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Zutripro

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Zutripro

Side Effects
Interactions

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 Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No specific interaction studies have been conducted with ZUTRIPRO Oral Solution.

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 ZUTRIPRO Oral Solution may cause an additive CNS depressant effect and should be avoided.

MAOIs and Tricyclic Antidepressants

Do not prescribe ZUTRIPRO Oral Solution 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 or hypertensive crisis may also occur when pseudoephedrine containing preparations are used with MAOIs [see WARNINGS AND PRECAUTIONS].

Anticholinergic Drugs

Hydrocodone and chlorpheniramine should be administered cautiously to persons receiving other anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects.

Additive adverse effects resulting from cholinergic blockade (e.g., xerostomia, blurred vision, or constipation) may occur when anticholinergic drugs are administered with chlorpheniramine [see WARNINGS AND PRECAUTIONS].

Drug Abuse And Dependence

Controlled Substance

ZUTRIPRO Oral Solution is a Schedule III controlled prescription containing hydrocodone bitartrate and should be prescribed and administered with caution.

Abuse

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 Oral Solution, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs.

Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, ZUTRIPRO Oral Solution should be prescribed and administered with caution.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.

Read the Zutripro Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 6/30/2011
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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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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