Adult Dosing

Upper respiratory symptoms

• 5 mL [5 mg/60 mg] PO q4-6 hrs PRN
• Max: 20 mL [20 mg/240 mg]/day

Pediatric Dosing

• Safety and effectiveness in patients <18 yrs of age have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of cough and nasal congestion associated with common cold

• Hypersensitivity to any of the ingredients of the product
• Concomitant use with MAOI or within 2 wks following cessation of MAOI therapy
• Narrow angle glaucoma
• Urinary retention
• Severe hypertension
• Severe coronary artery disease

• N/A

Renal Dose Adjustment

• Severe renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Severe hepatic impairment: Use with caution; dose adjustments not defined

See Supplemental Patient Information

• Hydrocodone component of this combination drug is associated with dose-related respiratory depression. Overdose of hydrocodone in adults and its usage in children <6 yrs is associated with fatal respiratory depression. Use naloxone hydrochloride and other supportive measures for antagonizing respiratory depression
• This combination drug exhibits potential for being abused due to its hydrocodone component. Psychic dependence, physical dependence, and tolerance may occur on repeated use. Undertake same degree of appropriate caution as for other opioid drugs while prescribing and administering this drug
• Head injuries, intracranial lesions, or a pre-existing increase in intracranial pressure may exaggerate respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure. Opioids are associated with obscuring the clinical course of patients with head injuries; avoid use of this hydrocodone/pseudoephedrine combination drug in such patients
• Significant drowsiness and impairment of mental and/or physical abilities may occur with this drug; instruct patients to avoid engaging in hazardous activities requiring mental alertness and motor coordination after ingestion of this combination drug solution. Avoid concomitant use of this drug solution with alcohol or other CNS depressants
• Therapy may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Paralytic ileus may occur on concomitant use of other anticholinergics with hydrocodone
• Avoid using this drug in patients receiving MAOI therapy or within 2 wks of stopping such therapy as an increase in blood pressure or hypertensive crisis may occur. Concomitant use of MAOIs or tricyclic antidepressants with this drug solution may potentiate the effect of either the antidepressant or hydrocodone
• CV and CNS adverse effects may occur in association with pseudoephedrine component of this combination drug. CNS stimulation with convulsions or CV collapse with accompanying hypotension may occur
• Advise patients to measure this drug solution with an accurate milliliter measuring device; avoid using a household teaspoon. Inform them that inaccurate measuring may lead to overdosage causing serious adverse reactions. Advise patients to ask their pharmacist for an appropriate measuring device and for instructions for measuring the correct accurate dose

Cautions: Use cautiously in

• Severe renal impairment
• Severe hepatic impairment
• Cardiovascular disorders
• Severe hypertension
• CAD
• Diabetes mellitus
• CNS depression
• Use of CNS depressants
• Alcohol use
• Substance abuse
• Increased ICP
• Thyroid disease
• Addison's disease
• Prostatic hypertrophy
• Urethral stricture
• Asthma
• Pulmonary impairment
• Acute abdominal conditions
• Geriatric patients

Supplemental Patient Information

• Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as driving a vehicle or operating machinery as therapy may produce marked drowsiness
• Caution patients that therapy may produce drug dependence

Pregnancy Category:C

Breastfeeding: Maternal use of maximum dosages of oral narcotics while breastfeeding can cause infant drowsiness in breastfed infants; newborns are particularly sensitive to even small dosages of narcotic analgesics, in the first week of life. However, because of small volumes of colostrum secreted in the first 2-3 days postpartum, the newborn's dosage is limited. Once the mother's milk comes in, it is best to avoid oral hydrocodone (and combinations) and administer nonnarcotic analgesic if necessary. Maximum recommended dosage is 30 mg/day. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones; immediately contact the physician if the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Small amounts of pseudoephedrine is excreted in breastmilk and are unlikely to harm the nursing infant; however, it may cause occasional irritability. A single dose of pseudoephedrine decreases milk production acutely and repeated use interferes with lactation. Mothers with newborns whose lactation is not yet well established or who are having difficulties producing sufficient milk should not receive pseudoephedrine. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). Pseudoephedrine drug is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 1 August 2011). Manufacturer advises caution and recommends to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• RESP: Respiratory depression
• CNS: Drug dependence, increased intracranial pressure, decreased mental alertness, insomnia, dizziness, weakness, tremor, convulsions, shock, sedation, psychomotor impairment, anxiety, fear, dysphoria, mood swings, nervousness, orthostatic hypotension, syncope, mental clouding, lethargy
• GI: Paralytic ileus, nausea, vomiting, constipation
• CV: Arrhythmias, hypertension, CV collapse, hypotension, palpitations
• GU: Ureteral spasm, urinary retention, spasm of vesicle sphincters
• DERM: Rash, pruritus

Hydrocodone

• Opioid agonist (semisynthetic narcotic antitussive and analgesic); precise mechanism of action is unknown; believed to act directly on the cough center. In excessive doses, depresses respiration
• Well absorbed
• Mostly metabolized by the liver; CYP450: CYP2D6, CYP3A4
• Excreted in urine (50-60% as metabolites, 15% as unchanged drug)
• Half-life: 3.8 +/- 0.3 hrs, 4.9 hrs (plasma half-life)

Pseudoephedrine

• Nasal decongestant; acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction and reducing nasal congestion. Also, relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors
• Partially metabolized by liver
• Renally excreted (55-75% unchanged)
• Half-life: 9-16 hrs (depends on urine pH), 5.6 hrs (plasma half-life)

US Trade Name(s)

• Rezira

US Availability

Rezira (hydrocodone/pseudoephedrine)

• SOLN: [5 mg/60 mg]/5 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations