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Tussionex Pennkinetic ER Oral
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Tussionex Pennkinetic ER Oral Overview

Hydrocodone is a semi-synthetic opioid derived from codeine. Hydrocodone is used orally as a narcotic analgesic and antitussive (cough medicine), often in combination with paracetamol (acetaminophen) or ibuprofen. Hydrocodone is prescribed predominantly within the United States; elsewhere it is rare. The International Narcotics Control Board reported 99% of the worldwide supply in 2007 was consumed in the United States. The DEA number for hydrocodone is 9193 and the aggregate production quota for 2014 is 99,625 kilograms in the U.S.A

Adverse effects

Common side effects of hydrocodone are nausea, vomiting, constipation, drowsiness, dizziness, lightheadedness, fuzzy thinking, anxiety, abnormally happy or sad mood, dry throat, difficulty urinating, rash, itching, and narrowing of the pupils. Serious side effects include slowed or irregular breathing and chest tightness.

Several cases of progressive bilateral hearing loss unresponsive to steroid therapy have been described as an infrequent adverse reaction to hydrocodone/paracetamol misuse. This adverse effect has been considered due to the ototoxicity of hydrocodone.Recently, researchers suggested that paracetamol is the primary agent responsible for the ototoxicity.

Contraindications and interactions

Patients consuming alcohol, other opioids, antihistamines, antipsychotics, antianxiety agents, or other central nervous system (CNS) depressants together with hydrocodone may exhibit an additive CNS depression. Hydrocodone may interact with serotonergic medications.

Pharmacology

As a narcotic, hydrocodone relieves pain by binding to opioid receptors in the CNS. It acts primarily on μ-opioid receptors, with about six times lesser affinity to δ-opioid receptors. In blood, 20–50% of hydrocodone is bound to protein.

Studies have shown hydrocodone is stronger than codeine but only one-tenth as potent as morphine at binding to receptors and reported to be only 59% as potent as morphine in analgesic properties. However, in tests conducted on rhesus monkeys, the analgesic potency of hydrocodone was actually higher than morphine.

Pharmacokinetics

In the liver, Hydrocodone is transformed into several metabolites. It has a serum half-life that averages 3.8 hours. The hepatic cytochrome P450 enzyme CYP2D6 converts it into hydromorphone, a more potent opioid. However, extensive and poor cytochrome 450 CYP2D6 metabolizers had similar physiological and subjective responses to hydrocodone, and CYP2D6 inhibitor quinidine did not change the responses of extensive metabolizers, suggesting that inhibition of CYP2D6 metabolism of hydrocodone has no practical importance. Ultrarapid CYP2D6 metabolizers (1-2% of the population) may have an increased response to hydrocodone; however, hydrocodone metabolism in this population has not been studied.

History

Hydrocodone was first synthesized in Germany in 1920 by Carl Mannich and Helene Löwenheim. It was approved by the Food and Drug Administration on 23 March 1943 for sale in the United States and approved by Health Canada for sale in Canada under the brand name Hycodan.

Hydrocodone was first marketed by Knoll as Dicodid, starting in February 1924 in Germany. This name is analogous to other products the company introduced or otherwise marketed: Dilaudid (hydromorphone, 1926), Dinarkon (oxycodone, 1917), Dihydrin (dihydrocodeine, 1911), and a dihydromorphine product Dimorphan. Paramorfan is the trade name of dihydromorphine from another manufacturer, as is Paracodin, for dihydrocodeine.

TUSSIONEX PENNKINETIC ER ORAL WARNING

One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin.

Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.

TUSSIONEX PENNKINETIC ER ORAL 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 a narcotic 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.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.
How to use Tussionex Pennkinetic ER

Take this medication by mouth with or without food, usually every 12 hours or as directed by your doctor. Do not take this medication more often than every 12 hours. 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, sweating, uncontrolled movements, nausea, vomiting, diarrhea) 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 immediately.

When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition persists or worsens.

TUSSIONEX PENNKINETIC ER ORAL SIDE EFFECTS

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. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (such as stimulant-type with stool softener).

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), trouble urinating, fast/slow/irregular heartbeat.

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

TUSSIONEX PENNKINETIC ER ORAL 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), certain brain disorders

(such as seizures, head injury, tumor, increased intracranial pressure), stomach/intestinal problems ( such as blockage, ileus, chronic constipation, Clostridium

difficile-associated diarrhea), glaucoma (narrow-angle), difficulty urinating (such as due to enlarged prostate or urethral stricture), personal or family history of

regular use/abuse of drugs/alcohol, kidney disease, liver disease, gallbladder disease, underactive thyroid (hypothyroidism), adrenal gland problem (such as Addison's

disease), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), heart problems (such as irregular heartbeat), a certain

spinal problem (kyphoscoliosis).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are

sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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.

Children may be more sensitive to the side effects of hydrocodone, especially breathing problems. Children may also be more sensitive to the effects of

chlorpheniramine. In young children, antihistamines may cause agitation/excitement instead of drowsiness.

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.

It is unknown if this drug passes into breast milk or may have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual

sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

TUSSIONEX PENNKINETIC ER ORAL INTERACTIONS

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), cimetidine, naltrexone, 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 affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, certain antihistamines (such as diphenhydramine), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine, hydromorphone).

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.

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.

TUSSIONEX PENNKINETIC ER ORAL OVERDOSE

If overdose is suspected, contact a poison control center or emergency room immediately.  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.

Notes

Do not share this medication with others. It is against the law.

Missed Dose

If you are prescribed this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised April 2014. Copyright(c) 2014 First Databank, Inc.

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