TRAM-a-dol

Commonly used brand name(s)

In the U.S.

• ConZip
• FusePaq Synapryn
• Rybix ODT
• Ryzolt
• Ultram
• Ultram ER

Available Dosage Forms:

• Tablet, Extended Release
• Suspension
• Capsule, Extended Release
• Tablet, Disintegrating
• Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For tramadol

Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The extended-release or long-acting tablets are used for chronic ongoing pain.

Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine.

tramadol is available only with your doctor's prescription.

Before Using tramadol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tramadol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tramadol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Rybix™ ODT, Ryzolt™, and Ultram® tablets in children younger than 16 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Ultram® ER extended-release tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tramadol in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., constipation; lightheadedness, dizziness, or fainting; stomach upset; weakness) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving tramadol.

Pregnancy

Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tramadol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tramadol with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone
• Rasagiline
• Selegiline

Using tramadol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetophenazine
• Amitriptyline
• Amoxapine
• Amphetamine
• Bromperidol
• Brompheniramine
• Bupropion
• Buspirone
• Carbamazepine
• Carbinoxamine
• Ceritinib
• Chlorpheniramine
• Chlorpromazine
• Chlorprothixene
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clorgyline
• Clovoxamine
• Cobicistat
• Cocaine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darunavir
• Desipramine
• Desvenlafaxine
• Dextroamphetamine
• Dextromethorphan
• Dolasetron
• Donepezil
• Dothiepin
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Eslicarbazepine Acetate
• Ethopropazine
• Femoxetine
• Fentanyl
• Fluconazole
• Fluoxetine
• Flupenthixol
• Fluphenazine
• Fluvoxamine
• Granisetron
• Haloperidol
• Hydrocodone
• Hydroxytryptophan
• Idelalisib
• Imipramine
• Iproniazid
• Isocarboxazid
• Ketamine
• Levomilnacipran
• Linezolid
• Lithium
• Lofepramine
• Lorcaserin
• Meclizine
• Melperone
• Meperidine
• Mesoridazine
• Methadone
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Moclobemide
• Molindone
• Morphine
• Morphine Sulfate Liposome
• Naratriptan
• Nefazodone
• Nilotinib
• Nortriptyline
• Olanzapine
• Oxycodone
• Oxymorphone
• Palonosetron
• Pargyline
• Paroxetine
• Peginterferon Alfa-2b
• Penfluridol
• Pentazocine
• Perphenazine
• Phenelzine
• Pimozide
• Piperaquine
• Pipotiazine
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Propoxyphene
• Protriptyline
• Remoxipride
• Risperidone
• Rizatriptan
• Sertraline
• Sibutramine
• Siltuximab
• St John's Wort
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Thiethylperazine
• Thioridazine
• Thiothixene
• Tranylcypromine
• Trazodone
• Trifluoperazine
• Triflupromazine
• Trimeprazine
• Trimipramine
• Valproic Acid
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone
• Zolmitriptan
• Zuclopenthixol

Using tramadol with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin
• Ondansetron
• Perampanel
• Quinidine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tramadol with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use tramadol, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of tramadol. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• CNS depression or
• Depression, history of or
• Drug abuse, history of or
• Head injury or
• Hormonal problems or
• Increased pressure in the head or
• Infections of the central nervous system (CNS) or
• Mental illness, history of or
• Phenylketone allergy, history of or
• Respiratory depression (hypoventilation or slow breathing) or
• Seizures or epilepsy, history of or
• Stomach problems, severe—Use with caution. The chance of serious side effects may be increased.

• Breathing or lung problems (e.g., asthma, hypercapnia), severe—Should not be used in patients with this condition.

• Kidney disease or
• Liver disease (including cirrhosis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

Proper Use of tramadol

Take tramadol only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you think that tramadol is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your doctor.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break, crush, or chew it. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the extended-release tablets whole with liquids. Do not break, crush, or chew it.

Dosing

The dose of tramadol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tramadol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For chronic pain:
  • For oral dosage form (extended-release tablets):
    • Adults—At first, 100 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and teenagers 16 years of age and older—At first, 50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

• For moderate to severe pain:
  • For oral dosage form (disintegrating tablets):
    • Adults and teenagers 16 years of age and older—At first, 50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and teenagers 16 years of age and older—At first, 25 milligrams (mg) per day, taken every morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of tramadol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using tramadol

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

tramadol will add to the effects of alcohol and other CNS depressants (medicine that makes you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor or dentist before taking any of these medicines while you are using tramadol.

