Hydromet (Page 2 of 10)

3 DOSAGE FORMS AND STRENGTHS

Oral solution: Each 5 mL contains hydrocodone bitartrate USP, 5 mg; and homatropine methylbromide USP, 1.5 mg and is available as a red colored, cherry flavored oral solution [see Description (11)].

4 CONTRAINDICATIONS

Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated for:

  • All children younger than 6 years of age [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.4)]

Hydrocodone bitartrate and homatropine methylbromide oral solution is also contraindicated in patients with:

  • Significant respiratory depression [see Warnings and Precautions (5.2)].
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.4)].
  • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.9)].
  • Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution [see Adverse Reactions (6)].

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Hydrocodone bitartrate and homatropine methylbromide oral solution contains hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and homatropine methylbromide oral solution exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)], which can lead to overdose and death [see Overdosage (10)]. 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 addiction or abuse, and refill only after reevaluation of the need for continued treatment.

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and homatropine methylbromide oral solution. Addiction can occur at recommended dosages and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing hydrocodone bitartrate and homatropine methylbromide oral solution. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2 Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including hydrocodone, one of the active ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution. Hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls respiratory rhythm and may produce irregular and periodic breathing. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression includes discontinuation of hydrocodone bitartrate and homatropine methylbromide oral solution, close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient’s clinical status [see Overdosage (10)]. Carbon dioxide (CO2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of hydrocodone bitartrate and homatropine methylbromide oral solution, the risk is greatest during the initiation of therapy, when hydrocodone bitartrate and homatropine methylbromide oral solution is used concomitantly with other drugs that may cause respiratory depression [see Warnings and Precautions (5.8)] , in patients with chronic pulmonary disease or decreased respiratory reserve, and in patients with altered pharmacokinetics or altered clearance (e.g. elderly, cachectic, or debilitated patients) [see Warnings and Precautions (5.4)].

To reduce the risk of respiratory depression, proper dosing of hydrocodone bitartrate and homatropine methylbromide oral solution is essential [see Dosage and Administration (2.1), Warnings and Precautions (5.5)]. Monitor patients closely, especially within the first 24 to 72 hours of initiating therapy or when used in patients at higher risk.

Overdose of hydrocodone in adults has been associated with fatal respiratory depression, and the use of hydrocodone in children younger than 6 years of age has been associated with fatal respiratory depression when used as recommended. Accidental ingestion of even one dose of hydrocodone bitartrate and homatropine methylbromide oral solution, especially by children, can result in respiratory depression and death.

5.3 Risks with Use in Pediatric Populations

Children are particularly sensitive to the respiratory depressant effects of hydrocodone [see Warnings and Precautions (5.2)]. Because of the risk of life-threatening respiratory depression and death, hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated in children less than 6 years of age [see Contraindications (4)].

Use of hydrocodone bitartrate and homatropine methylbromide oral solution in children also exposes them to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)] , which can lead to overdose and death [see Warnings and Precautions (5.1), Overdosage (10)]. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of hydrocodone in pediatric patients, hydrocodone bitartrate and homatropine methylbromide oral solution is not indicated for use in patients younger than 18 years of age [see Indications (1), Use in Specific Populations (8.4)].

5.4 Risks with Use in Other At-Risk Populations

Unresponsive Cough

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 in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Dosage and Administration (2.3) ].

Asthma and Other Pulmonary Disease

The use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [s ee Contraindications (4) ].

Opioid analgesics and antitussives, including hydrocodone, one of the active ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution, should not be used in patients with acute febrile illness associated with productive cough or in patients with chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient’s respiratory function.

Hydrocodone bitartrate and homatropine methylbromide oral solution-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of hydrocodone bitartrate and homatropine methylbromide oral solution [see Warnings and Precautions (5.2) ].

Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions (5.2) ].

Because of the risk of respiratory depression, avoid the use of opioid antitussives, including hydrocodone bitartrate and homatropine methylbromide oral solution in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients. If hydrocodone bitartrate and homatropine methylbromide oral solution is prescribed, monitor such patients closely, particularly when initiating hydrocodone bitartrate and homatropine methylbromide oral solution and when hydrocodone bitartrate and homatropine methylbromide oral solution is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.8) ].

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