Tramadol use

TRAMADOL DOSAGE

ULTRAM ER should not be used in patients with:

creatinine clearance less than 30 mL/min,
severe hepatic impairment (Child-Pugh Class C)

ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and DRUG ABUSE AND ADDICTION).

Adults (18 years of age and over)

Patients Currently on Tramadol Immediate-Release Products

For patients maintained on tramadol IR products, calculate the 24-hour tramadol IR dose and initiate a total daily dose of ULTRAM ER rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with ULTRAM ER, some patients maintained on tramadol IR products may not be able to convert to ULTRAM ER. Ultram ER should not be administered at a dose exceeding 300 mg per day. The concomitant use of ULTRAM ER with other tramadol products is not recommended.

Patients Not Currently on Tramadol Immediate-Release Products

For patients not currently treated with tramadol immediate-release (IR) products, ULTRAM ER should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. ULTRAM ER should not be administered at a dose exceeding 300 mg per day.

Individualization of Dose

Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of ULTRAM ER have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.

In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. ULTRAM ER should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

HOW SUPPLIED

ULTRAM ER (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms:

100 mg: Round, convex, white to off-white tablets imprinted with “100” over “ER” on one side in black ink Bottle of 30 tablets - NDC 0062-0653-30
200 mg: Round, convex, white to off-white tablets imprinted with “200” over “ER” on one side in black ink Bottle of 30 tablets - NDC 0062-0655-30
300 mg: Round, convex, white to off-white tablets imprinted with “300” over “ER” on one side in black ink Bottle of 30 tablets - NDC 0062-0657-30

Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F).

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 tramadol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tramadol or narcotic analgesics. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Although studies on birth defects have not been done in pregnant women, tramadol has not been reported to cause birth defects. In animal studies, there were drug-related birth defects observed. Studies done in animals given very high (toxic) doses resulted in lower than normal birth weights and some deaths in the fetuses and birth defects in some of the newborns. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

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.

Breast-feeding—Tramadol passes into breast milk and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

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.

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 tramadol, it is especially important that your health care provider know if you are taking any of the following:

Carbamazepine (e.g., Tegretol)—May decrease the effects of tramadol by decreasing the amount of medicine in the body

Central nervous system (CNS) depressants (medicines that cause drowsiness)—Using these medicines with tramadol may increase the chance of serious side effects or increase the risk of convulsions (seizures).
Neuroleptic drugs (antipsychotic drugs) (chlorpromazine [e.g., Thorazine], clozapine [e.g., Clozaril], haloperidol [e.g., Haldol], loxapine [e.g., Loxitane]) or

Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—The chance of convulsions (seizures) may be increased.

Other drugs that lower seizure threshold (epilepsy drugs)—May increase chances of seizures so caution is recommended

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:

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 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 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 taking tramadol .

Take this medicine only as directed. 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. Using too much of this medicine increases the chance of unwanted effects.

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 your medical doctor or dentist has directed you to take this medicine according to a regular schedule and 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—To store this medicine:

Keep out of the reach of children.
Store away from heat and direct light.
Do not store tramadol tablets in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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.

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.

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.

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

Also, 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; chest pain or discomfort; change in walking and balance; 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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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; itching of the skin; irritability; 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; troubled breathing; trouble in sleeping; weight increased or decreased

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of 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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 03/09/2006

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OVERDOSE

Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, and death.

Deaths due to overdose have been reported with abuse and misuse of tramadol, by ingesting, inhaling, or injecting the crushed tablets. Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids.

In the treatment of tramadol overdosage, primary attention should be given to the reestablishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals convulsions following the administration of toxic doses of ULTRAM ER could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.

CONTRAINDICATIONS

ULTRAM ER should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. ULTRAM ER is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. ULTRAM ER may worsen central nervous system and respiratory depression in these patients.

Tramadol is used for:

Treating moderate to moderately severe pain.

Tramadol is an analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Tramadol if:

you are allergic to any ingredient in Tramadol
you have severe diarrhea due to taking an antibiotic
you are intoxicated with alcohol, other opioids or narcotics (eg, morphine, codeine), sedatives or sleeping medicines (eg, temazepam, zolpidem), or other medicines
you are taking nefazodone, carbamazepine, or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tramadol :

Some medical conditions may interact with Tramadol . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you are allergic to codeine, a codeine-related medicine (eg, hydrocodone, dihydrocodeine, oxycodone), morphine, or a morphine-related medicine (eg, hydromorphone)
if you have a history of alcohol abuse, substance abuse, or suicidal thoughts or behaviors
if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system
if you have a history of stomach or intestinal problems, asthma or other lung or breathing problems, epilepsy, seizures, or chronic inflammation or ulceration of the bowels
if you have had recent abdominal surgery
if you have heart problems, liver problems (eg, hepatitis), kidney problems, thyroid problems, enlargement of the prostate gland, or urinary problems

Some MEDICINES MAY INTERACT with Tramadol . Tell your health care provider if you are taking any other medicines, especially any of the following:

Carbamazepine because it may decrease Tramadol 's effectiveness and increase the risk of seizures
Certain medicines for mental or mood disorders (eg, olanzapine, haloperidol), cyclobenzaprine, isoniazid, other opioid pain medicines (eg, codeine, hydrocodone), phenothiazines (eg, promethazine), sleeping medicines (eg, zolpidem), sodium oxybate (GHB), tricyclic antidepressants (amitriptyline), or weight loss medicines (eg, phentermine) because side effects, including excessive drowsiness, trouble breathing, liver problems, or seizures, may be increased
Furazolidone, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), nefazodone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or selegiline because they may cause serious and sometimes fatal reactions, including restlessness, fever, excessive sweating, confusion, twitching, and seizures
Oral anticoagulants (eg, warfarin) because the risk of its side effects, including bleeding, may be increased by Tramadol
Digoxin because the risk of its side effects, including nausea, vomiting, or slow heartbeat, may be increased by Tramadol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tramadol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tramadol :

Use Tramadol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Tramadol by mouth with or without food.
If you miss a dose of Tramadol and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tramadol .

Important safety information:

Tramadol may cause drowsiness and dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tramadol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tramadol ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Tramadol may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
Tell your doctor or dentist that you take Tramadol before you receive any medical or dental care, emergency care, or surgery.
Use Tramadol with caution in the ELDERLY; they may be more sensitive to its effects.
Tramadol should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Tramadol has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tramadol while you are pregnant. Tramadol is found in breast milk. Do not breast-feed while taking Tramadol .

When used for long periods of time or at high doses, Tramadol may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tramadol stops working well. Do not take more than prescribed.

Some people who use Tramadol for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you suddenly stop taking Tramadol , you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Tramadol :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; increased sweating; loss of appetite; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; fainting; fever; incoordination; muscle stiffness or tremor; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin; cold clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizures; stomach or intestinal pain.

Proper storage of Tramadol :

Store Tramadol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tramadol out of the reach of children and away from pets.

General information:

If you have any questions about Tramadol , please talk with your doctor, pharmacist, or other health care provider.
Tramadol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tramadol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.