Usual Adult Dose for Cough and Nasal Congestion

10 mL orally every 4 to 6 hours
Maximum dose: 40 mL in 24 hours

Comments:

• Each 5 mL contains hydrocodone 2.5 mg; pseudoephedrine 30 mg; guaifenesin 200 mg
• Measure dose with accurate measuring device.

Renal Dose Adjustments

Severe renal impairment: Use with caution

Liver Dose Adjustments

Severe hepatic impairment: Use with caution

Dose Adjustments

Elderly: Use with caution

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for all opioids intended for outpatient use. The new FDA Opioid Analgesic REMS is a designed to assist in communicating the serious risks of opioid pain medications to patients and health care professionals. It includes a medication guide and elements to assure safe use. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME CYP450 (CYP450) 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME:

• Use of this product may lead to opioid addiction, abuse, and misuse, which can lead to overdose and death.
• Reserve use of this drug for adults for whom cough suppression benefits outweigh risks, and who have had adequate assessment of the cough etiology.
• Assess each patients risks prior to prescribing; prescribe for the shortest duration consistent with individual treatment goals, and monitor all patients regularly for development of addiction or abuse; refill only after evaluating the need for continued treatment.
• Opioid Analgesic REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program; counsel patients and/or their caregivers, with every prescription on safe use, serious risks, storage, and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.
• Serious, life-threatening, or fatal respiratory depression may occur with use.
• Monitor for respiratory depression, especially at the beginning of therapy or in high risk patients.
• Accidental ingestion of even one dose of this drug, especially by children, can cause a fatal overdose of hydrocodone.
• Ensure accuracy when prescribing, dispensing, and administering this drug.
• Dosing errors can cause accidental overdose and death.
• Always use an accurate milliliter measuring device when measuring and administering liquid medications.
• Concomitant use with all CYP450 3A4 inhibitors may increase plasma hydrocortisone concentrations, potentially increasing or prolonging adverse drug effects, and may potentially lead to fatal respiratory depression.
• Discontinuing a concomitant CYP450 3A4 inducer may cause increased plasma hydrocodone concentration.
• Avoid use in patients taking CYP450 3A4 inhibitors or inducers.
• Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.
• Instruct patients not to consume alcohol or use prescription or non-prescription products containing alcohol while on this medication.
• Co-ingestion with alcohol may cause increased plasma levels and a potentially fatal overdose of hydrocodone.
• Use is not recommended in pregnant women.
• Prolonged use during pregnancy may cause neonatal opioid withdrawal syndrome, which can be life-threatening if not recognized and treated, and requires management according to neonatology expert protocols.
• If used for a prolonged period during pregnancy, advise the patient of the neonatal opioid withdrawal syndrome risk and ensure appropriate treatment will be available.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally as needed
• Measure each dose with an accurate measuring device; a household teaspoon is not an accurate measuring device

• Protect from light

• This drug is not indicated for pediatric patients under 18 years of age; use of hydrocodone in children less than 6 years of age has been associated with fatal respiratory depression.

• Monitor for the development of addiction, abuse, or misuse

• Advise patients to always use an accurate milliliter measuring device when measuring and giving liquid medications.
• Inform patients that a household teaspoon is not an accurate measuring device and could lead to overdosage and serious adverse effects.
• If a measuring device is not provided, a pharmacist can provide an appropriate measuring device and instructions for measuring the correct dose.
• Advise patients to store this drug safely out of the sight and reach of children; accidental use by a child should be considered a medical emergency as it can result in death.
• Patients should understand the risks of life-threatening respiratory depression, and should be informed as to when this risk is greatest.
• Women of child bearing potential should understand that prolonged use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome and prompt recognition and treatment will be necessary; breastfeeding women should speak to their health care provider prior to using this drug.
• Patients should discuss concomitant medication use with their healthcare provider to prevent significant drug interactions.
• Patients should not consume alcoholic beverages or take this drug with benzodiazepines or other CNS depressants; patients should avoid driving or operating machinery while taking this drug.
• Patients should be instructed to read the US FDA-approved Medication Guide each time this drug is dispensed; they should understand the safe use, serious risks, and proper storage and disposal of this drug.