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HYCOFENIX

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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:

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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.