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Zutripro

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Zutripro

Zutripro Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride) is a combination drug indicated for relief of cough and nasal congestion associated with the common cold and for relief of symptoms including nasal congestion associated with upper respiratory allergies in adults 18 years of age and older. Zutripro is not available as a generic. Side effects of Zutripro may include lethargy, headache, euphoria, tremor, and irritability.

Zutripro is supplied as a clear, colorless to light yellow, grape-flavored solution containing strengths of 5 mg hydrocodone bitartrate, 4 mg chlorpheniramine maleate, and 60 mg pseudoephedrine hydrochloride in each 5 mL dose. Zutripro is dosed in 5 mL of solution every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to over dosage, especially when half a teaspoon is measured. Zutripro contains hydrocodone bitartrate, which can cause dose-related respiratory depression. Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Zutripro. The use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate, one of the active ingredients in Zutripro Oral Solution, may increase the effect of either the antidepressant or hydrocodone. Patients should be advised to avoid the use of alcohol and other central nervous system depressants while taking Zutripro Oral Solution because additional reduction in mental alertness may occur; patients should not drive or do other tasks if mental alertness is compromised with this drug. Serious side effects include cardiac arrhythmias, ileus, hyper or hypotension and dependence. As with all opioids, administration of Zutripro Oral Solution to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used. Caution should be exercised when Zutripro is administered to nursing mothers. Hydrocodone, chlorpheniramine and pseudoephedrine are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Zutripro Oral Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Zutripro is not used in children under the age of 18 years old.

Our Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zutripro FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following:

Use of pseudoephedrine, a sympathomimetic amine, may result in the following:

Use of chlorpheniramine, an antihistamine, may result in:

  • Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]

The most common adverse reactions of ZUTRIPRO Oral Solution include: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, or sleeplessness; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, restlessness, insomnia, irritability, tremor.

Other adverse reactions include:

Cardiovascular: Fast, or slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitations, shock-like state, syncope.

Respiratory: Dryness of the pharynx and respiratory passages, occasional tightness of the chest, laryngismus, wheezing, or troubled breathing.

Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, and/or loss of appetite.

Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention, dysuria, urinary frequency, urinary hesitancy.

Dermatological System: Skin rash, pruritus, erythema, urticaria, excessive perspiration.

Endocrine System: Changes in glucose utilization, decreased lactation, early menses, glycosuria, gynecomastia, hypoglycemia, increased appetite, increased libido, pheochromocytoma stimulation.

Special Senses: labyrinthitis, tinnitus, vertigo, hypermetropia, lacrimation increased, mydriasis, photophobia.

Read the entire FDA prescribing information for Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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