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Zytram XL

(tramadol controlled release)

How does this medication work? What will it do for me?

Tramadol belongs to a group of medications called opioid analgesics. It is used to manage severe pain for people who need several days or more of pain control. It decreases pain by working on the central nervous system.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual starting dose of tramadol controlled release is 150 mg daily. The dose can be increased every 7 days to a maximum dose of 400 mg daily.

The medication may be taken with or without food, but it should be taken consistently (i.e., either always with food or always without food) and with a glass of water. The tablets should be swallowed whole and should not be broken, chewed, or crushed.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations.

It is important to take this medication exactly as prescribed by your doctor. If you miss one or more doses, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature; protect it from light, moisture, and high humidity; and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

75 mg
Each pale grey, film-coated, round, controlled release tablet, marked "T" on one side and 75 on the other contains tramadol 75 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, magnesium stearate, and talc; film coating: hypromellose, lactose, polyethylene glycol, titanium dioxide, iron oxide and FD&C Blue No. 2.

100 mg
Each white, film-coated, round, controlled release tablet, marked "T" on one side and "100" on the other contains tramadol 100 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, magnesium stearate, and talc; film coating: hypromellose, lactose, polyethylene glycol, and titanium dioxide.

150 mg
Each white, film-coated, oval, controlled release tablet, marked "T150" on one side, contains tramadol 150 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, magnesium stearate, and talc; film coating: hypromellose, lactose, polyethylene glycol, and titanium dioxide.

200 mg
Each white, film-coated, oval, controlled release tablet, marked "T200" on one side, contains tramadol 200 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, magnesium stearate, and talc; film coating: hypromellose, lactose, polyethylene glycol, and titanium dioxide.

300 mg
Each white, film-coated, oval, controlled release tablet, marked "T300" on one side, contains tramadol 300 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, magnesium stearate, and talc; film coating: hypromellose, lactose, polyethylene glycol, and titanium dioxide.

400 mg
Each white, film-coated, oval, controlled release tablet, marked "T400" on one side, contains tramadol 400 mg. Nonmedicinal ingredients: hydrogenated vegetable oil, magnesium stearate, and talc; film coating: hypromellose, lactose, polyethylene glycol, and titanium dioxide.

Who should NOT take this medication?

Do not take tramadol controlled release if you:

  • are allergic to tramadol or any ingredients of the medication
  • are allergic to other opioid medications (e.g., codeine, morphine)
  • are intoxicated with alcohol or other medications (such as hypnotics, other opioids like codeine or morphine, or psychotropic medications for mental health conditions) that can depress breathing and consciousness
  • are pregnant or breast feeding
  • have any blockage in the digestive system or conditions that slow down the effectiveness of the digestive system
  • have breathing problems (e.g., asthma, COPD)
  • have any condition that may cause decreased consciousness (e.g., head injury, increased pressure in the brain or spine)
  • have severe kidney function impairment
  • have severe liver function impairment
  • have mild or occasional pain that can be treated with other pain medications
  • have taken monoamine oxidase (MAO) inhibitor medications (e.g., phenelzine, tranylcypromine) within 14 days
  • need medication to treat pain resulting from surgery

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • blurred vision
  • constipation
  • cough
  • diarrhea
  • dizziness
  • drowsiness
  • dry mouth
  • fatigue
  • flushing
  • gas
  • headache
  • heartburn
  • itchy skin
  • loss of appetite
  • nausea
  • stomach pain
  • sweating
  • tremor
  • trouble sleeping
  • vomiting
  • weakness
  • weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abnormal, fast, or pounding heartbeat
  • breathing difficulty
  • confusion
  • difficulty urinating
  • joint pain

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a severe allergic reaction (e.g., hives; difficulty breathing; or swelling of the lips, mouth, throat, or tongue)
  • signs of too much medication (e.g., decreased breathing rate, severe dizziness, unconsciousness, vomiting, seizures)
  • signs of serotonin syndrome (e.g., agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, twitching)
  • symptoms of a severe skin reaction (e.g., high fever; rash; sores; painful blisters on the skin, mouth, or eyes; or skin peeling off)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergy: Some people who are allergic to codeine or other opioids also experience allergic reactions tramadol. Before you take tramadol, inform your doctor about any previous adverse reactions you have had to medications, especially opioid pain relievers. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing or swelling of the face and throat.

