Up to 12 hours of cough
control with a single dose

TRUST IN TUSSIONEX®: AN FDA-APPROVED PRESCRIPTION COUGH SYRUP THAT PROVIDES UP TO 12 HOURS OF COUGH CONTROL WITH JUST ONE DOSE

TUSSIONEX® Pennkinetic® extended-relief suspension provides up to 12 hours of relief per dose

Pennkinetic® Delivery

Learn more about TUSSIONEX®:

a Based on recommended doses cited in the Product Package inserts.

b ZutriproTM and ReziraTM are not indicated for use in children under 18 years of age.

c Applies to liquid formulations only.

d As with all CIII narcotics, TUSSIONEX® should be used for a short time to avoid development of psychic or physical dependence and/or tolerance.

e Tussionex®: 10 mg hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate/chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate/5 ml (1 tsp)

f Mycodone® and Tussigon®: 5 mg hydrocodone bitartrate/1.5 mg homatropine methylbromide/5 ml (1 tsp)

g ZutriproTM: 5 mg hydrocodone bitartrate/4 mg chlorpheniramine maleate/60 mg pseudoephedrine HCl/5 ml (1 tsp)

h ReziraTM: 5 mg hydrocodone bitartrate /60 mg pseudoephedrine HCl/5 ml (1 tsp)

TUSSIONEX® contains approximately 1.9 g of total carbohydrate (CHO) per 5 mL (1 g from granular sugar, 0.8 g from high fructose corn syrup, and 0.1 g from other CHO). Thus, total daily CHO load from the use of TUSSIONEX® at recommended adult dose is 3.8 g. Each 5 mL of TUSSIONEX® contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate.


One dose of TUSSIONEX® provides prolonged
hydrocodone concentrations

This graph illustrates the pharmacokinetic profile of TUSSIONEX® versus an immediate-release formulation and should not be interpreted as a comparison of product efficacy.

Study design: Mean (SD) steady-state hydrocodone (HC) and chlorpheniramine (CPM) plasma concentrations were profiled following administration of 10 mg (2 doses over 12 hours) of an immediate-release formulation of HC and CPM and a single dose (10 mg) of TUSSIONEX®. The immediate-release product consisted of 5 mg HC bitartrate and 4 mg CPM maleate, per 5 mL, while TUSSIONEX® contained the equivalent of 10 mg HC bitartrate, as a coated HC resin complex, and the equivalent of 8 mg CPM maleate, as an uncoated CPM resin complex, per 5 mL. Each subject received either 5 mL of the immediate-release product (at 8 AM, 2 PM, 8 PM, and 2 AM) or 5 mL of TUSSIONEX® (at 8 AM and 8 PM) for 7 days. Plasma samples through 12 hours were collected on the last day of each treatment week.

Based on pharmacokinetic data.

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. 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.