Obredon™

combination product containing antitussive and expectorant

 

Important safety information regarding Obredon™

INDICATION

OBREDON™  (Hydrocodone Bitartrate and Guaifenesin) Oral Solution (CII) is a combination product containing an opioid antitussive and expectorant indicated for symptomatic relief of cough and to loosen mucus associated with the common cold in adults and adolescents 18 years of age and older.

Click here for Full Prescribing Information for OBREDON™ Solution

IMPORTANT SAFETY INFORMATION

OBREDON™ Oral Solution is contraindicated for pediatric patients under 18; in individuals with hypersensitivity to Hydrocodone Bitartrate, Guaifenesin, or any of the inactive ingredients; individuals receiving monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping such therapy

Exercise caution when using because of the potential for respiratory depression. OBREDON™ Oral Solution is a Schedule II controlled prescription containing Hydrocodone Bitartrate and should be prescribed and administered with caution, particularly in patients with history of drug dependence as there is the possibility of psychic dependence, physical dependence, and/or tolerance. Abuse of Guaifenesin has been linked to formation of kidney stones. Avoid in patients with head injury, intra-cranial lesions, or increased intracranial pressure. Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as OBREDON™ Oral Solution may produce marked drowsiness. OBREDON™ Oral Solution should not be taken with alcohol or other CNS depressants. Use with caution in patients with acute abdominal conditions and in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy, urethral stricture, or asthma.

The most common adverse reactions of OBREDON™ Oral Solution include: Dizziness, headache, sedation, nausea, and decreased blood pressure.

To report SUSPECTED ADVERSE REACTIONS, contact Accelis Pharma at tel: 1-855-461-5100; FDA at
1-800-FDA-1088; www.fda.gov/medwatch

Prescribing Information