Author: James Anderson

Ultram Tramadol Hcl: Side Effects, Uses, Dosage, Interactions, Warnings

Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. Inaddition, abuse of opioids can occur in the absence of true addiction. ULTRAM contains tramadol, a substance with a high potential for abuse similar to other opioids. ULTRAM can be abusedand is subject to misuse, addiction, and criminal diversion [see WARNINGS AND PRECAUTIONS]. The following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with ULTRAM exists.

1. Extended-release drugs are released into the body slowly over time.
2. For this reason, breastfeeding is notrecommended during treatment with ULTRAM [see Use In Specific Populations].
3. A class of drugs is a group of medications that work in a similar way.
4. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.

Inform patients that ULTRAM may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS AND PRECAUTIONS]. Advise caregivers that ULTRAM is contraindicated in children younger than 12 years of age and in children younger than 18years of age following tonsillectomy and/or adenoidectomy. Advise caregivers of children ages 12 to 18 years of age receiving ULTRAM to monitor for signs of respiratory depression [see WARNINGS AND PRECAUTIONS]. The tramadol in ULTRAM may cause spasm of the sphincter of Oddi.

Generic Name(S): tramadol

Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they mayhave altered pharmacokinetics or altered clearance compared to younger, healthier patients [see WARNINGS AND PRECAUTIONS]. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use In Specific Populations]. Abuse and addiction are separate and distinct from physical dependence and tolerance.

This is not a complete list of side effects and others may occur. Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders. Since Ultram is used for pain, you are not likely to miss a dose. Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Ultram can slow or stop your breathing, and may be habit-forming.

Neonatal opioid withdrawal syndrome can present as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms and signs of neonatal opioid withdrawal syndromeand manage accordingly [see WARNINGS AND PRECAUTIONS]. Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with ULTRAM.

RxList does not provide medical advice, diagnosis or treatment. The safety and effectiveness of ULTRAM in pediatric patients have not been established. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours post dose was 100mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1. ULTRAM is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see CONTRAINDICATIONS]. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of ULTRAM in patients with impaired consciousness or coma.

How should I store Ultram?

This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. This includes prescription and over-the-counter medicines, vitamins, and herbal products. 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. Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times.

The concomitant use of ULTRAM with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in tramadol plasma levels and a decrease in the levels of the active metabolite, M1. A decrease in M1 exposure inpatients who have developed physical dependence to tramadol, may result in signs and symptoms of opioid withdrawal andreduced efficacy. The effect of increased tramadol levels may be an increased risk for serious adverse events including seizures and serotonin syndrome. Tramadol and its metabolite, O-desmethyltramadol (M1), are present in human milk. There is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production.

The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent opioid agonists. The minimum effective analgesic concentration of tramadol for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance [see DOSAGE AND ADMINISTRATION]. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. Forclinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist.

The use of ULTRAM in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated. This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see DRUG INTERACTIONS]. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion.

Lifestyle changes to help reduce obstructive sleep apnea

Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. See also Warning section.This medication is used to help relieve moderate to moderately severe pain. Tramadol belongs to a class of drugs known as opioid analgesics.

Before taking this medicine

Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis. Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with ULTRAM [see WARNINGS AND PRECAUTIONS, Patient Counseling Information]. Other drugs may interact with tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. The combination of tramadol with other substances places people at higher risk of suffering seizures.

Dizziness or drowsiness can cause falls, accidents, or severe injuries. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Avoid driving or hazardous activity until you know how this medicine will affect you. Never crush or break an Ultram tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. Stop taking all other opioid medications when you start taking Ultram. Never share Ultram with another person, especially someone with a history of drug addiction.