Breathing: This medication can suppress breathing. People at risk for breathing suppression (e.g., people with head trauma) should be closely monitored by their doctor while taking this medication.

Dependence and withdrawal: This medication can cause physical dependence, psychological dependence, and addiction. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Drowsiness/reduced alertness: This medication may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Kidney function: The kidneys are partially responsible for removing tramadol from the body. People with severely decreased kidney function may experience increased side effects and should not take tramadol controlled release. If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: The liver is partially responsible for removing tramadol from the body. People with severely decreased liver function may experience increased side effects and should not use tramadol. If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: This medication may cause seizures, especially when higher doses are used or when taken with other medications such as:

  • selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
  • tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)
  • cyclobenzaprine
  • neuroleptics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
  • opioids (e.g., morphine, codeine, oxycodone)
  • promethazine

The risk of seizures is also higher for people with epilepsy, a history of seizures, or who are at risk of seizures (e.g., people with head trauma). If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin syndrome: Severe reactions are possible when tramadol is combined with medications used to treat depression. The combination of tramadol and MAO inhibitors must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are also possible. If you are taking medications for depression or migraine headache, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Surgery: Tramadol may interact with other medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Tramadol can cross the placenta and may cause a baby to experience withdrawal effects when it is born, if the mother has been taking tramadol regularly during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking tramadol controlled release, it may affect your baby. This medication is not recommended for breast-feeding mothers.

Children: The safety and effectiveness of using this medication have not been established for children. Tramadol should not be taken by people under 18 years of age.

Seniors: Seniors may be more likely to experience side effects from this medication, especially seniors over 75 years of age.

What other drugs could interact with this medication?

There may be an interaction between tramadol controlled release and any of the following:

  • abiraterone
  • alcohol
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine, phentermine)
  • antiemetics (e.g., granisetron, ondansetron)
  • antipsychotics (e.g., chlorpromazine, haloperidol, quetiapine, olanzapine, risperidone)
  • aprepitant
  • azelastine
  • "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
  • barbiturates (e.g., phenobarbital)
  • benzodiazepines (e.g., clonazepam, diazepam, lorazepam) bosentan
  • buprenorphine
  • bupropion
  • calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
  • carbamazepine
  • celecoxib
  • chloroquine
  • clonidine
  • cobicistat
  • cocaine
  • cyclobenzaprine
  • cyclosporine
  • dabrafenib
  • dasatinib
  • deferasirox
  • desmopressin
  • dexamethasone
  • dextromethorphan
  • diphenhydramine
  • doxylamineenzalutamide
  • ergot derivatives (e.g., dihydroergotamine, ergoloid mesylates, ergonovine, ergotamine, methylergonovine)
  • grapefruit juice
  • HIV non-nucleoside reverse transcriptase inhibitors (e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • hydrochlorothiazide
  • hydroxyzine
  • imatinib
  • isoniazid
  • lidocaine
  • lithium
  • macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin)
  • metoclopramide
  • metronidazole
  • mifepristone
  • monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine, moclobemide)
  • nefazodone
  • norfloxacin
  • opioids (e.g., morphine, codeine, oxycodone)
  • phenobarbital
  • phenytoin
  • pramipexole
  • primidone
  • promethazine
  • HIV protease inhibitors (e.g., daraunavir, indinavir, lopinavir, ritonavir, saquinavir)
  • quinidine
  • quinine
  • rasagiline
  • rifabutin
  • rifampin
  • ropinirole
  • selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
  • selegiline
  • sibutramine
  • St. John's wort
  • terbinafine
  • tetrabenazine
  • tetracycline
  • ticlopidine
  • tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)
  • "triptan" migraine medications (e.g., sumatriptan, naratriptan)
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Zytram-XL

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