Hydrocodone and chlorpheniramine polistirex (Oral route)
klor-fen-IR-a-meen pol-ee-STYE-rex, hye-droe-KOE-done pol-ee-STYE-rex
- Tussionex Pennkinetic
- Suspension, Extended Release
- Capsule, Extended Release
Warnings:Oral route(Suspension, Extended Release)
Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; medication errors; cytochrome P450 3A4 interaction; concomitant use with benzodiazepines or other CNS depressants; interaction with alcohol; neonatal opioid withdrawal syndromeAddiction, Abuse, and MisuseHydrocodone polistirex/chlorpheniramine polistirex exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone polistirex/chlorpheniramine polistirex for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing hydrocodone polistirex/chlorpheniramine polistirex, prescribe hydrocodone polistirex/chlorpheniramine polistirex for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatmentLife-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone polistirex/chlorpheniramine polistirex. Monitor for respiratory depression, especially during initiation of hydrocodone polistirex/chlorpheniramine polistirex or when used in patients at higher risk.Accidental IngestionAccidental ingestion of even one dose of hydrocodone polistirex/chlorpheniramine polistirex, especially by children, can result in a fatal overdose of hydrocodone polistirex.Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering hydrocodone polistirex/chlorpheniramine polistirex. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone polistirex/chlorpheniramine polistirex.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone polistirex/chlorpheniramine polistirex with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of hydrocodone polistirex/chlorpheniramine polistirex in patients taking a CYP3A4 inhibitor or inducer.Risk from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of hydrocodone polistirex/chlorpheniramine polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol.Interaction with AlcoholInstruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone polistirex/chlorpheniramine polistirex. The co-ingestion of alcohol with hydrocodone polistirex/chlorpheniramine polistirex may result in increased plasma levels and a potentially fatal overdose of hydrocodone.Neonatal Opioid Withdrawal SyndromeHydrocodone polistirex/chlorpheniramine polistirex is not recommended for use in pregnant women. Prolonged use of hydrocodone polistirex/chlorpheniramine polistirex during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If hydrocodone polistirex/chlorpheniramine polistirex is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .
Antitussive, Opioid/Antihistamine Combination
Uses of This Medicine:
Hydrocodone and chlorpheniramine polistirex combination is used to treat cough and respiratory symptoms associated with a cold or allergy.
Hydrocodone polistirex is a narcotic cough suppressant. It acts directly on the cough center in the brain to prevent a cough. Chlorpheniramine polistirex is an antihistamine that treats or prevents the symptoms of an allergy.
When hydrocodone polistirex is used for a long time, it may become habit-forming. This could cause mental or physical dependence. Physical dependence may lead to unwanted withdrawal effects if hydrocodone is stopped suddenly. Talk to your doctor if you have questions.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Because of the toxicity of hydrocodone polistirex, use in children younger than 6 years of age is not permitted. Hydrocodone has caused serious breathing problems in young children, sometimes causing death. Hydrocodone and chlorpheniramine polistirex combination is not indicated for use in children younger than 18 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and chlorpheniramine polistirex combination in the elderly. However, elderly patients are more likely to develop age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Eslicarbazepine Acetate
- Gabapentin Enacarbil
- Glycopyrronium Tosylate
- Methylene Blue
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Secretin Human
- Sodium Oxybate
- St John's Wort
- Tolonium Chloride
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Acute pancreatitis (swelling of the pancreas) or
- Addison's disease (adrenal gland problem) or
- Alcohol abuse, or history of or
- Brain tumor, history of or
- Drug abuse or dependence, especially with narcotics, or history of or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Gallbladder disease or
- Head injury, history of or
- Hypothyroidism (underactive thyroid), severe or
- Increased pressure in the head or
- Lung or breathing problems (eg, COPD) or
- Problems passing urine or
- Stomach or bowel problems—May cause side effects to become worse.
- Asthma, acute or severe or
- Paralytic ileus (stomach or bowel blockage), known or suspected or
- Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.
- Hypotension (low blood pressure)—Use with caution. May make this condition worse.
- Kidney disease, severe or
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take the extended-release suspension with or without food.
Shake the extended-release suspension well before each use. Measure the dose with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Rinse the dosing spoon or measuring device with water after each use.
Swallow the extended-release capsule whole. Do not crush, break, or chew it.
Do not mix this medicine with liquids or other medicines.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For relief of cough and cold or allergy symptoms:
- For oral dosage form (extended-release capsules):
- Adults and children 12 years of age and older—One capsule every 12 hours. Each full-strength capsule contains hydrocodone 10 milligrams (mg) and chlorpheniramine 8 mg. Do not take more than 2 capsules in 24 hours.
- Children 6 to 11 years of age—One capsule every 12 hours. Each half-strength capsule contains hydrocodone 5 mg and chlorpheniramine 4 mg. Do not take more than 2 capsules in 24 hours.
- Children younger than 6 years of age—Use is not recommended.
- For oral dosage form (extended-release suspension):
- Adults—5 milliliters (mL) every 12 hours. Do not take more than 10 mL in 24 hours.
- Children—Use is not recommended.
- For oral dosage form (extended-release capsules):
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions While Using This Medicine:
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If your cough does not improve or if it gets worse within 5 days, call your doctor.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused capsules or oral liquid in a safe and secure place.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
Using this medicine can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
This medicine may make you drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: pale or blue lips, fingernails, or skin, confusion, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, extreme sleepiness or drowsiness, cold and clammy skin, or lightheadedness or fainting.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.
Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
If you are especially sensitive to the effects of this medicine, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Make sure any doctor or dentist who treats you knows that you are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Lightheadedness, dizziness, or fainting
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- Incidence not known
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- change in the ability to see colors, especially blue or yellow
- constricted, pinpoint, or small pupils (black part of the eye)
- cough producing mucus
- dark urine
- decrease in frequency of urination
- decrease in urine volume
- difficult, painful, or troubled breathing
- difficulty in passing urine (dribbling)
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- feeling sad or empty
- general feeling of tiredness or weakness
- hives, itching, skin rash
- irregular, fast or slow, or shallow breathing
- lack of appetite
- loss of consciousness
- loss of interest or pleasure
- lower back or side pain
- muscle aches
- overactive reflexes
- pain or cramping in the stomach
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale or blue lips, fingernails, or skin
- poor coordination
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- seeing double
- seeing, hearing, or feeling things that are not there
- shakiness and unsteady walk
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stuffy or runny nose
- talking or acting with excitement you cannot control
- tightness in the chest
- tingling of the hands or feet
- trembling or shaking
- trouble concentrating
- trouble sleeping
- uncontrolled movements of the face
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual weight gain or loss
- yellow eyes or skin
- More common
- dry mouth
- Incidence not known
- Back pain
- decreased appetite
- difficulty in moving
- false or unusual sense of well-being
- fear or nervousness
- feeling of warmth
- increased sweating
- joint pain
- muscle pain or stiffness
- redness of the face, neck, arms and occasionally, upper chest
- trouble getting pregnant
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 5/1/2020