Ultram

Ultram was a pain medicine similar to an opioid. It acted in the central nervous system (CNS) to relieve pain.

Ultram was used to treat moderate to severe pain in adults, when other pain treatments, such as non-opioid pain medicines, did not treat their pain well enough or were not tolerated.

The extended-release form of tramadol (Ultram ER) was for around-the-clock treatment of pain. Ultram ER was not for use on an as-needed basis for pain.

The brand Ultram has been discontinued, but generic tramadol tablets and extended-release tablets are still available. This information is retained for educational purposes only and may not be up to date.

Take Ultram exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Ultram in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share Ultram with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Stop taking all other opioid medications when you start taking Ultram.

Ultram can be taken with or without food, but take it the same way each time.

Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.

Never crush or break an Ultram tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

You may have withdrawal symptoms if you stop using suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover Ultram. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

You should not take Ultram if you have severe breathing problems, a blockage in your stomach or intestines, or if you have recently used alcohol, sedatives, tranquilizers, narcotic medication, or an MAO inhibitor (isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others).

Ultram can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking Ultram during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use tramadol with alcohol, or with other drugs that cause drowsiness or slow your breathing.

You should not take Ultram if you are allergic to tramadol, or if you have:

• severe asthma or breathing problems;
• a stomach or bowel obstruction (including paralytic ileus);
• if you have recently used alcohol, sedatives, tranquilizers, or narcotic medications; or
• if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine).

Ultram should not be given to a child younger than 12 years old.

Do not give Ultram to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Seizures have occurred in some people taking Ultram. Your seizure risk may be higher if you have ever had:

• a head injury, epilepsy or other seizure disorder;
• drug or alcohol addiction; or
• a metabolic disorder.

To make sure Ultram is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• liver or kidney disease;
• urination problems;
• problems with your gallbladder, pancreas, or thyroid;
• a stomach disorder; or
• mental illness, or suicide attempt.

If you use tramadol during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Breastfeeding is not recommended while taking tramadol. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction to Ultram (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Tramadol can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• a light-headed feeling, like you might pass out;
• seizure (convulsions); or
• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Ultram side effects may include:

• constipation, nausea, vomiting, stomach pain;
• dizziness, drowsiness, tiredness;
• headache; or
• itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Pain:

Adults (17 years or older): 50 to 100 mg orally every 4 to 6 hours as needed for pain-For patients not requiring rapid onset of analgesic effect: 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 daysMaximum dose: 400 mg per day.

Usual Adult Dose for Chronic Pain:

Extended-Release (ER):18 years or older (tramadol-naive): 100 mg orally once a day-Individually titrate in 100 mg increments every 5 days to an effective dose that minimizes adverse reactions-Maximum Dose: 300 mg/dayFor patients CURRENTLY receiving Immediate-Release (IR) Ultram:Initial Dose: Calculate 24-hour IR requirement and initiate with a total daily ER dose rounded down to the next lowest 100 mg increment orally once a dayConversion from OTHER Opioids: Discontinue all other around the clock opioid drugs prior to initiating therapy-Initial dose: 100 mg ER orally once a day-Individually titrate in 100 mg increments every 5 days to an effective dose that minimizes adverse reactions-Maximum Dose: 300 mg/day.

Usual Geriatric Dose for Pain:

Dose selection should be cautious generally starting at the low end of the dose rangeOver 75 years:Maximum dose of Immediate-release: 300 mg per day.

Usual Geriatric Dose for Chronic Pain:

Dose selection should be cautious generally starting at the low end of the dose rangeOver 75 years:Maximum dose of Immediate-release: 300 mg per day.

Usual Pediatric Dose for Pain:

Ultram is not recommended for use in pediatric patients17 years or older: See Adult Dose.

Since Ultram is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone or nalmefene (medicines to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone or nalmefene if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Many other drugs can be dangerous when used with Ultram. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
• other opioid medicines;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• sleep medicine, muscle relaxers, or other drugs that make you drowsy; or
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Other drugs may interact with tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Many other drugs can be dangerous when used with Ultram. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
• other opioid medicines;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• sleep medicine, muscle relaxers, or other drugs that make you drowsy;
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.
• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Many other drugs may interact with tramadol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.