Pronunciation:

TRA-ma-dole

Brand Names:

• Ultram
• Ultram ER

Dosage Forms:

• Tablet, Extended Release
• Tablet

Classifications:

Therapeutic—

Analgesic

Chemical—

Opioid

Uses of This Medicine:

Tramadol is used to relieve pain, including pain after surgery. The long-acting tablets are used for chronic ongoing pain. . The effects of tramadol are similar to those of narcotic analgesics. Although tramadol is not classified as a narcotic, it may become habit-forming, causing mental or physical dependence.

Tramadol 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—

There is no specific information on the relationship of age to the effects of tramadol tablets in patients less than 16 years of age, and tramadol extended-release tablets in patients less than 18 years of age .

Older adults—

Studies in older adults show that tramadol stays in the body a little longer than it does in younger adults. Your doctor will consider this when deciding on your doses.

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.

Other medicines—

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.

• Rasagiline
• Selegiline

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:

• Abdominal or stomach conditions (severe)—Tramadol may hide signs of other medical conditions.

• Addiction problems or
• Suicidal—Tramadol should not be used.

• Alcohol or drug abuse, or history of—May increase the serious side effects of tramadol.

• Epilepsy or
• History of seizures
• Increased risk for seizures caused by alcohol and drug withdrawal, brain or spinal cord infections, or head trauma—Risk of seizures may be increased.

• Head injury—Tramadol can hide signs of other medical conditions.

• Kidney disease or
• Liver disease—The chance of side effects may be increased. Your doctor will consider this when deciding on your doses.

Proper Use of This Medicine:

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 medical doctor or dentist.

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 (long-acting tablets):
    • Adults—100 mg once a day. Your doctor may increase your dose as needed. You should not take more than 300 mg per day.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.

• For pain:
  • For oral dosage form (tablets):
    • Adults—One-half to two 50-milligram (mg) tablets every four to six hours as needed, no more than 8 tablets in a day Your healthcare professional may want you to break the tablets in half for the first dose and increase your dose by half-tablets, up to a maximum of 2 full tablets per dose. By starting at a lower dose and slowly increasing the amount of medicine you take, this will help you get used to the medicine gradually. Your healthcare professional may want you to take 2 tablets for the first dose if you are having severe pain. This helps the medicine start working a little faster.
    • Children up to 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.

Precautions While Using This Medicine:

This medicine will add to the effects of alcohol and other CNS depressants (medicine that causes drowsiness). 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; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. 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 are not alert.

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 medical doctor or dentist. 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 medical 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) and pinpoint pupils of the eyes.

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.

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

Change in consciousness

chest pain or discomfort

convulsions (seizures)

decreased awareness or responsiveness

difficulty in breathing

dizziness or fainting

lack of muscle tone

lightheadedness

loss of consciousness

pinpointed pupils of the eyes

severe sleepiness

shortness of breath

slow or irregular heartbeat

unusual tiredness

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

Less common or rare

Abdominal fullness

abnormal or decreased touch sensation

blisters under the skin

bloating

blood in 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 pain

heart rate increased

indigestion

irregular heartbeat

loss of memory

numbness and tingling of face, fingers, or toes

numbness, tingling, pain, or weakness in hands or feet

pain in arms, legs, or lower back, especially pain in calves and/or heels upon exertion

pain or discomfort in arms, jaw, back or neck

pains in 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 hands or feet

trouble performing routine tasks

weak or absent pulses in legs

yellow eyes or skin

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

dizziness

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

unusual tiredness or weakness

vomiting

weakness

Less common or rare

Abnormal dreams

appetite decreased

back pain

bladder pain

blistering, crusting, irritation, itching, or reddening of skin

bloody or cloudy urine

body aches or pain

change in hearing

clamminess

cold flu-like symptoms

confusion

cough producing mucus

cracked, dry, scaly skin

decreased interest in sexual intercourse

difficult, burning, or painful urination

difficulty breathing

difficulty in 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, warmth on 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 limb

pain or tenderness around eyes and cheekbones

pain, swelling, or redness in joints

skin discoloration

swelling

swelling of hands, ankles, feet, or lower legs

tightness of chest

trouble in holding or releasing urine

trouble in 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:

Anxiety

body aches

diarrhea

fast heartbeat

fever, runny nose, or sneezing

gooseflesh

high blood pressure

increased sweating

increased yawning

loss of appetite

nausea or vomiting

nervousness, restlessness or irritability

shivering or trembling

stomach cramps

trouble in sleeping

unusually large pupils

weakness

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