Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following:
- Respiratory depression [see WARNINGS AND PRECAUTIONS and OVERDOSAGE]
- Drug dependence [see WARNINGS AND PRECAUTIONS]
- Increased intracranial pressure [see WARNINGS AND PRECAUTIONS and OVERDOSAGE]
- Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
- Paralytic ileus [see WARNINGS AND PRECAUTIONS]
Use of pseudoephedrine, a sympathomimetic amine, may result in the following:
- Central nervous system effects such as insomnia, dizziness, weakness, tremor, or convulsions [see WARNINGS AND PRECAUTIONS]
- Cardiovascular system effects such as arrhythmias, or increased blood pressure, cardiovascular collapse with accompanying hypotension [see WARNINGS AND PRECAUTIONS]
The most common adverse reactions are central nervous system and cardiovascular reactions and include the following: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, sleeplessness, tremor or arrhythmia.
Other adverse reactions include:
Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation.
Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention.
Dermatological System: Skin rash, pruritus.
Read the Rezira (hydrocodone bitartrate and pseudoephedrine hydrochloride) Side Effects Center for a complete guide to possible side effects »
No specific interaction studies have been conducted with REZIRA 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 REZIRA Oral Solution may cause an additive CNS depressant effect and should be avoided.
Monoamine Oxidase Inhibitors and Tricyclic Antidepressants
Do not prescribe REZIRA 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 an 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].
Drug Abuse And Dependence
REZIRA Oral Solution is a Schedule III controlled prescription containing hydrocodone bitartrate and should be prescribed and administered with caution.
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 REZIRA Oral Solution, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs.
Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, REZIRA 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.
Last reviewed on RxList: 8/2/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Rezira Information
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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