HYDROCODONE/CHLORPHENIRAMINE POLISTIREX ER SUSPENSION - ORAL

HYDROCODONE/CHLORPHENIRAMINE POLISTIREX ER SUSPENSION - ORAL

PHONETIC PRONUNCIATION: (HYE-droe-KOE-done/KLOR-fen-IR-a-meen POL-ee-STYE-rex)

COMMON BRAND NAME(S): Tussionex

GENERIC NAME(S): hydrocodone polistirex/chlorpheniramine polistirex

Uses

USES: This combination product is used to treat coughs and other symptoms caused by the common cold or allergies. This product contains 2 medications: hydrocodone and chlorpheniramine. Hydrocodone is an opioid cough suppressant (antitussive) that acts on a certain part of the brain (cough center) to reduce the urge to cough. Chlorpheniramine is an antihistamine that helps to relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Do not use this product in children younger than 18 years. There is a risk of serious (rarely fatal) side effects, such as breathing problems. Cough-and-cold products do not cure colds. Cough due to a common cold often does not need to be treated with medicine. Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms, such as drinking enough fluids, using a humidifier, or saline nose drops/spray.


How to use HYDROCODONE/CHLORPHENIRAMINE POLISTIREX ER SUSPENSION - ORAL

HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking hydrocodone/chlorpheniramine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually every 12 hours. Do not increase your dose or take this medication more often than every 12 hours or for longer than prescribed. Doing so may increase the risk of serious (possibly fatal) breathing problems. Shake this medication well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Do not mix this medication with other liquids or medications. Doing so can release all of the drug at once, increasing the risk of side effects. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. Though it helps many people, this medication has a risk for abuse and may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. Tell your doctor if your condition persists or worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, nausea/vomiting, constipation, blurred vision, dry mouth/nose/throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor. To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener). To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, agitation, confusion, hallucinations), stomach/abdominal pain, difficulty urinating, fast/slow/irregular heartbeat. Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, severe drowsiness/difficulty waking up, seizures. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to hydrocodone or chlorpheniramine; or to dexchlorpheniramine; or to hydromorphone; or if you have any other allergies. This product may contain inactive ingredients (including sulfites such as sodium metabisulfite), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, croup, sleep apnea, chronic obstructive pulmonary disease-COPD), brain disorders (such as seizures, head injury, tumor), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), glaucoma (narrow-angle), difficulty urinating (such as due to enlarged prostate or urethral stricture), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), kidney disease, liver disease, gallbladder disease, underactive thyroid (hypothyroidism), adrenal gland problem (such as Addison's disease), disease of the pancreas (pancreatitis), mental/mood disorders (such as confusion, depression, thoughts of suicide, toxic psychosis), heart problems (such as irregular heartbeat). This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may contain sugar. If you have diabetes, ask your doctor or pharmacist how to use this product safely. Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Using it during the last 3 months of pregnancy is not recommended because of possible harm to the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: anticholinergic drugs (such as benztropine, belladonna alkaloids, scopolamine), antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), naltrexone, certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), tricyclic antidepressants (such as amitriptyline, desipramine). The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydromorphone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or other cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Other medications can affect the removal of hydrocodone/chlorpheniramine from your body, which may affect how hydrocodone/chlorpheniramine works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others. Chlorpheniramine is very similar to dexchlorpheniramine. Do not use medications containing dexchlorpheniramine while using chlorpheniramine. This product may interfere with certain laboratory tests (including allergy skin testing, amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, severe drowsiness/dizziness, mental/mood changes (such as confusion, agitation), cold/clammy skin, fast/slow/irregular heartbeat, seizures, coma.

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Faq for HYDROCODONE/CHLORPHENIRAMINE POLISTIREX ER SUSPENSION - ORAL

Hydrocodone/Chlorpheniramine Polistirex ER Suspension is an oral medication that contains hydrocodone, an opioid pain reliever, and chlorpheniramine polistirex, an antihistamine. It is used to relieve cough and symptoms associated with allergies, such as sneezing, itching, and runny nose.

Hydrocodone/Chlorpheniramine Polistirex ER Suspension works by suppressing the cough reflex and reducing allergic reactions. Hydrocodone acts on the brain to decrease the intensity of coughing, while chlorpheniramine blocks the effects of histamine, reducing allergy symptoms.

Common side effects may include drowsiness, dizziness, constipation, dry mouth, blurred vision, and nausea. It is important to follow the prescribed dosage and consult with your doctor if these side effects persist or worsen.

Yes, hydrocodone is an opioid and can be habit-forming if misused or taken in high doses or for prolonged periods. It is important to take this medication only as directed by your doctor and to follow the recommended dosage to avoid addiction.

Patients with a history of allergies to hydrocodone, chlorpheniramine, or any other opioids should not take this medication. It is also not recommended for individuals with respiratory conditions such as asthma, bronchitis, or chronic obstructive pulmonary disease (COPD).

It is important to inform your doctor about all medications you are currently taking, including prescription, over-the-counter, and herbal products. Certain medications, such as sedatives, tranquilizers, and alcohol, may interact with Hydrocodone/Chlorpheniramine Polistirex ER Suspension, potentially causing severe side effects or increased drowsiness.

This medication should be stored at room temperature, away from light and moisture. It should be kept out of reach of children and pets.


Warning

WARNING: Taking hydrocodone/chlorpheniramine with other medications that may also cause drowsiness or breathing problems may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of hydrocodone/chlorpheniramine that works, and take it for the shortest possible time. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.