Hydromet

HYDROMET- hydrocodone bitartrate and homatropine methylbromide solution
Actavis Pharma, Inc.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse

Hydrocodone bitartrate and homatropine methylbromide oral solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. 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. Assess each patient’s risk prior to prescribing hydrocodone bitartrate and homatropine methylbromide oral solution, prescribe hydrocodone bitartrate and homatropine methylbromide oral solution for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and homatropine methylbromide oral solution. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and homatropine methylbromide oral solution therapy or when used in patients at higher risk [see Warnings and Precautions (5.2)].

Accidental Ingestion

Accidental ingestion of even one dose of hydrocodone bitartrate and homatropine methylbromide oral solution, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2)].

Risk of Medication Errors

Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate and homatropine methylbromide oral solution. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate and homatropine methylbromide oral solution [see Dosage and Administration (2.1), Warnings and Precautions (5.5)].

Cytochrome P450 3A4 Interaction

The concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients taking a CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.7), Drug Interactions (7.2,7.3)].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients taking benzodiazepines, other CNS depressants, or alcohol [see Warning and Precautions (5.8), Drug Interactions (7.5)].

Interaction with Alcohol

Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone bitartrate and homatropine methylbromide oral solution. The co-ingestion of alcohol with hydrocodone bitartrate and homatropine methylbromide oral solution may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see Warnings and Precautions (5.8) and Drug Interactions (7.1)].

Neonatal Opioid Withdrawal Syndrome

Hydrocodone bitartrate and homatropine methylbromide oral solution is not recommended for use in pregnant women [see Use in Specific Populations (8.1)]. Prolonged use of hydrocodone bitartrate and homatropine methylbromide oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If hydrocodone bitartrate and homatropine methylbromide oral solution is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.13)].

1 INDICATIONS AND USAGE

Hydrocodone bitartrate and homatropine methylbromide oral solution is indicated for the symptomatic relief of cough in patients 18 years of age and older.

Important Limitations of Use:
• Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].
• Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)].
• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Administer hydrocodone bitartrate and homatropine methylbromide oral solution by the oral route only.

Always use an accurate milliliter measuring device when administering hydrocodone bitartrate and homatropine methylbromide oral solution to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [see Warnings and Precautions (5.5)]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use.

Advise patients not to increase the dose or dosing frequency of hydrocodone bitartrate and homatropine methylbromide oral solution because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.2), Overdosage (10)]. The dosage of hydrocodone bitartrate and homatropine methylbromide oral solution should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [see Dosage and Administration (2.3), Warnings and Precautions (5.4)].

2.2 Recommended Dosage

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.

2.3 Monitoring, Maintenance, and Discontinuation of Therapy

Prescribe hydrocodone bitartrate and homatropine methylbromide oral solution for the shortest duration that is consistent with individual patient treatment goals [see Warnings and Precautions (5.1)].

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy [see Warnings and Precautions (5.2)].

Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Warnings and Precautions (5.4)]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with hydrocodone bitartrate and homatropine methylbromide oral solution, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)].

Do not abruptly discontinue hydrocodone bitartrate and homatropine methylbromide oral solution in a physically-dependent patient [see Drug Abuse and Dependence (9.3)]. When a patient who has been taking hydrocodone bitartrate and homatropine methylbromide oral solution regularly and may be physically dependent no longer requires therapy with hydrocodone bitartrate and homatropine methylbromide oral solution, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

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