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Tramadol (Oral route)

Pronunciation:

TRAM-a-dol

Brand Names:

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

Dosage Forms:

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

Classifications:

Therapeutic—

Analgesic

Chemical—

Opioid

Uses of This Medicine:

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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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.

Older adults—

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 CategoryExplanation
All TrimestersCAnimal 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.

Other 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 this medicine, 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 this medicine 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 this medicine 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
  • Desipramine
  • Desvenlafaxine
  • Dextroamphetamine
  • Dextromethorphan
  • Dolasetron
  • 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
  • Nortriptyline
  • Olanzapine
  • Oxycodone
  • Oxymorphone
  • Palonosetron
  • Pargyline
  • Paroxetine
  • 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
  • Zolmitriptan
  • Zuclopenthixol

Using this medicine 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
  • Perampanel
  • Quinidine
  • Warfarin

Other interactions—

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 this medicine 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 this medicine, 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 this medicine. 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 This Medicine:

Take this medicine 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 this medicine 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 this medicine 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 this medicine. 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 this medicine, 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 This Medicine:

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.

This medicine 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 this medicine.

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

This medicine 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.

This medicine 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 this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine 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 this medicine. 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 this medicine 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.

Side Effects of This Medicine:

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 this medicine, 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.


Last Updated: 11/4/2014

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