Hydrocodone/Guaifenesin

DEA Class; Rx

Common Brand Names; Obredon, Flowtuss

Hydrocodone is an opiate agonist antitussive agent; guaifenesin is an expectorant
Used to treat cough
Not indicated in pediatric patients under 18 years of age; contraindicated in neonates, infants and children less than 6 years of age

All children aged ≤6 years; use associated with fatal respiratory depression when hydrocodone was used as recommended; not approved for individuals aged <18 years

Known hypersensitivity to hydrocodone bitartrate, guaifenesin, or the inactive ingredients

Significant respiratory depression

Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment

Known or suspected gastrointestinal obstruction, including paralytic ileus

Anaphylaxis

Body as a whole: Coma, death, fatigue, falling injuries, lethargy Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush

Central nervous system: Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor

Dermatologic: Flushing, hyperhidrosis, pruritus, rash

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

Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi)

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), visual disturbances

Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression

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, neonatal withdrawal syndrome

Contains hydrocodone, a Schedule II controlled substance; as an opioid, hydrocodone exposes users to the risks of addiction, abuse, and misuse (see Black Box Warnings)

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended (see Black Box Warnings)

Children are particularly sensitive to the respiratory depressant effects of hydrocodone; because of the risk of life-threatening respiratory depression and death, hydrocodone is contraindicated in children aged <6 years (see Black Box Warnings)

Use in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated; life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance

If cough is unresponsive, do not increase dose; reevaluate within 5 days for possibly underlying pathology

Risk of accidental overdose and death owing to medication errors; clearly communicate dose and prescribe/dispense accurately (see Black Box Warnings)

Prolonged use during pregnancy can result in withdrawal in the neonate; neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts (see Black Box Warnings)

Adrenal insufficiency reported with opioid use, more often following use >1 month

Risk for severe hypotension, including orthostatic hypotension and syncope in ambulatory patients; risk increased in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs

Severe hypotension, including orthostatic hypotension and syncope reported in ambulatory patients; risk increased if ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs

Not recommended for use in pregnant women, including during or immediately prior to labor

Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise women not to breastfeed during treatment