydrochloride,
and guaifenesin) oral solution contains hydrocodone bitartrate (a
centrally-acting opioid antitussive), pseudoephedrine hydrochloride
(an indirect sympathomimetic amine), and guaifenesin (an expectorant).
Each 5 mL dose of HYCOFENIX contains: hydrocodone bitartrate, USP,
2.5 mg; pseudoephedrine hydrochloride, USP, 30 mg; and guaifenesin,
USP, 200 mg.
HYCOFENIX
also contains: black raspberry flavor, citric acid, D&C Red #33,
FD&C Blue #1, glycerin, methylparaben, polyethylene glycol, propylparaben,
purified water, saccharin sodium, sodium citrate, and sorbitol.
Hydrocodone Bitartrate
Pseudoephedrine Hydrochloride
Guaifenesin
What does HYCOFENIX look like?




What are the available doses of HYCOFENIX?
Oral solution: Each 5 mL contains
hydrocodone bitartrate, USP, 2.5 mg; pseudoephedrine hydrochloride,
USP, 30 mg; and guaifenesin, USP, 200 mg. ()
What should I talk to my health care provider before I take HYCOFENIX?
How should I use HYCOFENIX?
HYCOFENIX is indicated for symptomatic relief
of cough, nasal congestion, and to loosen mucus associated with the
common cold.
Important Limitations of Use:
see Pediatric Use ()
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 ()
Measure HYCOFENIX with an accurate milliliter measuring
device. ()
What interacts with HYCOFENIX?
Sorry No Records found
What are the warnings of HYCOFENIX?
Sorry No Records found
What are the precautions of HYCOFENIX?
Sorry No Records found
What are the side effects of HYCOFENIX?
Sorry No records found
What should I look out for while using HYCOFENIX?
HYCOFENIX is contraindicated
in:
p806216881476151971
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 []. Avoid use of opioid cough medications in patients taking
benzodiazepines, other CNS depressants, or alcohol.
What might happen if I take too much HYCOFENIX?
No human overdosage data are
available for HYCOFENIX.
Hydrocodone
Overdosage with hydrocodone is characterized
by respiratory depression (a decrease in respiratory rate and/or tidal
volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing
to stupor or coma, skeletal muscle flaccidity, dizziness, ringing
in the ears, confusion, blurred vision, eye problems, cold and clammy
skin, and sometimes bradycardia and hypotension. In severe overdose,
apnea, circulatory collapse, cardiac arrest and death may occur.
Pseudoephedrine
Overdosage with
sympathomimetics such as pseudoephedrine may give rise to giddiness,
headache, nausea, vomiting, sweating, thirst, tachycardia, precordial
pain, palpitations, difficulty in micturition, muscle weakness and
tenseness, anxiety, restlessness, and insomnia. Many patients can
present a toxic psychosis with delusion and hallucinations. Some may
develop cardiac arrhythmias, circulatory collapse, convulsion, coma,
and respiratory failure.
Guaifenesin
Overdosage with guaifenesin can cause depression
of the central nervous system. While present in polypharmacy overdoses,
one case of overdose with only significant levels of guaifenesin has
been reported. Symptoms included slurred speech, shallow respirations,
reduced heart rate with rhythm sinus bradycardia, followed by asystole.
Treatment of overdosage consists
of discontinuation of HYCOFENIX together with institution of appropriate
therapy. Primary attention should be given to the reestablishment
of adequate respiratory exchange through provision of a patent airway
and the institution of assisted or controlled ventilation. The opioid
antagonist naloxone hydrochloride is a specific antidote for respiratory
depression which may result from overdosage or unusual sensitivity
to opioids including hydrocodone. Therefore, an appropriate dose of
naloxone hydrochloride should be administered, preferably by the intravenous
route, simultaneously with efforts at respiratory resuscitation. For
further information, see full prescribing information for naloxone
hydrochloride. An antagonist should not be administered in the absence
of clinically significant respiratory depression. Oxygen, intravenous
fluids, vasopressors, and other supportive measures should be employed
as indicated. Gastric emptying may be useful in removing unabsorbed
drug.
How should I store and handle HYCOFENIX?
HYCOFENIX (hydrocodone bitartrate, pseudoephedrine hydrochloride, and guaifenesin) oral solution is supplied as a violet-colored, black raspberry flavored liquid containing 2.5 mg hydrocodone bitartrate, 30 mg pseudoephedrine hydrochloride, and 200 mg guaifenesin in each 5 mL. It is available in: White HDPE bottles of 16 fl. oz. (473 mL): 0178-3291-16 White HDPE bottles of 4 fl. oz. (118 mL): 0178-3291-04 Store solution at 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, with a childresistant closure.