Hycofenix

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include confusion, extreme weakness, pinpoint pupils, cold and clammy skin, weak pulse, slow breathing, fainting, or breathing that stops.

This medicine may cause blurred vision or impair your thinking or reactions. Avoid driving or operating machinery until you know how guaifenesin, hydrocodone, and pseudoephedrine will affect you.

Avoid drinking alcohol while you are taking this medication.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains a decongestant or expectorant.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach cramps or pain
• bloating
• blurred vision
• chest pain or discomfort
• cold, clammy, pale skin
• confusion
• constipation
• convulsions
• diarrhea
• difficult or troubled breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, or irregular heartbeat
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• shakiness in the legs, arms, hands, or feet
• slow heart rate
• sweating
• trembling or shaking of the hands or feet
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• drowsiness
• feeling of warmth
• headache
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed and calm
• sleepiness
• sudden sweating

• Trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
• Chest pain or pressure.
• Feeling confused.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Seizures.
• Very bad belly pain.
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Very hard stools (constipation).
• Feeling very tired or weak.
• Feeling very sleepy.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Headache.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Feeling sleepy.
• Upset stomach or throwing up.
• Sweating a lot.
• Feeling tired or weak.
• Hot flashes.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Oral solution: Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg; pseudoephedrine hydrochloride, USP, 30 mg; and guaifenesin, USP, 200 mg [ see Description (11)].

No specific interaction studies have been conducted with Hycofenix.

7.1 Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, or Other CNS Depressants (Including Alcohol)

The use of opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants concomitantly with Hycofenix may cause an additive CNS depressant effect and should be avoided.

7.2 MAO Inhibitors or Tricyclic Antidepressants

Do not prescribe Hycofenix if the patient is taking a prescription MAOI (i.e., certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s
disease), or for 2 weeks after stopping a MAOI drug. The use of MAOIs or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the
antidepressant or hydrocodone. An increase in blood pressure of hypertensive crisis may also occur when pseudoephedrine containing preparations are used with MAOIs
[ see Warnings and Precautions (5.7)].

7.3 Anticholinergic Drugs

Hydrocodone should be administered cautiously to persons receiving anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects [ see
Warnings and Precautions (5.6) ].

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
Hydrocodone bitartrate is a centrally-acting opioid antitussive and analgesic. It is affected by light and occurs as fine white crystals or crystalline powder which is derived from the opium alkaloid, thebaine. Its chemical name is morphinan-6-one, 4,5-epoxy-3-methoxy- 17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5);and may be represented by the following structural formula:

Pseudoephedrine Hydrochloride
Pseudoephedrine hydrochloride is benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)] hydrochloride and has the following chemical structure:

Guaifenesin
Guaifenesin is an expectorant and occurs as a white powder. Its chemical name is 3-(2-methoxyphenoxy)-1,2-propanediol, and may be represented by the following structural formula:

Overdosage
Advise patients not to increase the dose or dosing frequency of Hycofenix because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions (5.1) and Overdosage (10)].

Dosing
Advise patients to measure Hycofenix with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is measured. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [ see Dosage and Administration (2) and Warnings and Precautions (5.10)].

Concomitant Use of Alcohol and Other Central Nervous System Depressants
Advise patients to avoid the use of alcohol and other central nervous system depressants while taking Hycofenix because additional reduction in mental alertness may occur [ see Warnings and Precautions (5.4)].

Activities Requiring Mental Alertness
Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Hycofenix may produce marked drowsiness [ see Warnings and Precautions (5.4)].

Drug Dependence
Caution patients that Hycofenix contains hydrocodone bitartrate and can produce drug dependence [ see Warnings and Precautions (5.2)].

MAOIs
Patients should be informed that due to its pseudoephedrine component, they should not use Hycofenix with an MAOI or within 14 days of stopping use of an MAOI [ see Warning and Precautions (5.7)].

Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX 78230 1355

Applies to guaifenesin / hydrocodone / pseudoephedrine: oral liquid, oral tablet

General

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Some side effects of Hycofenix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.