Make sure your doctor knows about all the other medicines you are using. tramadol may increase your risk for seizures. (convulsions) and may cause a serious condition called serotonin syndrome.

tramadol can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

tramadol may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; swelling of your hands, face, or mouth; or chest pain while you are using tramadol.

tramadol may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to tramadol before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for awhile. However, if nausea or vomiting continues, check with your doctor. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking tramadol. Taking tramadol together with medicines that are used during surgery or dental or emergency treatments may cause increased side effects.

If you think you or someone else may have taken an overdose of tramadol, get emergency help at once. Signs of an overdose include convulsions (seizures); difficult or troubled breathing; irregular, fast or slow, or shallow breathing; pale or blue lips, fingernails, or skin; pinpoint pupils of the eyes, or shortness of breath.

Do not stop suddenly taking tramadol without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.

tramadol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Abdominal or stomach fullness
• abnormal or decreased touch sensation
• blisters under the skin
• bloating
• blood in the urine
• blood pressure increased
• blurred vision
• change in walking and balance
• chest pain or discomfort
• chills
• convulsions (seizures)
• darkened urine
• difficult urination
• dizziness or lightheadedness when getting up from a lying or sitting position
• fainting
• fast heartbeat
• frequent urge to urinate
• gaseous abdominal or stomach pain
• heart rate increased
• indigestion
• irregular heartbeat
• loss of memory
• numbness and tingling of the face, fingers, or toes
• numbness, tingling, pain, or weakness in the hands or feet
• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
• pain or discomfort in the arms, jaw, back, or neck
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale bluish-colored or cold hands or feet
• recurrent fever
• seeing, hearing, or feeling things that are not there
• severe cramping
• severe nausea
• severe redness, swelling, and itching of the skin
• shortness of breath
• sweats
• trembling and shaking of the hands or feet
• trouble performing routine tasks
• weak or absent pulses in the legs
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness
• decreased awareness or responsiveness
• difficulty with breathing
• lack of muscle tone
• lightheadedness
• loss of consciousness
• pinpointed pupils of the eyes
• severe sleepiness
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• agitation
• anxiety
• constipation
• cough
• diarrhea
• discouragement
• drowsiness
• dry mouth
• feeling of warmth
• feeling sad or empty
• feeling unusually cold
• fever
• general feeling of discomfort or illness
• headache
• heartburn
• irritability
• itching of the skin
• joint pain
• loss of appetite
• loss of interest or pleasure
• loss of strength or weakness
• muscle aches and pains
• nausea
• nervousness
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• runny nose
• shivering
• skin rash
• sleepiness or unusual drowsiness
• sore throat
• stuffy nose
• sweating
• tiredness
• trouble concentrating
• unusual feeling of excitement
• weakness

Less common or rare

• Abnormal dreams
• appetite decreased
• back pain
• bladder pain
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody or cloudy urine
• body aches or pain
• change in hearing
• clamminess
• cold flu-like symptoms
• confusion
• cough producing mucus
• cracked, dry, or scaly skin
• decreased interest in sexual intercourse
• difficult, burning, or painful urination
• difficulty with moving
• disturbance in attention
• ear congestion
• ear drainage
• earache or pain in ear
• excessive gas
• fall
• false or unusual sense of well-being
• feeling hot
• feeling jittery
• flushing or redness of the skin
• general feeling of bodily discomfort
• goosebumps
• headache, severe and throbbing
• hoarseness
• hot flashes
• inability to have or keep an erection
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• joint sprain
• joint stiffness
• joint swelling
• loss in sexual ability, desire, drive, or performance
• loss of voice
• lower back or side pain
• muscle aching or cramping
• muscle injury
• muscle pain or stiffness
• muscle spasms or twitching
• nasal congestion
• neck pain
• night sweats
• pain
• pain in the limbs
• pain or tenderness around the eyes and cheekbones
• pain, swelling, or redness in the joints
• skin discoloration
• swelling
• swelling of the hands, ankles, feet, or lower legs
• tightness of the chest
• trouble in holding or releasing urine
• trouble with sleeping
• troubled breathing
• weight increased or decreased

After you stop using tramadol, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Gooseflesh
• high blood pressure
• increased sweating
• increased yawning
• shivering or trembling
• unusually large pupils

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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Usual Adult Dose for Pain

Immediate-release: 50 to 100 mg orally every 4 to 6 hours as needed for pain
Maximum dose: 400 mg per day

Comments:
-Dose should be individualized; for patients not requiring rapid onset of analgesic effect, the tolerability may be increased by initiating at the lowest possible dose and titrating upward.

Use: For the management of moderate to moderately severe pain.

