August 2, 2015
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Tussionex

"By Matt McMillen
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Tussionex




PATIENT INFORMATION

TUSSIONEX® Pennkinetic ®
(hydrocodone polistirex and chlorpheniramine polistirex) Extended-release Suspension

Read this Patient Information before you start taking TUSSIONEX Pennkinetic Extended-Release Suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is TUSSIONEX Pennkinetic Extended-Release Suspension?

TUSSIONEX Pennkinetic Extended-Release Suspension is a prescription medicine used to treat cough and upper respiratory symptoms you can have with allergies or a cold. TUSSIONEX Pennkinetic Extended-Release Suspension is for adults and children age 6 years and older.

TUSSIONEX Pennkinetic Extended-Release Suspension contains two medicines, hydrocodone and chlorpheniramine. Hydrocodone is a narcotic cough suppressant. Chlorpheniramine is an antihistamine.

TUSSIONEX Pennkinetic Extended-Release Suspension is a controlled substance (CII) because it contains hydrocodone that can be a target for people who abuse prescription medicines or street drugs. Keep your TUSSIONEX Pennkinetic Extended-Release Suspension in a safe place, to protect it from theft. Never give your TUSSIONEX Pennkinetic Extended-Release Suspension to anyone else, because it may cause death or harm them. Selling or giving away this medicine is against the law.

Who should not take TUSSIONEX Pennkinetic Extended-Release Suspension?

Do not take TUSSIONEX Pennkinetic Extended-Release Suspension if you:

  • are allergic to any of the ingredients in TUSSIONEX Pennkinetic Extended-Release Suspension. See the end of this leaflet for a complete list of ingredients in TUSSIONEX Pennkinetic Extended-Release Suspension.
  • are a child under 6 years old. TUSSIONEX Pennkinetic Extended-Release Suspension can cause a decreased rate of breathing (respiratory depression) which can lead to death.

What should I tell my doctor before taking TUSSIONEX Pennkinetic Extended-Release Suspension?

Before you take TUSSIONEX Pennkinetic Extended-Release Suspension, tell your doctor if you:

  • have lung or breathing problems
  • have had a head injury
  • have pain in your belly (abdomen)
  • have eye problems, such as glaucoma
  • have prostate problems
  • have problems with your urinary tract (urethral stricture)
  • plan to have surgery
  • abuse alcohol
  • have kidney or liver problems
  • have thyroid problems, such as hypothyroidism
  • are pregnant or plan to become pregnant. If you take TUSSIONEX regularly before your baby is born, your newborn baby may have withdrawal symptoms because their body has become use to the medicine. Symptoms of withdrawal in a newborn baby may include:
    • irritability
    • crying more than usual
    • shaking (tremors)
    • jitteriness
    • breathing faster than normal
    • diarrhea or more stools than normal
    • sneezing
    • yawning
    • vomiting
    • fever

If you take TUSSIONEX regularly before your baby is born, your baby could have breathing problems.

  • are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take TUSSIONEX Pennkinetic Extended-Release Suspension or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using TUSSIONEX Pennkinetic Extended-Release Suspension with certain other medicines may affect each other. Using TUSSIONEX Pennkinetic Extended-Release Suspension with other medicines can cause serious side effects.

Especially tell your doctor if you:

  • take pain medicines such as narcotics
  • take cold or allergy medicines that contain antihistamines or cough suppressants
  • take medicines for mental illness (anti-psychotics, anti-anxiety)
  • drink alcohol
  • take medicines for depression including monoamine oxidase inhibitors (MAOIs)
  • take medicines for stomach or intestine problems

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take TUSSIONEX Pennkinetic Extended-Release Suspension?

  • Take TUSSIONEX Pennkinetic Extended-Release Suspension exactly as your doctor tells you.
  • Shake the TUSSIONEX Pennkinetic Extended-Release Suspension bottle well before you use it.
  • Do not mix TUSSIONEX Pennkinetic Extended-Release Suspension with other fluids or medicines. Mixing may change how TUSSIONEX Pennkinetic Extended-Release Suspension works.
  • TUSSIONEX Pennkinetic Extended-Release Suspension can be taken with or without food.
  • Only measure TUSSIONEX Pennkinetic Extended-Release Suspension with the dosing spoon that comes with your prescription. See Figure A. If you do not have a dosing spoon for your medicine, ask your pharmacist to give you a measuring device to help you measure the correct amount of TUSSIONEX Pennkinetic Extended-Release Suspension. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
    • One side of the dosing spoon is marked for a 2.5 mL dose. The other side of the spoon is marked for a 5 mL dose. Find the side of the spoon that has the dose you are taking.
    • Fill that side of the spoon so the medicine is level with the rim of the spoon. Do not overfill the spoon.
    • Rinse the spoon with water after each use.

Figure A

Dosing spoon - Illustration

  • If you take too much TUSSIONEX Pennkinetic Extended-Release Suspension, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking TUSSIONEX Pennkinetic Extended-Release Suspension?

  • TUSSIONEX Pennkinetic Extended-Release Suspension can cause you to be drowsy. Do not drive a car or use machinery while you take TUSSIONEX Pennkinetic Extended-Release Suspension until you know how it affects you.
  • Do not drink alcohol while taking TUSSIONEX Pennkinetic Extended-Release Suspension. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of TUSSIONEX Pennkinetic Extended-Release Suspension?

TUSSIONEX Pennkinetic Extended-Release Suspension may cause serious side effects, including:

  • Decreased breathing (respiratory depression) which can lead to death. Call your doctor or get emergency treatment right away if you have:
    • shallow or slow breathing
    • confusion
    • excessive sleepiness
  • drowsiness leading to inability to think clearly or do normal physical activities
  • bowel problems, including constipation and bowel obstruction

The most common side effects of TUSSIONEX Pennkinetic Extended-Release Suspension are:

  • nausea and vomiting
  • constipation
  • nervous system problems (anxiety, fear, dizziness, mood changes)
  • urinary tract problems
  • dry throat
  • chest tightness

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TUSSIONEX Pennkinetic Extended-Release Suspension. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TUSSIONEX Pennkinetic Extended-Release Suspension?

  • Store TUSSIONEX Pennkinetic Extended-Release Suspension in a safe place at 68°F to 77°F (20°C to 25°C).
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep TUSSIONEX Pennkinetic Extended-Release Suspension and all medicines out of the reach of children.

General information about TUSSIONEX Pennkinetic Extended-Release Suspension

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use TUSSIONEX Pennkinetic Extended-Release Suspension for a condition for which it was not prescribed. Do not give TUSSIONEX Pennkinetic Extended-Release Suspension to other people, even if they have the same condition. It may harm them and it is against the law.

This Patient Information Leaflet summarizes the most important information about TUSSIONEX Pennkinetic Extended-Release Suspension. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about TUSSIONEX Pennkinetic Extended-Release Suspension that is written for healthcare professionals.

For more information about TUSSIONEX Pennkinetic Extended-Release Suspension call 1-866-822-0068 or go to www.tussionex.com.

What are the ingredients in TUSSIONEX Pennkinetic Extended-Release Suspension?

Active Ingredient: hydrocodone polistirex and chlorpheniramine polistirex

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.

Last reviewed on RxList: 4/21/2015
This monograph has been modified to include the generic and brand name in many instances.

Tussionex - User Reviews

Tussionex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tussionex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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