• Clinical Info

Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Pain

Symptomatic relief of moderate to moderately severe pain.

Combinations of hydrocodone and NSAIAs or acetaminophen may produce additive analgesic effects because of differing mechanisms of action.

Cough

Symptomatic relief of nonproductive cough, alone or in combination with other antitussives or expectorants.

Dosage and Administration

Administration

Oral Administration

Administer orally.

Extended-release Suspension Containing Hydrocodone Polistirex

Do not dilute with fluids or mix with other drugs; shake well prior to administration.

Dosage

Available as hydrocodone bitartrate and hydrocodone polistirex; dosage expressed in terms of hydrocodone bitartrate.

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Cough

Hydrocodone Bitartrate

Oral

0.6 mg/kg daily in 3 or 4 divided doses, given as needed at intervals of ≥4 hours. Alternatively, 20 mg/m² daily in 3 or 4 divided doses.

Extended-release Suspension Containing Hydrocodone Polistirex

Oral

Children 6–12 years of age: 5 mg every 12 hours.

Adults

Cough

Hydrocodone Bitartrate

Oral

Initially 5 mg, then increase subsequent doses as needed. Usual dosage is 5–10 mg every 4–6 hours as needed.

Extended-release Suspension Containing Hydrocodone Polistirex

Oral

10 mg every 12 hours.

Pain

Oral

5–10 mg every 4–6 hours as needed.

Prescribing Limits

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Cough

Hydrocodone Bitartrate

Oral

Extended-release Suspension Containing Hydrocodone Polistirex

Oral

Children 6–12 years of age: Maximum 10 mg daily.

Adults

Cough

Hydrocodone Bitartrate

Oral

Maximum single dose is 15 mg.

Extended-release Suspension Containing Hydrocodone Polistirex

Oral

Maximum 20 mg daily.

Pain

Fixed Combination with Ibuprofen

Oral

Maximum 37.5 mg daily.

Fixed Combination with Acetaminophen

Oral

Maximum 60 mg daily.

Special Populations

Geriatric Patients

Reduce dosage in older patients.

Cautions

Contraindications

• Known hypersensitivity to hydrocodone or any ingredient in the formulation.
• Possible cross-sensitivity to hydrocodone if hypersensitive to other opioids.

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

CNS Depression

Performance of activities requiring mental alertness and physical coordination may be impaired.

Concurrent use of other CNS depressants may potentiate CNS depression. (See Specific Drugs under Interactions.)

Abuse Potential

Possible tolerance, psychologic dependence, and physical dependence following prolonged administration. Use only with careful surveillance in patients with a history of drug or alcohol dependence or abuse.

Sensitivity Reactions

Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.

Tartrazine Sensitivity

Some formulations may contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals. Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.

General Precautions

Increased Intracranial Pressure or Head Trauma

Potential for increased respiratory depressant effects and elevation of CSF pressure in patients with increased intracranial pressure, head trauma, or other intracranial lesions.

Adverse effects of opiates may obscure the existence, extent, or course of intracranial pathology.

Acute Abdominal Conditions

Administration may complicate assessment of patients with acute abdominal conditions. Reduce initial dosage in patients who have undergone GI surgery.

Obstructive Bowel Disease

Use may result in obstructive bowel disease, especially in patients with underlying intestinal motility disorder.

Respiratory Depression

Possible dose-related respiratory depression.

Potential for increased viscosity of bronchial secretions and suppression of cough reflex, with subsequent respiratory insufficiency, in patients with asthma or pulmonary emphysema who indiscriminately use antitussives.

Postoperative Patients

Suppression of cough reflex following thoracotomy or laparotomy may lead to postoperative retention of secretions; cautious use recommended.

Debilitated and Special Risk Patients

Use with caution in debilitated patients and in those with hypothyroidism, Addison’s disease, and prostatic hypertrophy or urethral stricture.

Fixed-Combination Preparations

When used in fixed combination with other drugs, consider the cautions, precautions, and contraindications associated with the other drug(s).

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether hydrocodone is distributed into milk. Discontinue nursing or the drug.

Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Safety and efficacy for the management of moderate to moderately severe pain has not been established.

Safety and efficacy of extended-release suspension containing hydrocodone polistirex as an antitussive not established in children <6 years of age.

Benefit-to-risk ratio should be carefully considered, especially in children with respiratory embarrassment (e.g., croup).

Risk of overdosage and toxicity (including death) in children <2 years of age receiving preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Use such preparations in children <2 years of age with caution and only as directed by clinician. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. Use with caution. (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution in severe hepatic impairment.

Renal Impairment

Use with caution in severe renal impairment.

Common Adverse Effects

Lightheadedness, dizziness, sedation, nausea, vomiting. Adverse effects occur infrequently with usual oral antitussive dosages.