Rezira
- Generic Name: hydrocodone bitartrate and pseudoephedrine hydrochloride
- Brand Name: Rezira
Rezira (Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride) side effects drug center
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- nausea
- vomiting
- constipation
- low blood pressure
- dizziness
- drowsiness
- lightheadedness
- weakness, or general feeling of being unwell (malaise)
- respiratory depression
- drug abuse and dependence
- increased intracranial pressure
- decreased mental alertness with impaired mental and/or physical abilities
- lack of energy
- anxiety
- fear
- mood changes
- nervousness
- sleeplessness
- tremor
- irregular heartbeat
- Addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence]
- Life-threatening respiratory depression [see WARNINGS AND PRECAUTIONS, OVERDOSE]
- Accidental overdose and death due to medication errors [see WARNINGS AND PRECAUTIONS]
- Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
- Interactions with benzodiazepines and other CNS depressants [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS]
- Paralytic ileus, gastrointestinal adverse reactions [see WARNINGS AND PRECAUTIONS]
- Increased intracranial pressure [see WARNINGS AND PRECAUTIONS]
- Obscured clinical course in patients with head injuries [see WARNINGS AND PRECAUTIONS]
- Cardiovascular and central nervous system effects [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Severe hypotension [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Adrenal insufficiency [see WARNINGS AND PRECAUTIONS]
Rezira (hydrocodone bitartrate and pseudoephedrine hydrochloride) is a combination of an opioid antitussive and a sympathomimetic amine indicated for relief of cough and nasal congestion associated with common cold. Common side effects of Rezira include:
Rezira is for oral use only. Rezira should be dosed at 5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours. Measure Rezira with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose. No specific drug interaction studies have been conducted with Rezira. There are no adequate and well controlled studies of Rezira in pregnant women. Rezira should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Caution should be exercised when Rezira is administered to breastfeeding 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 breastfeeding 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.
Our Rezira Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
SIDE EFFECTS
The following serious adverse reactions are described, or described in greater detail, in other sections:
The following adverse reactions have been identified during clinical studies, in the literature, or during postapproval use of hydrocodone and/or pseudoephedrine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions to REZIRA include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, tachycardia, arrhythmias including premature ventricular contractions, CNS stimulation including anxiety, restlessness, nervousness, tremor, and irritability.
Other Reactions Include
Anaphylaxis: Anaphylaxis has been reported with hydrocodone, one of the ingredients in REZIRA.
Body as a whole: Coma, death, fatigue, falling injuries, lethargy, weakness, hyperthermia.
Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush, atrial fibrillation, myocardial infarction.
Central Nervous System: Facial dyskinesia, insomnia, increased intracranial pressure, migraine, seizure, tremor.
Dermatologic: Flushing, hyperhidrosis, pruritus, rash. Cases of severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.
Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi), dysgeusia, ischemic colitis.
Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention. Laboratory: Increases in serum amylase.
Musculoskeletal: Arthralgia, backache, muscle spasm.
Ophthalmic: Miosis (constricted pupils), mydriasis (dilated pupils), visual disturbances.
Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression, hyperactivity, ataxia, confusion, hallucinations, hyperexcitability.
Reproductive: Hypogonadism, infertility.
Respiratory: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection.
Other: Drug abuse, drug dependence, opioid withdrawal syndrome.
Read the entire FDA prescribing information for Rezira (Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride)
© Rezira Patient Information is supplied by Cerner Multum, Inc. and Rezira Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
