Hydrocodone bitartrate and homatropine methylbromide oral solution is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in adult patients 18 years of age and older. (1)

Limitations of Use (1)
• Not indicated for pediatric patients under 18 years of age.
• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone bitartrate and homatropine methylbromide oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

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• Adults 18 years of age and older: 5 mL of the oral solution every 4 to 6 hours as needed; not to exceed 30 mL in 24 hours. (2.2)
• Measure hydrocodone bitartrate and homatropine methylbromide oral solution with an accurate milliliter measuring device. (2.1, 5.5)
• Do not increase the dose or dosing frequency. (2.1)
• Prescribe for the shortest duration consistent with treatment goals. (2.3)
• Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. (2.3)
• Reevaluate patient prior to refilling. (2.3)

• Oral solution: 5 mg of hydrocodone bitartrate and 1.5 mg of homatropine methylbromide per 5 mL. (3)

Actavis Hydromet Syrup

Rx Only

NDC 0472-1030-16

Hydromet Oral Solution  CII

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution

5 mg and 1.5 mg/5 mL

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

One Pint (473 mL)

• Children younger than 6 years of age. (4)
• Significant respiratory depression. (4)
• Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
• Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
• Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution. (4)

• Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy. (5.4)
• Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. (5.6)
• Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors: Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. (5.10)
• Seizures in patients with seizure disorders: Monitor during therapy. (5.11)
• Severe hypotension: Monitor during initiation of therapy. Avoid use in patients with circulatory shock. (5.12)
• Adrenal insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.14)

Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.

• Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. (7.5)
• Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping an MAOI. (7.6)
• Muscle Relaxants: Avoid concomitant use. (7.7)
• Diuretics: Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. (7.8)
• Anticholinergic drugs: Concurrent use may cause paralytic ileus. (5.9, 7.9)

• Pregnancy: Avoid use in pregnant women. May cause fetal harm. (8.1)
• Lactation: Breastfeeding not recommended. (8.2)
• Renal Impairment: Use with caution in patients with severe renal impairment. (8.6)
• Hepatic Impairment: Use with caution in patients with severe hepatic impairment. (8.7)