Durela

The usual starting dose of tramadol extended release is 100 mg once every 24 hours. Your doctor may gradually increase the dose by 100 mg every 5 days, up to a maximum of 300 mg every 24 hours.

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 capsules and tablets must be swallowed whole and must not be broken, chewed, dissolved or crushed. Doing so may cause too much medication to be absorbed into the body at one time and may be fatal.

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 that this medication be taken exactly as prescribed by your doctor. If you miss a dose, 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 do after missing a dose, contact your doctor or pharmacist for advice. If you miss several doses in a row, talk to your doctor before starting this medication.

Store this medication at room temperature 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.

100 mg
Each opaque, white capsule, imprinted in blue ink with "G 252" on the cap and "100" between lines on the body, contains 100 mg of tramadol as tramadol hydrochloride. *Nonmedicinal ingredients: *corn starch, D&C Red No. 7 Calcium Lake (E180), D&C Yellow No. 10 Aluminum Lake, Eudragit NE 30D, FD&C Blue No. 2 Aluminum Lake (E132), gelatin, hypromellose, lactose monohydrate 200 mesh, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone K30, propylene glycol, shellac, simethicone emulsion, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide.

200 mg
Each opaque, white capsule, imprinted in violet ink with "G 253" on the cap and "200" between lines on the body, contains 200 mg of tramadol as tramadol hydrochloride. *Nonmedicinal ingredients: *corn starch, D&C Red No. 7 Calcium Lake (E180), D&C Yellow No. 10 Aluminum Lake, Eudragit NE 30D, FD&C Blue No. 2 Aluminum Lake (E132), gelatin, hypromellose, lactose monohydrate 200 mesh, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone K30, propylene glycol, shellac, simethicone emulsion, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide.

300 mg
Each opaque, white capsule, imprinted in red ink with "G 254" on the cap and "300" between lines on the body, contains 300 mg of tramadol as tramadol hydrochloride. *Nonmedicinal ingredients: *corn starch, D&C Red No. 7 Calcium Lake (E180), D&C Yellow No. 10 Aluminum Lake, Eudragit NE 30D, FD&C Blue No. 2 Aluminum Lake (E132), gelatin, hypromellose, lactose monohydrate 200 mesh, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone K30, propylene glycol, shellac, simethicone emulsion, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide.

Do not take tramadol 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 that can depress breathing and consciousness, such as hypnotics, other opioids (e.g., codeine or morphine), or psychotropic medications (certain medications for mental health conditions)

• are treating pain caused by surgery

• are experiencing acute alcoholism or delirium tremens

• are experiencing acute asthma or other obstructive airway disease

• are experiencing acute respiratory depression

• are experiencing sudden, severe abdominal pain that may require surgery (e.g., appendicitis, pancreatitis)

• are less than 18 years old and have had a tonsillectomy and/or surgery to treat sleep apnea syndrome

• have a blockage or narrowing of the gastrointestinal tract

• have a head injury, brain tumour, or increased pressure inside the head or spinal cord

• have any condition that reduces the movement of masses through the digestive tract, such as ileus

• have mild pain, pain that comes and goes, or pain which can be treated with other pain medications

• have severe kidney function impairment

• have severe liver function impairment

• have taken monoamine oxidase (MAO) inhibitor medications (e.g., phenelzine, tranylcypromine) within the last 14 days

• have a history of seizures

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

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 interest in sexual activity

• decreased sexual ability

• dizziness

• drowsiness

• dry mouth

• fainting

• headache

• itchy skin

• loss of appetite

• muscle weakness

• nausea

• sweating

• trouble sleeping

• vomiting

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

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

• decreased coordination

• fast, slow, or irregular heartbeat

• low blood pressure (e.g., dizziness, fainting, light-headedness)

• symptoms of adrenal gland disorders (e.g., nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure)

• symptoms of a bowel blockage (e.g., abdominal pain, severe constipation, nausea)

• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)

• withdrawal symptoms (e.g., nausea, vomiting, diarrhea, anxiety, sweating)

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

• hallucinations

• seizures

• signs of a severe allergic reaction (e.g., hives; difficulty breathing; or swelling of the lips, mouth, throat, or tongue)

• signs of serotonin toxicity (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

• symptoms of overdose (e.g., trouble breathing; extreme drowsiness with slowed breathing; slow, shallow breathing; feeling faint, dizzy, confused; difficulty thinking, talking, or walking; seizures; hearing, seeing, or feeling things that are not there [also known as hallucinations])

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.

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.

Abdominal conditions: Tramadol slows down bowel motility. 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.

**Accidental use: **When tramadol is used by anyone other than the person for whom it was prescribed, the effects of even one dose may be fatal. Keep this medication out of sight and reach of children. If a child accidentally ingests this medication, get immediate medical attention.

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.

**Alcohol and other medications that cause drowsiness: **Consuming alcohol or taking medications that cause drowsiness or suppress breathing (e.g., antidepressants, sleeping pills, anxiety medications) while taking this medication increases the risk of dangerous side effects of the medication, including breathing problems, seizures, drowsiness, and a potentially fatal overdose. It is recommended that you avoid drinking alcohol while you are using this medication for pain.

Asthma and other respiratory conditions: Tramadol extended release may cause increased breathing difficulty for people having an acute asthma attack or for those with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) or other conditions that affect breathing. If you have asthma or other breathing disorders, 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: Tramadol can cause serious and life-threatening breathing problems. If you experience slowed, shallow, or difficulty breathing, seek immediate medical attention. If you are taking other medications that can slow breathing (e.g., anxiety medications, sleeping pills, alcohol) are a senior, or have chronic bronchitis or emphysema, you are more at risk of experiencing these symptoms.

