... Tussionex ® Pennkinetic ® (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension Rx only Rev. 01 / 2008 1E DESCRIPTION Each teaspoonful (5 mL) of TUSSIONEX Pennkinetic Extended-Release Suspension contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. TUSSIONEX Pennkinetic Extended-Release Suspension provides up to 12-hour relief per dose. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. TUSSIONEX Pennkinetic Extended-Release Suspension is for oral use only. Hydrocodone Polistirex Sulfonated styrene-divinylbenzene copolymer complex with 4, 5-epoxy-3-methoxy-17-methylmorphinan-6-one. Chlorpheniramine Polistirex Sulfonated styrene-divinylbenzene copolymer complex with 2 [p-chloro [2-( dimethylamino) ethyl ]-benzyl] pyridine. Inactive Ingredients Ascorbic acid, D & C Yellow No. 10, ethylcellulose, FD & C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, pregelatinized starch, propylene glycol, propylparaben, purified water, sucrose, vegetable oil, xanthan gum. CLINICAL PHARMACOLOGY Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar ...

... Warning on Unapproved Antitussives Containing Hydrocodone FDA Patient Safety News: Show #70, December 2007 FDA is taking action against companies that market unapproved drugs containing hydrocodone, a controlled substance. Hydrocodone is a narcotic widely used as an analgesic in approved products such as Vicodin. It is also used as a cough suppressant. The vast majority of these antitussive products have not been approved. Despite its potential for medical benefit, hydrocodone is a potentially lethal drug of abuse. Overdose can lead to cardiac arrest, coma and respiratory failure. FDA is particularly concerned about the use of unapproved hydrocodone cough medicines in children. No hydrocodone cough suppressant has been shown safe and effective for children under six, and yet some of these unapproved products have dosing instructions for children as young as two. Also, FDA has received reports of medication errors associated with changes in the formulation of unapproved hydrocodone products, as well as name confusion between approved and unapproved ones. There are seven FDA-approved antitussives that contain hydrocodone, and a variety of other approved cough suppressants without it. Providers should ...

... Unsafe Use of Extended-Release Tussionex Suspension FDA Patient Safety News: Show #75, May 2008 FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorpheniramine, an antihistamine. Overdoses of hydrocodone can result in respiratory depression and death. FDA has reviewed over a hundred adverse event reports associated with this product. Twenty four reports were in children under the age of six, nine of whom died. Tussionex is not approved for children under six because of the risk of respiratory depression and death. Even though it is specifically contraindicated in this age group some physicians are prescribing this product for them. Also, family members may take a prescription for an older family member and give it to younger children. Irrespective of the child's age, parents are also running into trouble when they try to measure the dose. For example, they may be using ordinary teaspoons, which can vary in size. Pharmacists can contribute to the problem if they ...

... Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products 2010 Safety Alerts for Human Medical Products 2009 Safety Alerts for Human Medical Products 2008 Safety Alerts for Human Medical Products 2007 Safety Alerts for Human Medical Products 2006 Safety Alerts for Human Medical Products 2005 Safety Alerts for Human Medical Products 2004 Safety Alerts for Human Medical Products 2003 Safety Alerts for Human Medical Products 2002 Safety Alerts for Human Medical Products 2001 Safety Alerts for Human Medical Products 2000 Safety Alerts for Human Medical Products-Hydrocodone in Unapproved Prescription Products Audience: Healthcare professionals, pediatricians, consumers [Posted 09 / 28 / 2007] FDA informed healthcare professionals and consumers of its intent to take action against companies that market unapproved prescription products containing hydrocodone, a narcotic widely used as a cough suppressant and to treat pain. The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and ...

... Unsafe Use of Extended-Release Tussionex Suspension FDA Patient Safety News: Show #75, May 2008 FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorpheniramine, an antihistamine. Overdoses of hydrocodone can result in respiratory depression and death. FDA has reviewed over a hundred adverse event reports associated with this product. Twenty four reports were in children under the age of six, nine of whom died. Tussionex is not approved for children under six because of the risk of respiratory depression and death. Even though it is specifically contraindicated in this age group some physicians are prescribing this product for them. Also, family members may take a prescription for an older family member and give it to younger children. Irrespective of the child's age, parents are also running into trouble when they try to measure the dose. For example, they may be using ordinary teaspoons, which can vary in size. Pharmacists can contribute to the problem if they ...

