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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 moderate to moderately 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 once 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, since doing so can result in serious harm or death. You may notice what appears to be a tablet shell in your stool. This is normal and occurs because the tablet shell may not completely dissolve after all the medication has been released in the body.

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 dose, take it as soon as possible 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. If you miss several doses in a row, contact your doctor before restarting this medication.

Store this medication at room temperature; protect it from light, moisture, and high humidity; and keep it out of the reach of children. Accidental ingestion of this medication by a child can result in severe harm or even death.

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 75 mg of tramadol. 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 100 mg of tramadol. 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 150 mg of tramadol. 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 200 mg of tramadol. 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 300 mg of tramadol. 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 400 mg of tramadol. 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 intoxicated with alcohol or experiencing alcohol withdrawal (delirium tremens)
  • 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 breathing problems resulting in increased carbon dioxide in the blood
  • have an abdominal condition that may require unplanned surgery (e.g., appendicitis, pancreatitis)
  • have severe kidney function impairment
  • have severe liver function impairment
  • have a seizure disorder
  • 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
  • are less than 18 years of age and have recently had your tonsils or adenoids removed for  obstructive sleep apnea syndrome

Do not give this medication to children less than 12 years of age.

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
  • decreased sexual ability or interest
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • infertility
  • itchy skin
  • loss of appetite
  • nausea
  • sweating
  • trouble sleeping
  • vomiting
  • weakness

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:

  • fainting
  • fast, slow, or irregular heartbeat
  • symptoms of bowel blockage (e.g., abdominal pain, severe constipation, nausea)
  • symptoms of low blood pressure (e.g., dizziness, fainting, lightheadedness)
  • symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
  • withdrawal symptoms (e.g., nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating)

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, hallucinations, confusion, 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)
  • slow, shallow, or weak breathing

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.

Accidental use: Accidental ingestion of tramadol by someone who it has not been prescribed for can lead to a fatal overdose. Children are especially at risk. Keep this medication out of sight and reach of children. If a child accidentally ingests this medication, get immediate medical help.

Alcohol and other medications that cause drowsiness: Do not combine this medication with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness or decreased breathing. Additional drowsiness, sedation, coma, and possibly death can occur with these combinations.

Abdominal conditions: Tramadol slows down bowel movement. This may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have bowel problems, 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.

Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body's organs, including how your body responds to injury or stress. On rare occasions, tramadol may cause your adrenal gland to function improperly. Your doctor may monitor your adrenal gland condition especially if you have experienced stress such as surgery, injury, or severe infection.

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.

Blood pressure: This medication may lower blood pressure. If you are taking other medications that lower your blood pressure, 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.

Breathing: This medication can suppress breathing. People at risk for breathing suppression (e.g., people with a head injury) should be closely monitored by their doctor while taking this medication. If you experience slowed, shallow, or difficult breathing, seek immediate medical attention. If you are taking other medications that can slow breathing (e.g., anxiety medications, sleeping pills) you are more at risk of experiencing these symptoms. If you have a severe chronic lung condition (e.g., asthma, bronchitis, emphysema), you should not take 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.

Heart rhythm: Higher doses of tramadol can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), 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.

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. 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.

Sleep apnea: Sleep apnea is a condition where you stop breathing for short periods while asleep. This can be caused or made worse by medications such as tramadol. Discuss with your doctor if you have sleep apnea or anyone notices that you stop breathing periodically while sleeping.

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 life-threatening 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 cause life-threatening breathing problems for 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
  • acetylsalicylic acid (ASA)
  • aclidinium
  • alcohol
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antiemetics (e.g., granisetron, ondansetron)
  • anti-Parkinson medications (e.g., amantadine, apomorphine, bromocriptine, levodopa, pramipexole, ropinirole)
  • antipsychotics (e.g., chlorpromazine, haloperidol, quetiapine, olanzapine, risperidone)
  • apalutamide
  • atropine
  • azelastine
  • "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
  • barbiturates (e.g., phenobarbital)
  • belladonna
  • benzodiazepines (e.g., clonazepam, diazepam, lorazepam)
  • benztropine
  • bosentan
  • brimonidine
  • buprenorphine
  • bupropion
  • buspirone
  • butorphanol
  • cabergoline
  • cannabis
  • chloral hydrate
  • chloroquine
  • cinacalcet
  • clonidine
  • cobicistat
  • cyclobenzaprine
  • darifenacin
  • deferasirox
  • desmopressin
  • dexmethylphenidate
  • dextromethorphan
  • diabetes medications (e.g., chlorpropamide, glyburide, linagliptin, liraglutide, lixisenatide, insulin, metformin, rosiglitazone)
  • disopyramide
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • domperidone
  • eluxadoline
  • entacapone
  • enzalutamide
  • ergot derivatives (e.g., dihydroergotamine, ergoloid mesylates, ergonovine, ergotamine, methylergonovine)
  • esketamine
  • flavoxate
  • flibanserin
  • HIV non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, etravirine, nevirapine, rilpivirine)
  • HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, ritonavir saquinavir)
  • ipratropium
  • lanreotide
  • lemborexant
  • linezolid
  • lithium
  • lumacaftor and ivacaftor
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • methadone
  • methylene blue
  • methylphenidate
  • metoclopramide
  • mifepristone
  • mirabegron
  • mirtazapine
  • mitotane
  • modafinil
  • monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine, moclobemide, selegiline, rasagiline)
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • nabilone
  • naltrexone
  • octreotide
  • opioids (e.g., morphine, codeine, oxycodone)
  • oxybutynin
  • ozanimod
  • pasireotide
  • pegvisomant
  • pentazocine
  • protein kinase inhibitors (e.g., ceritinib, dabrafenib, idelalasib, sunitinib)
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • rifabutin
  • rifampin
  • rotigotine
  • scopolamine
  • seizure medications (e.g., carbamazepine, gabapentin, levetiracetam, phenytoin, topiramate)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
  • St. John's wort
  • sarilumab
  • siltuximab
  • sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
  • tapentadol
  • tetrahydrocannabinol
  • terbinafine
  • testosterone
  • tiotropium
  • tocilizumab
  • tolterodine
  • trazodone
  • tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)
  • "triptan" migraine medications (e.g., sumatriptan, eletriptan, naratriptan)
  • tryptophan
  • umeclidinium
  • warfarin
  • zolpidem
  • zopiclone

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 – 2024. 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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