OBREDON

OBREDON- hydrocodone bitartrate and guaifenesin solution
NOVOTEC PHARMA LLC

WARNING: 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 [see Warnings and Precautions ( 5.1), Drug Interactions ( 7.1)] . Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

1 INDICATIONS AND USAGE

OBREDON Oral Solution is indicated for symptomatic relief of cough and to loosen mucus associated with the common cold.

Important Limitations of Use:Not indicated for pediatric patients under 18 years of age [see Pediatric Use ( 8.4)] .

2 DOSAGE AND ADMINISTRATION

2.1 Recommended dosage

Adults and adolescents 18 years of age and older: 10 mL every 4 to 6 hours, not to exceed 6 doses (60 mL) in 24 hours.

Administer OBREDON Oral Solution by the oral route only. Measure OBREDON Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Dosing ( 5.10)] .

3 DOSAGE FORMS AND STRENGTHS

Oral Solution:

Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg [see DESCRIPTION ( 11)] .

4 CONTRAINDICATIONS

OBREDON Oral Solution is contraindicated in:

  • Patients with known hypersensitivity to hydrocodone bitartrate, guaifenesin, or any of the inactive ingredients of OBREDON Oral Solution.
  • Patients receiving MAOI therapy or within 14 days of stopping such therapy [see DRUG INTERACTIONS ( 7.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants

Concomitant use of opioids, including OBREDON Oral Solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [see DRUG INTERACTIONS ( 7.1)] .

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.

Advise both patients and caregivers about the risks of respiratory depression and sedation if OBREDON Oral Solution is used with benzodiazepines, alcohol, or other CNS depressants [see PATIENT COUNSELING INFORMATION ( 17)] .

5.2 Respiratory Depression

Hydrocodone bitartrate, one of the active ingredients in OBREDON Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of hydrocodone bitartrate in adults has been associated with fatal respiratory depression, and the use of hydrocodone bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administering OBREDON Oral Solution because of the potential for respiratory depression. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated [see OVERDOSAGE ( 10)].

5.3 Drug Dependence

Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of OBREDON Oral Solution. Prescribe and administer OBREDON Oral Solution with the same degree of caution appropriate to the use of other opioid drugs [see DRUG ABUSE AND DEPENDENCE ( 9.2), ( 9.3)].

5.4 Head Injury and Increased Intracranial Pressure

The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of OBREDON Oral Solution should be avoided in these patients.

5.5 Activities Requiring Mental Alertness

Hydrocodone bitartrate, one of the active ingredients in OBREDON Oral Solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of OBREDON Oral Solution. Concurrent use of OBREDON Oral Solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur.

5.6 Acute Abdominal Conditions

OBREDON Oral Solution should be used with caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus [see DRUG INTERACTIONS ( 7.3)].

5.7 Co-administration with Anticholinergics

The concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Exercise caution when using OBREDON Oral Solution in patients taking anticholinergic medications [see DRUG INTERACTIONS ( 7.3)].

5.8 Co-administration with MAOIs or Tricyclic Antidepressants

OBREDON Oral Solution should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy. The use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate may increase the effect of either the antidepressant or hydrocodone [see CONTRAINDICATIONS ( 4) and DRUG INTERACTIONS ( 7.2)].

5.9 Persistent Cough

OBREDON Oral Solution should not be used in patients with a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus).

5.10 Dosing

Patients should be advised to measure OBREDON Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions [see OVERDOSAGE ( 10)]. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose.

5.11 Coexisting Conditions

OBREDON Oral Solution should be used with caution in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy or urethral stricture, and asthma.

5.12 Renal Impairment

OBREDON Oral Solution should be used with caution in patients with severe renal impairment. [see Renal Impairment ( 8.6)]

5.13 Hepatic Impairment

OBREDON Oral Solution should be used with caution in patients with severe hepatic impairment [see Hepatic Impairment ( 8.7)].

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