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Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids, including REZIRA, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [see DRUG INTERACTIONS].
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.
Advise both patients and caregivers about the risks of respiratory depression and sedation if REZIRA is used with benzodiazepines, alcohol, or other CNS depressants [see PATIENT INFORMATION].
Hydrocodone bitartrate, one of the active ingredients of REZIRA Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of hydrocodone bitartrate in adults has been associated with fatal respiratory depression, and the use of hydrocodone bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administrating REZIRA Oral Solution because of the potential for respiratory depression. If respiratory depression occurs, discontinue REZIRA Oral Solution and use naloxone hydrochloride when indicated to antagonize the effect and other supportive measures as necessary [see OVERDOSAGE].
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. Prescribe and administer REZIRA with the same degree of caution appropriate to the use of other opioid drugs [see Drug Abuse and Dependence].
Head Injury And Increased Intracranial Pressure
The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of REZIRA Oral Solution should be avoided in these patients.
Activities Requiring Mental Alertness
Hydrocodone bitartrate, one of the active ingredients in REZIRA Oral Solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of REZIRA Oral Solution. Concurrent use of REZIRA Oral Solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur.
Acute Abdominal Conditions
REZIRA Oral Solution should be used with caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus [see DRUG INTERACTIONS].
Co-administration With Anticholinergics
The concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Exercise caution when using REZIRA Oral Solution in patients taking anticholinergic medications [see DRUG INTERACTIONS].
Co-administration With MAOIs Or Tricyclic Antidepressants
REZIRA Oral Solution should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy as an increase in blood pressure or hypertensive crisis, may occur. In addition, the use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate, one of the active ingredients in REZIRA Oral Solution, may increase the effect of either the antidepressant or hydrocodone [see CONTRAINDICATIONS and DRUG INTERACTIONS].
Cardiovascular And Central Nervous System Effects
The pseudoephedrine hydrochloride contained in REZIRA Oral Solution can produce cardiovascular and central nervous system effects in some patients such as insomnia, dizziness, weakness, tremor, or arrhythmias. In addition, central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. Therefore, REZIRA Oral Solution should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or coronary artery disease.
Patients should be advised to measure REZIRA Oral Solution 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, which can result in serious adverse reactions [see OVERDOSAGE]. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose.
REZIRA Oral Solution should be used with caution in patients with severe renal impairment [see Use in Specific Populations; Pharmacokinetics].
REZIRA Oral Solution should be used with caution in patients with severe hepatic impairment [see Use in Specific Populations].
Patient Counseling Information
[See FDA-Approved Patient Labeling]
Patients should be advised not to increase the dose or dosing frequency of REZIRA Oral Solution because serious adverse events such as respiratory depression may occur with overdosage [see WARNINGS AND PRECAUTIONS; OVERDOSAGE].
Patients should be advised to measure REZIRA Oral Solution 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 DOSING AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Interactions With Benzodiazepines And Other Central Nervous System Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if REZIRA Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol. Because of this risk, patients should avoid concomitant use of REZIRA Oral Solution with benzodiazepines or other CNS depressants, including alcohol [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].
Activities Requiring Mental Alertness
Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as REZIRA Oral Solution may produce marked drowsiness [see WARNINGS AND PRECAUTIONS].
Patients should be cautioned that REZIRA Oral Solution contains hydrocodone bitartrate and can produce drug dependence [see WARNINGS AND PRECAUTIONS].
Patients should be informed that due to its pseudoephedrine component, they should not use REZIRA Oral Solution with a MAOI or within 14 days of stopping the use of an MAOI [see WARNINGS AND PRECAUTIONS].
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with REZIRA Oral Solution; however, published information is available for the individual active ingredients or related active ingredients.
Carcinogenicity studies were conducted with codeine, an opiate related to hydrocodone. In 2 year studies in F344/N rats and B6C3F1 mice, codeine showed no evidence of tumorigenicity at dietary doses up to 70 and 400 mg/kg/day, respectively (approximately 30 and 80 times, respectively, the MRHDD of hydrocodone on a mg/m² basis).
Two-year feeding studies in rats and mice demonstrated no evidence of carcinogenic potential with ephedrine sulfate, a structurally related drug with pharmacological properties similar to pseudoephedrine, at dietary doses up to 10 and 27 mg/kg, respectively (approximately 0.3 and 0.5 times, respectively, the MRHDD of pseudoephedrine hydrochloride on a mg/m² basis).
Use In Specific Populations
Pregnancy Category C.
There are no adequate and well controlled studies of REZIRA Oral Solution in pregnant women. Reproductive toxicity studies have not been conducted with REZIRA Oral Solution; however, studies are available with an individual active ingredient or related active ingredient. Hydrocodone was teratogenic in hamsters. Codeine, an opiate related to hydrocodone, increased resorptions and decreased fetal weight in rats. Because animal reproduction studies are not always predictive of human response, REZIRA Oral Solution should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
Hydrocodone has been shown to be teratogenic in hamsters when given in a dose approximately 35 times the maximum recommended human daily dose (MRHDD) (on a mg/m² basis at a single subcutaneous dose of 102 mg/kg on gestation day 8). Reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. In a study in which pregnant rats were dosed throughout organogenesis, a dose of codeine approximately 50 times the MRHDD of hydrocodone (on a mg/m² basis at an oral dose of 120 mg/kg/day of codeine) increased resorptions and decreased fetal weight; however, these effects occurred in the presence of maternal toxicity. In studies in which rabbits and mice were dosed throughout organogenesis, doses of codeine up to approximately 25 and 120 times, respectively, the MRHDD of hydrocodone (on a mg/m² basis at oral doses of 30 and 600 mg/kg/day, respectively), produced no adverse developmental effects.
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.
Labor And Delivery
As with all opioids, administration of REZIRA 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 REZIRA is administered to nursing mothers. Hydrocodone 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 REZIRA 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.
Safety and effectiveness of REZIRA Oral Solution in pediatric patients under 18 years of age have not been established. The use of hydrocodone in children less than 6 years of age has been associated with fatal respiratory depression [see WARNINGS AND PRECAUTIONS].
Clinical studies have not been conducted with REZIRA Oral Solution. Other reported clinical experience with the individual active ingredients of REZIRA Oral Solution has not identified differences in responses between the elderly and patients younger than 65 years of age. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The pseudoephedrine contained in REZIRA Oral Solution is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
REZIRA Oral Solution should be given with caution in patients with severe impairment of renal function. Pseudoephedrine is primarily excreted unchanged in the urine as unchanged drug with the remainder apparently being metabolized in the liver. Therefore, pseudoephedrine may accumulate in patients with renal impairment.
REZIRA Oral Solution should be given with caution in patients with severe impairment of hepatic function.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/27/2017
Additional Rezira Information
- Rezira Drug Interactions Center: pseudoephedrine-hydrocodone oral
- Rezira Side Effects Center
- Rezira FDA Approved Prescribing Information including Dosage
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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