Usual Adult Dose for Chronic Pain

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, tolerability can be improved by initiating slowly

Immediate-Release:
-Initial dose: 25 mg orally once a day; titrate in 25 mg increments every 3 days to reach a dose of 25 mg four times a day; thereafter increase by 50 mg as tolerated every 3 days to reach a dose of 50 mg four times a day
-Maintenance dose: After titration, 50 to 100 mg orally as needed for pain every 4 to 6 hours
-Maximum dose: 400 mg per day

Extended-Release:
-Initial dose (tramadol-naive): 100 mg orally once a day; titrate upwards in 100 mg increments every 5 days as needed and as tolerated.
-Maximum Dose: 300 mg orally per day

-Initial Dose for patients CURRENTLY receiving immediate-release tramadol: Calculate the 24-hour immediate-release requirement and initiate with a total daily dose rounded down to the next lowest 100 mg increment given orally once a day
-Individualize dose as needed and as tolerated
-Maximum Dose: 300 mg per day

Comments:
-Due to limitations of dose selection with extended-release formulations, some patients may not be able to convert from the immediate-release to the extended-release.
-The extended-release products should not be used with other tramadol products and should not be taken more often than once a day.

Use: For the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Usual Geriatric Dose for Pain

Immediate-Release:
-65 years or older: Start at the low end of the dosing range
-75 years or older: Maximum dose: 300 mg per day in divided doses

Comments:
-Dose should be individualized; initiating at the lowest possible dose and titrating upward may result in increased tolerability and fewer drug discontinuations

Use: For the management of moderate to moderately severe pain.

Usual Geriatric Dose for Chronic Pain

Immediate-Release:
-Age 65 years or older: Start at the low end of the dosing range
-Age 75 years or older: Maximum dose is 300 mg per day

Extended-release:
-Age 65 years or older: Use caution; start at the low end of the dosing range
-Age 75 years or older: Use even greater caution

Comments:
-Due to limitations of dose selection with extended-release formulations, some patients may not be able to convert from the immediate-release to the extended-release.
-The extended-release product should not be used with other tramadol products and should not be taken more often than once daily.

Use: For the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Usual Pediatric Dose for Pain

17 years or older:
Immediate-release: 50 to 100 mg orally every 4 to 6 hours as needed for pain
Maximum dose: 400 mg per day

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, tolerability can be improved by initiating slowly:
Immediate-Release:
-Initial dose: 25 mg orally once daily; titrate in 25 mg increments every 3 days to reach a dose of 25 mg four times a day; thereafter increase by 50 mg as tolerated every 3 days to reach a dose of 50 mg four times a day
-Maintenance dose: After titration, 50 to 100 mg orally as needed for pain every 4 to 6 hours
-Maximum dose: 400 mg per day

Comments:
-Dose should be individualized; starting at the lowest possible dose and titrating upward may result in increased tolerability and fewer drug discontinuations.

Use: For the management of moderate to moderately severe pain.

Renal Dose Adjustments

Immediate-release:
-CrCl less than 30 mL/min: Dosing interval should be increased to every 12 hours; maximum dose should not exceed 200 mg per day

Extended-release:
-CrCl less than 30 mL/min: Use is not recommended.

Liver Dose Adjustments

Immediate-release:
-Patients with cirrhosis: 50 mg orally every 12 hours

Extended-release:
-Severe hepatic impairment (Child-Pugh Class C): Use is not recommended

Trade Name: Ryzolt
Do not use in patients with any degree of hepatic impairment.

Dose Adjustments

-Withdrawal symptoms may occur if discontinued abruptly

Precautions

Immediate-release: Safety and efficacy have not been established in patients younger than 17 years.
Extended-release: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Hemodialysis patients can receive their regular dose on dialysis days since only 7% of dose is removed.
Peritoneal dialysis: No data available

Other Comments

OTHER COMMENTS:
Administration advice:
-May be taken with or without food
Extended release capsules and tablets:
-Swallow whole; do not crush, chew, split, or dissolve

General:
-Seizures and/serotonin syndrome may occur when used concomitantly with serotonergic agents (SSRIs, SNRIs, and triptans) or with drugs that significantly reduce the metabolic clearance of tramadol.
-Taking this drug in excessive doses, either alone or in combination with other CNS depressants, including alcohol, is a major cause of drug-related deaths.
-This drug should not be used for longer than therapeutically necessary; evaluate continued use at regular intervals.

Monitoring:
-Monitor regularly for the development of addiction, abuse, and misuse.

Patient advice:
-Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Patients should be instructed not to exceed the recommended dose, take with alcohol, or take with other products that may cause CNS depression without first speaking with their healthcare provider.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.

Tramadol Side Effects

• Tablets (immediate release): 50 mg.
• Tablets (extended release): 100, 200, and 300 mg.
• Capsule (extended release): 100, 200, 300 mg.