... the American Academy of Pediatrics, practitioners treating otitis media in patients with cochlear implants should consider antibiotic therapy more readily than they might for other patients. â €¢ Consider prophylactic antibiotic treatment perioperatively in children receiving cochlear implants. Additional Information: FDA MedWatch Safety Alert. Cochlear Implants. October 10, 2007. CDC Website. Use of Meningitis Vaccine in Persons with Cochlear Implants: FACT SHEET for Healthcare Professionals. June 4, 2007. Return to Top Return to FDA Patient Safety News Home Warning on Unapproved Antitussives Containing Hydrocodone FDA is taking action against companies that market unapproved drugs containing hydrocodone, a controlled substance. Hydrocodone is a narcotic widely used as an analgesic in approved products such as Vicodin. It is also used as a cough suppressant. The vast majority of these antitussive products have not been approved. Despite its potential for medical benefit, hydrocodone is a potentially lethal drug of abuse. Overdose can lead to cardiac arrest, coma and respiratory failure. FDA is particularly concerned about the use of unapproved hydrocodone cough medicines in children. No hydrocodone cough suppressant has been ...

... or before the meningitis developed. According to the American Academy of Pediatrics, practitioners treating otitis media in patients with cochlear implants should consider antibiotic therapy more readily than they might for other patients. â €¢ Consider prophylactic antibiotic treatment perioperatively in children receiving cochlear implants. Additional Information: CDC Website. Use of Meningitis Vaccine in Persons with Cochlear Implants: FACT SHEET for Healthcare Professionals. June 4, 2007. http :// www.cdc.gov / Vaccines / vpd-vac / mening / cochlear / dis-cochlear-faq-hcp.htm Warning on Unapproved Antitussives Containing Hydrocodone FDA is taking action against companies that market unapproved drugs containing hydrocodone, a controlled substance. Hydrocodone is a narcotic widely used as an analgesic in approved products such as Vicodin. It is also used as a cough suppressant. The vast majority of these antitussive products have not been approved. Despite its potential for medical benefit, hydrocodone is a potentially lethal drug of abuse. Overdose can lead to cardiac arrest, coma and respiratory failure. FDA is particularly concerned about the use of unapproved hydrocodone cough medicines in children. No hydrocodone cough suppressant has been shown safe ...

... the American Academy of Pediatrics, practitioners treating otitis media in patients with cochlear implants should consider antibiotic therapy more readily than they might for other patients. â €¢ Consider prophylactic antibiotic treatment perioperatively in children receiving cochlear implants. Additional Information: FDA MedWatch Safety Alert. Cochlear Implants. October 10, 2007. CDC Website. Use of Meningitis Vaccine in Persons with Cochlear Implants: FACT SHEET for Healthcare Professionals. June 4, 2007. Return to Top Return to FDA Patient Safety News Home Warning on Unapproved Antitussives Containing Hydrocodone FDA is taking action against companies that market unapproved drugs containing hydrocodone, a controlled substance. Hydrocodone is a narcotic widely used as an analgesic in approved products such as Vicodin. It is also used as a cough suppressant. The vast majority of these antitussive products have not been approved. Despite its potential for medical benefit, hydrocodone is a potentially lethal drug of abuse. Overdose can lead to cardiac arrest, coma and respiratory failure. FDA is particularly concerned about the use of unapproved hydrocodone cough medicines in children. No hydrocodone cough suppressant has been ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Prescribing Information-- Hycodan (hydrocodone and homatropine) Tablets January 2009 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-January 2009 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified Summary of Changes to Contraindications and Warnings WARNINGS Respiratory Depression Pediatric Use PRECAUTIONS Information for Patients ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Vicoprofen (hydrocodone bitartrate / ibuprofen) Tablets Prescribing Information and Medication Guide Jul 2008-- Vicoprofen (hydrocodone bitartrate / ibuprofen) Tablets July 2008 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-July 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Summary View Sections Modified MEDICATION GUIDE .Call your doctor for medical advice about side ...