About Cough and
Cough Suppressants

Cough is an expiratory action the body takes to clear the air passages. Both upper respiratory and lower respiratory symptoms may contribute to cough. Cough due to upper respiratory symptoms (often the common cold or allergies) may be a result of irritation from postnasal drip or other irritants in the upper airway. Some other possible causes of cough include URI (including acute bronchitis), COPD exacerbation, pneumonia, and allergy.1

Combination cough preparations are common2 and may contain an antitussive, such as hydrocodone or codeine, and an antihistamine, such as chlorpheniramine.

TUSSIONEX® is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.

Several hydrocodone-containing cough medications remain approved by the FDA2,3

On October 1, 2007, the FDA announced enforcement action to halt the sales and distribution of nearly 200 unapproved prescription cough medications containing hydrocodone. The FDA initiated this action after receiving reports of medication errors associated with formulation changes in unapproved hydrocodone antitussive products and reports of confusion over the similarity of names of these products. The agency was particularly concerned with the improper pediatric labeling of and the risk of medication errors involving these unapproved products. Some of these unapproved products had labels stating dosing information for children under the age of 6, and as young as 2 years old, when no evidence has been shown that they are safe or effective in this population.3

Extended Release (dosed every 12 hours):
  • TUSSIONEX® Pennkinetic® (hydrocodone polistirex/chlorpheniramine polistirex) suspension
  • TussiCaps® (chlorpheniramine polistirex/hydrocodone polistirex) capsules
  • Hydrocodone polistirex/chlorpheniramine polistirex suspension (generic)
Long-acting products typically require twice-a-day dosing.

Immediate Release (dosed every 4-6 hours):
  • Mycodone™ (homatropine methylbromide/hydrocodone bitartrate) syrup
  • Tussigon® (homatropine methylbromide/hydrocodone bitartrate) tablets
  • Homatropine methylbromide/hydrocodone bitartrate syrup/tablet (generics available)
  • ReziraTM (hydrocodone bitartrate/pseudoephedrine hydrochloride) oral solution
  • ZutriproTM (hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride) oral solution
Short-acting products may require multiple doses during the day and evening.

How Tussionex Works

IMPORTANT SAFETY INFORMATION

  • TUSSIONEX® is contraindicated in children less than 6 years of age due to the risk of fatal depression, and in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.
  • TUSSIONEX® may produce dose-related respiratory depression or irregular and periodic breathing. Caution should be exercised when TUSSIONEX is used postoperatively and in patients with pulmonary disease, or whenever ventilatory function is depressed.
  • The respiratory depressant effects of narcotics 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, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.
  • TUSSIONEX® is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, TUSSIONEX Pennkinetic Extended-Release Suspension should be prescribed and administered with caution.
  • The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
  • Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder.
  • Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy.
  • TUSSIONEX® should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
  • Hydrocodone suppresses the cough reflex; caution should be exercised when TUSSIONEX® is used postoperatively, and in patients with pulmonary disease.
Indication

TUSSIONEX® is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References:
1. Merck Manuals Online Medical Library. Cough. http://www.merckmanuals.com/professional/pulmonary_disorders/symptoms_of_pulmonary_disorders/cough.html#v910606. Updated July 2009. Accessed September 12, 2011.

2. US Food and Drug Administration (FDA) Approved Drug Products, Drugs @ FDA: Hydrocodone. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed September 28, 2011.

3. FDA takes action to stop marketing of unapproved hydrocodone products [press release]. Silver Spring, MD: US Food and Drug Administration; September 28, 2007. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108997.htm. Accessed September 12, 2011.

4. IMS Health, Inc. National Prescription Audit, 2010.

TUSSIONEX®, PENNKINETIC®, and COUGH RELIEVED. REST ASSURED.™ are trademarks of the UCB Group of companies. All other trademarks are owned by their respective trademark holders.