Dependence and withdrawal: This medication may become habit-forming if taken for long periods of time. 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. Drug abuse is not a problem for 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. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms when this medication is no longer required for pain control. Do not stop taking this medication without talking to your doctor or pharmacist.

**Diabetes: Tramadol may cause a decrease in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. **People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, 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.

Drowsiness/reduced alertness: This medication may cause drowsiness or affect the mental abilities needed to perform hazardous tasks. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Head injury: People with head injuries or increased pressure in the head may have a higher risk of experiencing side effects (breathing problems or seizures) or worsening of their condition while taking this medication. These people should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart rhythm: 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, people taking certain medications), 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. Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. 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. People with severely decreased kidney function should not use tramadol.

Liver function: The liver is partially responsible for removing tramadol from the body. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. 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. People with severely decreased liver function should not use tramadol.

Low blood pressure: Occasionally, blood pressure drops too low after taking tramadol. Get up slowly when rising from a sitting or lying down position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

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

• cyclobenzaprine

• monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine)

• neuroleptics (e.g., haloperidol, quetiapine, olanzapine, risperidone)

• opioids (e.g., morphine, codeine, oxycodone)

• promethazine

• selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)

• serotonin-norepinephrine reuptake inhibitors (SNRIs; e.g., duloxetine, venlafaxine)

• tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)

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 epilepsy or medical conditions that increase the risk 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 toxicity: Severe reactions are possible when tramadol is combined with other medications that affect serotonin, such as anti-depressants and "triptan" migraine medications. 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 antidepressants, 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 medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication.

**Uncontrolled pain: **If you experience pain that is not relieved by a normal dose of tramadol, speak to your doctor. Do not increase the amount of this medication you are taking without medical advice.

Pregnancy: The safety for both the mother and baby if this medication is used during pregnancy has not been determined. Withdrawal symptoms have been noted in newborns of mothers who used tramadol during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks. 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 extended release, it may affect your baby. You should avoid taking tramadol if you are breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. This medication should not be used in 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. Doses for seniors should generally be lower and increase more slowly than for other adults.

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

• abiraterone

• acetylsalicylic acid (ASA)

• aclidinium

• alcohol

• alpha agonists (e.g., clonidine, guanfacine)

• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)

• antihistamines (e.g., azelastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)

• anti-Parkinson's medications (e.g., amantadine, apomorphine, bromocriptine, levodopa, pramipexole, ropinirole)

• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, quetiapine, olanzapine, risperidone)

• apalutamide

• aprepitant

• atropine

• "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)

• barbiturates (e.g., butalbital, phenobarbital)

• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)

• benztropine

• bismuth subsalicylate

• bosentan

• brimonidine

• bromocriptine

• buprenorphine

• bupropion

• buspirone

• butorphanol

• cabergoline

• calcium channel blockers (e.g., diltiazem, verapamil)

• cannabis

• carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide)

• chloral hydrate

• cinacalcet

• cobicistat

• conivaptan

• cystic fibrosis transmembrane regulators (e.g., elexacaftor, ivacaftor, lumacaftor, tezacaftor)

• darifenacin

• desmopressin

• dextromethorphan

• diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, lixisenatide, metformin, rosiglitazone, sitagliptin)

• digoxin

• dimenhydrinate

• diphenoxylate

• disopyramide

• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)

• domperidone

• dronedarone

• entacapone

• enzalutamide

• eplerenone

• ergot derivatives (e.g., dihydroergotamine, ergoloid mesylates, ergonovine, ergotamine, methylergonovine)

• esketamine

• etravirine

• fesoterodine

• flunarizine

• general anesthetics (medications used to put people to sleep before surgery)

• glycopyrrolate

• grapefruit juice

• herbal medications (e.g., garlic, ginger, ginseng)

• HIV non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, etravirine)

• HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, ritonavir)

• hydroxychloroquine

• ipratropium

• lemborexant

• letermovir

• linezolid

• lithium

• macrolide antibiotics (e.g., clarithromycin, erythromycin)

• magnesium sulfate

• methadone

• methylphenidate

• metoclopramide

• minocycline

• 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

• other narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol)

• olopatadine

• oxybutynin

• peginterferon alfa-2b

• pegvisomant

• perampanel

• pizotifen

• pomalidomide

• pregabalin

• protein kinase inhibitors (e.g., dabrafenib, imatinib, nilotinib)

• pramipexole

• propiverine

• prucalopride

• quinine

• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin)

• rifabutin

• rifampin

• ropinirole

• rotigotine

• scopolamine

• St. John's wort

• seizure medications (e.g., carbamazepine, gabapentin, levetiracetam, phenytoin, rufinamide, topiramate)

• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, escitalopram, fluoxetine, paroxetine, sertraline, vortioxetine)

• serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron, palonosetron)

• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)

• sodium oxybate

• sodium phosphates

• somatostatin analogues (e.g., lanreotide, octreotide, pasireotide)

• sphingosine 1-phosphate receptor (S1P) receptor inhibitors (e.g., fingolimod, ponesimod, siponimod)

• spironolactone

• stiripentol

• sulfamethoxazole

• terbinafine

• tetrabenazine

• testosterone

• tetrahydrocannabinol

• thalidomide

• tiotropium

• tizanidine

• tolterodine

• trazodone

• tricyclic antidepressants (TCAs; e.g., amitriptyline, clomipramine, imipramine)

• trihexyphenidyl

• "triptan" migraine medications (e.g., eletriptan, sumatriptan, naratriptan)

• trospium

• 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/Durela