MEDICATION GUIDE

Tramadol hydrochloride ( tram' a dol hye" droe klor' ide) Tablets, USP, CIV

Tramadol hydrochloride tablets are:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about tramadol hydrochloride tablets:

• Get emergency help right away if you take too much tramadol hydrochloride tablets (overdose) . When you first start taking tramadol hydrochloride tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking tramadol hydrochloride tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your tramadol hydrochloride tablets. They could die from taking it. Store tramadol hydrochloride tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away tramadol hydrochloride tablets is against the law.

Important Information Guiding Use in Pediatric Patients:

• Do not give tramadol hydrochloride tablets to a child younger than 12 years of age.
• Do not give tramadol hydrochloride tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving tramadol hydrochloride tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
• Do not take tramadol hydrochloride tablets if you have:
• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or have narrowing of the stomach or intestines.
• An allergy to tramadol.

Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.

Before taking tramadol hydrochloride tablets, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.
• liver, kidney, thyroid problems
• pancreas or gallbladder problems

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of tramadol hydrochloride tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life- threatening if not recognized and treated.
• breastfeeding . Not recommended; it may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tramadol hydrochloride tablets with certain other medicines can cause serious side effects that could lead to death.

When taking tramadol hydrochloride tablets:

Do not change your dose. Take tramadol hydrochloride tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief. Do not take more than your prescribed dose and do not take more than 8 tablets per day. If you miss a dose, take your next dose at your usual time. Call your healthcare provider if the dose you are taking does not control your pain. If you have been taking tramadol hydrochloride tablets regularly, do not stop taking tramadol hydrochloride tablets without talking to your healthcare provider. After you stop taking tramadol hydrochloride tablets, ask your pharmacist how to dispose of any unused tablets.

While taking tramadol hydrochloride tablets DO NOT:

Drive or operate heavy machinery, until you know how tramadol hydrochloride tablets affects you. Tramadol hydrochloride tablets can make you sleepy, dizzy, or lightheaded. Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with tramadol hydrochloride tablets may cause you to overdose and die.

The possible side effects of tramadol hydrochloride tablets:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
• These are not all the possible side effects of tramadol hydrochloride tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient's pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

Additional Information for Patients

• If you are taking opioid pain medicines long-term, do not suddenly stop taking your medicine without first discussing with your health care professional a plan for gradually getting off the medicine. Stopping opioids abruptly or reducing the dose too quickly can result in serious problems, including withdrawal symptoms, uncontrolled pain, and thoughts of suicide.
• Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal such as:
  • Restlessness
  • Eye tearing
  • Runny nose
  • Yawning
  • Sweating
  • Chills
  • Muscle aches
• Other symptoms also may develop, including:
  • Irritability
  • Anxiety
  • Difficulty sleeping
  • Backache
  • Joint pain
  • Weakness
  • Abdominal cramp
  • Loss of appetite
  • Nausea
  • Vomiting
  • Diarrhea
  • Increased blood pressure or heart rate
  • Increased breathing rate
• Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide. Also contact them if you have any questions or concerns.

Additional Information for Health Care Professionals

• Do not abruptly discontinue opioid analgesics in patients physically dependent on opioids. Counsel patients not to discontinue their opioids without first discussing the need for a gradual tapering regimen.
• Abrupt or inappropriately rapid discontinuation of opioids in patients who are physically dependent has been associated with serious withdrawal symptoms, uncontrolled pain, and suicide. Abrupt or rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
• It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic.
• When deciding how to discontinue or decrease therapy in an opioid-dependent patient, consider a variety of factors, including the dose of the opioid analgesic the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
• There are no standard opioid tapering schedules that are suitable for all patients. A patient-specific plan should be used to taper the dose of the opioid gradually.
• In general, for patients who are physically dependent on opioids, taper by an increment of no more than 10 percent to 25 percent every 2 to 4 weeks. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper.
• If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to pause the taper for a period of time, raise the opioid analgesic to the previous dose, and then once stable, proceed with a more gradual taper.
• When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic.
• Patients who have been taking opioids for shorter time periods may tolerate a more rapid taper.
• Frequent follow-up with patients is important. Reassess the patient regularly to manage pain and withdrawal symptoms that emerge. Common withdrawal symptoms include:
  • Restlessness
  • Lacrimation
  • Rhinorrhea
  • Yawning
  • Perspiration
  • Chills
  • Myalgia
  • Mydriasis
• Other symptoms also may develop, including:
  • Irritability
  • Anxiety
  • Insomnia
  • Backache
  • Joint pain
  • Weakness
  • Abdominal cramps
  • Anorexia
  • Nausea
  • Vomiting
  • Diarrhea
  • Increased blood pressure or heart rate
  • Increased respiratory rate
• Patients should also be monitored for suicidal thoughts, use of other substances, or any changes in mood.
• When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer him/her for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches such as medication assisted treatment of opioid use disorder. Complex patients with comorbid pain and substance use disorders may benefit from referral to a specialist.

This Medication Guide has been approved by the U.S. Food and Drug Administration.